Kornimate/medical-research-clean huggingface dataset:
rtms in treatment of spasticity

Conditions: ALS

Summary: this is an open-label clinical trial to determine the safety and efficacy of rtms in reducing spasticity and improving quality of life among patients with upper motor neuron predominant motor neuron disease (mnd).

the study's objective is to evaluate the role of rtms for symptom reduction of spasticity among patients with upper motor neuron predominant motor neuron disease. this study is 12-week open label safety and efficacy trial. a total of 10 subjects with pls and umn/ mnd will be enrolled in this study.

Eligibility criteria:
inclusion criteria * age ≥ 18, men or woman * diagnosis of upper motor neuron predominant als, which also includes patients with primary lateral sclerosis (pls), as defined as only upper motor neuron features in at least 2 body segments. * emg within 3 months of enrollment with minimal or no evidence of lower motor neuron disease. * time from symptom onset \> 18 months * on a stable dose of, or has not taken, riluzole for at least thirty days. * has not taken, or has received at least 2 cycles of dosing of, edaravone prior to screening. * able to communicate clearly the desire to withdraw from the procedure at any stage. * impaired walking as measured by a hauser ambulation index of greater than 1 and less than 7 (2 to 6, inclusive). * mmse ≥ 22 and deemed by the pi as being capable of providing informed consent and following trial procedure. * has spasticity, equal or above 1 in the ashworth scale for spasticity in 2 or more muscle group of at least 3 months duration. * absence of exclusion criteria. exclusion criteria * patient has a history of drug or alcohol abuse within the past year; * patient has clinically significant abnormal laboratory values. * any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity * received botulinum toxin during the preceding 6 months * bedridden and patients with tracheostomy. * fixed-tendon contractures * poorly controlled epilepsy or recurrent seizures (subjects who have had one or more seizures in the year prior to visit 1 will be excluded) * unable to provide an informed consent * unable to comply with the procedures * unable to communicate clearly if the subject wants to withdraw from the procedure at any stage * history of brain surgery for any indication * has pacemaker, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices above the neck (dental implants are permitted), piercing or body modification above the neck, known history of tms related complications or side effects. * mmse \<22. * female patients of child bearing period who are not practicing contraception. * female patients who are pregnant. * inability to perform either rtms due to insufficient mep amplitude (\< 50 µv).
prevalence of mental health issues in endurance athletes.

Conditions: Depression, Anxiety; Mental Health Issue

Summary: participation in endurance sports has been increasing over the last few decades and our aim of our exploratory descriptive survey study is therefore to examine mental health issues in endurance athletes (marathon runners, ultra endurance runners, triathletes), employing the ioc assessment tool, to provide information on mental health issues in this population. secondary objects are to evaluate risk factors for mental health issues in endurance athletes (like exercise behaviour, competition behaviour, age, gender, medical issues)

this study is an exploratory descriptive survey study. the study protocol will be largely replicated from the ioc consensus paper and the questionnaires based according to smhat 1 with an athlete-specific screening tool (apsq) and further eleven subsequent disorder-specific screening tools: eleven disorder specific screening tools: 1. general anxiety disorder-7 (gad-7): assesses the presence of symptoms of anxiety. 2. patient health questionnaire-9 (phq-9): assesses the presence of symptoms of depression. 3. athlete sleep screening questionnaire (assq): assesses the presence of sleep disturbance. 4. alcohol use disorders identification test consumption (audit-c): assesses the presence of alcohol misuse. 5. cutting down, annoyance by criticism, guilty feeling, and eye-openers adapted to include drugs (cage-aid): assesses the presence of substance misuse, being slightly adapted for the smhat (no focus on alcohol use as already explored with the audit-c; additional question to explore which substance was used). 6. brief eating disorder in athletes questionnaire (beda-q): assesses the presence of disordered eating. 7. adhd 8. bipolar disorder 9. ptsd 10. gambling 11. psychosis additionally questions to assess exercise addiction will be used as it has been shown that exercise addiction may be particularly prevalent in endurance athletes. further questions about age, gender, country of origin, training data, past medical history and medication will be asked as well as a few specific questions about there thoughts on mental health issues as per ioc consensus paper

Eligibility criteria:
inclusion criteria: * endurance athletes (marathon runners, ultramarathon runners and triathletes) * over the age of 16 * all genders * recreational athletes (non- elite) * elite athletes (professional, international, college level) exclusion criteria: * athletes that that are not competing or have not competed in an official endurance race * athletes that are younger than 16 years of age.
abu dhabi sleep apnea (adsa) study

Conditions: Sleep Apnoea

Summary: obstructive sleep apnoea (osa) is a common medical problem which, despite increasing awareness, remains under-diagnosed. there is a close association between osa and obesity; 60-70% of patients diagnosed with osa are either obese or overweight \[1\]. osa is also very common among patients with type 2 diabetes. type 2 diabetes mellitus (t2dm) has reached epidemic status in the gulf region. osa worsens insulin resistance and leads to weight gain through sleep disturbance \[2\]. several mechanisms have been proposed for the associations of osa with diabetes and obesity \[3\]. at present there is little available information regarding the prevalence of osa in the uae, the relationship with t2dm and obesity, and the impact of osa on health outcomes in the emirati population. this research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.


Eligibility criteria:
inclusion criteria: participants aged between 18-64 years old. both gender male and female. exclusion criteria: paediatrics below the age of 18. any participant who is unable to take part
familylink and breastfeeding

Conditions: Breastfeeding

Summary: the central hypothesis guiding this project is that having mothers view live video of their babies while they are pumping increases milk volume, caloric density, and maternal pumping experience.


Eligibility criteria:
inclusion criteria: * mothers of 30 preterm infants (born before 34 weeks gestational age) admitted to the university of california, davis neonatal intensive care unit (nicu) * mother is pumping breastmilk * delivery at least 7 days prior * mother not an inpatient, exclusion criteria: * mother has hiv * mother without access to a computer, smartphone, or tablet to access familylink * infant delivered via surrogacy * maternal age outside limit of 18 to 50
epilepsy prevalence and intervention study in zhejiang province, china

Conditions: Epilepsy

Summary: to carry out the epidemiological investigation on epilepsy in zhejiang province, china, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.

to carry out the epidemiological investigation on epilepsy in zhejiang province, china, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.

Eligibility criteria:
inclusion criteria: newly diagnosed and untreated epilepsy; aged 14 and above; sign the informed consents. exclusion criteria: with intellectual development disorder; with serious heart and lung diseases.

Keywords: epilepsy prevalence, intervention
effect of caldine® on renal function in balanced hypertension

Conditions: Hypertension

Summary: the study aimed at comparing the evolution of renal function in patients showing a hypertension treated by various therapeutic strategies. due to the contract research organisation (cro) decision in september 2000, the database was locked and not accessible for boehringer ingelheim france. consequently it was decided to stop the study and not proceed to the analysis. thus, only safety data were processed in the safety database.


Eligibility criteria:
inclusion criteria: * patients with hypertension requiring treatment exclusion criteria: * none
phase iii study of asp2151 in herpes zoster patients

Conditions: Herpes Zoster

Summary: to evaluate the efficacy and safety of asp2151 (200 mg and 400 mg) in comparison with valaciclovir (vacv) 3000 mg in patients with herpes zoster.

a double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of asp2151 (200 mg and 400 mg) in comparison with valaciclovir (vacv) 3000 mg in patients with herpes zoster. the efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by day 4 of study treatment" to demonstrate the non-inferiority of asp2151 to vacv. the safety will be evaluated based on adverse events, laboratory tests, vital signs, and ecgs.

Eligibility criteria:
inclusion criteria: (1) patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash exclusion criteria: 1. patients who are not expected to have an adequate response to oral antiviral medication 2. an extreme decline in immune function 3. presence of serious complications 4. patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent: * ast or alt ≥ 2.5 x upper limit of normal * platelet count \< lower limit of normal * serum creatinine ≥ 1.5 mg/dl * creatinine clearance \< 50 ml/min 5. current or previous history of malignant tumor within 5 years before informed consent 6. diagnosis of autoimmune disease 7. evidence of bone marrow suppression
the predictive value of lubricin in patients with infective endocarditis

Conditions: Infective Endocarditis

Summary: the main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients

infective endocarditis is a challenging disease with a wide range of clinical presentations, making it difficult to diagnose. diagnosis primarily relies on clinical suspicion based on symptoms. blood cultures or other microbial tests confirming the presence of infection and echocardiography are supportive diagnostic tools. another marker that may become valuable in the near future for diagnosing infective endocarditis is lubricin. lubricin, a glycoprotein expressed by the prg4 gene, has been found to have significantly elevated levels in the plasma of animals with damaged or infected heart valves compared to healthy animals. furthermore, plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection. lubricin and procalcitonin will be studied from the blood samples routinely collected. during this academic study, procalcitonin and lubricin values will be measured by investigators. thus, the sensitivity and specificity of the lubricin parameter in patients with infective endocarditis will be evaluated.

Eligibility criteria:
inclusion criteria: * the patient must be between 18 and 65 years old * patients diagnosed with infective endocarditis according to the duke criteria exclusion criteria: - the patient being pregnant

Keywords: infective endocarditis lubricin glycoprotein procalcitonin
saeboflex dynamic hand orthosis for inpatient rehabilitation stroke patients

Conditions: Stroke

Summary: the purpose of this study is to determine what the potential utility of the functional tone management (f.t.m) arm training program using the saeboflex in an inpatient stroke rehabiliation hospital

therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. a significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. in an effort to address this deficit, the saeboflex dynamic hand orthosis was developed by occupational therapists. the f.t.m. arm training program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the last 2 years. it is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury outpatient population. two factors, other than the severity of the initial injury, have been clinically identified as having a significant affect on the outcomes achieved in f.t.m. arm training treatment. they are learned non-use and soft tissue shortening of the finger flexors. all treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. the purpose of this study is to explore the potential patient population that may qualify to use the saeboflex dynamic hand orthosis as a therapeutic option in the inpatient population.

Eligibility criteria:
inclusion criterion: * all patients admitted to the stroke rehabilitation program at the kessler institute for rehabilitation locations (east orange, saddlebrook, and chester). * approval from treating physician.

Keywords: stroke saeboflex hand function
safety study of gsk biologicals' rotavirus vaccine (rotarix®) administered to children aged <1 year in the united states

Conditions: Infections, Rotavirus

Summary: this observational cohort study, conducted through two existing large administrative health databases in the us (outside the vaccine safety datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with rotarix within 60 days of vaccination in a real life setting (routine use) in the us. this study will also include monitoring of kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination. this study involves three cohorts, one exposed and two control cohorts: infants who receive rotarix (exposed cohort) and infants who receive ipv vaccination (unexposed cohort a and b). this is a combined prospective and retrospective cohort study. prospective component of the study identifies and compares study outcomes following rotarix and ipv vaccination in the exposed cohort and unexposed cohort a, respectively. retrospective component of the study identifies and compares study outcomes following ipv vaccination in the unexposed cohort b.


Eligibility criteria:
inclusion criteria: for exposed cohort: * infants aged less than 1 year at study entry. * infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * have complete medical coverage and pharmacy benefits. * received at least one dose of rotarix from 1 august 2008. * infants receiving rotarix liquid formulation will also be eligible. for unexposed cohort a: * infants aged less than 1 year at study entry. * infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * have complete medical coverage and pharmacy benefits. * received at least one dose of ipv vaccine from 1 august 2008, with or without rotateq vaccination. * frequency-matched to the rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year. for unexposed cohort b: * infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth. * had complete medical coverage and pharmacy benefits. * received at least one dose of ipv vaccine. * vaccinated between 1 january 2006 (inclusive) and 31 july 2008 (inclusive). * not received any dose of rotavirus vaccination. * frequency-matched to the rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination. exclusion criteria: for exposed cohort: • subject has received any dose of rotateq prior to the first rotarix vaccine during the study period. for unexposed cohort a: • subject has received any dose of rotarix prior to the first ipv vaccine during the study period. for unexposed cohort b: • subject has received any dose of rotavirus vaccines prior to the first ipv vaccine.
study on cannabinoid receptor expression in gastrointestinal diseases

Conditions: Ulcerative Colitis; Crohn's Disease; Colon Cancer

Summary: the purpose of the study is to investigate phospholipid ligands and their receptors in inflammatory bowel diseases and colon cancer. several new species of lipids have been recently discovered which are able to transmit information to cancer cells in the large intestine. the lipids and their responsive receptors build an axis that is thought to influence the development of inflammation and cancer.

expression of cannabinoid receptors are examined in mucosal biopsies of the colon and blood leukocytes of patients with inflammatory bowel disease (ibd) or colon cancer in comparison to healthy individuals by polymerase chain reaction, western blots and flow cytometry. colonic endoscopic biopsies and blood are collected from adult patients with confirmed active ulcerative colitis (uc) and crohn's disease (cd), adult uc and cd patients in remission, colon cancer patients and from healthy individuals (controls). biopsies from healthy individuals (control group) will have undergone colonoscopy during standard screening for colorectal cancer or for the diagnostic workup of gastrointestinal symptoms without endoscopic or histologic evidence of colonic disease. for uc patients, duration and location of disease (montreal classification), endoscopic (mayo score) and clinical activity score, histological features and current and previous treatments (5-aminosalicylic acid, corticosteroids, immunomodulators) will be recorded. for cd patients, duration and location of disease is assessed, a harveybradshaw index and activity will be scored, histological features and current and previous treatments will be recorded. blood is collected and immediately processed for flow cytometric experiments. phospholipids are measured in serum and in colonic mucosal biopsy samples of all cohorts by mass spectrometry.

Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis (active/remission) * or crohn's disease (active/remission) * or colon cancer (or metastasis) exclusion criteria: * unable to give informed consent * pregnancy * intermittent illness or comorbidity during crohn/ulcerative colitis
novel approach to assess metabolic flexibility in a respiratory chamber

Conditions: Diabetes Mellitus, Type 2

Summary: the overarching aim of this study: to determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (δrq1) and sleep (δrq2) metabolic flexibility, as well as the time course changes in respiratory quotient, rq (i.e., peak rq, time to peak rq, nadir rq, time to nadir, slope).


Eligibility criteria:
inclusion criteria: * eligibility criteria include: * healthy male or female * ages 18-40 y * bmi between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted) * are willing to consume pre-prepared meals * are willing to maintain current physical activity, sleep schedule, and dietary habits during the study. * medically cleared for participation in the study by medical investigator exclusion criteria: * participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria: * unstable weight in the last 3 months \[gain or loss \>7 lb (or 3.2 kg)\] * currently working shift work * smoking or use of tobacco products within the last 3 months * amenorrhea (or absence of regular monthly cycles) * history of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dl * average screening blood pressure \>140/90 mmhg * previous bariatric surgery (or other surgeries) for obesity or weight loss * use of medications affecting metabolism or sleep * history of neurological disease * history of cardiovascular disease (or other chronic diseases) * pregnant, planning to become pregnant, or breastfeeding * adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.