Kornimate/medical-research-clean huggingface dataset:
clinical outcomes in narcolepsy and cataplexy: an evaluation of reboxetine treatment (concert)

Conditions: Narcolepsy; Cataplexy Narcolepsy; Excessive Sleepiness

Summary: concert (clinical outcomes in narcolepsy and cataplexy: an evaluation of reboxetine treatment) is a phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of axs-12 in patients with narcolepsy. subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by axs-12 (up to 10 mg daily) for three weeks, or to axs-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.


Eligibility criteria:
key inclusion criteria: * male or female subjects between 18 and 70 years of age, inclusive * primary diagnosis of narcolepsy with cataplexy * willing and able to comply with the study requirements exclusion criteria: * other clinically significant conditions potentially causing eds * clinically significant psychiatric disorders

Keywords: concert axs-12 eds cataplexy narcolepsy axsome reboxetine
treatment of posterior benign paroxysmal positional vertigo with mechanical rotational chair.

Conditions: Benign Paroxysmal Positional Vertigo; BPPV

Summary: comparison of treatment efficacy of epley maneuver and 360 maneuver in a mechanical rotational chair (trv chair) in patient with posterior benign paroxysmal positional vertigo (bppv).

open-label, randomized controlled trial comparing the epley maneuver with the 360 maneuver using the trv chair in both scenarios. patients diagnosed with posterior bppv will be randomized to receive treatment with either the epley maneuver or the 360 maneuver.

Eligibility criteria:
inclusion criteria: * age above 18 years * confirmed unilateral p-bppv (canalithiasis and cupulolithiasis) * understand written and spoken danish exclusion criteria: * pregnancy * weight ≥ 150 kg and or height ≥ 2m * not possible to attend follow-up visits * insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair * have received treatment for bppv in a mechanical rotational chair within the last 6 months * sedative antihistamines are taken within the past 7 days * comorbidities: heart failure (ef\<40), known cerebral aneurysm, cerebrovascular events (\<3 months), and dissection disease * spontaneous or gaze evoked nystagmus.

Keywords: benign paroxysmal positional vertigo vertigo dizziness vestibular diseases epley maneuver trv chair mechanical rotational chair
cognitive behavioral therapy for insomnia in euthymic bipolar disorder

Conditions: Bipolar Disorder; Insomnia

Summary: patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. changes in sleep are frequent signs of a new episode of (hypo)mania or depression. cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. the aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. the investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.


Eligibility criteria:
inclusion criteria: * fulfilling criteria for scid-1-verified bipolar i or ii disorder * euthymic, as defined by montgomery åsberg depression rating scale (madrs) not higher than eleven, and young mania rating scale (ymrs) not higher than five. * fulfilling dsm-iv criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the insomnia interview schedule (iis). exclusion criteria: * being or having been in a defined affective episode the last month before inclusion * hospitalization in the last two months before inclusion * working night shifts * sleep apnea * medical conditions incompatible with participation. * inability to cooperate in the 3-week initial phase before randomization.

Keywords: cognitive behavioral therapy cbt-i
influenza vaccination in cancer patients

Conditions: Cancer

Summary: the purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.

the participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; day 1 vaccination group and day 11 vaccination group. day 1 group will be vaccinated at day 1, when the cycle of chemotherapy begins. day 11 group will get the vaccine at day 11, 10 days after chemotherapy begins. as the rate of completion of study in the day 11 group is anticipated lower than day 1 group, we will assign the participants into day 1: day 11 with the different ratio; 4:5. hemagglutination inhibition ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants. all the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. and they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).

Eligibility criteria:
inclusion criteria: 1. patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer. specific definition of each term is like following: * the solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies. * cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks. * targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as xeloda are excluded. 2. patients who did not receive the influenza vaccination yet in the current year. 3. older than 19 years 4. eastern cooperative oncology group (ecog) performance status is 0, 1, or 2 5. cell blood count meets following criteria: * neutrophile count ≥ 1.5 x 10\^9/l * platelet count ≥ 100 x 10\^9/l * hemoglobin ≥ 8 g/dl 6. patients who can understand and agreed with the informed consents. exclusion criteria: 1. patients who have any contraindication for influenza vaccination. 2. patients who are supposed to receive the last chemotherapy at the enrollment 3. patients who receive simultaneous radiation therapy with cytotoxic chemotherapy 4. patients who receive any immunosuppressant (excluding steroid for anti-emetic effect) 5. patients with hiv and low cd 4+ t cell count (\< 500/ul) 6. patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine 7. patients who have transplanted organ and receive immunosuppressants 8. patients who are supposed to get prophylactic g-csf after chemotherapy 9. patients who are suspected to have active infectious disease.

Keywords: influenza vaccine cancer
radiofrequency and myofascial pain syndrome in postpartum pelvic pain

Conditions: To be Approved by the Ethics Committee

Summary: about 30% of women experience pain in the perineum and pelvic region one year after the vaginal labor, rising up to 50% when it is triggered during vaginal penetration, called this pain as dyspareunia. an early physiotherapy treatment could be the solution to the pain relief of these women. thus, the objectives of the present randomised clinical trail are (i) to determine the effectiveness of a physiotherapy treatment based on education therapeutic, the treatment of myofascial pain syndrome (mps) of the pelvic floor muscles (pfm), and pfm specific training with or without radiofrequency in reducing pain and improving sexual function; and, (ii) to know the facilitating factors and barriers in adherence and perceived self-efficacy towards physiotherapy treatment of women with pelviperineal pain in the postpartum. methodology: randomized clinical trial with examinator blinding and two parallel groups, followed by a qualitative study. thirty eight women per group will be needed with postpartum pelviperineal pain between 8 weeks after labour, with intensity ≥ 4 cm on the visual analogue scale. the assignment will be random to an experimental 1 group based on therapeutic education, plus conservative and invasive treatment of mps and specific pfm exercise versus an experimental 2 group consisted in the same treatment plus non-ablative radiofrequency treatment. in both cases, 12 individual supervised sessions will be held by a physiotherapist specialized in women's health, with evaluations pre- and post-intervention, at 3 and 6 months. the outcome variables will be the intensity of the pain, the presence of mps at pfm, the pfm contraction quality, sexual function and specific quality of life. the qualitative study will be carried out in the assessment 6 months post-intervention, through interviews semi-structured and focus groups. the interviews will be guided with previous questions established, recorded, transcribed and thematically analyzed by a panel of experts.


Eligibility criteria:
inclusion criteria: * primiparous women * eutocic vaginal birth * postpartum pelviperineal pain 8 weeks after birth * intensity ≥ 4 cm in the vas * freely signed the informed consent exclusion criteria: * multiparous women * instrumental delivery * cesarean delivery * avulsion of the levator ani muscle * diagnosis of coccygodynia and/or coccygeal pain * sphincter anal injury during vaginal birth * history of pelvic fractures and/or neoplasms * pregnant women * neurological diseases * vaginal infection or active urinary tract, or with any * uterine device with metallic components * women with cognitive, auditory and/or visual limitations to understand information, respond to questionnaires, consent and/or participate in the study.

Keywords: pelvic pain physiotherapy therapeutic adherence postpartum pelvic floor radiofrequency myofascial pain syndrome
pulmonary function and neuromuscular disease

Conditions: Neuromuscular Diseases

Summary: this study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : duchenne muscular dystrophy, werdnig-hoffinann disease, congenital myopathy, monitored in besançon university hospital.


Eligibility criteria:
inclusion criteria: * neuromuscular disease * followed-up in besançon university hospital * with at least 2 pulmonary function tests previously performed exclusion criteria: * mental deficiency * facial expressions disorders
handgrip and respiratory dysfunction in hd patients.

Conditions: Huntington Disease

Summary: hereditary neurodegenerative diagnosis of huntington's disease (hd) is associated with a progressive deterioration of the respiratory system function . this fact contributes strongly to the increased risk of aspiration pneumonia as a primary cause of death in people with hd. but regularly objective monitoring of the airway system condition is in common clinical practice almost impossible for high time requirements and the need for specialized expensive devices . this drives the need for a simpler and more cost-effective screening tool. in recent years published studies, working with all ages and genders, show correlation between hand grip strength (hgs) and respiratory parameters. as a second simple screening tool, we chose a short questionnaire called the index of pulmonary dysfunction.

goal: to identify a simple method for screening respiratory muscle and cough weakness in huntington\&#39;s disease (hd) patients, suitable for clinical practice. hypothesis 1: maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with maximal hand grip strength in hd patients. hypothesis 2: maximal inspiratory pressure, maximal expiratory pressure, and voluntary peak cough flow will be significantly correlated with the index of pulmonary dysfunction in hd patients.

Eligibility criteria:
inclusion criteria: * genetic confirmed diagnosis of huntington's disease exclusion criteria: * diagnosis of other concomitant neurological diseases; * a history of cardiovascular or lung disease; * respiratory symptoms such as cough, phlegm, wheezing, or dyspnea at the time of assessment

Keywords: huntington disease respiratory dysfunction peak cough flow handgrip strength screening tool
efficacy between arthrocentesis with high versus low molecular weight hyaluronic acid in treatment of tmj disorders

Conditions: Temporomandibular Joint Disorders; Arthrocentesis

Summary: the study will be carried out in patients in two groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the tmj proven by clinical examination, with no improvement after conservative treatment.

the measurement tool of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid then compare between efectevness of injection of high-molecular weight versus low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular tmj disorder. , 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise. 3-the presence of absence of clicking and cracking in jaw .

Eligibility criteria:
inclusion criteria: * pain or tenderness of the jaw * pain in one or both of the temporomandibular joints * aching pain in and around your ear * difficulty chewing or pain while chewing * aching facial pain * locking of the joint, exclusion criteria: * muscular tmj disorders * bleeding tendency
generation of prediction equations to analyze body composition of obese adults based on bia

Conditions: Bioelectrical Impedance Measurement of Healthy Adults

Summary: the study was based on the clinical trial bca-01 (nct01368640) "generation of prediction equations to analyze body composition of adults based on bioelectrical impedance analysis (bia)" and implicates an extension of the study collective. aim of the study is to develop prediction equations for calculating ffm, tbw, ecw and smm based on the gold standard reference methods adp, dxa, mri, d2o and nabr on the one hand and measurement data of the bia devices on the other hand.


Eligibility criteria:
inclusion criteria: * healthy adults in an * age range of 18 to 65 years * bmi \> 30 kg/m2 exclusion criteria: * acute and chronic diseases * regular intake of medications (except for contraceptives) * amputation of limbs * electrical implant as cardiac pacemaker * insulin pumps * artificial joints * metallic implants (except tooth implants) * claustrophobia * pregnancy or breastfeeding period * probands who cannot provide an icf by themselves * probands who might be dependent from the sponsor or the inv. site * current alcohol abuse * frequent hypersensitivity reactions/allergies determ. anamnestically * extensive tattoos at arms or legs
association between confocal laser endomicroscopic (cle) features and gastric mucosal microbiome

Conditions: Mucosal Microbiome; H.Pylori; Intestinal Metaplasia; Gastric Neoplasia

Summary: there might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

the gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the h.pylori infection. we hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.

Eligibility criteria:
inclusion criteria: * patients scheduled for gastroendoscopy examination * aged between 18 and 80 years old exclusion criteria: * antibiotic, probiotic or prebiotic usage within 2months * esophageal, gastric or duodenal cancer or other malignancy * history of upper gi tract surgery * coagulopathy or bleeding disorders * allergy to fluorescein sodium * pregnant or breast-feeding (for females) * impaired renal function

Keywords: mucosal microbiome h.pylori intestinal metaplasia gastric neoplasia endomicroscopy
neat!2 sedentary behavior reduction for individuals with past or present knee symptoms, injuries, or surgeries

Conditions: Sedentary Lifestyle; Knee Osteoarthritis; Knee Injuries; Knee Pain Chronic

Summary: this study will evaluate the effectiveness of an mhealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.

sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. to reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mhealth sedentary reduction, mhealth intervention plus coaching, and delayed mhealth group. sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.

Eligibility criteria:
inclusion criteria: * be at least 40 years of age * own an android or apple smartphone * have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for \>50% of their waking day * be willing to download the study application and be compatible on their smartphone * spend at least 7 hours/day sitting * have at least 4 days of valid accelerometer data at baseline * have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years * read, speak, and understand english exclusion criteria: * have any contraindications to activity * have a mobility limiting comorbidity * have a scheduled surgery within the next 6 months
segment iv hypertrophy after liver venous deprivation

Conditions: Major Hepatectomy

Summary: before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. recently liver venous deprivation has been described in some pioneer centre. the results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization. in major hepatectomy, and specially in right or extended right hepatectomy the segment iv plays an important role in the proportion of future liver remnant. despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. in particular the the degree of hypertrophy of segment iv after liver venous deprivation compared to portal embolization.


Eligibility criteria:
inclusion criteria: - patient with liver tumor selected for right hepatectomy with insufficient future liver remnant who have undergoes portal embolization or liver venous deprivation exclusion criteria: - left / extended left hepatectomy
impact of kinesiophobia on descending corticospinal and bulbospinal projections

Conditions: Kinesiophobia

Summary: fear of movement (kinesiophobia) is a phenomenon commonly observed in people suffering from chronic pain. the aims of this project are to better understand the neurophysiological basis of this phenomenon, in particular 1) the effect of kinesiophobia (induced by nocebo intervention) on the excitability of corticospinal projections and 2) the association between kinesiophobia and top-down inhibitory mechanisms.

the study will include 44 healthy (pain-free) participants. corticospinal measurements will be taken before and after the application of capsaicin cream (experimental pain paradigm). the investigators will manipulate kinesiophobia levels (assessed using the tampa kinesiophobia scale) upward by pretending to diagnose a musculoskeletal problem in half of the participants (nocebo ultrasound), and will measure the efficacy of top-down inhibitory mechanisms using a counter-irritation paradigm (thermode and cold pressor test : the subjects will be subjected to 5 thermal stimulations, 7 mechanical stimulations and 1 water bath at 10°c of the hand) and corticospinal parameters using transcranial magnetic stimulation. together, these results will allow a better understanding of the mechanisms associated with a predictor of pain onset (such as kinesiophobia), by studying its interactions with endogenous pain inhibition systems and the motor system, in order to develop relevant prophylactic treatments.

Eligibility criteria:
inclusion criteria: * aged 18 years old or older * healthy volunteers * capable of understanding instructions * abstain from tobacco and caffeine 2 hours before data collection * abstain from short-acting analgesics 6 hours before data collection exclusion criteria: * a painful condition or chronic pain * neurological disorders * shoulder pathology * skin diseases * capsaicin allergy * raynaud's syndrome * epilepsy * intracranial metallic foreign bodies, hearing aids and cochlear implants

Keywords: kinesiophobia experimental pain corticospinal excitability conditioned pain modulation input output curves
comparing two types of sedation to gynaecological patients

Conditions: Transcervical Resection of Endometrium; Transcervical Resection of Fibroids; Transcervical Resection of Polyp

Summary: the primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

investigate the difference between two types of anesthesia.

Eligibility criteria:
inclusion criteria: * \>18 years * females * are having a tcre, tcrf or tcrp * speak and understand danish * no mental problems exclusion criteria: * \<18 years old * don´t speak or understand danish * mental problems * lung problems * bmi \>40 * big fibroma: \>3x3 cm * abuser * allergy towards i propofol, remifentanil and/or citanest * pregnant