Kornimate/medical-research-clean huggingface dataset:
ni-0401 in active crohn's disease

Conditions: Moderate to Severe Crohn's Disease

Summary: the purpose of the study is to assess the safety and tolerability of daily intravenous ni-0401 treatment, compared to matching placebo. and to assess the ability of ni-0401 to modulate the cd3 complex on t-cells.


Eligibility criteria:
main inclusion criteria: 1. men and women between 18 and 70 years of age. 2. crohn's disease activity index (cdai) between 220 and 450. 3. raised plasma crp level. 4. endoscopic inflammation. 5. crohn's disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1. main exclusion criteria 1. have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation. 2. concomitant disease: * current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis) * previous diagnosis of, or known, malignancies * severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator * active infection requiring antibiotic therapy * serum anti hcv positive, serum hbsag positive, serum anti-hiv positive * history of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute cmv or ebv, active pneumocystic carinii * history of active tuberculosis (tb) or currently undergoing treatment for tb. patients with a positive tb skin test or chest x-ray are ineligible. patients with a history of bacille calmette guerin (bcg) vaccination and a newly positive tb skin test or a chest x-ray showing fibrotic lesions consistent with previous tb are ineligible. the ppd skin test must be read between 48 and 72 hours * stool examination positive for enteric pathogens, pathogenic ova or parasites, or clostridium difficile toxin within 4 weeks prior to study day 1
cold therapy and cross-education of muscle strength

Conditions: Cerebrovascular Stroke; Muscle Weakness

Summary: the aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (nmes) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.

in this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. patients were randomly assigned to the experimental group (n=12) or the control group (n=13). nmes has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. in addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. the cold application was done on a moist towel for five minutes using a cold pack. a five-minute break was given and a further 5-minute cold application was repeated. the cold application was done simultaneously with nmes. a conventional rehabilitation program was applied to all patients by a physiotherapist. before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. for force measurements, a force transducer (fc2211-0000-0100-l compression load cell, te connectivity company, france) was used. force transducer signals were received with a data acquisition device (powerlab® data acquisition system adinstruments, oxford, uk) and evaluated offline on the computer. the measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

Eligibility criteria:
inclusion criteria: * cases with stroke duration ≥1 month * brunnstrom stage ≥4 for lower limb * unilateral stroke * ability to walk at least 10 m (fac ≥3) * cooperating with the examination and tests exclusion criteria: * cold allergy * active inflammatory, rheumatological, or infectious disease * presence of lower extremity fracture * severe spasticity (mas\> 3) in ankle dorsiflexors * peripheral nerve lesions such as polyneuropathy, radiculopathy * parent rhythm/conduction block problem in the heart * uncontrollable hypertension (maxima \>140 mmhg, minima \>90 mmhg) * have a contracture on the ankle joint * the presence of skin lesions in the application area * finding or suspected active deep vein thrombosis

Keywords: cold therapy cross-education neuromuscular electrical stimulation hemiplegia
c752 for refractory/relapsed b cell non-hodgkin lymphoma

Conditions: Lymphoma, B-Cell; CAR-T

Summary: it is a single-arm, open-label clinical study to assess the safety and efficacy of the c752 car-t cells for patients with cd19+ refractory/relapsed b cell non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * written informed consent in accordance with federal, local, and institutional guidelines, males and females ≥18 years of age at the time of consent * documented diagnosis of relapsed/refractory b-cell non-hodgkin lymphoma * have progression by least one systemic treatment and no available standard of care treatment. * at least one measurable lesion by lugano 2014 * expected survival ≥ 12 weeks * have an ecog performance status of 0 or 1 * adequate organ function * screening test indicates histopathological cd19 + if the subject received cd19-targeted therapy * women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial exclusion criteria: * treatment with any prior hsct, gene therapy product, cell therapy product ect. * central nervous system involvement * hbv/hcv * hiv infection * concurrent use of systemic steroids or immunosuppression * uncontrolled active infection * wash-out period of from the last anti-cancer treatment * active second malignancy * have not recovered from the effects of previous therapy * have psychological or physical conditions that do not permit compliance with the protocol * pregnant or nursing (lactating) women
to evaluate efficacy and safety of z-215 in erosive esophagitis

Conditions: Esophagitis, Reflux

Summary: the purpose of this study is to evaluate the efficacy and safety of z-215 (10 mg, 20 mg, 40 mg) , compared with rabeprazole sodium 10mg in patients with erosive esophagitis of grade a to d as defined by the la classification grading system.


Eligibility criteria:
inclusion criteria: * in observation period, the participant must have endoscopically confirmed erosive esophagitis of grade a to d, as defined by the la classification grading system, and the target number of participants who are clearly grade c or d is 20% (96 participants) or more of the total participants. * outpatient (including inpatient for examination) exclusion criteria: * participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, barrett's esophagus ( columnar epithelium metaplasia\>=3 cm ) or high-grade dysplasia.however, participants with schatzki's ring ( \>=20mm ) are allowed to be included. * participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating\>=3mm) within 28 days prior to observation period . participants with above disease at endoscopy during the observation period. * participants with zollinger-ellison syndrome.participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others. * participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .
effect of freezing phenomenon in patients with parkinson's disease

Conditions: Patients With Parkinson's Disease

Summary: although the literature review indicates that plantar pressure may be related to freezing, there are not enough studies examining the effect of freezing phenomenon on pedobarographic pressure distribution and gait parameters. therefore, the aim of our study is to examine the effect of freezing phenomenon on gait parameters and pedobarographic pressure distribution in patients with parkinson's disease.

individuals diagnosed with idiopathic parkinson's disease by a physician and healthy individuals with similar demographic characteristics will be included in the study. individuals will be examined in 3 groups: a group of patients with parkinson's disease with freezing phenomenon, a group of patients with parkinson's disease without freezing phenomenon, and a healthy control group.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being between stage 2-3 according to the modified hoehn-yahr staging scale * having a score of 24 or above from the standardized mini mental test exclusion criteria: * presence of an additional neurological or psychiatric disease other than parkinson's disease * presence of uncontrollable dyskinesia or motor fluctuations * presence of postural hypotension, vision problems (that cannot be compensated with the correct lens) or vestibular disorders that may affect balance * presence of cardiopulmonary diseases that may affect walking * presence of orthopedic problems and inflammatory arthritis (such as fractures, osteoporosis, osteomyelitis) that may cause limitation of movement and affect gait and evaluations
tazemetostat for the treatment of relapsed/refractory follicular lymphoma

Conditions: Relapsed/Refractory Follicular Lymphoma With EZH2

Summary: treating relapsed/refractory follicular lymphoma with tazemetostat

this is an open-label, monotherapy, phase ii study clinical study. the objective is to evaluate the efficacy, safety, and pharmacokinetics of tazemetostat in the treatment of patients with relapsed/refractory follicular lymphoma. it is planned to enroll 39 chinese patients in 2 cohorts.

Eligibility criteria:
inclusion criteria: 1. fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure; 2. age ≥18 years; 3. patients with histologically confirmed r/r fl (grades 1, 2, 3a) 4. patients must have one measurable lesion 5. life expectancy ≥ 12 weeks; 6. eastern cooperative oncology group (ecog) performance status 0 to 2 7. adequate bone marrow function, renal function and hepatic function: 8. currently human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) or cytomegalovirus (cmv) is inactive: 9. female patients of childbearing potential must agree to adopt dual contraceptive method exclusion criteria: 1. previous use of tazemetostat or other ezh2 inhibitors; 2. patients with invasion of lymphoma to the central nervous system (cns) or the pia mater; 3. previous bone marrow malignancies, 4. abnormalities associated with mds and myeloproliferative neoplasms observed by cytogenetic testing and dna sequencing;
safety study to evaluate the effects of mild and moderate renal impairment on the pharmacokinetics of abt-335 and rosuvastatin when administered concomitantly

Conditions: Dyslipidemia, Renal Insufficiency

Summary: safety study to evaluate the effects of mild and moderate renal impairment on the pharmacokinetics of abt-335 and rosuvastatin when administered concomitantly


Eligibility criteria:
inclusion criteria body mass index (bmi) 19 to 33, inclusive either normal kidney function, or mild or moderate kidney impairment exclusion criteria use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease. history of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Keywords: dyslipidemia
anomalous self-experience in first episode psychosis - a six-year follow-up study

Conditions: Schizophrenia and Disorders With Psychotic Features; Affective Disorders, Psychotic; Self Concept

Summary: the objective of this study is to explore the longitudinal course of self-disturbances (sd) in schizophrenia. the main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. the overall aim is to expand our knowledge about the role of sds in psychotic disorders. increased knowledge here will aid diagnosis and treatment. the current study is a seven year follow-up of this representative cohort, with baseline measures of sds and a comprehensive clinical and neurocognitive assessment battery.


Eligibility criteria:
inclusion criteria: * patients who participated and completed base-line part of the study, * patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use. exclusion criteria: * patients with brain injury, * patients with on going substance use, * unable to provide informed consent statement. * not able to be interviewed.
sparing of the fovea in geographic atrophy progression

Conditions: Atrophy; Geographic Atrophy; Age-related Macular Degeneration; Eye Diseases

Summary: dry age-related macular degeneration (amd) is a common cause for severe visual loss in the elderly and represents an unmet need. so far no treatment is available for geographic atrophy (ga), which represents the advanced dry form characterized by expanding areas of outer retinal atrophy with corresponding absolute scotoma. the foveal retina may be spared until late in the course of the disease, a phenomenon termed "foveal sparing". however, the disease process ultimately also involves the central retina leading to irreversible loss of central vision. while the natural history of eyes with ga has been extensively studied with regard to the entire atrophic area, morphology-function analyses for "foveal sparing" ga in particular are still missing. such data are needed for various purposes including the future use in interventional pharmacological trials aiming to slow the progression of ga and to preserve the foveal retina. in this study, different imaging modalities for accurate detection and quantification of preserved foveal retinal areas will be assessed.


Eligibility criteria:
inclusion criteria: * informed consent * the study eye must have a contiguous well-demarcated area of ga either in a complete ring around the spared fovea or in a horseshoe pattern with a total atrophy size of ≤ 7 disk areas * patient is willing to undergo ocular examination exclusion criteria: * the presence or history of cnv (choroidal neovascular membrane) in the study eye * ocular disease in the study eye that may confound assessment of the retina, other than non-exudative amd (e.g., diabetic retinopathy, uveitis) * cataract surgery or ocular surgery in the study eye within 30 days prior to the baseline visit * current or previous participation in clinical studies investigating drugs, medical devices or supplements within 30 days prior to enrolment in the study - previous or concomitant therapy to reat amd (investigational or fda approved); oral supplements of vitamins and minerals are permitted * known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion

Keywords: retina retinal pigment epithelium
whether patients with achilles tendon tears have different lipid levels than healthy people: a retrospective study

Conditions: Achilles Tendon Rupture

Summary: to explore the difference of blood lipid levels between patients with achilles tendon rupture and healthy people without achilles tendon rupture, and to provide clues for further exploration of its mechanism.

data were collected from 287 patients with achilles tendon rupture repaired by yang yuping, deputy chief physician of the institute of sports medicine of peking university third hospital from january 2017 to december 2017. a total of 10,375 subjects who underwent physical examination in the physical examination center of peking university third hospital during the same period were selected as the control group, and 9,193 subjects were selected as the control group after excluding patients without blood lipid test results, professional athletes, hypertension and diabetes patients. the general data, blood glucose, blood lipid, blood uric acid, smoking and alcohol consumption of the subjects were collected through the hospital information system. the blood glucose, blood lipid, uric acid and other data of the control group and the achilles tendon rupture group were detected, and it was concluded that the blood lipid level of the patients with achilles tendon rupture group was higher than that of the control group.

Eligibility criteria:
inclusion criteria: * rupture of achilles tendon repair surgery experience exclusion criteria: * hypertension * diabetes * professional athlete * no blood lipid test results
retrospective / prospective clinical study of acrysof® iq restor® +2.5 d multifocal toric intraocular lenses

Conditions: Cataract; Presbyopia; Corneal Astigmatism

Summary: the purpose of this study is to characterize the safety and effectiveness of the acrysof iq restor +2.5 diopter (d) multifocal toric intraocular lens (iol) in subjects at least 3 months and no more than 14 months after iol implantation.

this is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after iol implantation.

Eligibility criteria:
inclusion criteria: * must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after iol implantation with the acrysof® iq restor® +2.5 d multifocal toric iol (models sv25t2, sv25t3, sv25t4 and sv25t5); * must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol; * must complete a visit within 10 days after iol implantation; * successful capsular bag implantation with no surgical complications; * other protocol-specified inclusion criteria may apply. exclusion criteria: * iol implanted prior to the acrysof® iq restor® +2.5 d multifocal toric iol; * ocular or intraocular infection or inflammation at the time of the preoperative visit; * any ocular surgery or intraocular laser procedure at or prior to the surgical visit; * any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit; * retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit; * known history of type 1 or 2 diabetes for more than 5 years; * any ocular or systemic co-morbidity at the preoperative visit; * pregnant at the preoperative visit or at the time of postoperative visit 2; * preoperative corneal astigmatism ≤ 0.50 d; * participation in another clinical study at the preoperative visit or at the time of the final study visit; * other protocol-specified exclusion criteria may apply.

Keywords: cataract intraocular lens acrysof iq restor + 2.5 d multifocal toric iol
surgical treatment of low energy pelvic fractures in the elderly

Conditions: Fracture

Summary: since may 2010 the department of trauma, basel university hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. these patients have not received a structured follow up examination or evaluation of outcome after surgery.

functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.

Eligibility criteria:
inclusion criteria: * elderly patients (age ≥55y ears) of any ethnic / sociodemographic background * pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring) * surgical stabilisation of the pelvic ring at basel university hospital between may 2010 and december 2014 * ambulatory before surgery * informed consent for study participation by the patient or legal representatives exclusion criteria: * refusal of consent by the patient or legal representatives to participate in the study * fractures within the last 3 months before follow-up * suspicion of a pathological fracture in the context of known or unknown malignancy * symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc. * pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)

Keywords: pelvic treatment outcome
a safety and efficacy clinical study to evaluate the narrowing of the aorto-iliac arteries while using gadodiamide

Conditions: Aorto-iliac Stenosis; Arterial Occlusive Diseases

Summary: magnetic resonance angiography (mra) is an examination similar to magnetic resonance imaging (mri) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using mr. the study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. intra-arterial digital subtraction angiography (iadsa) will be used as the standard of truth.

gehc has decided not to provide this detail

Eligibility criteria:
inclusion criteria: * study subjects must be adults with confirmed or suspected aorto-iliac stenosis. * the subject must have been referred for digital subtraction angiography. exclusion criteria: * the subject has a known hypersensitivity to either conventional x-ray or gadolinium based mr contrast media including, but not restricted to, the investigational product. * the subject is lactating. * the subject is pregnant as defined by a serum or urine beta-hcg pregnancy test obtained within 24 hours before administration of the investigational product. * the subject received or is scheduled to receive mri contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. * the subject received or is scheduled to receive x-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. * the subject received an investigational product other than omniscan (gadodiamide) within 30 days prior to omniscan administration or will receive an investigational product within the follow-up period proposed for this study. * the subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months. * the subject has a serum creatinine value of \>= 3.5 mg/dl (309.4 µmol/l). * the subject has previously been included in this study. * the subject has a contra-indication for mri according to accepted clinical guidelines. * the subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.

Keywords: aorto-iliac stenosis occlusion diagnostic imaging omniscan magnetic resonance angiography contrast media