Kornimate/medical-research-clean huggingface dataset:
long-term safety and tolerability of subcutaneous administration of tev-48125 for the preventive treatment of migraine

Conditions: Migraine

Summary: to evaluate the long-term safety and tolerability of subcutaneous (sc) administration of tev-48125 (at 225 mg once monthly \[except for a loading dose of 675 mg for cm patients\] or at 675 mg every 3 months) for the preventive treatment of chronic migraine and episodic migraine patients


Eligibility criteria:
inclusion criteria: * patient has a history of migraine (according to the international classification of headache disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis * patient fulfills the criteria for chronic migraine or episodic migraine in baseline information collected during the 28 day screening period * not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent. * patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator. exclusion criteria: - hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
acute effects of whole body vibration for individuals with parkinson disease

Conditions: Parkinson Disease

Summary: this is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with parkinson disease.

this study will provide valuable information towards the relationship between backward walking using the 3-minute backward walk test and whole body vibration (wbv). the 3mbwt has shown to have diagnostic accuracy for fall prediction in older adults. the 3mbwt has been found to be feasible within the acute stroke population. in a study, the 3mbwt revealed that in the geriatric population a score of more than 4.5 seconds were likely to report a fall history. gait parameters including a decrease in gait velocity (p\<0.01) have been found to worsen while performing dual tasks (serial-7 subtraction) in individuals with pd. research has shown when compared to other cognitive tests, the "serial sevens" tests increased the time required to perform the timed up and go in individuals with pd. this study will use a control group performing mid-squats on level ground and an intervention group performing mid-squats on a wbv machine. each group will perform 5 sets of mid-squats for 60 seconds with a 60 second rest period between each set. pre and post testing will involve three trials of the 3mbwt. the purpose of this study is to determine the immediate impact of wbv on backward walking velocity in individuals diagnosed with pd.

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson disease (pd) * classified hoehn and yahr stages i - iv * ability to walk independently for at least 5 minutes * alert and oriented to person, place and time * age between 40-85 years old exclusion criteria: * deep-brain stimulation surgery less than 24 months prior to the start of the study * physician changes in deep-brain stimulation parameters during the study * acute orthopedic injury or surgery that could impact gait * a neurological condition other than pd

Keywords: parkinson disease backward walking whole body vibration
elevate, a registry of patients with acute hepatic porphyria (ahp)

Conditions: Acute Hepatic Porphyria

Summary: this global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with ahp, and to further characterize the real-world safety and effectiveness of givosiran and other approved ahp therapies.


Eligibility criteria:
inclusion criteria: * documented diagnosis of ahp, per physician's determination exclusion criteria: * currently enrolled in a clinical trial for any investigational agent

Keywords: givosiran ahp acute hepatic porphyria
behavioral and pharmacologic treatment of binge eating and obesity: maintenance therapy

Conditions: Binge-Eating Disorder; Obesity

Summary: this study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (bed) in patients with obesity. this is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

binge eating disorder (bed), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. improved treatments for patients with obesity and bed are needed that can produce sustained clinical outcomes and promote weight loss. this study (maintenance stage) rct will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether nb medication results in superior maintenance and longer-term outcomes than placebo. this is the first controlled test of maintenance pharmacotherapy for bed and will be only the third rct for bed of any medication with follow-up after medication discontinuation.

Eligibility criteria:
inclusion criteria: * participated in acute treatment for binge-eating disorder and obesity; * had a positive response to acute treatment; * available for the duration of the treatment and follow-up (20 months); * read, comprehend, and write english at a sufficient level to complete study-related materials; and * able to travel to study location (new haven, ct) for monthly visits. exclusion criteria: * currently taking anti-depressant medications; * currently taking opioid pain medications or drugs; * currently taking medications that influence eating/weight; * history of seizures; * current substance use disorder or other severe psychiatric disturbance (e.g., suicidality); * past or current anorexia nervosa, bulimia nervosa; * pregnant or breastfeeding; * medical status judged by study physician as contraindication.
ultrasonographic assessment of lung recruitment maneuvers in children undergoing lengthy microsurgery operations

Conditions: Intraoperative Complications

Summary: the aim of this study will be to explore the clinical value of ultrasonic monitoring in the diagnosis of anesthesia-induced atelectasis, the assessment of the effects of lung recruitment, the best positive end-expiratory pressure (peep) after rm and in the detection of the point of lung re-collapse after rm in pediatric patients undergoing lengthy microsurgery operations using two levels of intraoperative fio2 (0.5 versus 0.3).

* to maximize the benefits, minimize the drawbacks and assess the adequacy of the recruitment maneuver; adequate monitoring at the bedside is essential. several methods have been proposed, including measuring end-expiratory lung volume or pulmonary compliance, volumetric capnography, oxygenation indices, electrical impedance tomography, computerized tomography and lung ultrasound. * for lung ct examination patients must be transported out to the radiation unit, which carries risk of transfer, high cost, and radiation exposure. the oxygenation method which is the most commonly used, but it is necessary to repeat arterial blood collection many times, which is cumbersome and expensive. * using lung ultrasound (lus) as real-time guidance during the recruitment maneuver has gained popularity recently owing to its' easy applicability and non-invasive nature. sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases in children, including obstructive and compressive atelectasis of different origins. furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis in children. * lus can identify children needing a recruitment maneuver to re-expand their lungs and help optimize ventilator treatment during anesthesia.

Eligibility criteria:
inclusion criteria: * age: 2-12 years old. * asa physical status classification i-ii. * undergoing lengthy microsurgery operations * and requiring endotracheal intubation and mechanical ventilation for more than 4 hours.- exclusion criteria: * asa physical status classification \>ii. * thoracic or abdominal surgery. * preexisting lung disease. * pre-operative chest infection or abnormal chest us findings. * cardiac patients.-
car-t cells for relapsed or refractory haematopoietic and lymphoid malignancies

Conditions: Leukemia; Lymphoma; Multiple Myeloma of Bone (Diagnosis)

Summary: this is an open, single-arm, phase i/phase ii clinical study to evaluate efficacy and safety of chimeric antigen receptor t cell immunotherapy (car-t) in the treatment of hematopoietic and lymphoid malignancies. a total of 50 patients are planned to be enrolled over a period of 2 years.

chimeric antigen receptor (car)-modified t cells targeted against cd19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. besides cd19, many other molecules such as cd22, cd30,bcma, cll-1, etc. may be potential in developing the corresponding car-t cells to treat patients whose tumors expressing those markers. investigators have developed a high efficient platform for constructing different cars and preclinical studies have demonstrated effective killing of corresponding target cells. in this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. the primary goal is safety assessment including cytokine storm response and any other adverse effects. in addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. be diagnosed a kind of relapsed or refractory haematopoietic and lymphoid malignancies: 2. ecog score≤2; 3. to be aged 1 to 70 years; 4. more than a month lifetime from the consent signing date. exclusion criteria: 1. serious cardiac insufficiency, left ventricular ejection fraction\<50%; 2. has a history of severe pulmonary function damaging; 3. merging other progressing malignant tumor; 4. merging uncontrolled infection; 5. merging the metabolic diseases (except diabetes); 6. merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis b or hepatitis c; 8. patients with hiv infection; 9. has a history of serious allergies on biological products (including antibiotics); 10. has acute gvhd on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; 11. pregnancy or lactation women; 12. any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
remote mental practice for freezing of gait in parkinson's disease: a randomized controlled trial

Conditions: Parkinson Disease; Freezing of Gait

Summary: this single-blind, randomized controlled trial investigates the effects of a remotely delivered intervention based on mental practice (mp) combined with physical practice (pp) on freezing of gait (fog) severity in people with idiopathic parkinson's disease (pd). fifty participants will be randomly assigned to either the experimental group (mp + pp) or a control group (pp + stretching). the intervention consists of 10 video-supervised sessions over 6 weeks. primary outcomes include the rapid turn test and percentage of time spent with fog (%fog). secondary outcomes include the new freezing of gait questionnaire (nfog-q), movement disorders society-unified parkinson's disease rating scale (mds-updrs), parkinson's disease questionnaire-39 (pdq-39), and telephone montreal cognitive assessment (t-moca). the study aims to demonstrate whether mp using dynamic neuro-cognitive imagery (dni) techniques can effectively reduce fog severity and improve motor and cognitive function in people with pd.

this trial aims to evaluate a home-based remote intervention delivered via encrypted video calls by physiotherapists trained in both mental practice (mp) and physical practice (pp) protocols. participants undergo 10 structured training sessions, each lasting 45-60 minutes, across six weeks. the experimental intervention consists of two blocks of first-person kinesthetic mp and two blocks of corresponding pp. the mp is guided using dni principles, emphasizing goal-directed control, body schema reinforcement, and environmental context. each block lasts approximately 10 minutes and focuses on gait-related challenges. safety measures, including environmental checks and the presence of a caregiver (when applicable), are verified before each session. the control group performs the same physical practice but replaces the mp with guided seated stretching exercises. assessments are conducted at baseline, post-intervention, and 30-day follow-up, by a blinded evaluator. the rapid turn test is video-recorded and independently analyzed. a repeated measures anova will be used for statistical analysis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic pd; * use of dopaminergic medication; * experiencing fog (positive response to the first question of the new freezing of gait questionnaire - nfog-q); * able to walk independently at home; * access to internet and video call device; * agree to participate in the study. exclusion criteria: * other neurological disorders; * severe cardiovascular and/or respiratory alterations; * uncorrected visual and/or auditory alterations; * cognitive impairment, detectable through the telephone montreal cognitive assessment (t-moca, \< 12); * inability to perform motor imageryt during the administration of the kinesthetic and visual imagery questionnaire - 20 (kviq-20, \< 20)

Keywords: parkinson disease freezing of gait mental practice telerehabilitation dynamic neuro-cognitive imagery motor imagery gait disorders
impact of obesity on postural control

Conditions: Balance; Postural Control; Mechanical Factor

Summary: the goal of the present study was to objectively evaluate the postural behaviour of type ii obese patients as compared to adults showing a normal body mass index (bmi) in critical postural tasks.


Eligibility criteria:
inclusion: * bmi \> 35 or bmi \< 25 exclusion: * muscular, neurological or cardiovascular deficits * competitive physical activities
improving sleep quality in heart failure

Conditions: Sleep Disturbance; Heart Failure

Summary: poor sleep quality is common in patients with heart failure. the limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. however, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. the nonbenzodiazepine, gaba receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. the investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.


Eligibility criteria:
inclusion criteria: * age 21-79 years old * hfref, ef ≤ 45% (by echocardiography) * nyha functional class i to iii * able to give written consent * on goal-directed medical therapy for hf, with stable dosing of hf medications for 2 weeks prior to enrollment * no hospitalizations for hf within the past month * positive response to experiencing any of the following sleep-related symptoms at least once a week: * difficulty falling asleep * waking up during the night and having difficulty getting back to sleep * waking up too early in the morning and being unable to get back to sleep. exclusion criteria: * use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks * current treatment with other sedating medications such as opioids * on therapy for pharmacological therapy for depression * history of alcohol/drug dependence * history of liver disease, hiv, or severe copd * on thorazine * current use of ketoconazole * current use of tricyclic antidepressants * current use of macrolide antibiotics * current use of anticonvulsant medications * pregnancy. a urine pregnancy test will be performed to exclude pregnancy in potential subjects.
increased rate of prophylaxis against venous thromboembolism due to ealerts

Conditions: Venous Thromboembolism

Summary: now, after a cluster randomized controlled trial, ealerts providing evidence-based guidelines on venous thromboembolism prophylaxis will be rolled out and evaluated hospital-widely.

an ealert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer. the ealerts provide evidence-based guidelines on venous thromboembolism prophylaxis. now, after a cluster randomized controlled trial, the ealerts will be rolled out and evaluated hospital-widely.

Eligibility criteria:
inclusion criteria: * all in-patients hospitalized in a ward with computerized physician order entry (cpoe), * staying at least 24 h in a ward exclusion criteria: * outpatients, * ward without cpoe, * patients transferred from an intervention to a control ward and vice versa

Keywords: venous thromboembolism/prevention & control
improving the humoral response to influenza vaccine in lung transplant recipients by an intradermal strategy

Conditions: Lung Transplantation; Influenza Vaccines

Summary: the purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients

influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. there are no studies that define the effect of intradermal doses in this population. we plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. after the initial i.m. injection, a second dose will be given intradermally 4 weeks later. antibody titers will be evaluated by a standard hemagglutination inhibition assay. we hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.

Eligibility criteria:
inclusion criteria: * lung transplant recipients greater than 3 months post-transplant exclusion criteria: * · egg allergy * previous life-threatening reaction to influenza vaccine (ie guillain barre syndrome) * on anticoagulants such as warfarin that precludes intramuscular injection * ongoing therapy for rejection * febrile illness in the past two weeks * unable to provide informed consent

Keywords: influenza vaccine intradermal lung transplantation
nociplastic pain symptoms and sensory profiles in low back pain

Conditions: Central Sensitisation; Low Back Pain

Summary: assessing associations between sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.

therefore, the investigators aims are: * the primary aim of the study is to assess associations between sensory profiles (adolescent/adult sensory profiles) and nociplastic pain symptoms, in the acute and chronic low back pain population. * the secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.

Eligibility criteria:
inclusion criteria: * patients with non-specific lbp * with or without radiating pain * aged 18-65 years * able to read and understand the dutch language exclusion criteria: * previous lumbar spinal surgery * radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.
the usefulness of interferon-γ release assays and tuberculin skin test for detection of latent tuberculosis infection

Conditions: Rheumatic Disease; Rheumatoid Arthritis; Ankylosing Spondylitis; Tuberculosis

Summary: the purposes of this study 1. to compare the positivity of tuberculin skin test(tst) and quantiferon-tb gold (qft-g), and determine the level of agreement between two tests in patients with rheumatic diseases 2. to evaluate the difference in the occurrence of active tb in patients who receive both qft-g and tst compared with those who receive only tst for detecting of latent tuberculosis infection(ltbi) who are candidates of tnf inhibitors.

study assessment 1. the positive rates of qft-g and tst as a screening test for ltbi * the positive rates of qft-g and tst will be analyzed * additional analysis will be performed according to the type of disease 2. the agreement between qft-g and tst as a screening test for ltbi * the agreement between qft-g and tst will be analyzed for patients with rheumatic diseases who examined both qft-g and tst * additional analysis will be performed according to the type of disease 3. the correlation of the occurrence of active tb and two tests (qft-g and tst) * the analysis of the correlation of the occurrence of active tb and two tests will be conducted for patients who have experienced anti-tnf agents 3-1. the occurrence of active tb in accordance with results of tst 3-2. the occurrence of active tb in accordance with results of qft-g 3-3. the difference in the occurrence of active tb in patients performed both qft-g and tst compared with those performed only tst for detecting of ltbi who are candidates of tnf inhibitors (pilot study).

Eligibility criteria:
inclusion criteria: * patients with rheumatic diseases who examined tst or qft-g in hanyang university hospital from 2004 to 2010 exclusion criteria: * n/a

Keywords: rheumatic disease, latent tuberculosis