Kornimate/medical-research-clean huggingface dataset:
tavns on the inpatient psychiatric unit

Conditions: Depression, Anxiety

Summary: this is a research study to find out if mental health symptoms in patients admitted to the institute of psychiatry are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or tavns. participants will receive ear stimulation during their inpatient treatment at the institute of psychiatry. participants will be randomly assigned to either receive ear stimulation for 1 day (up to 9 treatments over the course of a single day) or 3 days (up to 3 treatments per day), and will have a 50:50 chance of being in either group (like the flip of a coin). each treatment will last up to 30 minutes and there will be a break of at least 30 minutes in between treatments. the study team will ask participants to complete a group of questionnaires at the beginning and end of the study. in addition, there are several questionnaires that will be completed daily while participants are receiving ear stimulation. participants in the 1 day stimulation group will also receive 2 days of follow up questionnaires after the initial day of stimulation. the questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep. the ear stimulation treatments will not interfere with the care subjects are receiving from the medical team. in order to qualify for this study, participants must be actively receiving inpatient care at the musc institute of psychiatry.


Eligibility criteria:
inclusion criteria: * ages 18 and up * english speaking * admitted to 3 north's inpatient unit in musc's institute of psychiatry (iop) * have the capacity and ability to provide one's own consent and sign the informed consent document * primary depression diagnosis exclusion criteria: * facial or ear pain or recent ear trauma. * metal implant devices in the head, heart or neck. * history of brain surgery. * history of myocardial infarction or arrhythmia, bradycardia. * acute exacerbation of a chronic respiratory disorder or acute covid-related symptoms. * active gi symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus. * personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury. * individuals suffering from frequent/severe headaches. * individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic. * individuals who are catatonic or otherwise unable to participate in the informed consent process. * moderate to severe alcohol or substance use disorder. * pregnancy
sjm brady mri post approval study

Conditions: Bradycardia

Summary: the purpose of this post approval study is to evaluate the long-term safety of the fda approved st. jude medical tendril mri™ lead implanted with a sjm brady mri implantable pulse generator (ipg) such as the accent mri™, assurity mri™, endurity mri™ pacemaker, or similar model (sjm brady mri system) in subjects with a standard bradycardia pacing indication.

this is a prospective, multi-center clinical study designed to evaluate the long-term safety of the tendril mri™ lead implanted with any sjm brady mri pacemaker or similar model (sjm brady mri system) in subjects with a standard bradycardia pacing indication through 60 months of follow up. additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated mri scan(s). any enrolled subject implanted with the sjm brady mri system may be included in this evaluation if they are scheduled for or planning to have a mri scan during the course of the study.

Eligibility criteria:
inclusion criteria: 1. subject is able to provide informed consent for study participation (legally authorized representative is not acceptable). 2. subject is at least 18 years of age or of legal age to give informed consent specific to state and national law. 3. subject meets at least one of the following criteria: 1. is an accent mri ide study subject who is being rolled over into the sjm brady mri pas and still has at least one tendril mri™ lead implanted with a sjm brady mri pacemaker such as the accent mri or similar model. 2. is a subject who has been implanted with at least one tendril mri lead and a sjm brady mri pacemaker such as the accent mri or similar model, but is not part of the accent mri ide study and will be enrolled within 30 days after implant. 3. is a subject who will be implanted with at least one tendril mri lead and a sjm brady mri pacemaker such as the accent mri or similar model and will be consented either at or within 30 days before implant. 4. subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including mri scan procedures. exclusion criteria: 1. subject has been enrolled or intends to participate in a clinical drug and/or device study with an active treatment arm or that has any procedures, which could confound the results of this trial. 2. subject is not expected to be able to complete the study follow up schedule or duration due to any health condition such as has malignancy, is deemed a candidate for transplant or ventricular assist device, or in hospice care.

Keywords: bradycardia, pacemaker, mri scan
improving gait in patients with spinal cord injuries

Conditions: Spinal Cord Injuries

Summary: this study is part of a larger clinical trial that examines the potential of a 12-week treadmill-training program to improve walking in patients with spinal cord injuries (scis). patients in the trial are at least 1 year past their injury. this substudy tests a combination of two strategies to enhance the treadmill training program: electrically stimulating a muscle withdrawal reflex and providing body weight support by partially suspending patients as they walk on the treadmill.

patients with spastic paresis due to incomplete sci have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. if the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring. research in patients with scis has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. two technologies that may enhance the benefits of treadmill walking are body weight support (bws) and functional electrical stimulation (fes). preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. this study will evaluate the benefits of adding bws and fes to a treadmill-training program for patients with scis. during the treadmill training, patients are suspended in an apparatus to provide partial body weight support (bws). the training effects of bws locomotion with fes over the course of a multi-session training program will be examined. study visits will be scheduled 3 days each week for 12 weeks. participants will have follow-up visits at months 3 and 12. gait parameters modified by training will be identified and the nature of these changes will be characterized. specifically, walking speed, kinematics, electromyography (emg), and muscle strength will be assessed.

Eligibility criteria:
inclusion criteria: * spinal cord injury classified as american spinal injury association (asia) c * at least 1 year post injury exclusion criteria: * spinal cord injuries of other severities (classified asia a, b, d, or e)

Keywords: locomotion spinal cord injury, asia c body weight support (bws) functional electrical stimulation (fes) gait treadmill training physical therapy
cognitive-behavioral therapy for insomnia in adolescent psychiatry

Conditions: Insomnia

Summary: the study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (cbt-i) in adolescents with comorbid psychiatric disorders. participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). after diagnostic assessment, participants that fulfil inclusion criteria are offered the cbt-i intervention. pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.


Eligibility criteria:
inclusion criteria: * be between 13-17 years old * meet criteria for insomnia disorder (primary or secondary insomnia) according to dsm-iv-tr * have insomnia symptoms at a clinical level, as defined as more than 10 points on the isi-a * adequate swedish language skills exclusion criteria: * severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder) * autistic disorder * severe suicidality (defined as ≥17 points on mini-kid suicide subscale) * alcohol or drug dependence * psychotropic medication * previous (\> 5 sessions) or ongoing cbt-treatment for insomnia
methotrexate in the treatment of chronic idiopathic urticaria

Conditions: Chronic Urticaria

Summary: chronic urticaria is defined by urticarial lesions persisting at 6 weeks. the cause is not found in about 75% of cases (chronic idiopathic urticaria). the gold standard treatment consists of anti-h1 molecules. in severe cases, refractory to anti-h1, few therapeutic alternatives exist. methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

chronic urticaria, defined by its persistence beyond 6 weeks, is a common condition (0.1% to 3% of the general population), occurring at any age. the etiology is not found in nearly 75% of cases (chronic idiopathic urticaria). chronic idiopathic urticaria may resolve over several months or years. the quality of life of patients is usually strongly spoiled. the gold standard treatment consist of anti-h1 molecules. in severe cases, which are refractory to anti-h1, few therapeutic alternatives exist. two studies have shown a benefit when adding to anti-h1, montelukast, anti-leukotriene, or cyclosporine. methotrexate, which is another immunosuppressive drug, cheap and commonly prescribed by dermatologists, has been efficient in severe chronic urticaria, in an open study and in few case reports. methotrexate, an anti-metabolite drug which inhibits dihydrofolate reductase, is indicated in hematologic malignancies and in autoimmune diseases. it may be given by oral or parenteral administration, once a week, and requires regular monitoring of renal and hepatic function, and blood count.

Eligibility criteria:
inclusion criteria: patients who met the diagnostic criteria for chronic idiopathic urticaria, previously treated by * 3 different molecules of anti-h1 or * a combination of 2 different molecules of anti-h1 or * 1 molecule of anti-h1 with at least a double dose for a total treatment duration of ≥ 3 months before inclusion * with persistency of at least 7 days with urticarial lesions in the previous month exclusion criteria: * differential diagnosis of chronic idiopathic urticaria (urticarial vasculitis) * treatment with montelukast or immunosuppressive drugs during the previous month * contraindications to methotrexate * allergy to methotrexate * treatment which are contraindicated with methotrexate * pregnancy, possibility of getting pregnant (no effective contraception), breastfeeding * anomalies in liver function (transaminases or liver failure at a rate 1.5 x normal) * severe renal impairment (creatinine clearance calculated by the cockcroft formula \<50 ml / min) * chronic respiratory failure * active infectious chronic diseases (viral hepatitis, hiv) * history of neoplasia * mental deficiency * involvement in another drug clinical trial
effect and essentiality of vertebroplasty surgery in acute vertebral compression fractures

Conditions: Spinal Fractures

Summary: percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over china, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. this is a multiple center open-label randomised trial. patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. because of the procedure , neither patients nor investigators were blinded. the primary outcome was pain relief at 1 month and 1 year.

this study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. patients will be randomised into 2 arms with average amount. the participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods. patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. the primary outcome will be the pain release , categorised according to who classification.

Eligibility criteria:
inclusion criteria: * vertebral compression fracture on spine radiograph (minimum 15% height loss) * level of fracture at th5 or lower; back pain for 6 weeks or less * focal tenderness at fracture level on physical examination * bone oedema of vertebral fracture on mri * decreased bone density (t scores ≤-1) exclusion criteria: * severe cardiopulmonary comorbidity * suspected underlying malignant disease * radicular syndrome * spinal-cord compression syndrome * contraindication for radiography exam

Keywords: spinal fractures/surgery vertebroplasty quality-adjusted life years
antler plate on preventing mammary high-risk lesions from malignant development

Conditions: Breast Cancer Prevention

Summary: this study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

through estrogen receptor antagonists, tamoxifen can reduce the risk of breast high-risk disease progression to cancer, but only reduce the probability of some er and pr positive tumors, which has no preventive effect on triple negative breast cancer and her-2 positive breast cancer. in the first hospital of jilin university, the preparations containing antler ingredients have been clinically proven to be able to treat breast hyperplasia, which has been proved to be able to prevent breast cancer in basic research, and antler ingredients have been proved to be non-toxic and side effects in the treatment dose. this study aims to prove whether antler disk extract can be put into clinical practice to prevent breast precancerous lesions from developing into cancer.

Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 80 * atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology * women with breast cancer in first degree relatives * patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent exclusion criteria: * hepatorenal dysfunction, cardiovascular and cerebrovascular diseases * patients not suitable for this study judged by researchers
treatment of low back pain in patients with end-stage renal disease on hemodialysis

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine whether a physiotherapeutic intervention is effective in the treatment of low back pain in hemodialysis patients

low back pain is a significant morbidity in chronic hemodialysis patients affecting about 1/3 of them. among the physiotherapeutic interventions, the mckenzie method (spine 1983;8:141-4), has shown to be an effective approach to manage patients with low back pain. more specifically, it consists on standardized repetitive flexion and extension exercises of the lumbar spine. thus far, there has been no randomized intervention testing the effectiveness of physiotherapeutic interventions in chronic renal failure patients on hemodialysis. in this study we selected four of their main proposed exercises (flexion in standing, extension in standing, flexion in lying, and extension in lying position) to apply three times a week for eight weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic low back pain * chronic renal failure * hemodialysis therapy for more than 3 months exclusion criteria: * fractures of the spine * psychiatric diseases * alcohol of other drugs use * planned living donor transplantation * clinically unstable patients * chronic neurologic diseases

Keywords: low back pain physiotherapy hemodialysis end-stage renal disease
tecfidera and mri for brain energy in ms

Conditions: Multiple Sclerosis

Summary: the primary objective of this study is to test the hypothesis that dmf can improve mitochondrial function in the brain of people with ms. the investigators will assess mitochondrial function in the cerebral grey matter by measuring pcr and atp by 31p magnetic resonance spectroscopy (mrs) and naa in nawm by 1h mrs.


Eligibility criteria:
inclusion criteria: * diagnosis of ms by 2010 mcdonald criteria * relapsing clinical course * ages 18-55 * laboratory values that allow initiation of dimethyl fumarate (tecfidera) exclusion criteria: * systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease) * treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline mri scan. * treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant * prior treatment of greater than 1 month at any time with dmf * inability to tolerate mri procedures * pregnant/breastfeeding
pamidronate prophylaxis in multiple myeloma 30 mg/month versus 90 mg/month

Conditions: Multiple Myeloma

Summary: multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in the bone marrow. major symptoms are related to the bones due to an increased bone resorption and a decreased bone formation leading to bone pain and increased risk of fractures. the normal osteoclasts are responsible for bone degradation through stimulation from the malignant plasma cells. bisphosphonates have been shown to inhibit the osteoclast activity but may have serious side-effects due to renal toxicity and the optimal dose have not been established. in a randomized double blinded design it is aim to compare the standard of monthly injections of 90 mg pamidronate with 30 mg. the primary end-point is physical function estimated by eortc qlq-c30 questionnaire at 12 months after starting the treatment in newly diagnosed treatment demanding multiple myeloma. secondary end-points are skeletal related events, cost-utility analysis, response, response duration and survival and quality of life with respect to fatigue and pain.

patients with newly diagnosed treatment demanding multiple myeloma are after informed consent and approved inclusion criteria randomised by telephone call to copenhagen trial unit (ctu) and information on the target dose is send to the distributor, amgros, and the local pharmacy for preparation of the pamidronate solution. infusion is given for 2½ hours. before starting treatment the patient has to fulfil the first eortc qlq-c30 questionnaire that is send to the quality of life secretariat in oslo, norway. subsequent questionnaires are mailed directly to the patients every third month. the infusions are continued for 3 years and may be extended further upon the patient's request. every third month the number of skeletal event, the response and complications are recorded. skeletal x-rays are performed 9 and 24 months after starting the treatment.

Eligibility criteria:
inclusion criteria: * new diagnosed multiple myeloma with treatment demanding disease exclusion criteria: * life-expectancy less than 3 months, another active malignant disease, treatment with bisphosphonates for more than 3 months within the last 6 months, patients with creatinine above 400 µmol/l 4 weeks after starting chemotherapy, patients who cannot cooperate for monthly infusions, patients who do not give their informed consent

Keywords: multiple myeloma pamidronate prophylaxis dose comparison quality of life skeletal event response survival
safety of alk ragweed tablet

Conditions: Allergy

Summary: this trial is performed to assess whether alk ragweed tablet is safe to use in adults


Eligibility criteria:
inclusion criteria: * ragweed pollen induced rhinoconjunctivitis * adults of either sex (18-50 years of age) * positive skin prick test to ragweed exclusion criteria: * previous treatment with immunotherapy
[18f]hx4 pet/ct imaging for detection of hypoxia

Conditions: Head and Neck Cancer; Lung Cancer

Summary: the aim of this study is to investigate the radiotracer \[18f\]hx4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. each participant will undergo a diagnostic \[18f\]hx4 pet/ct scan before beginning radiotherapy treatment. patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether \[18f\]hx4 pet/ct scanning can predict patient outcome from radiotherapy treatment.


Eligibility criteria:
inclusion criteria: * patients with: 1. biopsy proven non-small cell carcinoma of the lung \>2.5 cm in size with any t and n status but m0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or 2. squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or nodal mass \>2. 5 cm in size, with any t and n status but m0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent. * participant must be willing and able to give informed consent for participation in the study. * patients must be 18 years old or above. * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. * have normal renal function, defined by creatinine clearance of \>60 ml/min. * able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination. * able (in the investigators opinion) and willing to comply with all study requirements. * willing to allow his or her general practitioner and hospital consultant, if appropriate, to be notified of participation in the study exclusion criteria * patients who are scheduled for surgery prior to radiotherapy will not be included. * female participant who is pregnant, lactating or planning pregnancy during the course of the study. * chronic kidney disease stage iii or worse, as defined by the nkf clinical practice guidelines (gfr \<60 ml/min per 1.73 m3 for 3 months or more). * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study. * participants who have been involved in another research study involving an investigational product in the past 12 weeks. * previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the investigators could compromise the data. * previous cancer diagnosis.

Keywords: hypoxia hx4 pet ct radiotherapy