Kornimate/medical-research-clean huggingface dataset:
development of follow-up nursing consultations for children at risk of post-resuscitation syndrome

Conditions: Stress Disorder, Post Traumatic

Summary: the investigator hypothesize that, during an ipde consultation 3 months after discharge from critical care, the investigator will identify ptsd in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care.


Eligibility criteria:
inclusion criteria: * patients aged between 1 and 17.5 years at inclusion * having stayed in a paediatric intensive care unit in one of the 2 participating centers: lyon or grenoble * requiring mechanical ventilation (invasive or non-invasive) for more than 24 hours exclusion criteria: * patients already under the care of a psychologist or psychiatrist * patients who died during their stay in intensive care * patients who died between discharge and 3 months * patients suspected of abuse * patient and/or parent refusal to participate * no social security affiliation * patients / parents who do not speak french
effects of teriparatide or denosumab on bone in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).


Eligibility criteria:
inclusion criteria: * ambulatory, postmenopausal women (no vaginal bleeding for at least 2 years prior to screening) with osteoporosis * bone mineral density (bmd) t-score of at least -2.5 at femoral neck (fn), total hip (th), or lumbar spine (ls) (lumbar vertebrae l1-l4, with at least 2 evaluable vertebrae), with or without atraumatic fracture after menopause, or * bmd t-score of at least -1.5 at fn, th, or ls (l1-l4, with at least 2 evaluable vertebrae), and 1 or more atraumatic fractures after menopause (vertebral or nonvertebral). nonvertebral fracture sites allowed are wrist, hip, pelvis, rib, humerus, clavicle, leg (femur, tibia, and fibula, excluding ankle) * laboratory values for serum calcium, parathyroid hormone (pth), and alkaline phosphatase must be within the normal reference range exclusion criteria: * has an increased risk of osteosarcoma (bone tumor); this includes paget's disease of bone, a previous bone tumor, or radiation involving the skeleton * has an allergy or intolerance to teriparatide or denosumab and/or is a poor candidate for teriparatide or denosumab treatment (investigator should refer to local product prescribing information) * has a history of exposure to dem or tet therapy in the 12 months prior to screening or a known allergy to dem or tet * has a condition that could put the participant at additional risk of an adverse event (ae) due to the bone biopsy procedure (for example, bleeding disorder) * has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest) * has a 25-hydroxyvitamin d concentration of \<10 nanograms per milliliter (ng/ml) * has currently active or suspected (within 1 year prior to enrollment) diseases that affect bone metabolism, other than osteoporosis (such as renal osteodystrophy, hyperthyroidism, osteomalacia, or hyperparathyroidism) * has a history of certain cancers within 5 years prior to trial entry * current or recent (within 1 year prior to enrollment) celiac disease, inflammatory bowel disease, gastric bypass, or other malabsorption syndrome * has significantly impaired hepatic or renal function * has had treatment with systemic glucocorticoids in doses ≥5 mg/day prednisone/day or equivalent in the 6 calendar months prior to screening * has taken any intravenous osteoporosis medication * has had prior treatment with other bisphosphonates and not been off of them for a specific period of time before trial entry * has participated in any other clinical trial studying teriparatide, pth, pth analog, or denosumab, or prior or current treatment with teriparatide, pth, pth analog, or denosumab
safety and tolerance of a nutritional intervention program- in.form 1.2

Conditions: Obesity

Summary: the study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. experience will be compared to a historical controls.

to investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education and a meal replacement formula and targeted nutraceuticals (prog 2) in generally healthy, overweight subjects, fifty subjects with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into different arms, 13-week intervention trial. to evaluate safety and tolerability, questionnaires were collected weekly. additionally, baseline, week 9 and 13 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. vitals signs, weight and body composition were monitored weekly.

Eligibility criteria:
inclusion criteria: generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required: * to be overweight or obese (bmi ≥ 27 kg/m2 and ≤ 50 kg/m2), * to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men), * and demonstrate signs of cardiometabolic dysfunction. specifically, subjects were required to have: * elevated ldl cholesterol ≥ 130 mg/dl * and/or elevated tg defined as tg ≥ 130 mg/dl. additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated ldl and tg): * hdl \< 50 mg/dl for women and \< 40 mg/dl for men, * blood glucose ≥ 100 mg/dl, hba1c ≥ 5.7%, * or homeostatic model assessment of insulin resistance (homa-ir) score defined as ≥ 2.0. exclusion criteria included: * pregnancy * lactation * recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements * recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia * chronic use of over-the-counter medication which would interfere with study endpoints including nsaids, laxatives and antacids * allergy or intolerance to study products * serious, unstable medical conditions including known infection with hiv, tuberculosis or hepatitis; cardiovascular disease; diabetes mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse; * abnormal laboratory findings * participating in or planning to begin a weight loss diet during the study period * difficulty in swallowing pills * lifestyle or schedule incompatible with the study protocol.
trial for shoulder pathology and pain in chronic sci

Conditions: Shoulder Pain

Summary: this research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. the research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.


Eligibility criteria:
inclusion criteria: 1. candidates will be men or women, 18 years of age or older. 2. candidates must have an sci and be at least 1 year post-diagnosis 3. candidates must use a wheelchair (manual or electric) for at least the majority of the time. 4. candidates must be able to transfer themselves without the help of others. 5. the presence of at least moderate shoulder pain (rating of \>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months. exclusion criteria: 1. patients younger than 18 years of age. 2. patients who have a history of pre-injury rotator cuff tears or shoulder injury. 3. patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Keywords: spinal cord injuries sci
successful aging and age-related decline

Conditions: Aging; Elderly; Cognitive Decline; Physical Decline; Intervention Study

Summary: recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. the investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline.

this is a longitudinal, controlled, cohort study. the overarching aim in this intervention study is three-fold: (1) to test hypotheses derived from ageing-related theories, (2) to provide robust measurable evidence both in the long-term and validate meaningful interventions, and (3) provide quantifiable cost-benefit ratio to suggested solutions. a cohort of malaysian older adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control.

Eligibility criteria:
malaysian older adults aged 60 and above who fulfil the following criteria will be recruited: inclusion criteria: * healthy and this includes those seeking regular medical attention, * have some form of mobility (ability to walk short distances at least 3m), * able to communicate in at least one of the following languages: english, malay, mandarin, tamil. exclusion criteria: * older adults with a history of stroke, * diagnosis of neurodegenerative diseases (such as alzheimer's disease or parkinson's) or psychiatric disorders, * uncorrected auditory and/or visual impairments, * currently on psychiatric medications, * immobile, * require full-time caregiver assistance, * with comprehension impediments from the assessment portion of this project, * a montreal cognitive assessment (moca) score of \<13.

Keywords: cognition physical activity biological aging intervention neuroscience mri eeg biological markers cost-benefit analysis age-related decline depression anxiety
gardasil™ vaccine impact in population study (v501-033)

Conditions: Human Papillomavirus Infections

Summary: this study will assess the impact of gardasil™ human papillomavirus (hpv) vaccine in the general female population by utilizing nationwide registry databases in the participating nordic countries.

time perspective: the study will be conducted using data collected both retrospectively/concurrently from registries and prospectively by questionnaire survey. baseline survey data were collected during a prior study from 2004-2005. safety monitoring: an expert panel on teratology consisting of one teratologist from each of the participating countries will review all available medical records related to any congenital anomalies to search for any emerging patterns that may be indicative of an association between gardasil™ exposure in the mother and the subsequent congenital anomalies in the babies.

Eligibility criteria:
inclusion criteria: - registry data: \* female residents of participating nordic countries who were alive on january 1st in the year the data will be used for analysis - survey data: --female residents alive in the participating countries on july 1, 2011 --women must provide consent to use questionnaire data and to link data to other registry databases - cervical sample collection: --for hpv data in the general population: cervical samples from residents of the participating countries who are 45 years and under collected between 2006 and 2007, or in 2011-2012 --for hpv data in lesional samples: cervical samples from women with a diagnosis of cin or cervical cancer between 2004-2006 and 2011-2012 exclusion criteria: - registry data: \* women who participated in protocol v501-015 (nct00092534) and are included in the long-term follow-up study - survey data: --women under 18 or above age 45 on july 1, 2011 --women who participated in protocol v501-015 and are included in the long-term follow-up study - cervical sample collection: --samples from women who participated in protocol v501-015 and are included in the long-term follow-up study --samples with inadequate integrity for hpv testing

Keywords: congenital anomaly pregnancy gardasil® nordic population-based
a phase ii study of rituximab combined with chop in t-cell angio-immunoblastic lymphoma

Conditions: Untreated T-cell Angioimmunoblastic Lymphoma

Summary: to evaluate the efficacy and the safety of a front-line treatment combining chop regimen and rituximab in patients aged 60 to 80 years with previously untreated ail.

this is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining chop regimen and rituximab in patients aged 60 to 80 years with previously untreated ail. it is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).analysis performed every 5 patients (based on triangular test). the duration of the treatment period is approximately 25 weeks and patients are followed until death. the total duration of the study is expected to be 2.5 years.

Eligibility criteria:
inclusion criteria: * patients with histologically proven t-cell angioimmunoblastic lymphoma (ail) on lymph node biopsy. * aged from 60 to 80 years. * patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion). * ecog performance status 0 to 2. * with a minimum of life expectancy \> 3 months. * negative hiv, hbv and hcv serological tests \< 4 weeks (except after vaccination). * having previously signed a written informed consent. exclusion criteria: * any other histological type of t-cell lymphoma. * central nervous system or meningeal involvement by lymphoma. * contra-indication to any drug included in the r-chop regimen. * concurrent severe disease (according to the investigator's decision). * active bacterial, viral or fungal infection. * poor renal function (serum creatinine level \> 150 µmol/l) or impaired liver function tests (total bilirubin level \> 30 µmol/l, transaminases \> 2.5 upper normal limits) unless they are related to the lymphoma. * poor bone marrow reserve as defined by neutrophils \< 1.5 x 109/l or platelets \< 100 x 109/l, unless related to bone marrow infiltration. * any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix. * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * patient under tutelage.

Keywords: t-cell angioimmunoblastic lymphoma rituximab
evaluation of oral morphine gel in oral mucositis induced by chemotherapy in children and young adults

Conditions: Cancer

Summary: chemotherapy kills tumor cells but can also damage healthy cells and cause significant digestive disorders such as ulcers of the mouth, called mucositis. mucositis are transient but their intensity may require special measures. mucositis are painful and morphine gel or intravenous morphine is used to relieve pain. however, the pain of oral mucositis induced by chemotherapy is not completely relieved by morphine administered intravenously. as part of the study, the investigators want to evaluate an oral gel containing a small amount of morphine so that it acts directly on the mucositis. the investigators believe that the direct action of morphine on mucositis may be more effective on pain.

the objective of the study is to compare the analgesic efficacy of topical morphine gel versus placebo gel in the pediatric oncohaematology oral mucositis induced by chemotherapy in children treated with systemic opioids. to confirm these results, we propose to conduct a randomized double-blinded study designed to compare the analgesic efficacy of morphine oral topical gel versus placebo gel in children over 5 years with mucositis induced by chemotherapy and treated with systemic opioids. this analgesic effect should reduce persistent pain to maintain oral feeding and thus delay the implementation of parenteral nutrition, and hence reduce the dose of systemic morphine and also reduce the adverse effects of opioids

Eligibility criteria:
inclusion criteria: * children older than 5 years or adults over 18 and up to 25 years with a chemotherapy * greater than or equal to grade 2 mucositis that has lasted for 24 hours and treated with systemic opioid exclusion criteria: * patients in emergency ward -patients having difficulties in understanding the study - * patients who have already been treated with oral morphine gel

Keywords: chemotherapy mucositis systemic opioids morphine
safety and efficacy of donepezil hcl 23 mg in patients with moderate to severe alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a multi-center, open-label, single-arm, prospective, phase iv trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe alzheimer's disease.

this study consisted of pre-treatment and treatment phase. pre-treatment phase was approximately 4 weeks including the screening and baseline process. in treatment phase, about 190 subjects received donepezil hcl 23 mg once daily for 24 weeks.

Eligibility criteria:
inclusion criteria 1. male or female aged 45 to 90 years 2. patients have eligible conditions of dementia diagnosis listed in dsm-iv 3. diagnosed as a probable alzheimer's disease patient according to nincds-adrda criteria 4. at the timing of screening, mmse less than or equal to 20 and cdr greater than or equal to 2 or gds greater than or equal to 4 5. patients, who have been taking stable donepezil 10 mg for 3 months or longer before the start of the study (screening visit), are evaluated as eligible to take donepezil 23 mg by investigator 6. patients who have not received any other medications for ad such as ache inhibitors at least for 3 months prior to the screening visit excluding donepezil hydrochloride (however, concomitant use of memantine is allowed if taken at stable dose that are less than or equal to the approved dose range for at least 3 months prior to screening) 7. medicines for cerebral activation such as gingko biloba is allowed to be taken if the patient has received it as stable dose for 3 months prior to the screening visit exclusion criteria 1. patients who have been participated in any other clinical trial 3 months prior to the screening visit 2. patients who are having any severe psychiatric disorder or schizophrenia 3. patients who are having a neurological disorder other than ad which affect the subject's cognition or ability to assess the cognition

Keywords: alzheimer's disease
a study of remote electrical neuromodulation for acute procedural pain

Conditions: Chronic Migraine

Summary: the purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the nerivio ® device, to relieve pain associated with receiving onabotulinumtoxina (botox) injections for chronic migraine prevention.


Eligibility criteria:
inclusion criteria: * meet the criteria for 1.3 chronic migraine based on ichd3 criteria. * currently receiving onabotulinumtoxina per preempt protocol for the treatment of chronic migraine. * have remained stable on their current headache medication for a minimum of 8 weeks. * patient is willing and able to comply with the protocol to the satisfaction of the investigator. * patient has the capacity to provide written, informed consent for themselves. exclusion criteria: * participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant). * participants with congestive heart failure (chf), severe cardiac or cerebrovascular disease. * participants with uncontrolled epilepsy. * change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study. * pregnant, trying to get pregnant or breastfeeding female participants. * subjects participating in any other interventional clinical study. * participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments. * participants who have previous experience with the device. * patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.

Keywords: onabotulinumtoxina (botox) injections
safety and efficacy of intravenous immunoglobulin igpro10 in patients with primary immunodeficiencies (pid)

Conditions: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Summary: the objectives of this trial are the assessment of safety and efficacy of igpro10 in patients with pid, and the assessment of tolerability of high infusion rates. to demonstrate safety, the number of infusions temporally associated with aes, the rate, severity and relationship of all aes and the vital sign changes during each infusion will be evaluated.


Eligibility criteria:
key inclusion criteria: patients with cvid (common variable immunodeficiency) or xla (x-linked agammaglobulinemia) who: participated in the phase iii clinical study with intravenous igpro10 (study number zlb03_002cr) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects) or were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg igg per kg body weight) at 3- or 4-week intervals for at least 6 months, and were interested in participating in the phase iii clinical study with subcutaneous igpro20 (study number zlb04_009cr) (referred to as 'new' subjects) written informed consent key exclusion criteria: diagnosis of epilepsia insulin dependent diabetes administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs history of cardiac insufficiency (nyha iii/iv), cardiomyopathy, congestive heart failure, severe hypertension

Keywords: immunoglobulin intravenous agammaglobulinemia hypogammaglobulinemia common variable immunodeficiency immunoglobulin g children
inspire trial for skin and soft tissue infections

Conditions: Skin and Soft Tissue (SST) Infection

Summary: the inspire skin and soft tissue infection trial is a cluster-randomized controlled trial of hca healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (cpoe) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen. note: enrolled "subjects" represent 102 individual hca healthcare hospitals that have been randomized into 92 clusters. hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.


Eligibility criteria:
facility inclusion criteria: 1. hca healthcare hospitals admitting adults for skin and soft tissue infection 2. facility use of meditech as their electronic health record system facility exclusion criteria: - note: unit of randomization is the hospital, however the computerized physician order entry (cpoe) alert intervention will calculate risk estimates for adults age \>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.

Keywords: sst cpoe empiric therapy