Kornimate/medical-research-clean huggingface dataset:
assessment of the prevalence of ttr amyloid neuropathy in a population of patients with neuropathy of unknown aetiology

Conditions: Familial Amyloid Neuropathy; Transthyretin Amyloidosis

Summary: familial amyloid neuropathy due to transthyretin gene mutations (ttr-fap) is a rare autosomal dominant inherited disease resulting in the abnormal multi-system deposition of amyloid proteins. these deposits produce a multi-organ disease. ap is usually fatal 10 to 15 years after onset of symptoms if untreated. the prevalence of the disease remains still poorly understood and usually the search for this pathology is done in a third line of investigation. so the average time to diagnosis is extremely long, from 12 to 24 month. now that the investigators have etiological treatment ( famidis (vyndaqel®) and diflunisal (dolobid)) of this disease, it is essential to be able to detect fap patients as early as possible. with this study, investigator decided to test for ttr mutation all patients presented with neuropathy of unknown etiology at the first line of investigation. the goal of this study is to evaluate the prevalence of fap-ttr among neuropathy and defined the best strategy to test this population for ttr mutations.


Eligibility criteria:
inclusion criteria: * adult patient (male and female) aged not more than 90 years old * patients with neuropathy identified by edx exam or small fibre neuropathy identified from a skin biopsy. * patients who have undergone the minimal assessment for neuropathy as defined by the has (french national health authority): biological analysis (fasting glucose, cbc, liver and renal functions, crp, pituitary tsh) * patients belonging to the social security system * patient who gave written informed consent non-inclusion criteria patients under legal supervision or guardianship patients with a confirmed documented diagnosis of the cause of neuropathy patients with evidence of charcot marie tooth neuropathy: very slowly progressive course, pes cavus. patients who have already been investigated for a ttr mutation pregnant women minors

Keywords: transthyretin mutation
continuous emg measurements in children with asthma during sleep

Conditions: Asthma in Children; Electromyography; Sleep-Disordered Breathing

Summary: the objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.


Eligibility criteria:
inclusion criteria: * paediatrician diagnosed asthma or bronchial hyperresponsiveness * aged 4 till 18 * admitted to the paediatric ward of medisch spectrum twente exclusion criteria: * admittance to the icu * patient has icd or pacemaker * parents and/or patient cannot understand or speak dutch * does not fit in one of the available hexoskin shirts
recovery sleepers: a pilot study of a sleep health intervention for college students in recovery

Conditions: Sleep; Addiction

Summary: the purpose of this research study is to examine how to improve sleep in college students in recovery from substance use disorder(s). this study is a pilot test of an experimental program called recovery sleepers (rs) to explore its feasibility and how well it works to improve sleep, wellbeing, and cravings.


Eligibility criteria:
inclusion criteria: * more than 18 years of age * enrolled (full- or part-time) at a college or university * have struggled with substance addiction in the past * more than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs * have an internet-enabled device with audio capabilities. exclusion criteria: * younger than 18 years of age * not enrolled at vcu * have not struggled with substance addiction in the past * have not had at least 3 months of self-reported continuous abstinence from alcohol and all * illegal drugs * in active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months) * unable to communicate in english both orally and in writing * do not have an internet-enabled device with audio capabilities.
clozapine plasma levels and the relationship to the genetic polymorphism in shizophrenic patients

Conditions: Schizophrenia

Summary: approximately 30-60% of all schizophrenia patients who fail to respond to typical antipsychotics may respond to clozapine. clozapine has long been considered the "gold standard" within the atypical neuroleptic spectrum, backed by years of clinical experience and research, but uncertainties remain in some aspects of this drug. one such question is the link between dose, blood levels and patient clinical response. the clozapine therapeutic plasma levels range between 250 - 450 ng/ml creating difficulties in using these results in routine clinical practice. approximately 30% - 51% of "treatment-resistant schizophrenia" patients do not fully respond to clozapine, a poorly understood phenomenon. factors relevant to clozapine-resistance include co-morbidity, drug misuse, poor adherence, inadequate duration of treatment and inadequate dose/plasma-levels. pharmacogenetic factors such as different polymorphisms in involved genes may play a role. pharmacodynamic and genetic data appear important in determining the clinical response to clozapine. clozapine-treated patients possessing different 3a4 polymorphisms, may respond differently as compared to other patients having normal 3a4 alleles. recently, the cyp2d6 has also been involved in this drug metabolic pathway. population pharmacokinetics of clozapine evaluated with the nonparametric maximum likelihood method. this pharmacogenetic explanation/hypothesis may explain clozapine- resistance in schizophrenics. the high variability in plasma levels requires a large study in order to be able to determine correlation between clinical efficacy and plasma levels and genotyping. a preliminary study will enable power analysis and adequate determination of sample size.


Eligibility criteria:
inclusion criteria: * dsm-iv criteria for schizophrenia (american psychiatric association 2000) * all clozapine mono-therapy patients (only 300 mg/day) who respond to treatment and achieved symptomatic remission (45, 46) and were stable for at least 3 month will be included * no change in benzodiazepine medications for the trial period. * legal ability and willingness to sign an informed consent form for participation in the study. exclusion criteria: * evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, cushing's disease, thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance- induced, as judged by a study physician. * unstable medical illness or neurologic illness (seizures, cva); breast, uterine, or ovarian cancer. * pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen. \[female patients will also have a pregnancy test.\].

Keywords: clozapine schizophrenia remissia polymorphism
effects of the odour of the very preterm infant on maternal psychobiology

Conditions: Premature Birth

Summary: at birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. the sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the chu of nice lead to a separation between mother and child, with a reduction in sensory interactions. the immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother. the hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. in the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.


Eligibility criteria:
inclusion criteria: * immediate postpartum mothers of newborns with a term of \< 33 weeks (32 weeks + 6 days) * primiparous mothers * mothers with vaginal delivery, without oxytocin infusion after delivery * mothers planning to breastfeed, with no maternal contraindication to breastfeeding exclusion criteria: * substance abuse: active smoking at the time of delivery, alcohol, drugs * use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics * active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning * chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn * language barrier not allowing proper explanation of the protocol and responses to questionnaires
dry needling and manipulation vs. mobilization, exercise and interferential electrotherapy for shoulder impingement (subacromial pain syndrome)

Conditions: Subacromial Pain Syndrome

Summary: the purpose of this research is to compare two different approaches for treating patients with shoulder impingement (subacromial pain syndrome): electric dry needling and spinal manipulation versus impairment-based mobilization, exercise, and interferential electrotherapy. physical therapists commonly use all of these techniques to treat shoulder impingement (subacromial pain syndrome). this study is attempting to find out if one treatment strategy is more effective than the other.

patients with shoulder impingement (subacromial pain syndrome) will be randomized to receive 2 treatment sessions per week for up to 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and spinal manipulation or (2) impairment-based mobilization, exercise and interferential electrotherapy.

Eligibility criteria:
inclusion criteria: 1. adult over the age of 18 years old that is able to read, write and speak english 2. primary complaint of anterolateral shoulder pain lasting longer than 6 weeks 3. one or more of the following special tests: 1. positive neer impingement test-i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized. 2. positive hawkins-kennedy test-i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion 4. pain with one or more of the following active movements and resisted isometric tests 1. pain with active shoulder elevation 2. pain with resisted shoulder external rotation at 90 deg of abduction 3. pain with resisted shoulder abduction in empty can test positon - i.e. 90 deg of shoulder abduction, 30 deg of horizontal adduction (i.e. in scapular plane) and full internal rotation (i.e. thumb down) exclusion criteria: 1. report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, ra, osteoporosis, severe vascular disease, malignancy, etc. 2. history of shoulder injection within the past 3 months. 3. history of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery. 4. isolated acromioclavicular joint pathology (i.e. the only location of symptoms is localized specifically with one finger directly over the acromioclavicular joint and nowhere else, and reproduced only with acromioclavicular palpation by the examiner.) 5. evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine 6. full-thickness rotator cuff tears (evidenced by mri and/or positive lag signs) 7. baseline spadi of not less than 20% 8. history of breast cancer on involved side. 9. prior treatments (eg. acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months. 10. pending litigation for an injury. 11. psychiatric disorders or cognitively impaired 12. pregnancy
multidrug resistance in newly diagnosed tb patient

Conditions: Tuberculosis

Summary: tuberculosis (tb) is one of the major public health threats, competing with the human immunodeficiency virus (hiv) as the cause of death due to infectious diseases worldwide. multi drug-resistant mycobacterium tuberculosis (mdr-tb) is one of the leading causes of death in the world. the resource constraints make it difficult to diagnose and monitor the cases of mdr-tb. genexpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe mdr multidrug-resistant tuberculosis (mdr-tb), caused by mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs according to current world health organization and the international union against tuberculosis and lung disease estimates, the median prevalence of mdr-tb has been 1.1% in newly diagnosed patients. the proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-tb treatment. xdr tuberculosis is caused by a strain of mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines mdr tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin the main causes of the spread of resistant tb are weak medical systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. although patients harboring mdr and xdr strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

to detect the prevalence of mdr t.b. using xpert mtb/rif ultra and xdr assay in newly diagnosed cases

Eligibility criteria:
inclusion criteria * newly diagnosed tuberculosis patient * diagnosed by direct smear for sputum or body fluid exclusion criteria: \* previously treated patient
acrysof® iq restor® +3.0 d multifocal toric intraocular lens (iol) clinical study in japan

Conditions: Cataracts

Summary: the purpose of this study is to evaluate safety and effectiveness of acrysof® iq restor® +3.0 d multifocal toric iol models snd1t3, snd1t4, snd1t5, and snd1t6 when implanted to replace the natural lens in japanese cataract patients.

eligible participants completed a preoperative examination of both eyes, implantation of the iol at the operative visit for each eye, and up to 8 postoperative visits: day 1-2, day 7-14, and day 30-60 after each implantation, and day 120-180 and day 330-420 after second eye implantation. the second implantation occurred within 30 days of the first.the primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. if both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Eligibility criteria:
inclusion criteria: * sign informed consent; * diagnosed with bilateral cataracts; * planned cataract removal by phacoemulsification; * potential postoperative visual acuity of 0.6 decimal or better in both eyes; * preoperative astigmatism ≥ 0.75 diopter; * clear intraocular media other than cataract in study eyes; * calculated lens power and astigmatism within the available range; * pupil size greater than or equal to 6 mm after dilation; * able to undergo second eye surgery within 30 days of the first eye surgery; * other protocol-defined inclusion criteria may apply. exclusion criteria: * irregular corneal aberration as demonstrated by corneal topography; * any inflammation or edema (swelling) of the cornea; * diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal; * diabetic retinopathy; * previous refractive surgery, retinal detachment, corneal transplant; * glaucoma; * pregnant, nursing, or suspected of being pregnant; * currently participating in another investigational drug or device study; * other protocol-defined exclusion criteria may apply.

Keywords: cataracts intraocular lens multifocal toric astigmatism presbyopia
a study on the management and outcome of patients with systemic al amyloidosis in europe

Conditions: AL Amyloidosis

Summary: this is a retrospective, observational, multicenter study to collect real-world evidence (rwe) data on systemic al-amy patients in europe. data from paper/electronic medical records and/or electronic databases from key reference centers in europe will be used. data will either be entered by the site staff in the electronic case report form (ecrf) or, where feasible, transferred directly, always in accordance to local regulations.

the lack of regulatory approved treatment options for al amyloidosis (al-amy) justifies the need to understand the current treatment practice and outcomes of this disease. there is a need for objective real-world evidence (rwe) that reflects how treatments are initiated, combined and sequenced, and how their relative effectiveness and safety profiles emerge outside a clinical trial setting. therefore, the aim is to generate rwe on systemic al-amy patients in europe, including patient characteristics, resource use, treatments and associated patient outcomes.

Eligibility criteria:
inclusion criteria: * age\>18 years * confirmed diagnosis of al-amy and symptomatic organ involvement. * initiated first line treatment for al-amy in the period 2004-2018. * patients who have signed a participation agreement/icf allowing data collection and source data verification in accordance with local requirements. the inclusion of deceased subjects in the study is permitted under the condition that consent waiver has been granted by the scientific committee and/or administrative board of the participating sites and/or any applicable regulatory body, as per local regulations, to either implement a hospital informed consent form (icf) already in place or provide written approval of this study-specific waiver. in the occasion that waiver of consent is not granted deceased subjects will not be enrolled in the study. exclusion criteria: * patients under the age of 18 will not be considered eligible for this study
the impact of proton pump inhibitors on the fecal microbiome

Conditions: Healthy; Clostridium Difficile Infection

Summary: the investigators hypothesis is that daily use of a proton pump inhibitor (ppi) is associated with significant alterations in the healthy fecal microbiome that are similar to those seen in persons with an initial episode of clostridium difficile infection (cdi).


Eligibility criteria:
table 1. inclusion criteria for healthy volunteers: 1. healthy individuals without chronic gastrointestinal problems or using antisecretory medications. table 2. inclusion criteria for clostridium difficile infection subjects: 1. newly diagnosed first episode of cdi prior to being treated. table 3. exclusion criteria for healthy subjects: 1. prior gastrointestinal surgery that has altered the anatomy of the esophagus, stomach, or small/large intestine including appendectomy and cholecystectomy. 2. chronic daily use of any medications that could alter gastrointestinal secretory or motor function (see table 2). 3. gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus). 4. females of childbearing age who are not practicing at least one form of birth control at least one month prior to starting the ppi or are pregnant or lactating (a pregnancy test will be performed on female subjects prior to ppi use). 5. significant untreated psychiatric disease. table 4. prohibited medications: 1. antibiotics within 2 months of the stool sample collection. 2. probiotics (e.g., florastor, align, flora-q, vsl#3, lactobacillus, bifidobacterium) within 2 weeks of the stool sample collection. 3. fiber supplements (e.g., metamucil, citrucel, benefiber), unless maintained on a stable dose for the last 3 months. 4. chronic use of medications that alter gastric ph: proton pump inhibitors (e.g., omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole) and histamine2 receptor antagonists (e.g., cimetidine, famotidine, ranitidine). 5. chronic use of medications that affect gastrointestinal motility and/or transit including prokinetic agents (e.g., metoclopramide (reglan), tegaserod (zelnorm), domperidone (motilium), erythromycin), narcotic analgesic agents (e.g., methadone, fentanyl, oxycodone, codeine, morphine, hydromorphone), laxatives including mineral oil, anticholinergic agents (e.g., bentyl, levsin), and antidiarrheal agents (e.g., kaopectate (donnagel), pepto-bismol (bismuth subsalicylate), imodium (loperamide), lomotil (atropine with diphenoxylate), codeine, tincture of opium).

Keywords: gut microbiota proton pump inhibitor clostridium difficile infection fecal microbiome single episode of cdi
etanercept (enbrel) special investigation (regulatory post marketing commitment plan)

Conditions: Arthritis; Rheumatoid

Summary: this survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

implemented as a special investigation by central registration system

Eligibility criteria:
inclusion criteria: * patients need to be administered etanercept in order to be enrolled in the survey * patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration. exclusion criteria: * patients who have been administered etanercept 50mg once a week * patients who have been administered etanercept 25mg once a week