Kornimate/medical-research-clean huggingface dataset:
noninterventional examination of subcutaneous (sc) tumor necrosis factor (tnf) inhibitors

Conditions: Rheumatoid Arthritis

Summary: this prospective, post marketing, observational, noninterventional study (nis) is designed to compare drug persistence in patients treated with certolizumab pegol (czp) and patients treated with any other subcutaneously (sc) administered tumor necrosis factor (tnf) inhibitor.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) * moderate to severe disease activity of ra * the patient receives tumor necrosis factor (tnf) inhibitor in combination with at least 1 synthetic disease modifying antirheumatic drug (dmard) * the decision to prescribe a tnf inhibitor in combination with dmard is made by the treating physician, prior to and independently from the decision to include the patient in this non-interventional study (nis) * male or female patients ≥ 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires) * the patient personally signed and dated patient data consent form (pdcf) prior to visit 2 * treatment is according to the summary of product characteristics (smpc) exclusion criteria: * known contraindications to tumor necrosis factor (tnf) inhibitors * prior use of any tnf inhibitors (including adalimumab, etanercept, infliximab, certolizumab, or golimumab), or other biologic dmards (including abatacept, rituximab, tocilizumab, or anakinra) * participation in an investigational study

Keywords: certolizumab pegol cimzia® tnf inhibitor dmard rheumatoid arthritis
yoga/pranayama for posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorder

Summary: this study aims to investigate the effect of a pranayama focused yoga intervention on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard psychotherapy/ trauma-focused cognitive-behavioral therapy (tf-cbt). therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of standard tf-cbt unit, while the control group will get standard tf-cbt alone. it should further be investigated, whether pranayama can enhance the affective tolerance of patients with post-traumatic stress disorder towards the used exposure techniques of tf-cbt.


Eligibility criteria:
inclusion criteria: * diagnosed ptsd according to icd-10 * pcl-5 score of at least 33 points * undergoing outpatient cbt * physical and mental ability to perform pranayama exclusion criteria: * severe comorbid mental or somatic disease that did not allow the patient to perform pranayama * pregnancy * regular practice of yoga or pilates in the last 12 months

Keywords: posttraumatic stress disorder cognitive-behavioral therapy complementary therapies yoga pranayama effectiveness safety randomized controlled trial
ropinirole in the treatment of bipolar depression

Conditions: Bipolar Disorder

Summary: to demonstrate efficacy and safety of requip in in treating bipolar depression.

this study is 8 weeks long, with an optional additional 8 weeks. the study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for bipolar disorder * current madrs score \> 16 * current mrs-sads score \< 10 * prior to participation in this study, each subject must sign an informed consent. * all patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). if patients are not taking any of these agents on study initiation, they will be required to start one of these agents at study initiation. study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents. exclusion criteria: * any serious acute medical illness * any clinically serious evidence of suicidality or score of 3 or greater on suicide item on madrs scale

Keywords: bipolar disorder, ropinirole, depression
does adding lidocaine to corticosteroid injections reduce pain intensity in hand surgery

Conditions: Hand Osteoarthritis; Trigger Finger; Carpal Tunnel Syndrome

Summary: the purpose of this study was to determine whether adding lidocaine to corticosteroid injections reduce pain intensity in hand surgery.

there is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. adding lidocaine adds to the volume of the injection, which might increase pain. it's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine. the aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.

Eligibility criteria:
inclusion criteria: * all patients offered a steroid injection in a hand surgeon's office * aged 18-89 years * english speaking patients * able to provide informed consent exclusion criteria: * non-english/spanish speakers
ohrqol and parental perception in a group of children and adolescents with down syndrome: a cross

Conditions: Quality of Life; Down Syndrome; Oral Health

Summary: the aim of the study is to evaluate oral health related quality of life of children and adolescents with down syndrome and parental perception, knowledge and attitude on oral health conditions of children and adolescents with down syndrome

oral disease and conditions can undermine self-image and self-esteem , dis-courage normal social interaction, and cause other health problems and lead to chronic stress and depression , they may also interfere with vital-functions such as breathing , food selection eating, swallowing and speaking, and with activities of daily living such as work, school, and family interactions . oral health related quality of life captures the aim of new prospective and defined as a multidimensional construct that reflects people's comfort when eating, sleeping and engaging in social inter-action, their self-esteem and their satisfaction with respect to their oral health . down syndrome (ds) is the most common neuro-developmental disorder of known genetic origin, arising from an extra copy of chromosome 21. children and adolescents with down syndrome present particular characteristics that may have a negative impact on their oral health and function. protruding large tongue and facial muscle hypotonicity impairing speaking and chewing abilities. bruxism, respiratory problems and mouth breathing are common among them. periodontal disease is the most significant oral health problem in people with down syndrome due immunological deficiency, poor masticatory function and poor oral hygiene . another common oral manifestation associated with the syndrome is malocclusion. in this regard, mandibular protrusion, anterior open bite, and posterior crossbite have been reported as prevalent outcomes among ds individuals . it has been shown that the impact of oral disease on oral health related quality of life of children with disabilities can be used in health service planning and priority setting. studies have recommended that people with a negative oral condition should receive treatment first , hence this vulnerable group of children needs to be prioritized in the planning of health services and oral health care programs

Eligibility criteria:
inclusion criteria: * parents of children and adolescents diagnosed with down syndrome who agree to participate in the study. * children and adolescents with down syndrome aged from 4 to 14 years. * both genders. exclusion criteria: -children/adolescents with multiple disabilities
european society of cutaneous lupus erythematosus (euscle)

Conditions: Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic

Summary: cutaneous lupus erythematosus (cle) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. the aim of the study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with cle.

methods: a core set questionnaire has been developed in the course of the "european society of cutaneous lupus erythematosus (euscle)", and a total of 40 patients (32 females, 8 males) in two centres, germany and sweden, were included in this study. results: cle was diagnosed in 39 individuals (5 with acute cle, 10 with subacute cle, 13 with chronic cle, and 18 with intermittent cle) and one individual presented with a systemic manifestation of the disease. furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified clasi were examined. interestingly, 75% of the patients with cle showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-ro/ssa in 12 and positive anti-la/ssb antibodies in 8 cases. the predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). conclusions: the new core set questionnaire enables the clinician to characterize the different skin manifestations involved in cle and to evaluate disease activity and reasonable treatment modalities. furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. in the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with cle.

Eligibility criteria:
inclusion criteria: * systemic or cutaneous lupus erythematosus confirmed by histological analysis * written informed consent available prior to any study-procedures exclusion criteria: * patients with conditions that are contrary to the above mentioned criteria

Keywords: standardized evaluation core set questionnaire epidemiological data laboratory analysis
the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the seine saint-denis

Conditions: Psychosis

Summary: a prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the seine saint-denis. this research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences. this will be the first clinical research work concerning adolescents and young adults using mental health services in the seine saint denis ouest.

the main objective of the study will be to quantify the rate of subjects seeking help in our units meeting the criteria of subject with an ultra-high risk of psychosis (uhr). secondary objectives: * observe the transition rate of these high risk patients at one year. * study the socio-demographic and general psychopathology profiles of 12 - 25 year olds using the services of cmp, casado, mobile team and rcl. * monitor the development of school and professional integration, the overall functioning and self-esteem of subjects at six months and one year.

Eligibility criteria:
inclusion criteria: * boys and girls consulting in the structures involved in the study of the seine-saint-denis department. * aged 12 to 25. * patients with an ultra high risk of psychosis. * affiliated with social security or with state medical aid (ame). exclusion criteria: * subject with known neurological pathology * subject with insufficient knowledge of french

Keywords: psychiatry- mental illness-young population- ultra-high risk of psychosis
supplementation after bariatric surgery

Conditions: Bariatric Surgery; Micronutrient Deficiencies; Obesity

Summary: the aim of this study is to assess medication adherence to vitamin and mineral supplements after bariatric surgery and identify factors that may influence adherence. all study participants are prescribed life-long treatment with daily oral vitamin b12 and calcium/vitamin-d. menstruating women are also prescribed daily oral iron supplementation. post-operative adherence rate is retrieved from pharmacy refill data, collected from the swedish prescribed drug register, the five first years after bariatric surgery.

the aim of this study is to assess medication adherence to vitamin- and mineral supplementation after bariatric surgery, identify factors that may influence adherence, as well as study the development of micronutrient deficinencies detectable by blood sampling. all study participants are prescribed life-long treatment with daily oral vitamin b12 and calcium/vitamin-d. menstruating women are also prescribed daily oral iron supplementation. post-operative adherence rate is retrieved from pharmacy refill data, collected from the swedish prescribed drug register, at one, two and five years after bariatric surgery.

Eligibility criteria:
inclusion criteria: * informed consent * patients subjected to bariatric surgery at vrinnevi hospital, norrköping, sweden exclusion criteria: * unable to read and understand swedish

Keywords: bariatric surgery (gastric bypass, gastric sleeve) micronutrient deficiencies adherence, medication
automatic thermomechanical massage bed for acute pain relief for chronic nonspecific low back pain

Conditions: Chronic Non-specific Low Back Pain

Summary: this prospective, double-blinded, sham-control, parallel-arm, randomized pilot trial will recruit n=40 participants, ages 18-65 (inclusive), with chronic low back pain (lbp) in the lower region, to be randomly assigned using 1:1 randomization method to receive a 40-minute single session of either active or sham automated thermo-mechanical therapy (att). all research procedures, including informed consent, att session, and pre- and post-att assessments, will be completed in one single session.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 * has had chronic non-specific lower back pain persisting for 12 weeks or more * conversational level of english exclusion criteria: * contraindications to mechanical manipulation of the back * history of back surgery within the past three years * recent back injury * presence of back implants or active implanted devices * low back pain resulting from other specific conditions (e.g., infection, neoplasm) * sensitivity to heat * circulatory insufficiency * heart disease * pregnant or breastfeeding * individuals with a history of substance use disorder * body weight over 298 lbs (135 kg)

Keywords: chronic pain low back pain automatic thermo-mechanical therapy
the basa study: breath analysis for severe asthma patients

Conditions: Severe Asthma

Summary: this study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. in the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (feno, gc-ms and ebc). a control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.


Eligibility criteria:
inclusion criteria: * severe asthma diagnosis according to the latest recommendation * eligible or in treatment with a biologic treatment for severe asthma * able to follow istructions * able and willing to sign the informed consent exclusion criteria: * not able to perform lung function measurements and the procedures of the study * acute respiratory or non respiratory infection (\<4 weeks) * not willing to continue the study

Keywords: severe asthma exhaled breath biologics monitoring
trial readiness and endpoint assessment in congenital myotonic dystrophy

Conditions: Congenital Myotonic Dystrophy

Summary: congenital myotonic dystrophy (cdm) is a multi-systemic, dominantly inherited disorder caused by a trinucleotide repeat expansion (ctgn) in the dmpk gene. cdm occurs when the ctgn increases between the adult myotonic dystrophy type-1 (dm1) parent and the child. children with cdm present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. there is a 30% mortality rate in the first year of life. as children grow, they are at risk for intellectual impairment, autistic features, gastrointestinal symptoms, and motor delay. the investigators will enroll children with cdm between ages 0-15 with visits at baseline and one year to evaluate appropriate physical functional outcomes, cognitive function and quality of life over time. functional outcome measures will be correlated with potential biomarkers in the children. completion of these specific aims will extend the understanding of disease progression in cdm and will provide the requisite information for successful therapeutic trials in children with dm.


Eligibility criteria:
cdm group inclusion criteria: * age 0-15 yrs * diagnosis of cdm, based on symptoms and genetic testing of expanded trinucleotide repeats. exclusion criteria: * any other non-dm1 illness that would interfere with the ability or results of the study in the opinion of site investigator * significant trauma within one month * internal metal or devices control group inclusion criteria: * age 0-15 yrs * healthy children on no medication exclusion criteria: * any illness or situation that, in the opinion of the site investigator, has the possibility to interfere with study procedures * dm type 1 and 2
peri-operative hypothermia in children

Conditions: Hypothermia Following Anesthesia, Sequela; Pediatric ALL

Summary: this study aims to determine the incidence of hypothermia in the local paediatric population in the peri-operative period, identify the risk factors involved, and thereafter develop and implement clinical practice guidelines to reduce iph such that temperature monitoring and heat conservation measures can be implemented in a cost-effective way. the secondary objectives are to determine the adverse outcomes of hypothermia and warming measures

background hypothermia, defined as core body temperature less than 36 degrees celsius, occurs frequently during the course of surgery in patients across all ages, especially in the young. it causes significant medical consequences including cardiac events, bleeding, surgical site infection, increased shivering and patient discomfort, as well as longer hospital stays. although guidelines exist for health care providers in terms of temperature management during surgery, these guidelines are not always followed as the warming measures can be costly, for example, single-use temperature probes and disposable blankets, with potential risks of the equipment overheating causing burns and contamination during surgery methodology the investigators aim to include up to 6,000 children presenting for either scheduled or emergency surgeries. core temperature before, during and after surgery using routine temperature monitoring devices such as tympanic, axillary, oral, rectal and spoton (a non-invasive method using a sticker placed on the forehead) will be measured. other outcomes collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries, shivering, discomfort, length of pacu and length of hospitalization, wound infection rates, . patients will receive the usual heat-loss prevention and warming measures. interim analysis of the first 2000 patients using the spoton method of continuous core temperature monitoring will be done to determine incidence and duration of peri-operative hypothermia. this monitoring modality will be compared for agreement with the conventional tympanic and forehead infra-red thermoscan methods. patient and perioperative risk factors predisposing to hypothermia will be identified to guide in the formulation of clinical practice guidelines tailored to the local population. guidelines will be implemented, and post-implementation incidence of iph will be determined a pre- versus post-implementation cost analysis will be carried out.

Eligibility criteria:
inclusion criteria: * all paediatric patients ages 16 and younger undergoing elective or emergency surgeries in paediatric major and day surgical operating theaters in kk women's and children's hospital. exclusion criteria: * patients undergoing operative procedures under local anaesthesia * patients with impaired temperature control e.g., severe head injury, febrile illness * patients who are admitted to intensive care unit (icu) post-operatively.
hsrt and imrt chemoradiotherapy for newly diagnosed gbm

Conditions: Glioma, Malignant

Summary: this study aims to evaluate the safety and effectiveness of the combination of 30gy/5fx hsrt and 20gy/10fx imrt adjuvant therapy. the total biological effective dose (bed) of the ptv is 72 gy in a ratio of alpha/beta ratio of 3, which equals to the conventional 60gy/30fx treatment. this study can provide evidence for future non-inferiority phase iii randomized controlled trials. the abbreviated course of radiotherapy can reduce the treatment time by half, benefit patients, and utilize the health resource.


Eligibility criteria:
inclusion criteria: 1. 18-70 years of age; 2. karnofsky performance status (kps) ≥ 60 within 14 days prior to registration; 3. histopathologically proved diagnosis glioblastoma multiforme; 4. underwent surgery, gross total resection or subtotal resection; 5. estimated survival of at least 3 months; 6. hgb \> 90/gl; absolute neutrophil count (anc) \> 1.5×109/l, platelets \> 80×109/l; creatinine \< 1.5 times the upper limit of laboratory normal value; bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) \< 3 times the upper limit of laboratory normal value; 7. signed informed consent form; 8. agreed to participate in the follow-up. exclusion criteria: 1. prior invasive malignancy unless disease free; 2. received irradiation or other anti-tumor adjuvant therapies; 3. brain stem disease or tumor greater than 6 cm in maximum diameter; 4. prior therapy with an inhibitor of vascular endothelial growth factor (vegf) or vegfr; 5. pregnancy or nursing mothers; 6. participated in other trials after diagnosis; 7. influence factors toward oral medications; 8. patients with ctcae5.0 grade 3+ bleeding within 4 weeks prior to registration; 9. suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade ii, poorly controlled arrhythmias (including men with qtc interval ≥ 450 ms, women ≥ 470 ms); according to nyha criteria, grades iii to iv insufficient function, or cardiac color doppler ultrasound examination indicates left ventricular ejection fraction (lvef) \<50%; 10. long-term unhealed wounds or fractures; 11. history of organ transplantation; 12. serious diseases that endanger patients' safety or affect patients' completion of research, according to the researchers' judgment.