Kornimate/medical-research-clean huggingface dataset:
multidisciplinary team in management of placenta accreta

Conditions: Placenta Accreta

Summary: comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only

cohort of 1000 patients of placenta accreta are followed regarding the incidence of urological injury in the cases with assistance from the urological staff members

Eligibility criteria:
inclusion criteria: * pregnant 38 weeks * placenta accreta exclusion criteria: * medical disorders complicating pregnancy

Keywords: placenta accreta
dialysis geriatric care model

Conditions: Chronic Kidney Diseases; Dialysis; Geriatric

Summary: the objectives of this study are to refine the dialysis care model with key stakeholder input and conduct a pilot randomized controlled trial (rct) to obtain evidence critical to inform a definitive rct.

the investigators designed a new dialysis care model that includes a centralized geriatric team that uses information from the geriatric screen for older dialysis patients (gold) to develop individualized recommendations for geriatric syndrome management based on the patient's priorities. the study population is older adults receiving hemodialysis and dialysis staff. the investigators will have patient participants complete the care model and undergo geriatric evaluation. this phase will be referred to as refinement aim 1. the investigators will then assess agreement of each gold instrument with its corresponding geriatric evaluation. the investigators will assess acceptability and feasibility of the care model through surveys and interviews with patients and dialysis staff to complete refinement aim 2. once the new dialysis care model is redefined, the investigators will conduct the third phase, pilot rct (geriatric care model vs. usual care) and assess geriatric problem management at 4 months, as well as, patient reported outcomes, physical function, and health care utilization at intervals up to 12 months. the analyses will include 1) measure of agreement using cohen's kappa, 2) qualitative rapid analyses, 3) descriptive statistics from acceptability and feasibility surveys, 4) descriptive statistics from pilot rct data, and 5) tests for difference in geriatric problem management between treatment and control groups. the study does not involve activity from participants that would exceed normal or routine care so there are negligible physical, financial, or legal risks.

Eligibility criteria:
patient inclusion criteria: * community-dwelling dialysis patients 55 and older * may have cognitive impairment patient exclusion criteria: * advanced dementia * non-english or spanish speaking * nursing home residents * hospice enrollees

Keywords: dialysis quality of life care model
daratumumab combined with bortezomib and dexamethasone in mayo 04 stage iii light chain amyloidosis

Conditions: Amyloidosis; Systemic

Summary: patients with light chain (al) amyloidosis who have advanced cardiac damage are at risk of premature mortality. there is ongoing unmet need for effective therapies to rapidly induce deep hematologic response and decrease the early death rate. lately, trials of daratumumab in newly-diagnosed and relapsed/refractory al amyloidosis have shown dramatic response rates. however, the benefits of upfront daratumumab in stage iii al patients, especially stage iiib patients, have not yet been demonstrated definitely in prospective studies. therefore, we designed a phase ii, single arm clinical trial to investigate the efficacy and safety of co-administration of daratumumab with bortezomib and dexamethasone (bd) regimen in treatment-naïve patients with mayo 04 stage iii al amyloidosis. we planned to enroll 40 patients, who would receive daratumumab and bd treatment for a total duration of 12 months. the primary endpoint is complete response and very good partial response at 3 months after treatment initiation. secondary endpoints include overall survival, organ response and adverse events.


Eligibility criteria:
inclusion criteria: * 18 years old adults. * biopsy proved treatment-naïve al amyloidosis. * mayo 2004 stage iii. * dflc \> 50mg/l. * patient must provide informed consent. exclusion criteria: * co-morbidity of uncontrolled infection. * co-morbidity of other active malignancy. * co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia. * co-morbidity of grade 2 or 3 atrioventricular block. * co-morbidity of sustained or recurrent nonsustained ventricular tachycardia. * seropositive for human immunodeficiency virus. * seropositive for hepatitis b (positive test for hbsag). participants with resolved infection (ie, hbsag negative but positive for anti-hbc and/or anti-hbs) must be screened of hbv-dna. those who are pcr positive will be excluded. * seropositive for hepatitis c (except in the setting of a sustained virologic response). * grade 2 or higher neuropathy according to national cancer institute common terminology criteria for adverse events. * neutrophil \<1×10e9/l，hemoglobin \< 7g/dl，or platelet \< 75×10e9/l. * severely compromised hepatic or renal function: alt or ast \> 2.5 × uln, total bilirubin \> 1.5mg/dl，or egfr \< 40ml/min (those with renal dysfunction due to renal involvement or renal hypoperfusion from cardiac amyloidosis could be included)

Keywords: light chain amyloidosis daratumumab bortezomib hematologic response prognosis
evaluation of multisite sampling to detect c. trachomatis or n. gonorrheae compared with vaginal sampling in women at risk for sexually transmitted infections

Conditions: Sexually Transmitted Infection

Summary: screening for stis in msm is based on multisite samples: urine, anal and oral for pcr targeting c. trachomatis, n. gonorrhoeae, m. genitalium and t. vaginalis, whereas only vaginal self-sampling is recommended in women. recent publications and observations suggest that a substantial number of stis are under diagnosed with the current recommendations. the main objective of the study is to assess the number and percentage of additional c. trachomatis and n. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative the secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.

1500 women will be included in 5 different screening stis centers in france based of the prevalence of stis in this population (10% c. trachomatis) and the hypothesis that this new strategy allows to detect 20% more underdiagnosed stis the sequential recruitment will concern women attending at one of the 5 stis screening centers, whether they are symptomatic or not. if they agree to participate in the study, the patients will take the samples themselves from the 3 sites (vaginal, anal and oral self-sampling) using standard swabs (brand). the sample will immediately be placed in the transport medium in each of the 3 sigma vcm tubes labeled by the patient, depending on the collection site. the study nurse will register the inclusion of patients, identify the tubes, collect information and send them to the local laboratory for the pcr to be performed. the study will be continued until the number of patients to be included for each of the centers is obtained. the anonymized data will be entered on an excel database. the results of the pcrs will be collected a posteriori by the ides to populate the database. the pcr result will be given both qualitatively (positive/negative) and ct value for c. trachomatis and n. gonorrhoeae infections.

Eligibility criteria:
inclusion criteria: * women coming for sti screening at a cegidd * asymptomatic or not * women aged at least 18 years * having given her consent to participate exclusion criteria: * patient having received antibiotic treatment covering c.trachomatis and n.gonorrheae in the month preceding the screening * patient under guardianship or curatorship * patient under legal protection * pregnant or breastfeeding woman

Keywords: sexually transmitted infection pcr c. trachomatis n. gonorrhoeae screening
a study to evaluate the safety and efficacy of the qlt proprietary olopatadine-ppds in subjects with seasonal allergic conjunctivitis to ragweed in an environmental exposure chamber model.

Conditions: Seasonal Allergic Conjunctivitis to Ragweed

Summary: the purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an environmental exposure chamber model.


Eligibility criteria:
inclusion criteria: * history of allergic conjunctivitis to ragweed for at least one year * positive skin prick test to ragweed pollen within 12 months prior to visit 1 * bcva of at leat 20/400 exclusion criteria: * structural lid abnormalities (ectropion, entropion) * active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment * presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy * history of ophthalmic abnormality, including a history of dry eye * perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period * history of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection * presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease * currently on any chronic ocular topical medications * use of topical or systemic ocular medications during the study period * history of complications, adverse events, trauma or disease in the nasolacrimal area * history of symptomatic epiphoria
effect of early pelvic binder use in emergency management of suspected pelvic trauma: a retrospective cohort study

Conditions: Pelvic Fracture

Summary: the investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.

there is currently no universal consensus on all aspects of management of pelvic injuries. among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. in theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.the application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ed). the present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.

Eligibility criteria:
inclusion criteria: * traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or glasgow coma score (gcs) \< 13; systolic blood pressure \< 90 mmhg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. - exclusion criteria: * not meet the criteria and loss follow up (transfer to other hospital or data not available) -
study evaluating approach to treatment of haemophilia a and b in spain

Conditions: Hemophilia A; Hemophilia B

Summary: analyze the clinical and therapeutic approach to treatment of haemophilia a and b in habitual clinical practice conditions in spain.

analyze the clinical and therapeutic approach to treatment of haemophilia a and b in habitual clinical practice conditions in spain during the first 3 years since diagnosis. assess haemophilia a or b patient profile, study different kinds of hanitual clinical treatment of haemophilia a and b patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.

Eligibility criteria:
inclusion criteria: * haemophilia a or b patients of any age * written informed consent

Keywords: approach haemophilia a and b
somatic stem cells in endometriosis

Conditions: Endometriosis

Summary: human endometrium is a very dynamic tissue characterized by cyclical process of proliferation, differentiation and cellular shedding as part of each menstrual cycle. this issue suggests the presence of somatic stem cells. endometriosis is characterized by presence of endometrium outside the uterine cavity. the existence of a somatic stem cell population in endometrium could explain the incorrect proliferation of these cells, which would lead to formation of endometriotic foci.

throughout the life of the woman, the endometrium undergoes a series of continuous modifications that require a highly accurate feedback mechanism and specialized and must be based on the activity of the stem cell population. endometriosis is an estrogen-dependent chronic disease characterized by the presence of functional endometrium outside the uterine cavity, mainly in the peritoneum and ovary (giudice and kao, 2004). it affects 6-10% of women of reproductive age, often resulting in a series of gynecological problems, including dysmenorrhea, pelvic pain and infertility. the nature of endometriosis suggests that the initiation of ectopic endometrial lesions may be due to stem or progenitor cells, which is consistent with the theory of retrograde menstruation (starzinski-powitz et al. 2001; leyendecker et al. 2002, gargett, 2006; gargett, 2007, sasson and taylor, 2008). to date, no direct evidence of the role of somatic stem cells of the endometrium in the pathogenesis of endometriosis. however, numerous studies show that ectopic endometrial cells implant in many established models used for the study of endometriosis.(masuda et al., 2007b; sasson and taylor, 2008; gargett y masuda.,2010)

Eligibility criteria:
inclusion criteria: inclusion criteria for patients with endometriosis: 1. female patients with ovarian endometriosis, peritoneal and recto-vaginal. 2. aged between 20 and 40. 3. signing of informed consent for collection and storage of biological samples. exclusion criteria: 1. contraindications for endometrial biopsy. 2. failure to sign informed consent for collection and storage of biological samples.
osteopathy and obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (osa).

osteopathic compression will be compared to a placebo manoeuvre. efficacy will be assessed by measuring pharyngeal collapsibility

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or more * obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour * body mass index \<40kg/m2 exclusion criteria: * pregnant or lactating women * participating to another trial * acute infectious disease of upper respiratory airway tract at inclusion * facial neuralgia at inclusion * patients not able to stop treatment for osa within one week before each visit * allergy to latex * dental extraction within 15 days before inclusion * pharyngeal surgery in the past * incapable adult

Keywords: osteopathy
open-label safety and tolerability study of nbi-98854 for the treatment of pediatric subjects with tourette syndrome

Conditions: Tourette Syndrome

Summary: this is a phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of nbi-98854 administered once daily for 24 weeks in pediatric subjects with tourette syndrome.


Eligibility criteria:
inclusion criteria: 1. have participated in and completed study nbi-98854-ts2003 2. have a clinical diagnosis of tourette syndrome (ts) 3. if using maintenance medication(s) for ts or ts spectrum diagnoses (e.g. obsessive-compulsive disorder \[ocd\], attention-deficit hyperactivity disorder \[adhd\]), be on stable doses 4. be in good general health 5. adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 6. subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study exclusion criteria: 1. have an active, clinically significant unstable medical condition within 1 month prior to screening 2. have a known history of long qt syndrome or cardiac arrhythmia 3. have a known history of neuroleptic malignant syndrome 4. have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2 (vmat2) inhibitors 6. have a blood loss ≥250 ml or donated blood within 56 days prior to baseline 7. have a known history of substance (drug) dependence, or substance or alcohol abuse 8. have a significant risk of suicidal or violent behavior 9. have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study
lifestyle change and quality of life in obese patients with stage i/ii endometrial cancer in remission

Conditions: Endometrial Cancer; Weight Changes

Summary: rationale: exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably. purpose: this randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage i or stage ii endometrial cancer in remission.

objectives: primary * determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage i or ii endometrial cancer in remission. secondary * determine the feasibility and acceptability of lifestyle interventions in these patients. outline: this is a randomized, controlled study. patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months. * arm ii: patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months. after completion of study treatment, patients are followed at 1 year. projected accrual: approximately 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed endometrial cancer meeting the following criteria: * stage i or ii disease * post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy * disease in remission * body mass index (bmi) ≥ 25 patient characteristics: performance status * ecog 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: not specified

Keywords: stage i endometrial carcinoma stage ii endometrial carcinoma weight changes
a study to learn about how a new pneumococcal vaccine works in children

Conditions: Pneumococcal Disease

Summary: the purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. during this time participants will have 2 clinic visits and 1 phone visit for the 1-dose group, or 3 clinic visits and 1 phone visit for the 2-dose group. at these clinic visits, participants will be asked if any side effects were experienced. the participants will also have to give blood samples during some clinic visits.


Eligibility criteria:
inclusion criteria: * male or female toddlers ≥12 to ≤15 months of age at the time of consent. * healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. * have received 3 infant doses of 20vpnc at 2, 4, and 6 months of age, with the last dose administered \>56 days before enrollment into the study. documented confirmation of receipt will be collected prior to randomization. exclusion criteria: * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis). * major known congenital malformation or serious chronic disorder. * other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vpnc) or planned receipt during study participation.
lateral position mri in preterm infants, an observational study

Conditions: Prematurity; Magnetic Field Exposure; Sedation Complication

Summary: the goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone mri. the main question it aims to answer are: * number of apneas during sedation * maintenance of eupnea during deep sedation

premature babies will be sedated in lateral position during magnetic resonance imaging. during procedure we provide a close control about eupnea maintenance (sao2 and etco2) in order to verify the safety of laying.

Eligibility criteria:
inclusion criteria: * \< 40 weeks post conceptional age (pca) exclusion criteria: * \> 50 weeks pca * previous treatment with hypothermia for neonatal asphyxia * patients who received invasive positive pressure ventilation within the previous 48 h * preexisting cardiac arrhythmias * presence or suspicion of oncological pathology * neuromuscular or metabolic diseases * previous brain or abdominal surgery * presence of epicranial venous accesses * upper respiratory tract infections * refusal of informed consent by parents or inability to express it