Kornimate/medical-research-clean huggingface dataset:
effectiveness of a brief psychological mindfulness based intervention for the treatment of depression in primary care

Conditions: Depressive Disorder

Summary: the aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in primary care between different groups: a mindfulness intervention applied face to face in group format, a control group that will receive treatment as usual (tau) consisting of medical treatment and the same mindfulness intervention applied by information and communication technologies (icts). the principal hypothesis is that face to face intervention will be more effective than tau

the aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in primary care between different groups: 1) a face-to-face mindfulness intervention in group format (10-12 people/group), 2) a control group which will received primary care tau (usual medical treatment) and 3) the same mindfulness intervention applied by information and communication technologies (icts) (internet-based program). all participants in the two psychological intervention groups will also receive usual medical treatment managed by their general practitioner. each group will be composed of 40 participants with a total sample of 120. the principal hypothesis is that face to face intervention will be more effective than tau. secondary hypothesis, are: 1) the online computerized program will be more effective than tau; 2) the differences between face-to-face and online format will be analyzed. finally, a qualitative study will be conducted in order to analyze the feasibility, acceptance, barriers and causes of drop-outs and success, expectations, experiences and attitudes that could be obstacles or facilitators in the interventions, both in patients and in health professionals. this study will allow us to understand the experiences of depressed patients with these interventions and their differences.

Eligibility criteria:
inclusion criteria: * be adult * willingness to participate in the study and signing informed consent * ability to understand and write spanish. * dsm-5 diagnose of major depression or dysthymia, mild or moderate depression expressed as score lower than 14 in the patient health questionnaire (phq) * duration of depressive symptoms 2 months or more * to have and to handle the computer and internet exclusion criteria: * any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.), * other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.), except for anxious pathology or personality disorders * any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk

Keywords: mindfulness internet program depression cost-effectiveness
clinical study to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of afq056 in children with fragile x syndrome (fxs)

Conditions: Fragile X Syndrome

Summary: the aim of this study is to characterize the pharmacokinetics and safety/tolerability of afq056 in children with fragile x syndrome(fxs)


Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of fxs * at screening and first baseline, vital signs, body weight and body mass index (bmi) must be age-specific within normal ranges. exclusion criteria: * use of any other investigational drug within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to screening until end of study visit. * history of hypersensitivity to afq056 or any mglur antagonist. * female patients who are confirmed or suspected to be sexually active. * history or presence of any clinically significant disease of any major system organ class, within the past 2 years prior to screening including but not limited to psychiatric, neurological, cardiovascular, endocrine, metabolic, renal, or gastrointestinal disorders (except for typical features of fxs). * smokers. * loss of ≥10% of total blood volume within 8 weeks (or less if required for this age group and/or by local regulation) prior to dosing or longer if required for this age group and/or by local regulation. * significant illness that did not completely resolve at least four weeks prior to the first baseline visit. * any abnormal laboratory values at screening or first baseline that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject. * use of (or use within at least 5 half lives before dosing) concomitant medications that are strong/moderate inhibitors or inducers of cyp1a1/2, cyp2c9/19 or cyp3a4 * history or presence of hepatitis b/c or hiv at screening

Keywords: fragile x syndrome pharmacokinetics safety and tolerability
gonadotropin-releasing hormone (gnrh) antagonist during 3 days

Conditions: Infertility

Summary: in this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a gnrh antagonist during 3 consecutive days at initiation of the cycle, is possible.

a recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a gnrh antagonist during three subsequent days prior to the start of gonadotropin stimulation in a gnrh antagonist protocol. this regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (coh). since this regimen is valid in case of elevated progesterone, gnrh antagonists pretreatment may prove to be a valid tool for scheduling ivf treatment in patients with normal progesterone values on day 2 of the cycle. in this prospective randomised trial, the investigators study the impact of administration of a gnrh antagonist during 3 consecutive days at initiation of the cycle.

Eligibility criteria:
inclusion criteria: * \< 39 years old on day of randomisation * fsh \< 12 (in the early follicular phase) * normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation. * regular menstrual cycles of 21-35 days, presumed to be ovulatory. * bmi between 18 and 29 (both inclusive) * 1st or 2nd trial * ivf or icsi * randomisation at out-patient clinic exclusion criteria: * ≥ 39 years old on day of randomisation * endometriosis ≥ grade 3 * pcos

Keywords: ivf icsi gnrh antagonist pretreatment
monoferric for prenatal iron deficiency

Conditions: Obstetric Labor Complications

Summary: a prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

intravenous therapy (iv) monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg iv in a cohort of pregnant participants with iron deficiency.

Eligibility criteria:
inclusion criteria: * participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for iv iron by their treating provider as part of their standard of care treatment. * iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dl or less than or equal to11 g/dl, respectively, and ferritin less than 50 μg/l * experience intolerance to oral iron or are greater than 28 weeks gestation * willing to participate in the study exclusion criteria: * known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis * prior iv iron intolerance or hypersensitivity reaction
post-stenting assessment of reendothelialization with ofdi after cto procedure (perfecto)

Conditions: Chronic Total Occlusion of Coronary Artery; Optical Coherence Tomography; Ischemic Cardiomyopathy; Neointimal Hyperplasia; Stent Thrombosis

Summary: the objective of perfecto is to assess the reendothelialization at 3 months after successfully cto percutaneous intervention (pci) with new generation drug eluting stent (des) by ofdi analysis. designed as a multicentric, observational and prospective study which will be conducted at university hospital of poitiers (france), a systematic ofdi analysis will be realized immediately after cto-pci and at 3 months. known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.


Eligibility criteria:
inclusion criteria: * successfully cto revascularization by pci with immediate post-pci ofdi analysis * 3 months follow-up with ofdi analysis of the recanalized coronary artery * aged 18 or over * written informed consent exclusion criteria: * contraindication or impossibility to realize a safety coronary ofdi (severe tortuosities) * severe renal insufficiency (creatinine clearance \< 30 ml/min) * pregnancy or women with child-bearing potential * bacteriemia or septicemia * severe hemodynamic instability * severe coagulation disorders
natural language processing and quality assessment in primary care

Conditions: Diabetes

Summary: the investigators propose to use a natural language processing system (nlp) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. as part of a randomized trial, we plan to use a previously validated mailed survey (ncqa provider recognition program) that requests information on the last foot exam, use of aspirin and tobacco. patients who have been identified by nlp as not having had a foot exam will be randomized into treatment and control arms. both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. the treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. nlp will be repeated after 6 months to compare the impact of the patient education materials.


Eligibility criteria:
inclusion criteria: * primary care patients with diagnosis of diabetes exclusion criteria: * unwilling to give informed consent

Keywords: foot exam health services practice improvement quality preventive services natural language processing
risk-reducing surgeries for hereditary ovarian cancer

Conditions: Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Ovariectomy; Hysterectomy

Summary: based on studies of "inherited susceptible genes among epithelial ovarian cancer" (nct03015376, clinicaltrials.gov) and "cohort study of universal screening for lynch syndrome in chinese patients of endometrial cancer" (nct03291106, clinicaltrials.gov), we provide risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer with relevant pathogenic mutations.


Eligibility criteria:
inclusion criteria: * carriers with known and definite mutation genes of hereditary ovarian cancer. * with children and without further requirement of pregnancy. * no less than 35 years for carriers with mutation gene of brca1. * no less than 40 years for carriers with mutation gene of brca2. * no less than 45 years for carriers with mutation genes of brip1, rad51c, rad51d and rad51. * no less than 50 years for carriers with mutation genes of atm, msh2, mlh1, sh6, pms2, epcam and stk11. exclusion criteria: * without children. * not reaching appreciate ages. * with contraindications of laparoscopy. * refusal of risk-reducing surgeries.
a study of 18f-av-45 in alzheimer's disease (ad) and healthy volunteers

Conditions: Alzheimer's Disease

Summary: this study will test if two av-45 pet scans up to 4 weeks apart in ad subjects and healthy volunteers provide the same results. the study will also test two different av-45 injection methods in a small subgroup of enrolled ad subjects (slow vs. fast bolus group).


Eligibility criteria:
inclusion criteria (ad group): * greater than 50 years of age * probable ad according to the national institute of neurological and communication disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria * mild/moderate dementia as evidenced by a mini-mental state examination (mmse) score ranging from 10 to 24, boundaries included, at screening * history of cognitive decline gradual in onset and progressive over a period of at least 6 months inclusion criteria (healthy volunteer group): * 35 to 55 years of age, inclusive * mmse of 29 or greater exclusion criteria (both groups): * neurodegenerative disorders other than ad, including, but not limited to parkinson's disease, pick's disease, fronto-temporal dementia, huntington's chorea, down syndrome, creutzfeldt-jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy * diagnosis of other dementing / neurodegenerative disease * diagnosis of mixed dementia * cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation * clinically significant infarct or possible multi-infarct dementia as defined by the nincds criteria * evidence on screening mri or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of ad pathology) * clinically significant psychiatric disease * history of epilepsy or convulsions * clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances * current clinically significant cardiovascular disease * received investigational medication within the last 30 days

Keywords: amyloid imaging positron emission tomography 18f-av-45 florbetapir f 18 diagnostic imaging
effects of phrenic nerve stimulation during swallowing : experimental model of aspiration

Conditions: Velopharyngeal Insufficiency

Summary: the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration

phrenic nerve stimulation during swallowing

Eligibility criteria:
inclusion criteria: stroke with aspiration exclusion criteria: obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis

Keywords: aspiration phrenic nerve magnetic stimulation
post-authorization safety study of etoricoxib and other anti-inflammatory therapies in european patients with ankylosing spondylitis (mk-0663-163)

Conditions: Ankylosing Spondylitis

Summary: this study is a population-based cohort of patients with ankylosing spondylitis (as) from general medical practices in the uk, france, and germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (cox-2) inhibitors / nonsteroidal anti-inflammatory drugs (nsaids). the main objective of the study is to describe in european participants with as: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.


Eligibility criteria:
inclusion criteria: * a recorded ankylosing spondylitis diagnosis in the database * a recorded as diagnosis following the applicable "acceptable data quality" date for the database that contains the patient's records * at least 6 months of registered medical records in the database after the applicable "acceptable data quality" date as described above, and prior to the recorded as diagnosis * complete information on gender and birth year

Keywords: ankylosing spondylitis
use of motor rehabilitation courses in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: in 2022, the prevalence of cerebral palsy (cp) is 2.5 cases per 1000 live births. in france, 125,000 persons are affected by cp. many treatments and therapies exist to reduce cp-related disorders, but cp remains uncurable. motor rehabilitation courses (mrc) are one of those therapies used with children with cp. their uses has not been studied in france yet. the aim of this survey is to find out about the use of motor rehabilitation courses for children with cp and, where appropriate, the content of these courses. this questionnaire will be used to determine the use and different types of mrs in which children participate.

in total, the questionnaire contains 131 items divided into 13 groups. the estimated filling time is 20 minutes. the questionnaire is divided as follows: 1. information document for the research participant 2. about the person with cerebral palsy 3. about the respondent 4. about the usual motor rehabilitation 5. about participation in motor rehabilitation courses 6. 7) 8) information about mrs 9) relationship of care or treatment received to participation in mrs 10) information about the child 11) information about the child's environment 12) additional comments from the respondent regarding the mrs 13) respondent's opinion on the questionnaire

Eligibility criteria:
inclusion criteria: * child with a diagnosis of cerebral palsy * aged between 6 and 18 years exclusion criteria: * child diagnosed with cp after age 6 * between 1 and 6 years of age

Keywords: cerebral palsy children motor rehabilitation course survey and questionnaire
a study of crenolanib with fludarabine and cytarabine in pediatric patients with relapsed/refractory flt3-mutated acute myeloid leukemia

Conditions: Relapsed/Refractory FLT3-mutated AML

Summary: this is a phase ii, multicenter, single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsed/refractory flt3-mutated aml. patients will receive up to two courses of salvage chemotherapy with fludarabine, cytarabine, and crenolanib. response will be assessed between day 29-43 of each course.


Eligibility criteria:
inclusion criteria: 1. age ≥ 1 years and ≤ 21 years 2. confirmed diagnosis of aml according to world health organization (who) 2016 classification 3. definitive evidence of a flt3-itd and/or flt3-tkd (d835/i836) mutation at the time of enrollment 4. patients must have histologically or molecularly confirmed relapsed or refractory aml 5. karnofsky or lansky performance score ≥ 50. use karnofsky for patients \> 16 years old and lansky for patients ≤ 16 years of age. 6. adequate renal function, defined as: * creatinine clearance or radioisotope gfr ≥ 70 ml/min/1.73 m2 or * normal serum creatinine based on age/gender 7. adequate liver function, defined as: * serum total bilirubin ≤ 1.5x uln for age, * serum aspartate aminotransferase (ast) ≤ 3.0x uln for age, and * serum alanine aminotransferase (alt) ≤ 3.0x uln for age. exclusion criteria: 1. patients with any of the following current or previous diagnoses: * acute promyelocytic leukemia (apl) * down syndrome * dna fragility or bone marrow failure syndromes (such as fanconi anemia, bloom syndrome, kostmann syndrome, or shwachman syndrome) * aml secondary to prior mds/mpn, including chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia * blastic plasmacytoid dendritic cell neoplasm * acute leukemia of ambiguous lineage * b-lymphoblastic leukemia/lymphoma * t-lymphoblastic leukemia/lymphoma, including early t-cell precursor lymphoblastic leukemia (etp-all) 2. patients who are refractory to first line (induction and re-induction) and a second line (1st salvage) treatment for aml. 3. patients who have received more than 1 prior allogeneic hsct 4. patients will be excluded if they have a systemic fungal, bacterial, viral or other infection of which they exhibit ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. 5. patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period. 6. known severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia) 7. known, active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) 8. currently receiving prophylactic treatment of hepatitis b with anti-viral therapy 9. known infection with human immunodeficiency virus (hiv)
quality of life in patients with mild to moderate active proctitis treated by mesalazine (pentasa®)

Conditions: Distal Ulcerative Colitis

Summary: this national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. this study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice


Eligibility criteria:
inclusion criteria: * patient aged 18 years or older. * patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (mayo score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion. * patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (montreal classification e1 or e2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion. * treatment of the current flare with pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit. * patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written informed consent form. exclusion criteria: * patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis. * patient with left sided, colitis or pancolitis. * patient with severe proctitis (mayo score ≥ 11 at inclusion). * patient previously treated with biologics. * patient treated with immunosuppressive within 1 month before study inclusion. * patient treated with corticosteroids within 2 weeks before study inclusion.