Kornimate/medical-research-clean huggingface dataset:
mapping stress and pain interactions (g072323n)

Conditions: Fibromyalgia; Chronic Low Back Pain; Subacute Low Back Pain

Summary: the over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (msk) pain and a pain-free control group. * the primary objective is to characterize stress systems functioning and their relation to pain in individuals with subacute versus chronic, and localized versus widespread msk pain, and compare to pain-free controls. * the secondary objective is to define the contribution of stress system functioning to trajectories of msk pain, including pain chronification or recovery from pain. researchers will compare primary musculoskeletal pain groups with pain-free controls. participants will: * fill out online questionnaires. * provide a sample of hair and saliva to assess chronic and acute stress hormone levels, respectively. saliva samples will be collected both in the lab and at home. * be subject to psychophysiological monitoring. * partake in quantitative sensory testing measuring pain thresholds, tolerances and pain modulation of pressure and heat. these tests will be repeated twice: before and after an acute-stress induction task. * partake in a series of stress-inducting tasks. * be subject to mri-scans of the brain, including structural and functional mr acquisitions (e.g., during rest and during pain inductions). participants will be invited for a second session of the same assessments six months later to observe possible connection between pain trajectory and stress system (dys)function.


Eligibility criteria:
inclusion criteria: • participants aged 18 to 45 years with a bmi between 18.5 and 35 kg/m², who are proficient in the dutch language and do not meet the exclusion criteria listed below exclusion criteria: * body weight \>150 kg (maximum weight for the mri scanner). * postmenopausal individuals. * use of hormone replacement therapy. * current or history of severe psychiatric, neurological (related to the brain, spinal cord, or nerves), endocrine (related to the hormonal system), or cardiovascular (related to the heart and blood vessels) conditions (e.g., cancer, cardiovascular disease, epilepsy, diabetes, etc.). * history of spinal surgery, spinal trauma, severe spinal deformities, or neurogenic back pain. * having a severe communicative or cognitive disorder. * use of medication that is not stable for at least 1 month prior to the test session. * regular drug use (≥1 time per week). * contraindications for mri (such as claustrophobia, implanted electronic devices like a pacemaker, metal splinters in the body, etc.). * currently pregnant or have been pregnant in the past year. * breastfeeding.

Keywords: stress system musculoskeletal pain pain chronification pain processing neural correlates of pain stress reactivity stress recovery autonomic nervous system (ans) hypothalamus-pituitary-adrenal axis (hpa axis) chronic widespread pain chronic localized pain oxytocin low back pain fibromyalgia
alpha radiation emitters device for the treatment of squamous cell carcinoma (dart)

Conditions: Skin Squamous Cell Carcinoma

Summary: a unique approach for skin squamous cell carcinoma (scc) treatment employing intratumoral diffusing alpha radiation emitter device

this will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with alpha dart seeds for the treatment of skin squamous cell carcinoma (scc) tumors. treatment will be delivered through radioactive sources (alpha dart seeds) inserted into the tumors in the skin. this approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. lesions with histopathological diagnosis of squamous cell carcinoma will be studied. reduction in tumor size 30-45 days after dart insertion will be assessed. safety will be assessed by the incidence, severity and frequency of all adverse events (ae).

Eligibility criteria:
inclusion criteria: * subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor. * subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread). * subjects' age is over 18 years old. * subjects' ecog performance status scale is ≤ 2. * subjects' life expectancy is more than 6 months. * female subjects of childbearing age will have evidence of negative pregnancy test. * subjects are willing to sign an informed consent form. exclusion criteria: * subject has a tumor with a maximal diameter \> 5 centimeters. * subject has an ulcerative lesion. * subject has a tumor of keratoacanthoma histology. * subjects' ecog performance status scale is ≥ 3. * patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * patients under immunosuppressive and/or corticosteroid treatment. * volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of dart. * pregnant women. * subjects not willing to sign an informed consent form.

Keywords: skin scc skin carcinoma, squamous
clinical validation of mμsors for non-invasive blood glucose detection in non-diabetic subjects

Conditions: Diabetes Mellitus

Summary: this is a single-center, open-label, prospective study. blood glucose is measured at different time points during oral glucose tolerance test and hypoglucose clamp test in healthy subjects, using both venous plasma and multi-channel microspatial offset raman scattering spectroscopy (mμsors). venous plasma glucose was set as gold standard. the two measurements were collected synchronously so as to calculate the mean absolute relative difference (mard) and the consensus error grid (ceg). accuracy of non-invasive blood glucose testing by mμsors will be in-depth validated specifically in the 3-10 mmol/l glucose range.

in order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμsors technology specifically in the 3-10 mmol/l glucose range, this study will conduct oral glucose tolerance tests and hypoglucose clamp tests on healthy subjects at different time points during the tests. in oral glucose tolerance tests, there will be 9 points as follows: 0-min and post glucose-load 30-min, 60-min, 90-min, 120-min, 150-min, 180-min, 210-min and 240-min. while in hypoglucose clamp tests, blood glucose will be set at around 3.0-4.0mmol/l for about 1.5-2.0 hours, blood glucose will be detected every 10 minutes.

Eligibility criteria:
inclusion criteria : * male or female. * aged\>=18 years for ogtt participants or aged between 20 and 40 years for hypoglucose clamp tests participants. * fasting blood glucose (fpg) \< 6.1 mmol/l and glycated hemoglobin (hba1c) \< 5.7% during the screening period. * there are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested. * confirmed as healthy based on the results of physical examination, medical history, vital signs and clinical laboratory tests. * fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form. exclusion criteria : * with diabetes history. * any history of serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry or metabolic abnormality, or any other disease that can interfere with the test results, which the investigator considers significant. * alcohol dependency or drug abuse. * those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial). * those who have used any drugs that affect blood glucose levels (such as insulin, oral hypoglycemic drugs, steroid hormones, thyroxine, etc.) within 28 days before screening; * pregnancy or lactation period. * difficulty in venous blood collection or fainting of needles or blood. * other circumstances that the investigator considers inappropriate to participate in the study.
study of angiomax in infants under six months with thrombosis

Conditions: Thrombosis

Summary: the goals of this study are: 1. to assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. to determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (act) or activated partial thromboplastin time (aptt) in infants under six months with arterial or venous thrombosis; 3. to determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (uh) or low molecular weight heparin (lmwh).

the goals of this study are: 1. to assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; 2. to determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (act) or activated partial thromboplastin time (aptt) in infants under six months with arterial or venous thrombosis; 3. to determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (uh) or low molecular weight heparin (lmwh).

Eligibility criteria:
inclusion criteria: * parent/legal-guardian has provided written informed consent before initiation of any study related procedures. * objectively confirmed thrombotic event by either doppler ultrasound, echocardiogram, ct scan, mri, mr angiogram, mr venogram, venogram or arteriogram. * age less than 6 months . * gestational age greater than 35 weeks * expected life expectancy at least 14 days. * no contraindication to anticoagulation i.e. bleeding complications. exclusion criteria: * active or recent (less than 7 days) bleeding. * known allergy to angiomax or hirudin, or known sensitivity to any component of the product. * participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment. * refusal to undergo blood transfusion should it become necessary. * any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial. * baseline prolonged pt (\>18 secs) or aptt (\>55 secs) * platelet count \< 50,000 cells/mm3 * birth trauma * planned or indicated surgery within 30 days * major or minor bleeding event

Keywords: neonates thrombosis bivalirudin direct thrombin inhibitor
the effect of reflexology in patients with viral bronchiolitis

Conditions: Bronchiolitis; Chemical; Reflexology

Summary: to test the influence of reflexology on bronchiolitis.

reflexology has been used in different respiratory tract infections on pulmonary function tests in patients with asthma, with some success. it has also been tested in newborns with respiratory distress syndrome, where it has decreased respiratory rate. whole body massage was found to be helpful in newborns with opioid withdrawal syndrome. it has been shown to be a safe treatment and well tolerated even among very young infants. therefore, the investigators decided to evaluate effect of reflexology treatment in patients with viral bronchiolitis.

Eligibility criteria:
inclusion criteria: * all children admitted due to bronchiolitis exclusion criteria: * children whose parents refused participation

Keywords: bronchiolitis reflexology
safety and usability of the stelo exoskeleton in people with acquired brain injury and spinal cord injury

Conditions: Spinal Cord Injury; Acquired Brain Injury

Summary: gait impairment in people with acquired brain injury (abi) and spinal cord injury (sci) can be very heterogeneous. for this reason, stelo has been developed: a new concept of exoskeleton based on modular technology for gait assistance. it allows a personalised configuration according to the functional capacity of each patient, as the therapist can choose which robotic joints to use depending on the therapeutic goal and on the patient recovery phase. the objective is to analyse the usability of the stelo modular exoskeleton in people with abi and sci.

a test phase will be conducted in healthy volunteers as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in the abi or sci population (phase 2). after verifying that the device is safe in healthy people, phase 2 will begin: it consists of a total of 10 visits. these visits will include gait training sessions using the stelo modular exoskeleton.

Eligibility criteria:
inclusion criteria: * weight \< 100 kg. * height 150-190 cm. * hip width between 30 - 45 cm. * distance from hip joint centre to knee joint centre: 36 cm - 50 cm. * distance from the centre of the knee joint to the ground: 43.5 - 59.5 cm. * shoe size eu 36-45. * patients must be able to follow simple commands. * age 18-85 years. * diagnosis of abi or sci. * fac level in participants with abi \< 4. * wisci ii level in participants with sci \< 20. exclusion criteria: * spasticity (mas) = 4 in lower limbs. * skin alterations in the areas of contact with the device. * planned surgical intervention during the duration of the study. * two or more osteoporotic fractures in the lower limbs in the last 2 years. * presence of other pathologies causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease). * surgical operation in the 3 months prior to the start of the study on the limbs and/or spine. * psychiatric disorders that interfere with proper use of the device or participation in the study such as impulsivity or inability to understand simple commands.

Keywords: exoskeleton modular sci abi gait spinal cord injury acquired brain injury
a follow-on study of donanemab (ly3002813) with video assessments in participants with alzheimer's disease (trailblazer-ext)

Conditions: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Cognitive Impairment

Summary: the main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing


Eligibility criteria:
inclusion criteria: * participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the trailblazer-alz study. * have a study partner * stable symptomatic alzheimer's disease (ad) medications and other medication that may impact cognition for at least 30 days prior to randomization into part a exclusion criteria: * current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than ad), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study. * have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against aβ in any other study. * poor venous access * contraindication to pet or mri imaging
diagnostic pocus of patellar tendinopathy in female athletes

Conditions: Patellofemoral Disorder

Summary: purpose: the purpose of this study is to determine the clinical effectiveness of point-of-care diagnostic ultrasound in the assessment of patellar tendon pathologies

participants will receive information about the study and informed consent will be provided. participants will voluntarily agree to be a participant in the study. participants will sign the informed consent, and complete the pocus demographic information sheet, if they qualify then they will have both of their patellar tendons examined through the use of the butterfly iq diagnostic ultrasound. following the examination, they will complete the knee injury and osteoarthritis outcome score (koos) and the knee injury and osteoarthritis outcome patellofemoral subscale (koos-pf) and then complete the study.

Eligibility criteria:
inclusion criteria: * 18-25 yr. old female student-athletes who participate in jump-centric activities exclusion criteria: * anyone who does not fit the inclusion criteria (18-25 yr old female student-athletes who participate in jump-centric activities

Keywords: pocus
comparison of static & dynamic back extensor endurance exercises in lbp

Conditions: Back Pain

Summary: this study will help to find the effects of static and dynamic back extensors exercises for chronic low back pain.

low back pain (lbp) is a very common health problem worldwide and a major cause of disability which affecting performance at work and general well-being. determine the effects of static and dynamic back extensors exercises for chronic low back pain.

Eligibility criteria:
inclusion criteria: * females * 25-55 years * low back pain \> 3 month * postural dysfunction exclusion criteria: * red flags indicative of serious spinal pathology with signs and symptoms of nerve root compromise (with at least two of dermatomal sensory loss, myotomal muscle weakness and reduced lower limb reflexes) * individuals with any obvious spinal deformity or neurological disease; * pregnancy * previous spinal surgery * previous experience of static and dynamic endurance exercise.

Keywords: low back pain endurance static dynamic exercises pain
enhancing foster care relationships through attachment-based intervention: protocol of safe family study

Conditions: Parenting Sensitivity; Foster Care

Summary: background: children in out-of-home care constitute a vulnerable population often experiencing mental health challenges related to early adversity and placement disruptions. the circle of security parenting® (cos-p) program is an attachment-based intervention designed to enhance carer sensitivity and reflective functioning, ultimately improving the quality of carer-child relationships. methods this study protocol follows a mixed-methods randomized controlled trial evaluating the effectiveness of the cos-p program for foster carers in france. a total of 70 foster carers will be randomly assigned to either the intervention group (receiving cos-p in addition to treatment as usual) or the waitlist control group (receiving treatment as usual only). quantitative measures, including the caregiving composite questionnaire, parenting stress index, and the marschak interaction method, will be administered at baseline and at follow-up). qualitative data will be collected through focus groups with foster carers and cos-p facilitators, and through self-confrontation interviews with a subset of foster carers. discussion: this study is the first to evaluate cos-p for foster carers in france. findings will provide valuable insights into the program's effectiveness in improving carer-child relationships and foster carer well-being, ultimately contributing to better outcomes for children in out-of-home care. the study will also explore potential moderators of treatment outcome and shed light on the subjective experiences of participants.


Eligibility criteria:
inclusion criteria: foster carers: 1. signed informed consent form. 2. commitment to attend all eight sessions of the cos-p program. 3. employed by cps haute-loire or by one of the two participating private agencies. foster children: 1. placed with a foster carer participating in the study. 2. aged from 1 to 6 years. 3. in permanent placement (5 or more days per week with the foster carer). 4. consent obtained from all individuals holding parental responsibility.

Keywords: foster care, attachment, circle of security parenting intervention, resilience, intervention evaluation
investigating how childhood tumours and congenital disease develop

Conditions: Childhood Tumor; Congenital Disorders

Summary: every cell and every organ in the human body derives from a fertilised egg. as the fertilised egg divides, a human being develops and grows. the process of how the fertilised egg divides and forms a human being is very sophisticated and is directed by the genetic information, the dna, that is present in every cell. when errors, mutations, in the dna code arise, the orderly process of human development can be disrupted. this can lead to the development of tumours during childhood and congenital diseases (that is, abnormalities that children are born with). the aim of this study is to define exactly which dna errors underpin childhood tumours and congenital diseases.

cancers and some congenital anomalies are caused by changes (mutations) in the genetic code (dna) of cells. the use of next generation sequencing (ngs) has enabled the study of the genetic changes that underpin these diseases, genome wide and at base pair resolution. a key question about the molecular pathogenesis of a range of childhood tumours and congenital anomalies that remains unanswered is the order in which the different mutations arise. to define the order in which mutations arise, the investigators will need to reconstruct the life history of individual tumours / anomalies. this can be achieved by segregating the major clone ('ancestral' cell) from sub-clones or by studying multiple areas from the same lesion. although this approach allows timing of mutations to some degree, in childhood tumours and congenital lesions this approach is fundamentally limited by the inability to define embryonic mutations. the basis of the limitation is that the lesions in question is conventionally compared to the patient's germline (the genetic information they have from birth). in such a comparison embryonic mutations will be misclassified as either germline or somatic (acquired). to overcome this limitation one would have to compare the lesion to the parental germline. thus, here this study proposes to perform the first ngs study of childhood tumours and congenital anomalies, focusing on defining the embryonic pathogenesis. a unique feature of this study will be that lesions will be compared to the parental germline to define embryonic mutations. a focus of the analysis will be to define order in which mutations arise.

Eligibility criteria:
inclusion criteria: * presence of childhood tumour / congenital disease, or relative of participant with childhood tumour / congenital disease * sufficient \&#39;surplus to diagnostic/clinical use\&#39; tissue is available * child assent and parental/guardian consent obtained where applicable exclusion criteria: * insufficient surplus tissue is available
study in patients with knee osteoarthritis treated by embolization using nbgm200

Conditions: Knee Osteoarthritis (Knee OA)

Summary: study in patients with knee osteoarthritis treated by embolization using nbgm200


Eligibility criteria:
inclusion criteria: * osteoarthritis proven by mr-imaging exclusion criteria: * current local infection * life expectancy less than 6 months