Kornimate/medical-research-clean huggingface dataset:
efficacy of cerebellar transcranial magnetic stimulation to treat hereditary spinocerebellar ataxias

Conditions: Spinocerebellar Ataxias

Summary: spinocerebellar ataxia (sca) is a type of autosomal dominant ataxia and there is currently no effective treatment. the goal of this clinical trial is to learn the efficacy of navigated itbs (intermittent theta-burst stimulation) targeting the cerebellum to treat hereditary spinocerebellar ataxias in adults and explore the role and neural plasticity mechanisms. it will also learn about the safety of cerebellar transcranial magnetic stimulation. the main questions it aims to answer are: 1. does navigated itbs targeting the cerebellum improve the symptoms and clinical scale score of ataxias? 2. safety evaluation measures included treatment-related dizziness, head and neck pain, tinnitus, hearing loss, and epilepsy. adverse reactions were reported by both subjects and investigators. participants will: 1. navigated itbs targeting the cerebellum or sham stimulation every day for 7 day, 2. assessments were made at baseline, within 24 hours after the end of treatment, after 12 weeks, and after 24 weeks of telephone follow-up.

1. gait analysis, electroencephalogram (eeg), functional magnetic resonance (fmri) and a series of clinic scales were used to further observe the therapeutic effect and reveal the possible mechanism of neuroplasticity. 2. forty-two itbs sessions（1,800 pulses per session, 50-minute intersession interval） were delivered as 6 daily sessions over 7 consecutive days at 80% resting motor threshold (adjusted for cortical depth).

Eligibility criteria:
inclusion criteria: * sca1/2/3 patients confirmed by genetic testing * aged 18-65 years * presence of ataxia with a score3-20 on the scale for the assessment and rating of ataxia (sara) and a score\<60 on the international cooperative ataxia rating scale (icars) * signed informed consent by patients or their family members exclusion criteria: * patients with serious medical conditions (such as kidney failure, liver disease) and uncontrolled high blood pressure or diabetes * patients with severe cognitive and behavioral disorders or mental illness * pregnant and lactating patients; use other ongoing clinical medications, except for neuroprotective agents such as coenzyme q10, butylphthalein, or cyticholine; if patients are taking valproate, riluzole and other drugs but they and their guardians have a strong desire for treatment, they can be evaluated again after washout. * history of stroke, encephalitis and epilepsy * pacemakers, electronic devices and intracranial metal objects.
feeding readiness and oral feeding success in preterm infants

Conditions: Preterm; Feeding Behavior; Enteral Feeding Intolerance

Summary: to examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.

the preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. however, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. this also means long hospital stays for premature babies. therefore, the american academy of pediatrics (aap) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital. many studies have been conducted on preterm infants on optimizing oral feeding performance. studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. these sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods. it has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding. this thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.

Eligibility criteria:
inclusion criteria: * the mother's milk * preterm babies with a gestational age of 30-33 weeks * no facial deformity, * no respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding, * no need for oxygen support, * there will be preterm infants who are not fed orally, but who are started with tube (orogastric) feeding. exclusion criteria: * transferred to another center during the research, * unexpected complication development during the research, * occurrence of a pathology that will prevent or complicate oral feeding, * in cases where there is no voluntary consent of the parent * the mother is covid positive

Keywords: preterm feeding readiness oral feeding sensorimotor intervention neonatal nursing
the effect of laughter yoga practiced after burn dressing

Conditions: Burns; Laughter Yoga

Summary: burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. research shows a relationship between burn dressing changes and increased pain, anxiety, and stress. it can also be said that anxiety negatively affects wound healing. this study aimed to determine the effect of laughter yoga, a non-drug method, on reducing or completely eliminating pain and anxiety after burn dressing and increasing the level of mental well-being. this study is planned to be conducted in a randomized manner.

the burn center will consist of patients receiving treatment at the burn clinic. data will be obtained through the introductory information form, visual analogue scale (vas), state anxiety scale and warwick edinburgh mental well-being scale. patients who will receive burn dressing will be visited in the clinic before the dressing and will be informed about the study. sampled individuals will be placed into intervention and control groups using a random number table created with ms excel software. the average hospital stay of patients is three weeks. within the scope of the study, laughter yoga will be applied 2 hours after the dressing to the patients who are treated in the burn clinic for three weeks and are included in the intervention group. for the control group, staii state anxiety scale, visual analog scale (vas) and warwick edinburgh mental well-being scale levels will be determined in the same periods without any application. the data obtained will be analyzed with appropriate statistical methods using the spss for windows 23.0 program (statistical package for the social sciences).

Eligibility criteria:
inclusion criteria: * receiving inpatient treatment in hospital due to burns, * between the ages of 18 and 60, (sick individuals over the age of 60 may have chronic diseases and have problems complying with commands) * those with moderate or large severity burns (according to the turkish ministry of health, burn injury treatment algorithm (11)). * in individuals with 2nd degree burns, the total burn width does not exceed 40%, and in those with 3rd degree burns, the total burn width does not exceed 10%, * at least 2 days have passed since the burn injury (the inflammatory phase has passed during the wound healing process and is in the proliferation phase), * not in the maturation phase according to the wound healing process, no burns in the abdomen and head and neck area (due to preventing the possible negative effects of laughter yoga on the specified areas) * patients who volunteer to participate in the research will be included in the study. exclusion criteria: * using anxiolytic and sedative drugs, * having a psychiatric illness, * patients with communication disabilities will not be included in the research.

Keywords: burns laughter yoga
dexcom continuous glucose monitoring system use in areal-world, global registry (dexcom global registry)

Conditions: Diabetes

Summary: "to evaluate the use of the dexcom cgm system when used according to approved commercial labeling during standard clinical use and its impact on intended users in a real-world setting"

"the dexcom global registry is a non-randomized, open-label, multi-center registry with the goal of collecting dexcom cgm system data in a real world setting.the registry study involves retrospective and/or prospective data collection associated with dexcom cgm system use."

Eligibility criteria:
inclusion criteria: * meets dexcom cgm system indications for use (ifu) per approved commercial labeling * has at least one hba1c (hemoglobin a1c) measurement within three (3) months prior to the dexcom cgm system use start date that is at least three (3) months after any prior cgm use * subject is willing and able to use dexcom cgm system according to approved product labeling * subject is willing and able to complete applicable patient reported outcome assessments/ surveys * subject is willing and able to comply with the protocol * subject is willing and able to comply with provider requirements for at least two provider encounters per year according to applicable clinical practice guidelines * subject or the subject's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an irb/ec approved waiver of consent exclusion criteria: * is contraindicated for a dexcom cgm system per approved commercial labeling * in the investigator's opinion, the subject is not considered to be a suitable candidate
efficacy and safety of tolvaptan in subjects with chronic kidney disease between late stage 2 to early stage 4 due to autosomal dominant polycystic kidney disease

Conditions: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease

Summary: the purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (adpkd)

the protocol will extend the understanding of the efficacy and safety of tolvaptan treatment in adpkd patients with late stage 2 to early stage 4 ckd (chronic kidney disease). this trial will compare the efficacy of tolvaptan treatment in reducing the annualized change in estimated glomerular filtration rate (egfr) from pre-treatment baseline to post-treatment follow-up, as compared with placebo, in subjects who tolerate tolvaptan during an initial run-in period. the change in egfr, calculated by the chronic kidney disease-epidemiology (ckd-epi) formula, will provide kidney function data that are complementary to the data demonstrating the benefits previously observed primarily in adpkd subjects with earlier stages of disease. also, it will compare the efficacy of tolvaptan treatment in reducing the decline of annualized egfr slope, as compared with placebo, in this type of subjects. finally, it will compare the overall and hepatic safety profile of tolvaptan with placebo and to compare incidence of adpkd complications (outcomes) during the trial

Eligibility criteria:
inclusion criteria: * male and female subjects with egfr between 25-65 ml/min/1.73m2 (if aged 18 to55) or egfr between 25-44 ml/min/1.73m2 (if aged 56 to \<66) * tolvaptan naïve * diagnosis of adpkd by modified pei-ravine criteria 1) 3 cysts per kidney by sonography or 5 cysts by ct or mri with family history of adpkd or 2) 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history exclusion criteria: * women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (imp) * women who are breast-feeding and/or who have a positive pregnancy test prior to receiving imp * need for chronic diuretic use * hepatic impairment or liver function abnormalities other than that expected for adpkd with typical cystic liver disease * advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury * contraindications to required trial assessments * medical history or medical findings inconsistent with safety or compliance with trial assessments

Keywords: chronic kidney disease autosomal dominant polycystic kidney disease
comparison of slow and fast transition from stimulants to atomoxetine in children and adolescents with attention deficit/hyperactivity disorder(adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: children and adolescents with attention deficit hyperactivity disorder (adhd) who are not tolerating or not responding well to stimulant therapy will be included in this study. two different strategies for transition from stimulant to atomoxetine will be used: slow (10 weeks) and fast (2 weeks). changes in adhd symptoms and tolerability of medication will be compared between the two different switching approaches.

study b4z-ew-lyfj is a phase iv multicentre, open label, controlled study in approximately 120 patients with adhd from 6 years to 16 years of age. after the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). after completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.

Eligibility criteria:
inclusion criteria: * outpatients between 6-16 years of age * diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) diagnostic criteria for adhd must be met * normal laboratory and electrocardiogram (ecg) results * normal intelligence * must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy exclusion criteria: * less than 20 kg or more than 70 kg at study entry * concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk * medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions * taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor * immediate need for stimulant discontinuation due to tolerability problems * previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine

Keywords: adhd children stimulant atomoxetine adolescents
association between low dose acetylsalicylic acid (asa) and proton pump inhibitors and risk of acute myocardial infarction or coronary death

Conditions: Nonfatal Myocardial Infarction; Coronary Death

Summary: the purpose of this study is to estimate the risk of myocardial infarction (mi)/coronary death associated with use of monotherapy low dose asa (single antiplatelet) as well as concomitant use of monotherapy low dose asa and proton pump inhibitors (ppis) in first- time users of low dose asa for secondary prevention using a uk primary care database.

number of anticipated subjects: in case-control analysis 5.000-10.000

Eligibility criteria:
inclusion criteria: * as above (study population description). * all individuals aged 50-84 years with at least two year of enrolment with the primary care physician (pcp) and a computerized prescription history of at least one year before the start of the study. exclusion criteria: * recorded diagnosis of cancer prior to study start. * alcohol abuse or alcohol-related disease prior to study start. * patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (pcp) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.

Keywords: mi low dose aspirin ppi epidemiology
acupressure for cancer-related fatigue

Conditions: Breast Cancer

Summary: this study develops and pilot tests the efficacy of a home-based, self-administered acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical functioning and other quality of life outcomes (distal outcomes) of chinese immigrant breast cancer survivors (versus usual care control group).

we will enroll 124 foreign-born, chinese-speaking women from southern california and maryland areas with moderate to severe levels of fatigue, diagnosed with stage 0-iv breast cancer, aged 21-74, and 1-5 years post-primary treatment. using an adaptive treatment strategy design, participants will be randomized to either the acupressure intervention or control groups. the acupressure group will learn how to press three chief energy acupoints on each side of the body through de novo 11-minute chinese-language video and practice acupressure every day (one minute per acupoint; a total of 6 minutes per day) for an 8-week intervention period. participants will be telephone interviewed twice: at baseline and 8-weeks post-intervention follow-up.

Eligibility criteria:
inclusion criteria: * 1) be between ages 21 to 74 * 2) be first-generation immigrants * 3) speak chinese (mandarin and/or cantonese) * 4) be diagnosed with breast cancer at stage 0, i, ii iii or iv * 5) have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment * 6) have not had recurrence * 7) have moderate to severe levels of fatigue. exclusion criteria: * have hypothyroidism and anemia * being using acupuncture

Keywords: chinese women cancer-related fatigue acupressure
comparative safety and immunogenicity of 1.0 µg intramuscular (i.m.) and 2.0 µg subcutaneous (s.c.) dosing with vax102 (m2e-flagellin) universal influenza vaccine in healthy adults

Conditions: Influenza

Summary: 1. to assess the safety, reactogenicity, tolerability, and adverse events (aes) of the vax102 vaccine in a two dose regimen (day 0 and day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. to assess the immunogenicity (anti-m2e serum antibody concentration) of the vax102 vaccine in a two dose regimen (day 0 and day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (elisa) in a healthy adult population.


Eligibility criteria:
inclusion criteria: * adult men or women aged 18 to 49 years inclusive. * able and willing to provide written informed consent to participate. * healthy, as determined by medical history, physical examination, and vital signs. * willing to receive the unlicensed (vax102) vaccine given as an i.m. or s.c. injection. * willing to provide multiple blood specimens collected by venipuncture. * females should avoid becoming pregnant during the course of the study * women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination. * must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits. exclusion criteria: * persons under 18 years old or 50 years or older. * persons with chronic illnesses such as cancer, diabetes, liver or kidney disease. * person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination. * persons who have had a prior serious reaction to influenza vaccine. * persons with a history of anaphylactic-type reaction to injected vaccines. * persons with a history of drug or chemical abuse in the year preceding the study. * persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study. * persons who received any other vaccine within one week prior to enrollment (may delay enrollment). * persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment). * persons currently participating in another research study involving any study medications (medicines or vaccines).

Keywords: influenza vaccine m2e universal influenza vaccine
the sad study - sleep, anxiety & depression study a prospective cohort study

Conditions: Patients With Anxiety and Depression, Who Have; Obstructive Sleep Apnoea; COPD

Summary: the prevalence of anxiety and depression in our osa population is more than in copd and the general population of north west adelaide. (principal hypothesis). cpap therapy in osa population produces a positive effect on the anxiety and depression scale. the investigators intend to study the prevalence of anxiety and depression in patients with sleep disorders in comparison to patients with copd and subsequently, to assess whether cpap has a role in controlling anxiety and depression in depressed and anxious patients with sleep apnoea. this is a two phase study, in first phase; investigator will assess the prevalence of anxiety and depression, in a population with sleep disorders to check whether it is different to the prevalence in the copd population. the prevalence of depression in sleep disorder population will also be compared with the adelaide north western general population, which was reported in the north west adelaide health study. according to this epidemiological survey, which was conducted from 2008 to 2010, the prevalence of depression in adelaide north western general population was 20%.during the second phase of the study investigator will evaluate the effect of cpap on anxiety and depression scores in the depressed and anxious patients with sleep apnoea by comparing the pre and post cpap anxiety and depression status. the hospital anxiety and depression (had) scale will be used to assess anxiety and depression, which is a well-documented tool for assessing symptoms of anxiety and depression in patients with somatic diseases.

aim (s) / objective of study 1. to compare the prevalence of anxiety and depression in patients with sleep disorders (osa), copd and the general population of north west adelaide. 2. to study the effect of cpap on depression and anxiety in patients with sleep apnoea who also have anxiety and depression. study design/ setting/location/population this is a multicenter prospective cohort study run at the lyell mcewin hospital (lmh) and the queen elizabeth hospital (tqeh), among patients attending the respiratory and sleep outpatient clinics at the lyell mcewin hospital (lmh) and the queen elizabeth hospital (tqeh). these both sites are teaching tertiary hospital. study outcomes 1. primary outcome to establish the prevalence of anxiety and depression in patients with sleep disorders and compare how this prevalence differs from its prevalence in copd and in the general population. 2. secondary outcome to evaluate whether treatment with cpap improves anxiety and depression symptoms (had scale) at 3 and 12 months in osa patients with anxiety and depression.

Eligibility criteria:
inclusion criteria: * patients attending the respiratory and sleep outpatient clinics at lmh and tqeh with osa or copd * aged over 18 years exclusion criteria: * unwilling or unable to give informed written consent