Kornimate/medical-research-clean huggingface dataset:
metabolic effects of a caloric restriction high/low glycemic index diet plus metformin in overweight/obese subjects

Conditions: Obesity

Summary: the prevalence of obesity and type 2 diabetes has increased dramatically worldwide. research on glycemic index (gi) diets has been largely developed, however the combination with metformin in humans was not investigated yet. we hypothesized that the low-gi diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. this study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low gi diets, and low-gi diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.

all groups (low/high-gi and low-gi + metformin) showed significant reduction in anthropometric parameters, but only low-gi and low-gi + metformin groups have an improvement in body composition parameters. in addition, the low-gi group achieved better results in metabolism of carbohydrates (glucose, insulin, cederholm index, and homa-β) and lipids (chol, tag, ldl-c, vldl-c, and tc/hdl-c). these results show the benefits of low-gi diet on metabolic parameters in overweight or obese type 1 subjects.

Eligibility criteria:
inclusion criteria: * participants were adults (18-50 y), with body mass index (bmi) between 25-35 kg/m². * subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: hypocaloric diet with predominating high glycemic index foods; * subjects with altered glycemic response presented at the 120 min point either glycemia \ 40 µui/ml: hypocaloric diet with predominant low glycemic index foods; * subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dl and insulin \>40 µui/ml: hypocaloric diet with predominant low glycemic index foods and metformin. exclusion criteria: * smokers * pregnant or lactating * diagnosis of any metabolic diseases * were under medication and therapeutic diet, except oral contraceptive for women.

Keywords: glycemic index caloric restriction energy intake glucose lipid metabolism cholesterol hdl cholesterol ldl cholesterol obesity metformin
aerobic training on spasticity and gross motor function in children with diplegic cerebral palsy

Conditions: Cerebral Palsy

Summary: to determine the effects of aerobic training on spasticity and gross motor function in children with diplegic cerebral palsy.cerebral palsy (cp) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . the spastic cp is found to be the commonest presentation followed by athetoid, ataxic and mixed types. children with cerebral palsy (cp) have decreased capacity to participate in play and sports activities .reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. aerobic training via lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with cp. the tools used will be gmfm-66 and modified ashworth scale. study will be conducted on thirty two patients in two groups. group a will be control group that will be provided with conventional physiotherapy (stretching exercises , trunk control training, walk and breathing exercises) and group b will be experimental group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. data will be analyzed using spss 22.0.


Eligibility criteria:
inclusion criteria: * 6-12 years of age both genders will be included. * ability to follow simple verbal instructions. * ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system \[gmfcs\] levels i-iii) * spastic diplegic cerebral palsy scoring on ashworth scale of 1, 1±, 2 exclusion criteria: * orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months * botulinum toxin injections within the preceding 3 months * serial casting or new orthotic devices within the preceding 3 months * initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months * inability or unwillingness to maintain age appropriate behavior * serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures * significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle

Keywords: aerobic training gross motor function stationary cycle diplegic cerebral palsy
effect of the inhibitors of the way jak-stat on regulatory b cells

Conditions: Rheumatoid Arthritis

Summary: this study will investigate whether inhibitors of the jak / stat signaling pathway can increase anti-inflammatory functions of b cells in patients with ra using in vitro and in vivo experiments.

this study will first analyze the effect of inhibitors of the jak / stat pathway in vitro on b-cell phenotypes and functions in 30 ra patients and 30 patients with osteoarthritis. it will also study the phenotypes and functions of b cells in ra patients for whom jak / stat inhibitor treatment has been prescribed by the patient's usual rheumatologist. the analysis will be done before the start of treatment and 3 months later. the phenotypes of b-cells will be assessed by flow cytometry with intra- and extra-cellular stainings. the functions of b cells will be assessed by their ability to differenciate naïve t cells in coculture.

Eligibility criteria:
inclusion criteria: * general criteria * patient, of 18 and more years old * subject affiliated to a social security system * subject not being in period of exclusion with regard to another protocol * absence of pregnancy in the inclusion (date of the last period, use of a contraceptive method, ß -hcg impulsive person in case of doubt) * informed consent * criteria of inclusion of the group rheumatoid arthritis (in vitro studies): * rheumatoid arthritis, corresponding to the the classification acr / eular 2010 criteria * criteria of inclusion of the group arthritis (in vitro studies): * spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements. * criteria of inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by jak / stat inhibitors : * rheumatoid polyarthritis, corresponding to the classification acr / eular 2010 criteria * patient to whom a treatment by inhibitor of the way jak / stat was proposed in current care of rheumatoid arthritis. exclusion criteria: * general criteria * corticosteroid therapy superior to 10 mg / j * drip of corticoids in the previous month * pregnant or breast-feeding patients * patient under protection(saving) of justice * under guardianship patient or guardianship * current infection * criteria of non-inclusion of the group rheumatoid polyarthritis ( in vitro studies): * treatment by immunomodulateur or biotherapics (anti-tnf alpha, tocilizumab, abatacept or rituximab) in the previous year * criteria of non-inclusion of the group arthritis ( in vitro studies): * history of autoimmune disease or néoplasie * treatment by immunomodulateur or biotherapics (anti-tnf alpha, tocilizumab, abatacept or rituximab) * criteria of non-inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by jak / stat inhibitors : treatment by rituximab in the previous year

Keywords: rheumatoid arthritis regulatory b cells jak/stat inhibitors
effect of extra- fine versus coarse-particle inhaled corticosteroids (ics) on ventilation heterogeneity in children with poorly controlled asthma

Conditions: Asthma

Summary: the primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung mri is prevalent children with poorly controlled asthma despite guidelines-based treatment with ics. the secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ics (hfa-bdp) improves ventilation heterogeneity compared to treatment with a coarse particle ics (fluticasone hfa or dry powder).


Eligibility criteria:
inclusion criteria: * boys and girls between the ages of 6 and 17 years * diagnosis of asthma based on naepp3 criteria * poor asthma control based on one or more of the following criteria: an act ≤ 19 and/or acq ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ics and/or an anti-leukotriene within six months before enrollment. * any airflow obstruction based on hankinson et al reference standards: fev1 % \< 80% predicted, an fev1/fvc ratio \< 90% predicted, and/or an fef 25-75 \< 70% predicted at the screening and/or randomization visits. * frequent severe exacerbations as reflected by ≥ 2 bursts of systemic corticosteroids (≥ 3 days each) in the previous 12 months. * serious exacerbations reflected by at least one hospitalization, icu stay, or mechanical ventilation in the previous 12 months * "not well controlled" by naepp or gina asthma treatment guidelines * for post-pubertal females, negative urine pregnancy screen and willing if sexually active (as counseled by a female study coordinator in private) to using a consistent and appropriate method of birth control for the duration of the study. exclusion criteria: * premature birth \< 35 weeks estimated gestational age * maintenance oral prednisone (defined as daily or alternate day for the past three months before screening) or omalizumab treatment for asthma control * any significant medical condition that might inform maldistribution of ventilation apart from asthma including bronchiectasis, cardiac disease, congenital anomalies of the respiratory system, neurodevelopmental delay with cognitive impairment, ciliary dyskinesia syndromes, immune deficiency, recent lower respiratory infection (within six weeks of screen visit). co-morbidities associated with asthma including sleep apnea syndrome, obesity, gerd, and right middle lobe syndrome are not criteria for exclusion. * claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker, or other contraindication to mr scanning. subjects with any implanted device that cannot be verified as mri compliant will be excluded. * chest circumference greater than that of the helium coil. the circumference of the coil is approximately 42 inches. * inability to understand simple instructions or to hold still for 10 seconds.
tissue retractors for radiation therapy of head and neck tumors

Conditions: Head and Neck Cancer

Summary: the rate of therapy-associated side effects during and after radiotherapy of head and neck tumors is essential. the most effective approach to reducing acute toxicity is to cut out healthy tissue from the radiation field. the distance between the tumor and normal tissue can be individually increased using personalized, 3d printer-based tissue retractors (gwr). even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. the current randomized phase ii study evaluates the use of gwr with regard to acute toxicity. in addition, quality of life, long-term toxicity as well as local control and overall survival 12 months after radiotherapy are evaluated.

the most effective approach to reducing acute toxicity after radiotherapy is to cut out healthy tissue from the radiation field. gwr can increase the distance between the tumor and normal tissue. even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. adequate immobilization also reduces unwanted movements, especially of the tongue. the gwr are manufactured as combinable modules according to the "modular principle". this improves reproducibility and flexibility and reduces development and manufacturing costs. the study is being conducted as a monocentric, prospective, randomized phase ii study. a total of 34 patients who meet the inclusion criteria are examined for acute toxicity after radiotherapy of a malignant head and neck tumor. the primary goal of the study is to reduce acute toxicity through individual immobilization of the jaw and tongue. secondary study goals are the evaluation of quality of life and long-term toxicity as well as local control and overall survival twelve months after radiotherapy. in both groups, radiation therapy is carried out in accordance with guidelines using image-guided radiotherapy.

Eligibility criteria:
inclusion criteria: * diagnosis of a malignant head and neck tumor * clinical target volume of radiotherapy may include portions of at least one region: oral cavity; upper jaw; lower jaw; oropharynx; hypopharynx; large salivary glands * indication for radiotherapy alone (postoperative or definitive) * age ≥ 18 years * karnofsky performance score ≥ 60 * completed wound healing after tumor resection * the patient's consent and written consent * ability of the patient to assess the nature and scope as well as possible consequences of the clinical study * adequate contraception in women of childbearing potential and in men exclusion criteria: * pre-radiation in the head and neck area * multifocal, diffuse growing tumors * inadequate regression of toxicities from previous therapies * jaw clamp (cutting edge distance ≤ 2 cm) * simultaneous systemic tumor therapy during radiation (especially chemotherapy and immunotherapy) * indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance) * missing written declaration of consent
phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation

Conditions: Multiple Myeloma

Summary: this is a multicenter, randomized, open-label, phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.


Eligibility criteria:
inclusion criteria: * must have a new diagnosis of multiple myeloma according to imwg criteria and have received induction +/- consolidation. * must have received only one line of therapy and achieved at least a partial response (≥pr) as per imwg 2016 response criteria (kumar 2016) without evidence of progression at the time of first treatment dose. * must not be intolerant to the starting dose of lenalidomide. * must not have received any maintenance therapy. * have an ecog performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment * have clinical laboratory values within prespecified range. exclusion criteria: * received any prior bcma-directed therapy. * any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (eg, chimeric antigen receptor modified t cells, nk cells). * discontinued treatment due to any ae related to lenalidomide as determined by the investigator. * progressed on multiple myeloma therapy at any time prior to screening. * received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 days prior to first treatment dose. * received a live, attenuated vaccine within 4 weeks before first treatment dose. non-live vaccines or non-replicating authorized for emergency use (eg. covid-19) are allowed.

Keywords: maintenance teclistamab
adequacy of pain management for upper extremity fracture after discharge from a pediatric emergency depart

Conditions: Fracture

Summary: pain is a common cause for children seeking care in the emergency department (ed). children with orthopedic injuries often require pain control when seeking emergency care. despite the high prevalence of ed visits requiring pain control, pain is often poorly assessed and treated in ed settings. currently, no standard of care exists for the management of this fracture-related pain in children discharged from the ed. furthermore, discrepancies in analgesia administration to patients of various racial groups seeking emergency care have been documented but are poorly understood. no research currently exists comparing pain severity between upper extremity fractures requiring simple splinting to those treated with sedated reduction and splinting. furthermore, there is no research regarding the prevalence of significant post-discharge pain nor the differences among ethnic and age groups treated in the ed. research questions: what is the prevalence of significant post-discharge pain in children treated for upper extremity fractures? is there a difference in severity between those children requiring reduction versus simple splinting? is there a difference in pain severity noted among different ethnic or age groups? design this is a prospective, un-blinded, observational study that will include patients seeking treatment for an upper extremity fracture.


Eligibility criteria:
inclusion criteria: * parents/guardians of patients presenting to the ed will be included if: * the patient is younger than 18 years old * the patient has an isolated upper extremity fracture (including clavicle, humerus, forearm, wrist) undergoing ed splinting with or without reduction * the parent/guardian is english, spanish, somali, or hmong-speaking * the parent/guardian lives with the child * he/she has a working telephone number exclusion criteria: * potential subjects presenting to the ed will be excluded from study participation if: * there is suspicion of child abuse or neglect * the parent/guardian is not english, spanish, somali, or hmong-speaking * the patient is critically ill * the fracture requires operative reduction/treatment * the patient is medically complex * the patient has a pre-existing bone disease or chronic pain syndrome

Keywords: emergency pediatric fracture pain
physical activity and symptom disturbance regarding cross-trimester

Conditions: Pregnancy Related

Summary: this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).

based on the tpb, this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). moreover, the study will explore the effect factors, predictors and transition factors regarding pregnant women's regular exercise intention and behavior across trimesters.

Eligibility criteria:
inclusion criteria: * inclusion criteria were women in 8-16 weeks of gestation with a singleton pregnancy who had no obstetric or medical complications exclusion criteria: * excluded were those who had american college of obstetrics and gynecology (acog) absolutely contraindication exercise, such as insulin-dependent diabetes, gestational diabetes, hypertension, and multiple-gestation pregnancies
study to assess in-home use of evolocumab (amg 145) using a prefilled syringe or a prefilled autoinjector/pen

Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia

Summary: the primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.


Eligibility criteria:
inclusion criteria: * fasting ldl-c at screening \> 85 mg/dl * fasting triglycerides less than or equal to 400 mg/dl (4.5 mmol/l) exclusion criteria: * new york heart association (nyha) iii or iv heart failure * uncontrolled cardiac arrhythmia * uncontrolled hypertension * type 1 diabetes or poorly controlled type 2 diabetes * uncontrolled hypothyroidism or hyperthyroidism

Keywords: ldl-c, triglycerides, high cholesterol
soft robotics for infants with cerebral palsy

Conditions: Cerebral Palsy

Summary: children with spastic cerebral palsy suffer from significant weakness that contributes to abnormal posture and movement. it is thought that this arises due lack of frequency sufficient tension to encourage normal muscular growth underlying the need for early intervention to encourage walking. the failure of muscle growth to keep pace with bone growth is most evident in the bi-articular muscles and contributes to joint contractures and gait abnormalities such as toe-walking and flexed-knee gait. recently, our research team has developed a novel, lightweight (0.2kg at knee joint) and portable (energetically autonomous) soft wearable robotic knee system that can provide active powered knee assistance and synchronized proprioceptive feedback for the gait training of stroke patients' standing and walking.


Eligibility criteria:
inclusion criteria: * capable of understanding the proposed exercises; * aged 2 to 15 years; * maximum weight 75 kg; * children with no deformations that could prevent the use of the exoskeleton; * gross motor function classification system (gmfcs) levels i to iii; * able to signal pain or discomfort. exclusion criteria: * unhealed skin lesions in the lower limbs; * aggressive or self-harming behaviors; * severe cognitive impairment.
role of the autonomic nervous system in hiv-lipodystrophy

Conditions: HIV Infections; Lipodystrophy-Syndrome

Summary: the study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in hiv-infected patients by measuring heart rate variability and various metabolic pathways in hiv patients receiving highly active antiretroviral therapy.


Eligibility criteria:
inclusion criteria: * hiv-infection * age above 18 years * no aids defining event during last 6 months * no infection during last 6 weeks * no concommitant drug interfering with insulin sensitivity and ans-activity
blood loss and preeclampsia

Conditions: Pre-Eclampsia; Complicating Pregnancy; Blood Loss; Coagulation Disorder

Summary: study of blood loss in preeclamptic patients using mathematical formulae

pre-eclampsia is a symptom complex that occurs in 2-5% of all pregnancies and leads to significant morbidity and mortality. it is associated with a risk of impaired coagulation caused by a reduced platelet count, very rarely by disseminated intravascular coagulation disorders. the degree of clotting correlates with the severity of preeclampsia. it is planned to calculate the blood loss using mathematical formulas and to compare the different blood loss in the two groups (preeclampsia vs. healthy pregnant women). furthermore, this project will try to correlate the blood loss with the underlying coagulation situation. the aim is to be able to better assess the bleeding risk in healthy pregnant women, but also in pre-eclamptic patients in the future.

Eligibility criteria:
inclusion criteria: * elective or urgent caesarean section * written informed consent exclusion criteria: * emergency caesarean section * familial coagulation disorder * hematological disorders that affect the platelet count, e.g. myelodysplastic syndrome (mds) * taking anticoagulants * taking aspirin in the last 14 days * use of nsars in the last 24 hours

Keywords: pre-eclampsia blood-loss impaired coagulation