Kornimate/medical-research-clean huggingface dataset:
clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis

Conditions: Japanese Patients With ALS

Summary: to evaluate the pharmacokinetics of single doses of edaravone oral suspension in patients with amyotrophic lateral sclerosis


Eligibility criteria:
inclusion criteria: the key criteria are listed below. * patients aged between 20 and 75 years at the time of informed consent * japanese patients * among patients with als, those "clinically definite als," "clinically probable als" or "clinically probable-laboratory-supported als" according to el escorial revised airlie house criteria * patients who can consent to contraception * patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study exclusion criteria: the key criteria are listed below. * patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy * patients undergoing treatment for malignancy * patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except als) and infections requiring antibiotics. patients who have a problem in general condition and are judged ineligible by the investigator * body mass index (bmi) of \ 30.0, or a body weight of \<50 kg * patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
program to prevent osteoporosis in girls

Conditions: Osteoporosis

Summary: osteoporosis is a condition defined by decreased bone mass. osteoporosis generally affects older women and can lead to bone fractures. one way to prevent osteoporosis is to build strong, healthy bones during childhood. this study will evaluate a program designed to improve girls' bones. the program encourages eating foods rich in calcium and participating in physical activity.

osteoporosis affects more than 25 million people in the united states. the majority of bone fractures in older women are related to osteoporosis. calcium intake and physical activity are two modifiable behaviors associated with peak bone mass. interventions targeting these behaviors among youth have tremendous public health potential for preventing osteoporosis. this study will assess the feasibility and effectiveness of a 2-year behavioral program designed to increase calcium intake and physical activity among girls ages 9 to 11. thirty girl scout troops will be recruited for the study. girls will be randomized either to the eating and exercise behavior change program or to a control group. program components focus on behavioral skills development, goal setting, and self-monitoring for dietary calcium intake and physical activity. the program also works to increase social support from peers and parents. the program will take place during 10 weeks of both the 5th and 6th grade years. the program also includes supporting programs during winter and summer breaks. outcome assessments will be conducted at baseline, and at 6, 12, and 24 months. primary outcomes will include dietary calcium intake, physical activity, and bone mineral density.

Eligibility criteria:
inclusion criteria * member of a girl scout troop with at least eight 5th grade girls * member of the greater minneapolis or st. croix valley girl scout organization * only troops with unanimous parental consent will be included in the trial

Keywords: bone health weight-bearing physical activity calcium
gut microbiome profiling in patients with chronic heart failure

Conditions: Heart Failure With Reduced Ejection Fraction; Nonischemic Cardiomyopathy

Summary: the goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. the main questions the study aims to answer are: 1. how does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure? 2. how do these changes relate to heart failure disease severity and complications?

during this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. these individuals will undergo longitudinal profiling. this will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.

Eligibility criteria:
inclusion criteria: * heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%) * non-ischemic cardiomyopathy * body mass index (bmi) 18-40 kg/m2 exclusion criteria: * treated diabetes * advanced kidney disease * cirrhosis * significant gastrointestinal disease including any history of inflammatory bowel disease * history of extensive bowel resection * active malignancy or systemic chemotherapy within the past 12 months * active infection * current or recent (within 4 weeks) use of systemic antibiotics, commercial probiotics, immunosuppressive or immunomodulatory medications * pregnancy/lactation

Keywords: gut microbiome gut microbiota heart failure nonischemic cardiomyopathy multiomics
non-invasive stroke volume-based ﬂuid management in elderly patients undergoing hip fracture surgery under spinal anaesthesia

Conditions: Fluid Management; Haemodynamic Instability

Summary: the study is going to be a single-centre prospective randomized trial. patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (sv) algorithm with the use of nexfin monitor. primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. secondary outcomes included the incidence of intraoperative hypotensive episodes (with map\<65mmhg) in both groups and the requirement of vasoactive drugs to support blood pressure

the study is going to be a single-centre prospective randomized trial in elderly patients undergoing hip fracture surgery under spinal anesthesia. patients will be randomly allocated to either control group (anesthetist-directed fluid therapy) or goal directed fluid therapy group, in which fluid therapy was guided by stoke volume (sv) algorithm with the use of nexfin monitor. in patients of the control group management of the hemodynamic status will be performed in the discretion of the attending anesthesiologist, with the aim of keeping mean arterial pressure (map) \> 65mmhg. the type and amount of delivered fluids, and vasoactive or inotropic drugs will be recorded. in goal directed fluid therapy group, fluid management will be guided by the nexfin monitor, based on stroke volume of the patient under continuous tracking. baseline sv will be measured after the patients will be turned to left/right position (at which they are going to stay throughout the whole procedure) and before the implementation of regional anesthesia. fluid challenges of 250 ml will be repeated until the sv fails to increase by 10%. at this point, preload is considered optimized and sv optimum iss defined. sv trigger is defined as sv opt - 10%. after obtaining these values, the anesthetic and surgical interventions could proceed. during surgery, n/s 250ml boluses will be administered when sv is below sv trigger. inotropic drugs will be administered (dobutamine infusion at 0.2-10mcg/kg/min) if co is below 3.5 l/min and vasopressors (phenylephrine bolus doses of 50-100mcg) if sv and co are within the target range but map is below 65mmhg. primary outcome measures were the time to hospital discharge since surgery and the occurence of complications developed during the postoperative period. secondary outcomes included the incidence of intraoperative hypotensive episodes (with map\<65mmhg) in both groups and the requirement of vasoactive drugs to support blood pressure

Eligibility criteria:
inclusion criteria: * patients scheduled for hip fracture repair * over 60 years of age * american society of anesthesiologists (asa) physical status ii, iii, iv exclusion criteria: * refusal or inability to consent, * a plan for general anesthesia * expected unreliable measurements of nexfin monitor (e.g. peripheral vascular disease, finger edema).
vanderbilt childhood obesity registry

Conditions: Childhood Onset Obesity; Pediatric Obesity; Childhood Obesity

Summary: in order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

obesity is an epidemic effecting the pediatric population. currently, 17% of children are classified as obese and 32% as overweight. many of these children develop complications including type 2 diabetes, dyslipidemia, hypertension and hepatic steatosis. obesity is a global epidemic that lacks effective treatment options. obesity has many underlying causes including genetic predisposition and environmental factors. understanding the genetic basis of obesity may allow for more precisely targeted interventions including specific dietary plans and pharmacologic treatments. the most common cause of genetic obesity is haploinsufficiency of the melanocortin-4 receptor (mc4r). in obese adult cohorts, the prevalence of pathogenic mc4r mutations is 1-2%. commercial testing is available for many obesity syndromes, but the cost is high and charges are not always covered by insurance. clinicians have little motivation to test patients for mc4r mutations as no treatments are available and it is not clear if genetic testing results change patient behavior. this particular lab and other groups are working to develop novel pharmacologic treatments for obesity syndromes, such as mc4r deficiency. in order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, the investigators aim to develop a registry for patients with early onset obesity.

Eligibility criteria:
inclusion criteria: 1. bmi \>97th percentile for age and gender before 6 years old 2. able to give written, informed consent/assent exclusion criteria: 1. diagnosis of prader-willi syndrome 2. use of exogenous steroids or other medications known to cause abnormal weight gain 3. cushing's syndrome, untreated growth hormone deficiency or untreated hypothyroidism as an etiology for the obesity 4. hypothalamic obesity (obesity due to a brain tumor, head trauma or other brain lesion) 5. currently pregnant
botulium toxin type a in non infectious chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: the present work aims to assess the effectiveness and safety of topical application of btx - a compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients

a prospective comparative study will be carried out on 30 participant of both sex at otorhinolaryngology department, benha university hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing. the patients will be divided randomly into two groups: * group a (topical group) : 15 patients * group b (injected group) : 15 patients all patients will be subjected to: 1. full clinical evaluation: a) full history taking b) clinical examination by * anterior rhinoscopy to evaluate the nasal cavity to exclude purulent discharge , nasal polyps or anterior septal deviation. * nasal endoscopy to exclude nasal infection signs ,nasal polyps ,the posterior septal deviation or adenoid . c) investigations:ct nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology . 2. intervention : * btx -a available in the egyptian market in the form of powder vial (allergan) containing 100 units, will be dissolved in 10 cc saline to obtain clear colorless solution in which each 1cc contain 10 units. * in group a (topical group) ,topical application in the form of merocel soaked with 20 units of btx_a (2ml) will be placed at each side of the nasal cavity for 30 minutes. * in group b (injected group), 20 units of btx_a (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . 3. follow up follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness .

Eligibility criteria:
inclusion criteria: * patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study. exclusion criteria: * patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps). * having systemic illness such as dm, htn, malignancy or tuberculosis. * history of nasal surgery such as turbinate reduction surgery orseptoplasty. * acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge * radiological finding of nasal tumors or fungal sinusitis. * any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy . * use of systemic or local corticosteroid less than 1 month prior the study. * pregnancy or lactation. * history of allergy to botox or local anesthetic agents.

Keywords: chronic rhinosinustitis botulium toxin a
bendamustine plus rituximab for mantle cell lymphoma: a multicenter retrospective analysis(br-mcl)

Conditions: Mantle Cell Lymphoma

Summary: this study with retrospective data collection does not entail sample size calculation. the study will involve patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma and meet the inclusion/exclusion criteria at each participating study site. considering the incidence of mantle cell lymphoma in korea and the number of participating sites, the expected sample size is approximately 40.

1. inclusion criteria : patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the who classification) 1) mantle cell lymphoma 2) leukemic non-nodal mantle cell lymphoma 3) in situ mantle cell neoplasia 2. age ≥ 19 years 3. patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included. 2. exclusion criteria : 1. patients whose clinical and pathological data are not available 2. patients who were not treated with a combination of bendamustine and rituximab data of patients who received bendamustine + rituximab for relapsed/refractory mantle cell lymphoma collected before the date of first submission of an irb application for new project will be analyzed. the aim is to publish the data analysis and study results before december 2020. the expected overall study period is until december 2020.

Eligibility criteria:
inclusion criteria: * 1. patients newly diagnosed with mantle cell lymphoma by a pathologist (based on the 2016 revision of the who classification) 1. mantle cell lymphoma 2. leukemic non-nodal mantle cell lymphoma 3. in situ mantle cell neoplasia 2. age ≥ 19 years 3. patients who received bendamustine + rituximab as initial therapy and patients who received bendamustine + rituximab for the treatment of relapsed/refractory condition are both included. exclusion criteria: * 1. patients whose clinical and pathological data are not available 2. patients who were not treated with a combination of bendamustine and rituximab
pain perception of people who are unable to have headache

Conditions: Headache; Pain, Head; Muscle Tenderness; Healthy

Summary: headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in europe. despite this high prevalence, there are persons who have never, in their whole life, encountered a headache. the aim of the study is to identify factors that protect against headache by studying pain perception, muscle tenderness and pain tolerance in people who never have had a headache (headache resistant) versus non-resistant controls. the investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache. the investigator examining: quantitative sensory testing (cold pain threshold and heat pain threshold), muscle tenderness (total tenderness score) and cold pressor test (time in the water and pain rating). all tests are performed the same day, by one investigator who are blinded to the grouping of the participants.


Eligibility criteria:
inclusion criteria: * headache resistant and non-resistant male participants from the danish blood donor study. * weight: 45 kg to 95 kg exclusion criteria: * daily consumption of any medication. * consumption of any medication less than 12 hours prior to the study day. * headache on the study day or 48 hours prior to the study day. * amnestic or clinical signs of hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) or hypotension (systolic blood pressure \<90 mmhg and/or diastolic blood pressure \<50 mmhg). * any severe cardiovascular disease, including cerebrovascular illness. * amnestic or clinical signs of current mental illness. * amnestic or clinical signs of current substance or drug abuse. * amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.

Keywords: headache healthy muscle tenderness quantitative sensory testing cold pain threshold heat pain threshold total tenderness score cold pressor test headache resistant
a study assessing rocatinlimab on vaccine antibody response in moderate-to-severe atopic dermatitis (ad) (rocket - voyager)

Conditions: Atopic Dermatitis; Moderate-to-severe Atopic Dermatitis

Summary: the primary objectives of this study are to: * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at week 24 * estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococcal response at week 24


Eligibility criteria:
inclusion criteria: * age ≥ 18 years to 54 years with a diagnosis of ad according to the american academy of dermatology (aad) consensus criteria (2014) present for at least 12 months * history of inadequate response to topical corticosteroids (tcs) of medium, high, or higher potency (with or without topical calcineurin inhibitors) * subjects with previous systemic treatment for ad are also considered as inadequate responders to topical treatments and are potentially eligible to be included in the study after appropriate washout. * validated investigator's global assessment for atopic dermatitis (viga-ad) score ≥ 3 exclusion criteria: * treatment with a biologic product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 * treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1: * systemic corticosteroids * systemic immunosuppressants * phototherapy * janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week, prior to day 1: * tcs of any potency * topical calcineurin inhibitors (tci) * topical phosphodiesterase-4 inhibitors (pde4) * other topical immunosuppressive agents * combination topical agents containing a corticosteroid or calcineurin inhibiting component, pde4 inhibitors, or other topical immunosuppressive agents * treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 pre-randomization. * treatment with any meningococcal vaccine within 1 year prior to screening, or treatment with any tetanus-, diphtheria-, or pertussis containing vaccine within 5 years prior to screening

Keywords: moderate-to-severe atopic dermatitis ad rocatinlimab
rtms for post-stroke fatigue

Conditions: Stroke; Stroke, Chronic; Fatigue

Summary: this experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for people with post-stroke fatigue. fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. participants in this trial will receive a type of magnetic stimulation called repetitive magnetic stimulation, or rtms. the investigators will measure feelings of fatigue, and other clinical characteristics related to mood and cognition, before and after participants receive rtms.


Eligibility criteria:
inclusion criteria: * 35 - 80 years of age * more than 6 months post-stroke * able to walk 10m unassisted * clinically present fatigue exclusion criteria: * contraindications to mri/tms/rtms (e.g. implanted metal within the head, history of seizures) * inability to follow simple three-step instructions * multiple strokes on opposite hemispheres * cerebellar and/or brainstem strokes * diagnosed comorbid neurological conditions (e.g. multiple sclerosis, parkinson's disease, moderate/severe tbi) * comorbid psychological conditions (e.g. depression, anxiety, ptsd) * strokes within stimulation sites * pregnancy * severe hypertension (resting sbp \> 200, dbp \> 120)

Keywords: non-invasive brain stimulation post-stroke fatigue perception of fatigue repetitive transcranial magnetic stimulation rtms
dexamethasone-induced hiccup in chemotherapy patients treated by methylprednisolone rotation

Conditions: Dexamethasone-induced Hiccup in Chemotherapy

Summary: the aims of this study were to investigate the feasibility of methylprednisolone rotation as treatment of dih.

we planned a randomized prospective trial for cancer patients with dih. the objective of the present study was to determine whether the rotation of corticosteroids affects the incidence and intensity of dih without compromising the antiemetic efficacy.

Eligibility criteria:
inclusion criteria: * all solid cancer patients on chemotherapy * age \>18 years * received dexamethasone as an antiemetic exclusion criteria: * brain metastases * hiccups before dexamethasone administration * uncontrolled diabetes mellitus * uncontrolled esophagitis or peptic ulcer

Keywords: dexamethasone hiccup chemotherapy methylprednisolone