Kornimate/medical-research-clean huggingface dataset:
a canadian, multi-centre, observational registry to study adherence and long term outcomes of therapy in pediatric subjects using saizen® via easypod™ auto-injector for growth hormone treatment

Conditions: Growth Disorders

Summary: this is a canadian, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospital and to assess the level of adherence of subject receiving saizen® via easypod™ .

subjects will be enrolled in a multicenter, longitudinal observational registry. parents/subjects will provide their informed consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: - to assess the level of adherence of subjects prescribed saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject prescribed saizen via easypod™ * to identify adherence subject profiling

Eligibility criteria:
inclusion criteria: * prescribed saizen® via the easypod™ auto-injector (saizen® health canadian approved indications: growth hormone insufficiency or deficiency, turner's syndrome, chronic renal failure, small for gestational age * under 18 years of age, or over 18 without fusion of growth plates * parent's or legal guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/legal guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined by health canada regulations. adult consent is defined at 18+ in the province of quebec, 16+ in the remainder of canada. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects) * contra-indications to saizen® as defined in saizen® canadian product monograph. * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
locomotor training in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. it has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. in this study, 40 patients with impaired ambulation due to multiple sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.the locomotor training will be accomplished via a robotic device, the lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.

in this study, subjects with confirmed diagnosis of multiple sclerosis were randomized into one of two treatment arms. subjects in the lokomat arm trained on the lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. the lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. subjects were suspended in a harness while in the lokomat with full to partial body weight support as needed. after the training in the lokomat, they practiced overground walking for 10 minutes. the other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the lokomat group for intensity, duration and frequency. they did not practice overground walking. primary outcome measure was speed to accomplish 25' timed walk.

Eligibility criteria:
inclusion criteria: * persons with secondary progressive or primary progressive multiple sclerosis who are ambulatory with difficulty and /or assistive device exclusion criteria: * ataxia * unable to ambulate * within 3 months of exacerbation

Keywords: impaired ambulation
advanced mri for posterior fossa tumours

Conditions: Cerebellar Mutism; Posterior Fossa Syndrome

Summary: post-operative paediatric cerebellar mutism syndrome (pcms) is a well-recognised complication of resective surgery for brain tumours of the cerebellum and fourth ventricle in children. occurring in around 25% of infratentorial craniotomies, it is characterised by a delayed onset of mutism and emotional lability, and may comprise motoric and cognitive cerebellar deficits. transient mutism gives way to prolonged, and often incomplete, recovery. neuroimaging studies are beginning to reveal anatomical and functional aberrancies in the brain of children with pcms. the cerebellar efferent pathways are likely to be implicated as a neuroanatomical substrate in the development of pcms, as shown by a handful of diffusion tractography studies to date. however, the pathophysiology of this condition still remains unclear. hypoperfusion of supratentorial cortical and subcortical structures may mediate the speech and behavioural deficits seen in pcms, and is a candidate for a causal pathophysiological mechanism. this study aims to prospectively image children with pcms using advanced mri techniques including diffusion tractography and arterial spin labelling, and to correlate this with clinical descriptions of the syndrome. all children referred to great ormond street hospital for children with a posterior fossa brain tumour will be imaged pre-operatively, post-operatively and at delayed follow-up. in tandem with this, clinical assessments will be made of children post-operatively to ascertain which patients develop pcms. in addition, anonymised advanced mri data on healthy controls will be used as a comparator group.


Eligibility criteria:
inclusion criteria: age \<18 referred and operated upon within study period brain tumour of cerebellum, ivth ventricle, brainstem undergoing craniotomy for resection (including re-do surgery) no restrictions as to tumour histology or grade (embryonal tumour / glioma / ependymoma) informed consent given by parents exclusion criteria: non-neoplastic infratentorial lesions claustrophobia contraindication to mri pregnant female scans missing at \>2 timepoints tumour resection surgery at another hospital if no pre- or post-operative scans available
screening for the transthyretin-related familial amyloidotic polyneuropathy (ttr fap)

Conditions: Polyneuropathy, Amyloid; Neuropathic Pain; Cardiac Failure; Orthostatic Hypotension; Gastrointestinal Disorders

Summary: an international, multicenter, epidemiological observational study investigating the prevalence of transthyretin-related familial amyloidotic polyneuropathy (ttr-fap) in participants with small fiber polyneuropathy of no obvious etiology.

transthyretin-related familial amyloid polyneuropathy (ttr-fap) is an autosomal dominant, progressive neurodegenerative disease, with fatal outcome occurring within ten years after onset. familial amyloid polyneuropathy (fap) associated with mutations in the transthyretin (ttr) gene is the most common form of genetic amyloidosis. it accounts several thousand cases worldwide, with val30met mutation identified in most patients and with endemic foci in portugal, sweden and japan. ttr fap is caused by the systemic deposition of amyloidogenic variants of the transthyretin protein ((ttr) in the extra-cellular space of tissues and result in disruption of organ function.the typical presentation of ttr-fap is a progressive sensory-motor polyneuropathy, which usually begins with loss of thermal and pain sensation in the feet, slowly ascends up the limbs and is associated with variable autonomic disturbances and extra-neurological manifestations (especially a cardiomyopathy). the goal of the trap2.1 study is to investigate the prevalence of transthyretin-related familial amyloidotic polyneuropathy (ttr-fap) in a cohort of 500 subjects with small fiber polyneuropathy of no obvious etiology, based on the subject's clinical presentation.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant * the participant is aged between 18 and 85 years of age * the participant is diagnosed with small fiber polyneuropathy of no obvious etiology * the participant has no diagnosis of alcoholism, according to international guidelines * the participant has not undergone chemotherapy for carcinoma exclusion criteria: * inability to provide informed consent * the participant is younger than 18 years or older than 85 years of age * the etiology of the small fiber polyneuropathy is clearly determined * the participant has a diagnosis of alcoholism, according to international guidelines * the participant has undergone chemotherapy for carcinoma

Keywords: transthyretin-related (attr) familial amyloid polyneuropathy ttr fap biomarker
modafinil for treatment of fatigue in als patients

Conditions: Fatigue

Summary: the purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (als), and to evaluate incidence and frequency of adverse events, if any.

als is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). palliative care, including symptom management, can contribute greatly to improved quality of life. in this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of als * ages 18-80 * clinically significant fatigue (4.5+ on fatigue severity scale with duration 3+ months plus impairment in 1+ categories of role function) * speaks english * able and willing to give informed consent * can communicate verbally or with assistive device * can swallow capsules * forced vital capacity 50+% exclusion criteria: * untreated hypothyroidism (tsh \> 4.25 uiu/ml) * untreated and uncontrolled hypertension * clinically significant anemia (hct \< 33%) * untreated or under-treated major depressive disorder * current clinically significant suicidal ideation * started antidepressant medication for treatment of depression during past 6 weeks * currently taking psychostimulant medication * history or current psychosis or bipolar disorder * fecund women not currently using barrier methods of contraception

Keywords: fatigue low energy als treatment
peer intervention latino immigrant msm

Conditions: HIV Infections; Sexually Transmitted Diseases

Summary: this study evaluates a peer intervention with hiv/sti self-testing kits to increase hiv/sti testing and prep uptake among latino immigrant men who have sex with men. half of participants will receive the "listos" intervention (peer counseling, prep information, and hiv/sti testing kits) and half will receive the active control intervention (peer only group with no hiv/sti testing kits).

hiv testing is crucial for early detection of hiv infection; yet, latino immigrants are at high risk for late hiv diagnosis. increased screening for hiv and stis is particularly important for latino immigrant men who have sex with men (msm), a group disproportionately at risk for hiv that also encounters barriers to health access due to factors associated with immigrant status. latino msm recently experienced a significant increase (25%) in new hiv diagnoses (2008-2015), while diagnoses among msm overall remained stable. based on these trends, 1 in 4 latino msm will be diagnosed with hiv in their lifetimes, highlighting their urgent need for hiv prevention. notably, pre-exposure prophylaxis (prep) can reduce risk of hiv among high-risk groups; yet, only 3% of latinos who could benefit from prep have received it. as undiagnosed hiv contributes to 40% of new hiv infections, and stis increase hiv risk, targeted interventions that address latino immigrant msm's barriers to hiv/sti testing and prep uptake are critical for curbing the hiv epidemic. studies have shown that peers can influence hiv-related behaviors by enhancing information, motivation, and behavior skills (imb model). peers share characteristics with the target population, which facilitates role modeling and can empower individuals to engage in behaviors. while peer interventions have demonstrated success in shaping behaviors among latino msm, their utility for addressing immigrant-specific barriers to hiv/sti testing and prep use is less understood. while the imb model and empowerment theory highlight relevant psychological determinants of behavior, competent attention to structural factors (i.e. access) is key for hiv prevention. the availability of hiv/sti self-testing kits presents opportunities to overcome structural barriers to testing. hiv/sti self-testing kits are convenient testing methods as they allow for at-home testing, reducing the need for health care visits. the research combines these approaches (peers and hiv/sti self-testing kits) to address individual and structural barriers to hiv prevention among latino immigrant msm.

Eligibility criteria:
inclusion criteria: * male sex (at birth) * adult aged 18 and older * immigrant (not born in continental u.s.) * latino (identifies as either latinx or hispanic * reports sex with men in past 12 months * reports not knowing their hiv status or being hiv negative exclusion criteria: * does not identify as latino/hispanic * born in the continental u.s. * female sex (at birth) * does not report sex with men in the last 12 months * reports being hiv positive * younger than 18 years old
task sharing counseling intervention by community health workers for prenatal depression in south africa

Conditions: Moderate Depression; Clinical Depression; Postpartum Depression

Summary: the objective of this randomised controlled trial (rct) is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in south africa(i.e. provided by non-specialist health workers)

specific objectives: 1. to determine the effectiveness and cost-effectiveness of task sharing care to community health workers (chws), compared to enhanced usual care in south africa, on both primary outcome measures (severity of prenatal maternal depression symptoms) and on a series of secondary outcome measures (functional status, health care utilization, social support and postnatal infant growth). 2. to examine factors influencing the implementation of the task sharing intervention and future scale up, by assessing feasibility, sustainability, quality, and safety, and by qualitative exploration of the experience of task sharing from the perspectives of both chws and patients.

Eligibility criteria:
inclusion criteria: 1. women attending antenatal clinics at the michael mapongwana community health centre in khayelitsha, presenting for their first booking appointment, no later than 28 weeks gestation 2. living in khayelitsha 3. 18 years or older 4. screen positive for depression with a cut off of 13 or more on the epds 5. able to give informed consent exclusion criteria: * require urgent medical attention or have severe mental health problems, defined as a diagnosis of schizophrenia, bipolar mood disorder, or currently experiencing an episode of psychosis. * women who do not speak isixhosa as a first language

Keywords: task sharing task shifting prenatal depression counselling lay health workers
hippocampal complex volume and memory dysfunction in cushing's syndrome

Conditions: Cushing's Syndrome

Summary: objectives: i. evaluate whether chronic hypercortisolemia is specifically toxic to hippocampal cells and causes structural reduction of hippocampal volume in patients with cushing's syndrome. ii. determine whether reduced hippocampal volume is associated with specific memory dysfunction. iii. examine the relationships of adrenal androgen to hippocampal volume and memory dysfunction. iv. examine the reversibility of hippocampal structural changes and cognitive dysfunction after cortisol levels are normalized.

protocol outline: patients undergo a psychiatric evaluation for mood and cognition during confirmation of diagnosis. neuropsychologic exams include pencil and paper test and a cognitive assessment. endocrine studies include dexamethasone and corticotropin-releasing hormone stimulation tests. the hippocampal complex volume is assessed with coronal magnetic resonance imaging. there is a follow-up 1 year after the initiation of treatment.

Eligibility criteria:
protocol entry criteria: * adults and teenagers with untreated, spontaneous active cushing's syndrome * diagnosis verified at the university of michigan medical center, including the following: excessive cortisol secretion measured by urinary-free cortisol, cortisol secretion rate, and plasma cortisol level * lack of normal circadian cortisol secretion and failure to suppress following 2 mg of dexamethasone

Keywords: cushing's syndrome endocrine disorders rare disease
effects of aromatherapy on childbirth

Conditions: Parturition; Natural Childbirth; Labor Pain

Summary: aromatherapy is a form of complementary medicine that uses scented materials known as essential oils for the purpose of affecting a person's health or mood. although aromatherapy has been used in childbirth for centuries, there are no high-quality studies examining whether the treatment works. methodology we would like to see if aromatherapy affects a woman's experience of childbirth by lowering associated anxiety and pain. consenting participants will be randomly allocated to one of these groups: 1. aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense) 2. non-essential oil (baby oil) 3. standard maternity care we will gather primary data, e.g. if she's been in labour before and her awareness of complementary medicine. we will also conduct the spielberger state-trait anxiety inventory with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions to keep the swab with the oil on it near to her. she can also put more oil on the swab as she requires. postnatally, data will be collected from her notes regarding pain relief used, duration of labour, augmentation of labour, and any other medical interventions of note. we will also complete the anxiety scale with her once more. before her discharge we ask the mother for any comments regarding her experience of the labour. the results from all three cohorts will then be compared. there will also be opportunity for the midwife to make any comments regarding his/her perception of the participant's labour. finally we will hold a focus group with midwives regarding the practicalities for implementation of aromatherapy in maternity care


Eligibility criteria:
inclusion criteria: * women in labour and expecting a normal delivery, * aged \> 16 who are able to make informed consent; * singleton pregnancy; * spontaneous or induced labour onset; * prior to elective or emergency caesarean section. exclusion criteria: * preterm labour; * pool births; * scheduled caesarean section.

Keywords: aromatherapy childbirth obstetrics labour complementary medicine delivery, obstetric
mass closure vs layer by layer closure

Conditions: Abdominal Wall Wound; Ventral Hernia; Incisional Hernia

Summary: to assess two different ways of closure of laparotomy in children and infants

introduction: the technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles. there are two ways to close this laparotomy incision. these ways are either closure in mass or layer by layer closure. neither of them is superior to the other. the main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia. the aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision. patients and methods: - study design: the study was performed during the period from january 2020 to october 2024. it is a randomized control trial. inclusion criteria were infants younger than 3 years. we excluded infants with history of prematurity, previous abdominal operations and infants with congenital abdominal wall defects. an informed consent was obtained from the parents or the care giver of every participant. randomization was obtained using closed envelop method. patients were categorized into two groups a and b. group a included patients that their exploratory wound was closed with mass closure method using vicryl® 2/0 round needle. group b included patients that their exploratory wound was closed layer by layer using the same suture material. in both groups the ratio of the suture length to the wound was 3 to 1. - the measured variables: the variables that were addressed were 1. the mean operative time in minutes, 2. the incidence of wound dehiscence, 3. the occurrence of wound infection, 4. the development of an incisional hernia 5. long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision. * follow up protocol: all patients were scheduled on a follow up regimen. they were examined weekly for one month post-operative. then monthly for one year. the anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively. this helped assessment of the dynamics and structure of the muscles at the site of the incision. - statistical analysis: statistical analysis was conducted using spss ™ statistical package ver. 21 (ibm spss, ny, usa). numerical data were compared using an independent sample t-test, whereas categorical data were compared using the chi-square test. statistical significance was set at p \<0.05.

Eligibility criteria:
inclusion criteria: * all infants and children with transverse laparotomy exclusion criteria: * previous abdominal operations * children and infants with congenital abdominal wall defects

Keywords: transverse laparotomy incisional hernia mass closure layer by layer closure