Kornimate/medical-research-clean huggingface dataset:
p4 (pregabalin for peripheral posttraumatic pain)

Conditions: Neuralgia

Summary: to evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain


Eligibility criteria:
inclusion criteria: * diagnosis of posttraumatic peripheral neuropathic pain (nep) syndrome, including post-surgical nep, nep due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event exclusion criteria: * subjects whose posttraumatic neuropathic pain is due to complex regional pain syndrome (crps, type i or type ii) * nep not due to trauma, and not peripheral pain

Keywords: phase 4, post-traumatic neuropathic pain, neuropathic pain, nep, post surgical pain, nerve injury, phantom limb pain, international
follow-up of niv at home in patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the aim of this study is to verify whether full video home polysomnography (sleep study) with nocturnal transcutaneous co2 monitoring is feasible in the follow-up of non-invasive ventilation (niv) in patients with duchenne muscular dystrophy. the researchers would like to investigate whether they could perform sufficient measurements in the home situation and see if correct decision for further treatment could be made. furthermore, the researchers will make an analysis on the minimal requirements of measurements to make a correct decision for the treatment of these patients.


Eligibility criteria:
inclusion criteria: * patients with dmd \> 18 years using niv * signing the written informed consent exclusion criteria: * /

Keywords: duchenne muscular dystrophy non-invasive ventilation feasibility home unattended full-video polysomnography transcutaneous capnography
the matrix oct substudy

Conditions: Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

Summary: residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary pci, but an initial increase in stent thrombosis has been reported. in order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of pci has been proposed. this aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (oct) at the end of primary pci and at 3-5 days follow-up. a subgroup of patients enrolled in the matrix (minimizing adverse haemmhorragic events by transradial access site and angiox study) study will be selected showing the following inclusion criteria: * patients affected by stemi undergoing primary pci with stent implantation and randomised to bivalirudin treatment, * patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-pci, * patients whose anatomy is suitable for oct evaluation.


Eligibility criteria:
inclusion criteria: * patients enrolled in the matrix (minimizing adverse haemmhorragic events by transradial access site and angiox study) study showing the following features: 1. patients affected by stemi undergoing primary pci with stent implantation and randomised to bivalirudin treatment, 2. patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-pci, 3. patients with a coronary anatomy suitable for oct evaluation. exclusion criteria: * the same criteria used in matrix (minimizing adverse haemmhorragic events by transradial access site and angiox study) study.
qlb and radical cystectomy, postoperative pain

Conditions: Postoperative Pain; Chronic Pain Post-Proceduraal; Nausea and Vomiting, Postoperative

Summary: there are ca 1000 new cases of bladder cancer in finland/year. the curative therapy for high risk bladder cancer is radical cystectomy. the golden standard is still an open surgery despite development of laparoscopic techniques. epidural analgesia is considered as most effective for the treatment of postoperative pain. however, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. it is more beneficial than other peripheral blocks, since it covers also the visceral nerves. contrary to the need of epidural catether a single shot qlb has reported to last up to 48 hours. inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain. 44 patients aging 18-85 will be recruited based on a power calculation. the primary outcome measure is the acute postoperative need for rescue analgesics. secondary outcomes are acute pain (nrs scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. the 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural. the primary outcome measure is the acute postoperative need for rescue analgesics. secondary outcomes are acute pain (nrs scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Eligibility criteria:
inclusion criteria: * patients with bladder cancer coming to the open radical cystectomy. exclusion criteria: * age under 18y or over 85y, * diabetes type 1 with complications, * no co-operation or inadequate finnish language, * persistent pain for other reason.

Keywords: bladder cancer radical cystectomy epidural analgesia quadratus lumborum block postoperative pain
comparing alkalinizing agents efficacy on stone risk in patients on a metabolically controlled diet

Conditions: Kidney Stone

Summary: the purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

kidney stones are a common medical problem, occurring in almost 10% of people in the united states1. furthermore, 50% of patients will recur within 10 years2. metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. non-surgical interventions include both dietary counselling, as well as pharmacotherapy. one of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary ph and raise the urine citrate levels. this is particularly useful as correction of very acidic urinary ph (\<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6. the most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (urocit-k) now exceeds $15/day in cost8. there have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. a pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.

Eligibility criteria:
inclusion criteria: * adults aged 18 and older. * with or without a history of stone disease. exclusion criteria: * they are unable to take any of the medications due to health reasons. * participants are pregnant or nursing. * participants are unable to adhere to the metabolic diet. * participants had a prior adverse event from one or more of the medications.
auriculotherapy treatment in fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia (fm) is the most common cause of diffuse pain in the bones and joints, and one of the most frequent causes of referral to the pain management unit. it affects mainly women; they are referred by a rheumatologist, an internal medicine physician or by their family physician. fm produces various degrees of disability and pain, and has an important impact on quality of life. sleep disorders, fatigue and cognitive dysfunctions are almost always part of the clinical presentation. the wide range of symptoms and signs, the unknown etiology, the lack of efficacy of pharmacological treatments make management of fm a very difficult task. in france the consensus includes limitation of pharmacological treatment, encouraging physical rehabilitation and referring the patients to a specialized pain clinic where multidisciplinary management will be undertaken. in our hospital the investigators favor non pharmacological therapies and propose to the fm patients to learn relaxation and self-hypnosis, physical rehabilitation and use of trans cutaneous electrical neurostimulation. auriculotherapy (at) is a complementary therapy, based on the idea that the ear is a microsystem which reflects the entire body, represented on the auricle, the outer portion of the ear. mapping of the auricle has been described, according to the fact that pathology of different organs can induce specific changes in the auricle, for example color change or sensitivity. treating specific areas, which somehow would be "connected" to the affected organ could also improve the functioning of the body or relieve pain. at uses placement of needles at points tailored to the patient's pathology. whatever the mechanisms involved, the effectiveness of atis currently supported by randomized controlled trials. it is validated by who since 1987, mapped in an international nomenclature initially proposed by nogier. the investigators regularly use at in fm patients in our pain management unit to alleviate symptoms as pain, sleep disorders, anxiety. the investigators established a clinical trial in this population to assess impact of fm (assessed with fibromyalgia impact questionnaire) following 3 months of at management (primary outcome). sleep disorder, fatigue, anxiety and depression, cognitive and physical dysfunction are also evaluated as secondary outcomes. the remnant effect of at is also evaluated, 3 month after the end of the treatment by the same tests.


Eligibility criteria:
inclusion criteria: * fibromyalgia (criteria from acr) exclusion criteria: * history or existing of inflammatory rheumatims, lupus, systemic diseases that may explain the pain syndrom * history or existing of severe psychiatric desorder * history or existing of hemophilia * with anticoagulant treatment * local counterindication to auriculotherapy * valvular prosthesis * auriculotherapy during the last 12 months * new psychotherpeutic treatment which interfer with auriculotherapy * pregnancy * breath feeding * rmi for the next 5 months

Keywords: auriculotherapy
psychometric properties mobility measures ms

Conditions: Multiple Sclerosis

Summary: current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, according to disability level. therefore, several aspects will be inquired: * was there an effect of rehabilitation * is the measure able to detect change over time? and thus the change exceed measurement error and is it clinically important (responsiveness) * does the measure assess what it claims to measure (validity) * is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects) * does the measure gives similar results under consistent test conditions on another testing day (reliability) worldwide, theoretical approaches to physical therapy and rehabilitation in multiple sclerosis often appear significantly different. since the present research protocol will be performed at different centers across european countries (and us sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels. some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).


Eligibility criteria:
inclusion criteria: * diagnosis of ms according to mcdonald criteria24, * expanded disability status scale25 (edss) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician * no relapse within the last month * no changes in disease modifying treatment and no corticoid-therapy within the last month * receive at least 10 sessions of physical therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months exclusion criteria: * other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, ...) * other neurological impairments with permanent damage (stroke, parkinson, ...) * ms-like syndromes such as neuromyelitis optica * not able to understand and execute simple instructions
air vs. cutaneous control mode for preterm infants ≤ 32 wg in incubators: impact on body growth and morbidity

Conditions: Preterm Infant; Body Temperature

Summary: previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. hypothermia can be decreased by reducing body heat losses to the environment. the investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. the secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. a software is used to calculate the body heat loss (bhl) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce bhl to zero. this software has been validated in a previous pilot study (degorre et al. 2015). this study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (atc) or skin servocontrol (ssc).


Eligibility criteria:
inclusion criteria: * preterm infant born between 25+0 and 32+0 weeks of gestation * preterm infant included in the study before 24 +/- 12 hours of life * preterm infant nursed in a closed incubator * written informed consent from his parents exclusion criteria: * newborn infant with polymalformative syndrome * life threatening events or serious heart disease

Keywords: preterm neonates incubator management body temperature relative air humidity thermoneutrality
the endocrine impact of the duodenal-jejunal bypass sleeve on type 2 diabetes - potential role of the incretin hormones

Conditions: Type 2 Diabetes; Obesity

Summary: we want to evaluate the impact of the endobarrier gastrointestinal liner (djbs) on glucose metabolism as well as gut and pancreatic hormone secretion.

duodenal-jejunal bypass sleeve (djbs) is being developed for the treatment of obesity, and initial clinical outcomes suggest that this minimally invasive endoscopic technique potentially has beneficial effects on type 2 diabetes also. however, the mechanisms behind the antidiabetic effects of the procedure remain unknown. we want to elucidate how the djbs might change postprandial secretion of gut and pancreatic hormones.

Eligibility criteria:
inclusion criteria (obese subjects with type 2 diabetes): * treatment with djbs * written informed consent * antidiabetic monotherapy/or diet * \> 18 years old * not anemic exclusion criteria (obese subjects with type 2 diabetes): * antidiabetic treatment with insulin, glp-1-agonists, dpp4-inhibitors or more than one orally administered antidiabetic drug. * anemia inclusion criteria (obese subjects without type 2 diabetes): * treatment with djbs * written informed consent * not anemic * hba1c \< 6,0% or hba1c \< 6,5% and normal glucose tolerance test and normal fasting plasma glucose (\< 6,0 mm) exclusion criteria (obese subjects without type 2 diabetes): * hba1c \> 6,5 % and/or a non-normal glucose tolerance test and/or fasting plasma glucose \> 6,0 mm

Keywords: djbs duodenal-jejunal bypass sleeve duodenal-jejunal bypass liner endobarrier obesity type 2 diabetes incretin hormones postprandial glucose metabolism
a study to investigate the effect of inhaled fluticasone propionate on the bronchial responsiveness to leukotriene d4 in asthmatics patients

Conditions: Asthma; Mild Asthma

Summary: investigate if asthmatics treated with flixotide (fp) 500 mcg bid during 14 days get reduced bronchial reactivity after inhalation of leukotriene d4. two 14 days treatment periods where patients received fp 500 mcg bid and placebo. washout at least 21 days between treatments. bronchial challenge with methacholine and leukotriene d4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.


Eligibility criteria:
inclusion: * diagnosed history of asthma * non smoker last two years * \< 5 pack years * fev1 \>70% of predicted * mild and stable asthma * only using short acting b2-agonist as rescue for the last 4 weeks * have a history of atopy. exclusion: * any significant respiratory disease, other than asthma * subjects with seasonal asthma may not be included if they are in their season * use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks * upper or lower rti within 6 weeks * evidence of any disease that in the investigators mind would affect the results of the study * participating in another study within 4 weeks * females who are pregnant, intend to be or who are lactating * methacholine pd20 \> 454mcg * negative scin prick test

Keywords: mild asthma flixotide methacholine bronchial challenge leukotriene d4
effects of dry needling on spasticity, functions, balance and independence level in patients with stroke

Conditions: Stroke; CVA (Cerebrovascular Accident)

Summary: the aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity.

the aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity. in this study, goniometric measurement, modified ashworth scale, nine hole peg test, 10 meter walking test, fullerton advanced balance scale and functional independence scale will be used for outcome measurement. the participants will be randomised into two groups; group 1 will receive ndt and group 2 will receive both ndt and dry needling therapy. both groups will be given 45 minutes of ndt, 3 sessions per week in 4 weeks period (total of 12 sessions). group 2 will also receive dry needling therapy 3 sessions per week in 4 weeks period (total of 12 sessions). dry needling will be applied on m. gastrocnemius, m.quadriceps, m.flexor carpi radialis and m.biceps brachii muscles. the application time on each muscle will be 60 seconds (sec). fast in and fast out technique will be used for dry needling therapy. all patients will be measured before treatment (t1) and after treatment (t3). an inter-measurement will be performed after the treatment session (t2) in addition to t1 and t3 measurements in the group 2, to evaluate the acute effects of dry needling therapy. no additional treatment will be applied to the group 1. all assessments will be performed by the same physiotherapist.

Eligibility criteria:
inclusion criteria: * first time stroke, * patients who has spasticity due to stroke, * at least 6 months after stroke, * individuals between the ages of 18-75 will be included in the study. exclusion criteria: * any contraindication for dry needling (eg, anticoagulants, infections, bleeding, etc.), * having diabetes, * having cardiovascular diseases, * having any other neurological problems, * application of botox within 6 months prior to the study, * individuals included in another treatment program will not be included in the study.

Keywords: dry needling neurodevelopmental therapy spasticity balance functions independence
bone changes in atrophic maxilla treated by split-crest technique

Conditions: Atrophy; Edentulous Ridge

Summary: the effect of adding nanobone on horizontal bone gain in ridge splitting.

in cases of a very narrow ridge, one of the augmentation protocols is alveolar ridge-splitting techniques (rst) or alveolar ridge expansion techniques with simultaneous implant insertion. the piezoelectric surgical devices implemented for conducting bone osteotomy through the use of micrometric ultrasonic vibrations have been widely used in recent years in maxillofacial surgery. its biggest advantages are that it allows for cutting with micrometric sensitivity while cutting hard tissues, it offers a clear vision of the surgical site due to its cavitation effect, it does not cause any damage to the soft tissues while performing these cuts, and that the bone tissue heals more quickly and seamlessly, after the cuts made by piezosurgery device. the fully synthetic bone substitute, nanobone® (artoss, rostock, germany), which will be applied in this clinical study, is basically a nanocrystalline hydroxyapatite embedded in a silica gel matrix, achieved by means of specific sol-gel techniques. features such as interconnecting pores on the nanoscale, the open sioh or sio groups of polysilicic acid, its large internal surface, and the high porosity of this biomaterial are all related to the calcification processes observed within the implantation bed. while the ha component is responsible for nanobone osteoconductive properties, the silica component is believed to induce connective tissue formation, osteoblast proliferation, bone matrix mineralization, and calcification, thus combining osteoconductive and osteoinductive properties. this phenomenon is associated with the rearrangement of the silica matrix, which could be observed in vivo.

Eligibility criteria:
inclusion criteria: * age: 18-70. * patients with an edentulous site in maxilla. * ridge width of \<6mm at the edentulous site. * ridge height of \>9mm at the edentulous site. * patients who are compliant to oral hygiene measures for 4 weeks. * patient consent approval and signing. exclusion criteria: * smokers. * systemic disease that contraindicates implant placement or surgical procedures. * no or poor patient's compliance. * history of radio or chemo-therapy. * psychological problems. * pathology at the site of intervention. * pregnancy. * insufficient crown height space or mesio-distal dimension that contradict the placement of a dental implant.