Kornimate/medical-research-clean huggingface dataset:
closing the loop in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the main objective of this study is to evaluate the feasibility of closed loop insulin pump therapy to improve overnight glucose control in adults with type 1 diabetes.

people with type 1 diabetes(t1d) need regular insulin injections or continuous delivery of insulin using an insulin pump in order to keep the blood glucose levels normal. we know that keeping blood sugars in the normal range will help prevent long term diabetes related complications involving the eyes, kidneys and heart. however, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). this is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. this can be achieved by what is called a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. this system is being developed in cambridge and we have trialed this on 16 children and adolescents with t1d in a clinical setting over the past year. we have found that this system is very effective at preventing hypoglycaemia in this group of patients. we will recruit 12 adults with t1d on insulin pump therapy, and the studies will be done in a clinical research facility. the subjects will be studied on two nights. on one night they will have their normal insulin pump therapy and on the other night their insulin pump will be varied according to information about blood glucose values from the continuous glucose sensor. this information will be manually typed into the computer every 15 minutes from 8pm until 8am. the algorithm will advise of the insulin infusion rate and this will be manually changed by a trained nurse every 15 minutes throughout the night.

Eligibility criteria:
inclusion criteria: * type 1 diabetes, as defined by who for at least 6 months or confirmed c-peptide negative. * on insulin pump therapy for at least 3 months exclusion criteria: * non-type 1 diabetes mellitus * any physical/psychological disease likely to interfere with the study * taking medication likely to interfere with interpretation of the results * known/suspected allergy against insulin * patients with clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator * ongoing severe recurrent hypoglycaemia as judged by the investigator.
acute pain assessment using facial expression analysis

Conditions: Acute Pre and Post Operative Pain

Summary: managing pain, which affects 20-50% of the population, is a major issue in daily clinical practice. evaluation of pain intensity is essential to adapt treatment but as it mainly relies on self-report, this assessment is difficult or impossible in non-communicating patients. in these cases, pain can only be evaluated by medical staff by the observation of pain-related characteristics like facial expression of pain (fep). however, recognition of fep is subjective, time-consuming and subject to multiple biases frequently leading to underestimation of pain and consequently under-treatment. some of these biases could be solved by the use of facial recognition technology, allowing objective, automated and time-saving pain assessment. def-i aims to address technical issues and achieve the development of facial expression recognition digital tool able to evaluate severe acute pain in clinical practice, with high validity and utility by improving the quality of the images to be analyzed, by studying larger samples of patients, data and images, in order to correlate more efficiently the pain intensity felt by a patient with the expression of his face. the main objective of this study is to verify whether it is possible to quantitatively correlate the intensity of acute postoperative pain felt by a patient with his facial expression. the secondary objective is to define a reliable computer algorithm that qualitatively correlates the type of acute postoperative pain experienced by a patient with his facial expression.


Eligibility criteria:
inclusion criteria: * any adult patient undergoing surgery in our institution during the study duration, * able to express pain intensity on nrs exclusion criteria: * patient to be operated on in the area of the face or eye * patient with altered facial morphology related to a dressing, suture, wound, trauma or oedema on the face * patient not compliant or unable to clearly express pain
somatosensory assessment and rehabilitation of allodynia (sara)

Conditions: Complex Regional Pain Syndrome; Peripheral Nerve Injuries; Hand Fractures

Summary: this pilot study will test a new therapy, somatosensory rehabilitation, for the painful sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome (crps). several methods for measuring pain and sensitivity that emphasize the person's evaluation of their own symptoms and the impact of these symptoms on their daily activities will also be tested to make sure they are consistent and accurate. previous research has suggested one of the assessments may also be used to assist in the identification of crps: this simple test will be evaluated to see if it can accurately identify persons with this disorder (for which there is currently no diagnostic test). together, this will improve treatment of crps through early, accurate diagnosis and the ability to measure important changes in this painful condition, and set up future studies for this new rehabilitation treatment method.

we will test four groups: persons with crps of one upper extremity, persons with recent hand fractures (\<12 weeks) or peripheral nerve injuries with residual sensory deficits at the time of the study, and healthy normal volunteers with a battery of assessments for crps, including a technique to precisely localize and quantify static mechanical allodynia.

Eligibility criteria:
inclusion criteria: * diagnosis of a) complex regional pain syndrome or b) peripheral nerve injury or c) recent hand trauma without peripheral nerve injury in a single upper extremity confirmed by physician or medical record. * participant and most responsible physician give consent to exclusive focus on somatosensory rehabilitation for the duration of the trial (6 months). the participant may continue any oral medications but any planned use of topical medication, injections or iv medication in the affected limb is contra-indicated. use of these modalities in an emergency situation would of course take priority. exclusion criteria: * history of cardiac or vascular disease or known sensitivity to sympathetic stress or cold intolerance or medically unstable * confounding diagnoses: whiplash, nerve root compression, metabolic diseases such as diabetes or thyroid problems, and/or peripheral neuropathy * open wounds on testing sites * unable to provide informed consent

Keywords: allodynia complex regional pain syndrome peripheral nerve injuries clinical measurement properties
morphee : mechanisms of cell death induced by extracorporeal photochemotherapy

Conditions: Cutaneous T-Cell Lymphoma; Graft Vs Host Disease; Graft Rejection

Summary: the objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.

extracorporeal photochemotherapy (ecp) is a cell therapy used for its immunomodulation and tolerance induction capabilities. its main indications are the control of graft-versus-host (gvh) disease in hematopoietic cell allografts, treatment and control of rejection in solid organ transplantation and the treatment of cutaneous t-cell lymphoma. data on the mechanisms of action of ecp remains very patchy. this lack of data limits the discussion on therapeutic regimens by disease. ecp consists of repeated apheresis sessions to collect leukocytes from the patient. the cells are then photosensitized, irradiated with uva and reinjected into the patient in a closed circuit. in the context of gvh, induced cell death would stimulate the expansion of regulatory cells (treg), restore a th1/th2 balance and decrease th17 polarization. the ecp also allows the expansion of treg in solid organ transplantation. conversely, ecp would restore or activate an antitumor immune response in cutaneous t lymphoma. the type of cells collected and treated would play a major role in the effects obtained. however, these hypotheses must be consolidated, in particular by detailing the initial role of cell death. several questions remain, on the chronology of cell death in the different treated subpopulations, on the uptake by phagocytes, but especially on the type of cell death induced according to the cell type (necroptosis, apoptosis, pyroptosis, autophagy). the data generated will allow for validation or detail of the mechanisms of resolution of the inflammation and/or the anti-tumour effect observed.

Eligibility criteria:
inclusion criteria: * adult patients * treated with ecp for at least 1 month, for control of gvhd in hematopoietic cell allograft (acute or chronic gvhd), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous t-cell lymphoma exclusion criteria: * subjects with limited legal capacity. * subjects judged by the investigator to be unlikely to comply with study procedures * subjects with no social security coverage. * pregnant women. * subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.

Keywords: cell death extracorporeal photochemotherapy
relationship between isometric muscle strength and gross motor function in children with unilateral cerebral palsy

Conditions: Hemiplegia; Cerebral Palsy

Summary: muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.

cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. the motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder the development and changes in motor function, both natural and with therapy, can be assessed using the gross motor function measure (gmfm) created for children with cp

Eligibility criteria:
inclusion criteria: 1. their age between 6 and 12 years old. 2. grade 1and 2 according to the modified ashworth scale (rw and smith, 1987). 3. they could walk with limitation or holding on according to gmfcs (level i, ii) (palisano et al., 1997). 4. they were able to understand and follow verbal instructions. exclusion criteria: 1. children with any visual or auditory problems. 2. children with any surgical interference in the lower limb. 3. children with any structural deformities in joints and bones of lower limbs. 4. children with any special medications affecting muscle functions (anti-spastic drugs). 5. children who suffer from other diseases or associated disorders that interfered with physical activity.

Keywords: hemiplegia cerebral palsy muscle stength gmfm
memantine versus donepezil in early stages of alzheimer's disease

Conditions: Dementia, Alzheimer Type

Summary: it is well known that in the brain of the patients with alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. memantine is a low affinity antagonist of nmda glutamate receptors. the use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. the effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.

on the basis of the excess of glutamatergic stimulation, our objective is to demonstrate whether memantine could have a neuroprotective effect in alzheimer's disease when administered in the early stages and in comparison to donepezil. the patients would be randomized to receive one of these drugs. at baseline we would evaluate the patients from a clinical standpoint with the adas-cog, the neuropsychiatric inventory and a scale of daily living activities.we also would carry out magnetic resonance spectroscopy in several areas of the brain (medial temporal lobe, prefrontal region, cingulate gyrus and occipital lobe) so as to measure the concentration of n-acetyl-aspartate which is a marker of neuronal density.then we treat the patients with either memantine or denepezil and after 6 months we would repeat the same procedures as we did at baseline.

Eligibility criteria:
inclusion criteria: * clinical criteria of probable alzheimer's disease in the stages mild-to-moderate with a mini-mental score higher than 15 points. exclusion criteria: * previous treatment with anticholinesterase drugs or memantine. * advanced stages of the disease * lack of a reliable caregiver. * dementias other than alzheimer's disease

Keywords: alzheimer's disease memantine donepezil magnetic resonance spectroscopy randomized trial
study of real-world evidence with sglt2i (dapagliflozin) and dpp4i (sitagliptin) in type 2 diabetes patients in spain

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to develop a retrospective, multicenter and observational study in spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a dpp4 inhibitor. this is a widely used molecule in spain with a large safety profile. it was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with t2dm. 2. age: 18-75 years. 3. treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date. 4. the patient must have at least two follow-up visits. the basal initial visit, where all the relevant information is collected and a second follow-up visit. 5. the next information of the subjects should be available at the recruitment of the basal visit: sex, age (years), date of diagnosis of t2dm, weight, height, systolic and diastolic blood pressure, body mass index (bmi: kg / m2), concomitant medication (antihta, statins, aspirin, etc.), glucose basal fasting (mg / dl), hba1c (%) and estimated gfr by ckd-epi (ml / min / 1.73m2). 5. the patient must sign the informed consent to participate in the study. exclusion criteria: 1. impediment of the patient to give him informed consent. 2. patients diagnosed with type 1 diabetes. 3. women with gestational diabetes.
the north american pancreatitis study

Conditions: Pancreatitis

Summary: this study will investigate several genes and other factors measured in the blood that may cause recurrent acute pancreatitis and chronic pancreatitis. no treatment is offered as part of this study. subjects have one single visit to provide a blood sample for genetic testing and to answer a questionnaire. subjects are not given results of genetic testing. the study is currently enrolling african american subjects and controls only.

this study seeks to enroll african american people with and without pancreatitis. there is only one study visit to obtain consent, a blood sample and complete a questionnaire. subjects must be patients of a participating center; controls must present to a participating center for enrollment.

Eligibility criteria:
inclusion criteria: african american pancreatitis patients who are at least 14 years of age with a diagnosis of acute or chronic pancreatitis * controls who do not have pancreatitis and must be at least 18 years of age exclusion criteria: * unable or unwilling to sign informed consent

Keywords: african americans pancreatitis controls
testosterone replacement therapy decreases plasma paraoxonase 1 enzyme activity in male patients with hypogonadism

Conditions: Hypogonadism

Summary: the purpose of this study is investigating the effect of testosterone treatment on paraoxonase level in male patients with hypogonadotrophic hypogonadism


Eligibility criteria:
inclusion criteria: * volunteers patients with hypogonadism exclusion criteria: * coronary heart disease * other pituitary/hypothalamic disorders or other non-hypogonadism diseases * none was receiving vitamins, lipid-lowering drugs, or other medications known to interfere with pon1 activity, lipid profile, or gonadal function

Keywords: hypogonadism paraoxonase hipogonadism
clinical study to assess the influence of a saw palmetto preparation in patients with benign prostatic hyperplasia (bph) and sexual dysfunctions

Conditions: Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Summary: assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with bph and sexual dysfunctions.


Eligibility criteria:
inclusion criteria: * patients with bph and sexual dysfunctions (erectile dysfunction or decrease in libido) * ipss \> 4 * bsfi, sexual drive questions \< 5 exclusion criteria: * lack of libido which is due to a psychic disease or a depressive mood -excessivly strong lack of libido in the judgement of the investigator within the last two months * patients with severe vascular disorders (microangiopathies) * patients with known neuropathies * severe diabetes mellitus * patients with hypertension who are for less than two months on a stable antihypertensive medication * known bad compliance of the patient

Keywords: sexual dysfunctions benign prostatic hyperplasia saw palmetto
impact of implantation of an laa occluder on anp and bnp level and quality of life

Conditions: Atrial Fibrillation

Summary: closure of the laa by several devices is a alternative therapy to oral anticoagulation in patients with atrail fibrillation. nothing is known about the acute influence of a device closure of the laa on the secretion of anb nad bnp hormones. therefore aim of our study is to measure anb and bnp levvels before and after implantation of an laa closure device.

anb and bnp levels are measured before, directly after and late after 24 h in central or periphereal venous blood from patients undergoing interventional laa closure.

Eligibility criteria:
inclusion criteria: * patients undergoing laa closure exclusion criteria: * none

Keywords: left atrial appendage occluder watchman device atrial fibrillation atrial natriureitc peptide brain natriuretic peptide
school-based paraeducator education for engagement at recess

Conditions: Autism Spectrum Disorder; Neurodevelopmental Disorders

Summary: the purpose of the proposed three-site study is to test whether an educator-level implementation strategy, coaching, with or without a school-level implementation strategy, school-based teams, will maximize paraeducators' use (fidelity and sustainment) of an evidence-based social engagement intervention, remaking recess (rr). rr aims to improve peer related social skills for autistic students and their non-autistic peers who are socially isolated or peripheral and need support during recess.


Eligibility criteria:
inclusion criteria: * students: elementary aged students in k-5th grade who are autistic or have a neurodevelopmental disorder (age 5-12) * educators: paraeducators, teachers, or other school personnel that work with k-5th grade students in a public school in the united states (age 18+) exclusion criteria: * students or educators that have previously participated in remaking recess studies will not be eligible to enroll in this study.
assessment of microfragmented adipose tissue loaded on bovine graft versus bovine graft only on ridge preservation.

Conditions: Tooth Mobility

Summary: evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.

all patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group. after 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on cbct. radiographic assessment that will be achieved by cbct scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.

Eligibility criteria:
inclusion criteria: * patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium. * age group: above 21 years * remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis. exclusion criteria: * general contraindications to implant surgery. * subjected to irradiation in the head and neck area less than 1 year before implantation. * poor oral hygiene and motivation. * severe bruxism or clenching. * systemic, immunologic, or debilitating diseases that could affect normal bone healing \& local pathosis. * treated or under treatment of intravenous amino bisphosphonates. * active infection or severe inflammation in the area intended for implant placement. * patients participating in other studies if the present protocol could not be properly followed. * heavy smokers

Keywords: unrestorable caries lesions or affected periodontium.
treadmill training in fragile x-associated tremor/ataxia syndrome

Conditions: Fragile X Associated Tremor-ataxia Syndrome

Summary: a pilot trial to determine the feasibility of treadmill training with dual training in patients with fragile x-associated tremor/ataxia syndrome (fxtas).

there is substantial evidence that physical exercise can improve motor and cognitive function in individuals with parkinson's disease, traumatic brain injury or chronic stroke survivors. however, to the investigator's knowledge, no studies have explored the effect of treadmill training with or without a cognitive dual task on gait, balance and cognition in fragile x - associated tremor/ataxia syndrome (fxtas), which is characterized by action tremor, cerebellar gait ataxia, parkinsonism, peripheral neuropathy and cognitive deficits, all of which increase the risk for falls and progressive disability. there are presently no medications or treatment interventions that have been shown to effectively manage the symptoms of fxtas or delay disease progression, and it is currently not clear whether either the st or dual-task treadmill training paradigms would be feasible or effective in fxtas. a total of 10 individuals with fxtas will recruited from the rush university movement disorders clinic or the fxtas clinic database at rush university. the subjects will be assigned to either 6 weeks of dual-task treadmill exercise training combined with a cognitive task (intervention group) occurring 3 times weekly, or control group. the primary outcome measures will be feasibility, safety and patient adherence. the assessments will occur at baseline, week 3, week 6, 1 month \& 6 month post-training.

Eligibility criteria:
inclusion criteria: * a diagnosis of possible, probable or definite fxtas * able to stand and walk without support for 2 minutes exclusion criteria: * any neurologic or musculoskeletal problems * history of traumatic brain injury * significant cardiopulmonary or cardiovascular disease * dementia or other significant cognitive impairment * unstable psychiatric disorders

Keywords: dual-task feasibility fxtas treadmill training