Kornimate/medical-research-clean huggingface dataset:
comparison of conventional dose regimen and new dose regimen of pregabalin

Conditions: Pain, Neuropathic

Summary: the purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.

pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. a way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. the proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. however, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods

Eligibility criteria:
inclusion criteria: * pain score nrs ≥3 patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy) * adult patients aged 19 to 85 years * patients who pre-agreed to the study exclusion criteria: * patients complaining of severe pain (nrs ≥ 8) * creatinine clearance of \<30 ml / min, the liver was more than 3 times normal * patients complaining of dizziness, patients with definite orthostatic hypotension * pregnant or lactating patients * patients who previously experienced side effects after administration pregabalin.
efficacy and safety of bnp105 in the treatment of recurrent aphthous stomatitis

Conditions: Aphthous Stomatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of bnp105 in the treatment of recurrent aphthous stomatitis.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * age greater than or equal to 12 years; * one minor recurrent aphthous stomatitis with onset of symptoms within 48 hours; * moderate to severe baseline pain, with vas ≥ 60 mm (eva scale 0-100 mm). exclusion criteria: * any clinical findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participants diagnosed with: behcet's disease, rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, reiter's syndrome, crohn's disease, ulcerative colitis); * participants with diseases that affect healing (e.g. diabetes); * immunocompromised participants; * participants with aphthous herpetiform ulceration or major aphthous ulceration; * participants using medication to treat oral ulcerations (systemic or local); * participants who used analgesics or anti-inflammatory drugs in the 6 hours prior to the beginning of the study; * participants who used systemic antibiotics in the 2 weeks prior to the beginning of the study; * participants using medications that can confuse pain assessment (psychotropics, antidepressants and sedative-hypnotics), except when on a stable dose for at least 30 days prior to the screening visit, and the dose cannot be changed during the clinical trial; * participants with current smoking habits. * participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception; * known hypersensitivity to the formula components used during the clinical trial; * participants with current or medical history of cancer in the last 5 years; * participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.

Keywords: aphthous stomatitis
factors associated with quality of life in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to investigate the relationship between quality of life and factors that may affect quality of life (pain, stiffness, functional status and depression) in knee osteoarthritis.

participants aged between 40-65 years, willing to participate in the study and diagnosed with knee osteoarthritis will be included in the study. necessary demographic information will be obtained with the prepared data form. numerical rating scale (nrs), western ontario and mcmaster universities osteoarthritis index (womac osteoarthritis index), knee injury and osteoarthritis outcome score (koos), lower extremity functional scale (lefs), beck depression scale, short form - 36 (quality of life questionnaire) will be used for evaluation. the data obtained in the study will be entered into spss 17 package programme (greasley, 2007). minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. the data of the study will be analysed using analysis of moment structures (amos) statistical package programmes. in all analyses, p\<0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being diagnosed with knee osteoarthritis * in studies between the ages of 40 and 65 exclusion criteria: * other orthopaedic surgery in the lower extremity * cognitive impairment at a level that prevents understanding and answering the questionnaire * presence of neurological disease
assessment of surgical correction of patello-femoral instability by eos 3d kinematics

Conditions: Patellofemoral Dislocation

Summary: assessment of surgical correction of patello-femoral instability by eos 3d kinematics

patella instability induces repetitive patella dislocation, which impairs day-to-day life. surgery is commonly used to stabilise the patella during knee flexion. however proofs of efficacy of surgery on patello-femoral kinematics have not yet been found. analysis of the patello-femoral kinematics is crucial to understand, assess et correct the patella instability. the investigators have developed, validated and published a 3d analysis method from biplanar x-rays (eos 3d imaging). our aim in this study is to assess the correction of the patello-femoral kinematics after surgery using the eos 3d imaging method.

Eligibility criteria:
inclusion criteria: * age above 15 years and 3 months (minimal age to be allowed for adult orthopedic surgery in the hospital) * patients with patello-femoral instability (at least one patella dislocation) * patients with corrective surgery planned * patients must be covered by public health insurance * signed informed consent form by the patient or by the parents or legal guardian of the patient (if patient is under 18) exclusion criteria: * previous existing surgery for patella instability on the same knee * previous existing surgery on the extensor apparatus of the knee * female patients with pregnancy * patients deprived of liberty by administrative or court order

Keywords: patella eos 3d imaging
demineralized bone matrix in opening wedge osteotomy for hallux valgus deformity

Conditions: Hallux Valgus

Summary: this study evaluates the demineralized bone matrix in "hallux valgus".

demineralized bone matrix use for filling in the space removed bone in open wedge osteotomy and correction. the purpose this study is to test therapeutic benefits of demineralized bone matrix. investigator will recruit thirty patients. total evaluation period will be 12 months. in this period, investigator will examine correction rate, fusion rate, functional test, adverse event.

Eligibility criteria:
inclusion criteria: * (1) the patient ranging in age from 20 to 75 years * (2) has to be operated over 5mm osteotomy for correcting hallux valgus. * (3) the patients who were able to comply with the research protocol. exclusion criteria: * (1) bursitis in metatarsal bones has affected surgery. * (2) has rheumatism * (3) the patient who has clinical sign of infection on the operated site at pre-screening * (4) patient who has failure of peripheral blood circulation caused by chronic disease and neurological symptoms * (5) in the opinion of investigator, the patient is not suitable to participate in this study

Keywords: demineralized bone matrix
randomized control trial of micronized purified flavonoid fraction for post operative treatment in anal fistula surgery

Conditions: Anal Fistula

Summary: the aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

the current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. this condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy. mpff is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. more research has also shown the effects of mpff on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. since other anorectal surgery has similar complications. therefor we conducted this randomized control trial to evaluate the benefits of mpff after anal fistula surgeries.

Eligibility criteria:
inclusion criteria: * patients who undergo fistulectomy or fistulotomy are included. exclusion criteria: * emergency operation * participants who had trans-sphincteric anal fistula, extra-sphincteric anal fistula * participants accompanied by severe liver cirrhosis * participants accompanied by coagulation disorders * participants taking anticoagulant * participants taking corticosteroids as long-term medication. * participants who had colorectal cancer * participants taking analgesic drugs (morphine or others) as long-term medication * participants bed-ridden * participants who had history of human immunodeficiency virus (hiv) infection * pregnant woman

Keywords: flavnoids fistulotomy fistulectomy
treatment of latent autoimmune diabetes of the adult

Conditions: Diabetes

Summary: the purpose of the study is to clarify whether patients classified as latent autoimmune diabetes of the adult (lada) benefit from early treatment with insulin added to per oral treatment and lifestyle measures.

latent autoimmune diabetes of the adult (lada) is usually defined as a form of diabetes where the onset of diabetes takes place approximately after 30 years of age, where there is presence of beta-cell directed antibodies (mostly anti-gad) and where there is no clinical need for insulin treatment during the first 6 months after the diagnosis of diabetes. the aetiology and treatment of lada patients is much less elucidated than is the case for type 1 diabetes (dm1) and type 2 diabetes (dm2). lada constitutes about 10 % of the total diabetic population in many countries. lada is therefore more common than insulin-requiring dm1. lada patients lose beta-cell function faster than patients with dm2. residual beta-cell function in dm1 is coupled to better metabolic control with lesser degree of hyperglycemia, lesser frequency of hypoglycaemic events and lesser diabetic complications. to retain beta-cell function in lada patients is thus highly desirable. there are several strategies to retain beta cell function. one therapeutic strategy is to induce some degree of "beta cell rest" by treatment with exogenous insulin. several observations indicate that such a strategy can have beneficial effects. this is a scandinavian multicenter non-blinded clinical trial with 78 participants with newly diagnosed lada. participants will be randomized to either insulin- or per oral antidiabetic treatment. participants will be followed up for 2 years after inclusion. beta cell function and glycemic control will be monitored.

Eligibility criteria:
inclusion criteria: * diabetes diagnosed during 0-3 years before entering the study. * age \> or equal to 30 years \< or equal to 75 years * anti-gad positivity * fasting c-peptide \> or equal to 0,3 ng/ml * no need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes. * hba1c \> 15 % above the upper limit of normal exclusion criteria: * renal insufficiency (plasma creatinine \> 150 mol/l) * severe retinopathy (proliferative or pre-proliferative) * severe cardiac disease (nyha iii-iv) * chronic severe illness judged by the investigator * females of reproductive age who wish to become pregnant during the study

Keywords: latent autoimmune diabetes adults beta cell rest insulin secretion
deep venous thrombus characteristics and venous dynamics with subsequent thrombus resolution and post-thrombotic syndrome

Conditions: Deep Vein Thrombosis

Summary: the goal of this study is to examine in vivo thrombosis characteristics with ultrasound shear wave elastography (swe) and determine the relationship with thrombus resolution and postthrombotic syndrome (pts) in patients with acute proximal deep vein thrombosis (dvt).


Eligibility criteria:
inclusion criteria: * diagnosis of acute, proximal (popliteal and above) dvt with or without pulmonary embolism within 72 hours * ≥18 years old exclusion criteria * prior episode of dvt * contraindication to standard therapeutic anticoagulation

Keywords: thrombus resolution post-thrombotic syndrome
probiotics in respiratory tract infections in children

Conditions: Infections, Respiratory Tract

Summary: the purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children


Eligibility criteria:
inclusion criteria: * age 3-12 yrs * at least one episode of respiratory tract infection in the previous epidemiological season * direct telephone access available * informed consent signed exclusion criteria: * vaccination against the influenza * chronic adeno-tonsillar pathology * recurrent otitis * sinusitis * respiratory allergy * acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome * lactose intolerance * functional or organic constipation * down syndrome * congenital or acquired heart disease * cerebral palsy * any chronic hepatic, renal, metabolic, or immune system disease

Keywords: children respiratory tract infections prevention
exposures to perinatal adverse experiences: multimodal omics signature of stress vulnerability and resilience and preventive strategies

Conditions: Perinatal Depression

Summary: the study aims at identifying: 1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it. 2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk; 3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women; in order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum. women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health. blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses. saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses. clinical and psychological data will be collected from women at all timepoints.


Eligibility criteria:
inclusion criteria: * pregnant women of a singleton pregnancy * age ≥ 18 years exclusion criteria: * uterine anomalies and obstetric complications * comorbidity with severe or chronic diseases * substance abuse * language barrier
fast track in elective neurosurgery: the role of low propofol bis-nol guided general anaesthesia for full, early and safe awakening

Conditions: Supratentorial Brain Tumor Surgery

Summary: to evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.

the project will have a total duration of 24 months and will mainly consist of a data collection phase (months 1-24) and a data analysis and results publication phase (months 15-24). preoperative clinical and socio-demographic data will be collected from patients' medical records. psychological variables will be administered to the patient before elective neurosurgical surgery. bis-guided general anesthesia will be induced by administering sedative and analgesic drugs to the effector site ce (effect site) by target-controlled infusion (tci). propofol and remifentanil will be titrated to maintain blood pressure, body temperature, pco2 and sao2 in a normal range and bis values between 40 and 60. pharmacological data will be relevant at the end of the intervention from the drug infusion pumps. the recovery room multidisciplinary team will assess the quality of awakening following the awakening chart (figure 1). this assessment involves dichotomous scoring (yes/no; correct/incorrect) of specific items. to assess the recovery of consciousness, during the pre-extubation phase, simple requests/questions will be asked of the patient: show tongue; show two fingers; give phone number; state place; identify what day is today; report date of birth; notify residence; perform simple multiplication (e.g., 4x5). the following variables will be collected during the periestubation phase: cough, blood pressure ± 20% of baseline, chills, nrs \> 3, rass \ 0. an abbreviated version of the stai questionnaire will also be administered to the patient to assess anxiety on awakening. awakening is considered good and optimal only if a score of 13 is achieved.

Eligibility criteria:
inclusion criteria: * patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled: * age greater than or equal to 18 years exclusion criteria: * psychiatric illness in history and/or taking psychotropic drugs * glasgow coma score (gcs) \< 15 * presence of overt cognitive decline or speech disorders * patients younger than 18 years of age * intraoperative hypothermia (\< 36°) * intraoperative hypotension (map \< 20% of baseline)

Keywords: general anaesthesia bis bispectral index nol nocipection level neuroanesthesia target colled infusion tci craniectomy awakening eras fast track propofol remifentanil pain nociception rass
impact of telemonitoring in the management of complex ibd in spain: m-teccu

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Telemedicine

Summary: m-teccu is a study: multicenter, randomized and open. it consists of two parallel groups to compare the efficacy of the teccu web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice.

clinical trial with an open, randomized and controlled non-inferiority medical device, in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex ibd is evaluated, in comparison with the usual follow-up in outpatient clinics. patients with complex ibd are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. the patients in the telemonitoring group (g_teccu) follow these controls through the teccu platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. on the other hand, the patients of the control group (g_control) carry out the controls according to the same schedule as g_teccu, but following the usual clinical practice.

Eligibility criteria:
inclusion criteria: * patients ≥18a * ibd (cd or uc) diagnosed according to ecco criteria * start treatment with immunosuppressants and/or biological therapies due to luminal activity * signed informed consent exclusion criteria: * pregnant women * presence of active perianal disease, ileoanal reservoir, or definitive stoma * patients with mental illness or other poorly controlled illness * patients with active cancer diagnosis * terminal patients and/or palliative care (secpal) * family members of the research team * patients without a telephone line to connect with a mobile, tablet and/or computer / inability to drive * cognitive or linguistic difficulties * patients included in another experimental study