Kornimate/medical-research-clean huggingface dataset:
biobrace® augmentation in anterior cruciate ligament reconstruction procedures

Conditions: ACL Tears

Summary: this research study will evaluate mid-term clinical safety and performance outcomes of the biobrace® reinforced implant when used to augment a tissue graft during anterior cruciate ligament (acl) reconstruction.

this is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (aclr) procedures where the tissue graft is augmented with biobrace®. subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.

Eligibility criteria:
inclusion criteria: 1. underwent acl reconstruction with a tissue graft augmented with biobrace® within the past 24 months from study start date or scheduled to undergo acl reconstruction with a tissue graft augmented with biobrace®. 2. between 14 and 70 years old at the time of surgery. 3. can understand the content of the subject information / informed consent form (icf) for the prospective portion of the study. 4. is willing and able to participate in the prospective data collection protocol and comply with the required data collection. 5. if the subject has already undergone aclr within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively: 1. international knee documentation committee (ikdc) 2. knee injury and osteoarthritis outcome score junior (koos, jr.) 3. patient-reported outcomes measurement information system (promis-10) 4. tegner activity scale (tas) 5. anterior cruciate ligament - return to sport after injury (acl-rsi) 6. positive diagnostic imaging by mri at baseline indicating an acl tear exclusion criteria: 1. has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study. 2. is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study. 3. underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn mcl is treated non-operatively). 4. females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.

Keywords: acl reconstruction biobrace augmentation
assessment of functional and symptom outcomes for survivors of paranasal sinus, nasopharyngeal and skull base tumors

Conditions: Tumors

Summary: to learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer

objectives: * to estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors. * to estimate the prevalence of health promotion behaviors during skull base tumor survivorship * to identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors. * to develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (pros) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors. * to assess the utility and limitations of pros in evaluating functional impairments and symptom burden in skull base patients.

Eligibility criteria:
inclusion criteria: 1. previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or md anderson pathology report. 2. age ≥ 18 years 3. plan to obtain the majority of treatment at mdacc including surgery and radiotherapy 4. ability to understand and willingness to sign written informed consent exclusion criteria: 1. history of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy. 2. existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment. 3. previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
long term follow up of subjects exposed to genetically engineered t cell receptors

Conditions: Solid and Hematological Malignancies

Summary: subjects who previously took part in an adaptimmune study and received genetically changed t cells (including but not limited to mage-a10ᶜ⁷⁹⁶t and mage-a4ᶜ¹º³²t) are asked to take part in this long term follow-up study. subjects will be asked to join this study once they complete the parent interventional study. the purpose of this study is to find out if the genetically changed t cells that subjects received in the parent study have any long-term side effects. no additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. for a period of 15 years starting from last administration of the genetically changed t cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed t cells.

this is a non-therapeutic, multi-center, long-term follow-up (ltfu) study of subjects who have received lentivirus-mediated genetically engineered t cell receptors in an adaptimmune sponsored clinical trial. the study is designed in accordance with fda and ema guidance on gene therapy trials. the study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in adaptimmune clinical studies. the study will include subjects who have received various t cell receptors including but not limited to mage-a10ᶜ⁷⁹⁶t and mage-a4ᶜ¹º³²t. subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (rcl), and chemistry and hematology laboratory assessments. subjects will be followed for survival.

Eligibility criteria:
inclusion criteria: * subjects must have received t cell receptor therapy in an adaptimmune clinical study * subjects who have provided informed consent prior to their study participation exclusion criteria: * not applicable

Keywords: cell therapy t cell therapy spear t cell immuno-oncology metastatic t cell receptor long term follow up genetically engineered
effects of benfotiamine on intraepidermal nerve fiber density (ienfd)

Conditions: Diabetic Neuropathies

Summary: the aim of the present study is to assess before, as well as 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes mellitus and diabetic sensomotoric neuropathy.


Eligibility criteria:
inclusion criteria: * have type 1 or type 2 diabetes mellitus based on the disease diagnostic criteria (who) classification on ongoing insulin or/and oral antidiabetic therapy with a stable regimen for the previous 3 months * male or female subjects aged between 18 and 75 years, inclusive * have an hba1c level ≤ 9.5% without optimizing potential * mtcns (modified toronto clinical neuropathy score) ≥ (above or equal to) 6) or (a score on the mnsi (michigan neuropathy screening instrument)questionnaire of ≥4 or a score on the mnsi examination ≥2.5) * medical history without major pathology (with the exception of type 2 diabetes) as judged by the investigator, especially no major peripheral artery disease. * body mass index (bmi) between 25 and 45kg/m2, both inclusive exclusion criteria: * subjects with secondary forms of diabetes such as due to pancreatitis. * current or previous treatment (less than 6 months) with benfotiamine, b-vitamins, vitamin b complex, alpha lipoic acid or actovegin. * have any contraindications, known allergy, or hypersensitivity to benfotiamine. * have any contraindications, known allergy, or hypersensitivity to local anesthetics. * neuropathy by other origin than diabetes. * other severe pain that might impair the assessment of neuropathic pain. * treatment with more than one of following: tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, anticonvulsants, class i antiarrhythmics with na-channel inhibition (mexiletine, flecainid, propafenon and others) or neuroleptics in patients receiving these drugs for neuropathic pain.

Keywords: diabetes neuropathy
active drug surveillance program of ferriprox use

Conditions: Transfusional Iron Overload

Summary: observational, open label, prospective, multi-center, post-marketing drug surveillance program.

a post-marketing, drug surveillance program evaluating the use, monitoring, benefits and adverse effects of ferriprox under clinical conditions in newly treated patients.

Eligibility criteria:
main inclusion criteria: * patients who started ferriprox therapy less than one month or are to initiate ferriprox therapy at the time of enrolment into the program. main exclusion criteria: * patients treated with ferriprox for more than one month prior to enrolment.

Keywords: ferriprox deferiprone dfp l1
acupoint application with yanqing zhitong ointment for chronic non-specific low back pain

Conditions: Non-specific Low Back Pain

Summary: this is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. the patients will be randomly assigned either to yanqing zhitong ointment acupoint application group (treatment group) or the acupuncture group (control group) in a 1:1 ratio.

this is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. the main acupoints are ashi points, shenshu(bl23), guanyuanshu(bl26). the primary outcome measure is the change of mcgill pain questionnaire (mpq) before and after treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosed with non-specific low back pain 2. aage from 18 to 65 3. vas between 4 and 7 4. no other treatment in the past 3 months 5. no other simultaneous relevant treatment 6. voluntarily joining this study with informed consents exclusion criteria: 1. pregnant women 2. with skin ulcers or contusion wounds 3. past history of severe allergy to transdermal preparations 4. complicated with serious diseases
ultrasound use for difficult lumbar punctures in pediatric oncology patients

Conditions: Leukemia

Summary: hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. when lp is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of lp may require fluoroscopy-guidance with associated radiation exposure. this investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. the investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.


Eligibility criteria:
inclusion criteria: * all patients undergoing lp as per heme-onc clinic who have been deemed to be difficult lp placements. exclusion criteria: * patients having concomitant procedures (bone marrow bx, etc.)
passive enhanced safety surveillance of stamaril® vaccine in korea

Conditions: Yellow Fever

Summary: this is a passive enhance safety surveillance (ess) of stamaril® vaccine in korea. the objective is to collect suspected related adverse events following vaccination with stamaril® in routine practice.

this ess replaces the routing post-marketing surveillance required after product approval in korea.

Eligibility criteria:
vaccination with stamaril® vaccine in routine practice in korea

Keywords: yellow fever stamaril®
investigating the effects of sensory input orthotics in disorders of posture and movement

Conditions: Cerebral Palsy

Summary: the purpose of this research study is to use tools for measuring function and movement in pediatric populations to measure the impact of input orthotic interventions in children with cerebral palsy.

sensory processing begets movement. in persons with disorders of posture and movement due to cerebral palsy, an impaired ability to integrate multiple senses including pressure from ground, limb proprioception, and vestibular inputs leads to a movement pattern that is coarse, spastic and inefficient. in the pediatric rehab clinic spastic movement disorders have been treated with flexible, molded orthotics for the foot and ankle (afo) to enhance sensation of ground reaction forces, and flexible elastomeric compression garments to enhance body and limb proprioception. while the investigators observed substantial improvements in gait quality and postural stability using sensory input orthotics, these clinical observations have not been objectively quantified. the goal is to use validated tools for measuring function and movement in pediatric populations in order to gather data on the value of sensory input orthotic interventions in children with cerebral palsy. under the term, sensory input orthotic, the following items are included which will be used in this study. 1) a flexible, thin polypropylene shell ankle-foot orthotic designed according to hylton et al. journal of p\&o 1989. 2) wearable elastomeric compression garments manufactured by spio or from the boston brace dmo garment line. 3) a vibrating anklet that provides subsensory vibrational stimulation to the leg, manufactured by accelera.

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy * ages 6 months to 21 years * no prior prescription of sensory input ankle-foot orthotics * clinical diagnosis of abnormal gait and mobility exclusion criteria: • joint contracture that severely limits function such as ability to passively open the hand, extend the arm at the elbow or to stand with feet flat on the ground or knees in an extended position.
development of small airway disease questionnaire

Conditions: Asthma

Summary: the aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to fef50% to discriminate between asthmatic patients with and without small airways disease.

inflammation of the small airways contributes to the severity of the disease and affects the quality of life of patients with asthma. however, the exact role and relevance of small airways disease in asthma is still unclear. this is partly due to the difficulty of measuring small airways pathology with a sensitive and specific parameter. the most commonly used variable as an indicator of small airway obstruction is the fef50%. currently, it is not known which clinical symptoms are associated with small airways disease and how a patient will perceive small airway abnormalities. this knowledge is important to assess small airways disease in patients with asthma and adjust therapy to improve quality of life.the primary purpose of this study is to develop a questionnaire for patients with asthma with and without small airways disease for general and specialist practice.

Eligibility criteria:
inclusion criteria: * a doctor diagnosis of asthma * age: ≥ 18 and ≤ 75 years * an fef50% value that is included in either the lowest or the highest 25th percentile. (percentiles based on the total asthma patient group present from asthma/copd service) exclusion criteria: * recent exacerbation of asthma (\<2 months) or upper respiration tract infection (\<2 weeks) * severe airway obstruction at baseline, fev1pred\< 50% or \< 1.2l * diagnosis of copd or another pulmonary disease * pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator). * restriction, defined as fvc \ 0.7

Keywords: asthma small airways disease questionnaire
clinical study of stalevo in the treatment of early parkinson's disease

Conditions: Parkinson Disease

Summary: the main goal of pd research is to develop disease-modifying drugs to delay or prevent the underlying neurodegenerative process. levodopa, as the gold standard for pd treatment, is associated with the occurrence of motor complications. many previous studies have confirmed that stalevo can reduce the side effects of levodopa alone. moreover, the effects of stalevo on the treatment of pd patients have been extensively studied, but the efficacy of stalevo in early pd patients has been less studied. therefore, it is necessary to further study the treatment of early pd with stalevo, and observe whether increasing the number of medication can reduce the occurrence of dyskinesis. the research results will help to deepen the understanding of stalevo in the treatment of early pd and its clinical efficacy.


Eligibility criteria:
inclusion criteria: * volunteer to participate in the trial and sign the informed consent * the enrolled patients were 30 to 70 years old, diagnosed as primary parkinson's disease according to the 2015 mds parkinson's disease diagnostic criteria, h-y grade \<3, and the onset time was less than 5 years * patients can take stable dopamine receptor agonists or other anti-parkinson's disease drugs (drugs have not been adjusted in the past 4 weeks), and have not used amantadine or entacapone within 1 year. exclusion criteria: * atypical parkinsonism and secondary parkinsonism
idh in diabetic haemodialysis patients and association with dialytic age

Conditions: Intra-dialytic Hypotension

Summary: intradialytic hypotension (idh ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension

intradialytic hypotension (idh ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.intradialytic hypotension is a decrease in systolic bp by ≥20 mm hg or a decrease in mean arterial pressure of 10 mm hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to the national kidney foundation.intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. it is associated with poor long-term outcomes. patients with intradialytic hypotension show increased morbidity and mortality.the etiology of intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. the main causes intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,impaired vasoconstriction induced by dysregulation of autonomic nervous system. diabetes mellitus is the most common cause of chronic renal failure .diabetic patients are more prone to cardiovascular diseases than non-diabetics .although diabetes is in relation with hypertension ,it is associated with autonomic neuropathy which contribute to intradialytic hypotension . recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.

Eligibility criteria:
inclusion criteria: all haemodialysed end stage kidney disease patients of the haemodialysis unit in assiut health insurance hospital exclusion criteria: * 1-advanced heart failure 2-clinical instability requiring hospital admission. 3-history of alcohol or substance abuse 4-previous history of psychotic disorders
hpg80 (circulating progastrin) as a blood biomarker for high-grade glial tumors

Conditions: Glial Cell Tumors

Summary: proglio is a french mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hpg80 (circulating progastrin).


Eligibility criteria:
inclusion criteria: * female or male 18 years of age or older. * patients with a high grade primary glial tumor (astrocytoma grade 3; glioblastoma; anaplastic oligodendroglioma) * patients scheduled to begin radiation and/or chemotherapy. * able to give informed consent to participate in the research. * enrolled in a social security plan or beneficiary of such a plan. exclusion criteria: * patient under guardianship or curatorship * psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial. * refusal to participate. * pregnant or breastfeeding woman.

Keywords: glial cell tumors progastrin hpg80
predictive value of piiinp urinary for the development of chronic renal failure in patients with cystic fibrosis after lung transplantation (muco-irc)

Conditions: Lung Transplantation; Cystic Fibrosis; Renal Failure

Summary: chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. their medical history prior to the lung transplantation has already exposed to kidney damage. post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses. the measurement of renal function of patients by formula to estimate gfr in routine use is unreliable and other markers seem indispensable. the purpose of this study is to evaluate two markers, piiinp (procollagen iii aminoterminal peptide n), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease.


Eligibility criteria:
inclusion criteria: * bearer of lung transplantation (single or double lung, with or without associated cardiac transplantation) * suffering from cystic fibrosis * aged 18 and over * with at least 6 months of transplantation * having a glomerular filtration rate measured by technical radionuclide \> 30 ml / min * having given written consent to the study patients meeting these criteria will enter in the "organic" in the study (determination of piiinp urinary) exclusion criteria: * lung transplantation for a condition other than cystic fibrosis * patient refused follow-up * patients with advanced liver disease (conditions that interfere with the assay of piiinp) * minor * pregnant women, * major trust, benefiting from a regime of legal protection (guardianship, trusteeship, safeguarding justice. * patient unable to grant informed consent.

Keywords: cf