Kornimate/medical-research-clean huggingface dataset:
permanent versus delayed-absorbable monofilament suture

Conditions: Hysterectomy; Sacrocolpopexy

Summary: this is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (pop) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (scp) with a light-weight polypropylene mesh (upsylon™ y-mesh) using permanent (polytetrafluoroethylene, gore-tex) versus delayed absorbable monofilament (polydioxanone, pds) suture for vaginal mesh attachment through at least 3 years after surgery.

this is an extension study of a randomized controlled trial that will be conducted at the same 5 clinical sites as the primary study - all subjects who participated in the original randomization and did not withdraw from the study are eligible for the extension study including those with a history of secondary treatment following pact rct study participation.

Eligibility criteria:
inclusion criteria: * patients who have participated in the pact study trial (permanent versus delayed-absorbable monofilament suture for vaginal graft attachment during minimally-invasive total hysterectomy and sacrocolpopexy: a randomized clinical trial) exclusion criteria: * patient is not willing to sign consent * patient does not want to fill-out questionnaires

Keywords: pelvic organ prolapse vaginal mesh
jak2 inhibitors ruxolitinib in patients with myelofibrosis

Conditions: Myelofibrosis

Summary: jak2 inhibitor ruxolitinib before allogeneic hematopoietic stem cell transplantation (hsct) in patients with primary or secondary myelofibrosis : a prospective phase ii

jak2 inhibitor ruxolitinib before allogeneic hematopoietic stem cell transplantation (hsct) in patients with primary or secondary myelofibrosis

Eligibility criteria:
inclusion criteria: * age between 18 and 69 years * no comorbidity contraindicating the transplantation : * severe respiratory failure defined as dyspnea grade iii or more * severe cardiac failure defined as ef \< or = 30% * severe renal failure defined as creatinine clearance \< 30 ml/min or dialysis * dementia or non-ability to give informed consent for the protocol * major alteration of performance status defined as ecog \> 2 * severe liver disease defined as a cirrhosis or bilirubin \> 2 x uln, or ast/alt \> 5 x uln * primary or secondary myelofibrosis diagnosed according to who definition (tefferi, et al 2007) * palpable splenomegaly or splenomegaly measured by any imagery (maximum size\> 15 cm by ultrasound scan, magnetic resonance imaging or computer tomography) * disease if intermediate or high risk according to published criteria and summarized as follows: at least one criterion among the following: * haemoglobin \< 100 gr/l (unrelated to medication toxicity) * leucocytes \ 25 g/l * poor prognosis cytogenetics : complex karyotype, abnormalities of chromosomes 5, 7 or 17 , +8, 12p-, inv(3), 11q23 two criteria among the following criteria : * general symptoms (weight lost \> 10% in less than 6 months, night swears, specific fever \> 37.5°c) * peripheral blastosis \> 1% observed at least twice * thrombocytopenia \< 100 g/l (unrelated to treatment toxicity) exclusion criteria: * myelofibrosis transformed into acute leukaemia with 20% blasts of more in blood or bone marrow * previous treatment with jak2 inhibitor * thrombopenia \< 50 g/l * comorbidities contraindicating the transplantation * comorbidity score sorror \> 3 * pregnant or lactating women

Keywords: jak2 inhibitor ruxolitinib primary or secondary myelofibrosis
comparison of 2 types of cervical specimens in patients with a pathological screening smear

Conditions: Cervical Cancer; Pathological Screening Smear

Summary: the recommendations on the method and the realization of the cervico-uterine smears are clear. with regard to performing endocervical curettage, several methods are possible without precise consensus. in general, the kevorkian curette is widely used. however, it is often reported by doctors and patients that curettage is painful. some articles show that the cytobrush would be less painful. while keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.


Eligibility criteria:
inclusion criteria: * women followed for a cervical pathology requiring endocervical curettage: * agc type (glandular cell atypia) with positive hpv test * frottis asc-h, lsil, ascus hpv + with non-contributive colposcopy (zt3) exclusion criteria: * pregnant woman * women under the age of 25 or over 65 * stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material) * presence of a vaginal lesion on colposcopic examination

Keywords: endocervical curettage kevorkian cytobrush fcv
functional electrical stimulation (fes) driven stepping in individuals with spinal cord injury

Conditions: Spinal Cord Injury

Summary: the research is being done to find out if functional electrical stimulation (fes) stepping can improve the function of people with spinal cord injury that paralyzes.

muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. the fes stepping in this study will be done through a device called the rt600 fes stepper (rt600).

Eligibility criteria:
inclusion criteria: * male, female, age 18-65, all ethnic groups * spinal cord injury, traumatic and non-traumatic * c1-t12 neurological level * asia class a-d * chronic injury \> 6 months from the injury * visible motor response to fes stimulation (visible muscle contraction evoked with electrical stimulation) * subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues * subjects are able to comply with procedures and follow-up exclusion criteria: * concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability * history of inability to tolerate electrical stimulation * cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke nyha class iii or iv, history of arrhythmia with hemodynamic instability * uncontrolled hypertension (resting systolic bp \> 160mmhg or diastolic bp \>100mmhg consistently) * presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps * unstable long bone fractures of the lower extremities * presence of stage iii or greater skin ulcerations that would preclude application of stimulating pads * malignancy * history of epileptic seizures * women who are pregnant * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * fractures less than 6 months

Keywords: spinal cord injury functional electrical stimulation rehabilitation
phamacokinetics and safety profiles of da-1229_01 2.5/500mg in healthy subjects at fed state

Conditions: Healthy

Summary: this phase i clinical study is to evaluate the safety/tolerability and pharmacokinetics of da-1229_01(2.5/500 mg x1 tablets) at fed state


Eligibility criteria:
inclusion criteria: * healthy volunteers * bmi between 18 and 30 kg/m2 * body weight : male≥50kg, female≥45kg exclusion criteria: * allergy or drug hypersensitivity * clinically significant medical history
feasibility in france of a mindfulness-based group therapy for adolescents with chronic pain

Conditions: Chronic Pain

Summary: the main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. this program is an adaptation of the mbi-a (mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in canada). the secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

paediatric chronic pain can lead to serious consequences in terms of daily functioning (school absenteeism and loss of social interactions) and global quality of life. mindfulness-based interventions (mbi's) approaches which emphasize acceptance rather than control of pain have gained increasing attention in adults with chronic pain. the effectiveness of mbi's for chronic pain in paediatric population remains largely unknown. an mbi program for adolescent was conducted in toronto's hospital for sick children and happened to be feasible and well received for adolescents with chronic pain conditions. the aim of the present program is to study the feasibility in france of a mindfulness program dedicated for adolescents with chronic pain. an eight-session, two hour mindfulness based intervention dedicated to adolescents will be provided. the intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.

Eligibility criteria:
inclusion criteria: * teenagers from 12 to 17 years of age followed at the children's hospital of toulouse, as part of the multidisciplinary consultation of pain * including french. * with the consent of the teenager and the parents * affiliated person or beneficiary of a social security scheme. exclusion criteria: * intellectual deficit not allowing to participate in a meditation program * participating in research involving body therapies

Keywords: pain pediatrics mindfulness adolescents
the establishment and improvement of community acquired pneumonia monitoring and disposal network in beijing

Conditions: Community Acquired Pneumonia

Summary: in the 21st century, threats to human health of new respiratory infectious diseases increased. the project aim is to establish pneumonia pathogens network in beijing and understand the pathogen spectrum distribution.


Eligibility criteria:
inclusion criteria: 1. confirmed community acquired pneumonia 2. age≥14 ys 3. new appear of cough or cough become severe 4. new infiltration showed by chest radiology(x-ray or ct) 5. fever t\>37.8o c or \<35.6o c 6. white blood cell\>10,000/mm3 , left shift or leukopenia\<4000/ul） exclusion criteria: 1. pregnancy or breast-feeding 2. over one week after the onset of symptoms 3. hiv infection 4. recent 90-day hospitalized history(length of stay greater than 2 days) 5. live in nursing homes or rehabilitation hospitals

Keywords: pathogen
correction of multiplanar deformities around the knee with monolateral external fixator

Conditions: Deformities Around the Knee in Pedietrics

Summary: angular deformities around the knee are one of the common cause of presentation at pediatric orthopedic clinic. although these conditions are commonly benign and self-limiting. the mechanical axis of the lower extremity is a straight line extending from the center of the femoral head to the center of the ankle. the horizontal distance in millimeters from the center of the knee joint to the mechanical axis is the deviation of the mechanical axis. the goal of treatment is to correct malalignment of the lower extremity and perhaps to prevent or delay the onset of osteoarthritis by normalizing the mechanical axis


Eligibility criteria:
inclusion criteria: * genu valgus having tibio-femoral angle more than 15 degrees. * genu varus having metaphyseal-diaphyseal angle of more than 11 degrees * more than one plane defirmity * age 10 - 16 yrs * range of motion: 1. full extension 2. more than 100 in flextion exclusion criteria: * genu recurvatum. * flexion deformity. * pathological conditions (e.g: bone softening diseases * dysplasia * limb length discrepancy
the correlation between airway inflammation and loss of deep inhalation bronchoprotection in asthmatics

Conditions: Asthma

Summary: the loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be related to the degree of airway hyperresponsiveness, a hallmark of asthma. in several studies, asthmatic individuals with mild airway hyperresponsiveness (ahr) (methacholine pc20 \> 2 mg/ml) had a difference in methacholine pc20 with and without deep inhalations that averaged 1.8 doubling methacholine concentrations (p=0.0003). conversely, asthmatic individuals with moderate to severe ahr (methacholine pc20 ≤ 2 mg/ml) had a non-significant difference in methacholine pc20 with and without deep inhalations (p=0.09). this loss of deep inhalation bronchoprotection is also now believed to play an important role in the pathogenesis of asthma. airway inflammation is another of the key features of asthma and information on airway inflammation is increasingly being used in the diagnosis and treatment of asthma. the level of airway inflammation (as measured by fraction of exhaled nitric oxide and sputum eosinophilia) has also been shown to be correlated to the level of airway hyperresponsiveness (as measured by methacholine pc20). in addition, glucocorticoids have been shown to decrease airway hyperresponsiveness, further suggesting that these two phenomena, airway inflammation and airway hyperresponsiveness, are related. we therefore suggest that the degree of airway inflammation is related to the loss of deep inhalation bronchoprotection and expect there to be a negative correlation between the degree of deep inhalation bronchoprotection and airway inflammation.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma exclusion criteria: * other lung disease(s) * smoking
veritas in non-bridging ventral hernia repair

Conditions: Hernia

Summary: the main study objective is to determine the frequency of hernia recurrence following use of veritas collagen matrix.


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * ability to understand and read english * must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the veritas collagen matrix using the underlay technique, with our without component separation * must be of ambulatory status * primary closure can be obtained during surgery * repair is such that one piece of veritas can be used to reinforce the repair exclusion criteria: * hernia is undetectable on physical exam * there is evidence of existing cancer * bmi ≥ 40 * use of chronic immunosuppressive therapy, including steroids or cytotoxic agents * any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products

Keywords: ventral hernia abdominal wall hernia incisional hernia biologic mesh veritas collagen matrix veritas
asd (autism spectrum disorder) telehealth for distress related to covid-19

Conditions: Psychological Distress; Stress, Psychological; Autism Spectrum Disorder

Summary: the purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the emotional support plan), intended to support autistic adults to cope with their negative emotions during and/or after the covid-19 pandemic. the first objective is to develop and refine a brief telehealth-delivered treatment, the emotional support plan (esp), to help promote adults to cope during periods of acute distress, such as those experienced during the covid-19 pandemic. the second objective is to assess the feasibility and effectiveness of the esp to support autistic adults to implement emotion regulation strategies during periods of acute distress. the last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).


Eligibility criteria:
inclusion criteria adults 18 years or older with previously established diagnoses in asd will be invited to participate. adults who have a verbal iq above 70 or who are students admitted to a college or university will be included in the study. exclusion criteria * individuals who are younger than 18 years old or who does not have diagnosis of asd will excluded from the study as the purpose of the current research is to evaluate the validity of esps in adults with autism. * adults who are unable to understand english will be excluded because the instruments being investigated are currently only validated in english and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides english. * subjects without access to a compatible ios and android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. individuals will not be excluded from the study based on race, ethnicity or gender. * subjects who have a verbal iq below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention. * if the pi's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.

Keywords: smartphone ecological momentary intervention (emi) ecological momentary assessment (ema)
total lymphoid irradiation pre-hsct in severe congenital neutropenia

Conditions: Severe Congenital Neutropenia; GATA2 Deficiency

Summary: severe congenital neutropenia (scn) is a group of primary immunodeficiencies caused by distinct gene mutations and characterized by neutrophil maturation impairment, which leads to neutropenia, predisposition to severe bacterial and fungal infections, and myeloid malignancies. granulocyte-colony stimulation factor is used for pathogenetic therapy, however, no adequate response is seen in some patients. the only curative option for scn is hematopoietic stem cell transplantation (hsct). an indication for hsct in scn is: no adequate response to g-csf therapy, or development of malignancies, or found unfavorable mutations of scn genes, leading to poor response to g-csf and high risk of malignant transformation. one of the major peculiarities of hsct in scn is a high risk of graft failure. that was described in few studies in scn transplantation and was also observed in our scn hsct cohort. we also consider the role of tcrab/cd19 graft depletion, which is routinely used in our center for gvhd prophylaxis in increased risks of graft failure. another problem often observed in our patients is the relatively high risks of death of infections, developed after graft failure. due to predominantly early hsct graft failure development, non-sufficient immuablation is presumed as the main reason for graft failure. because of the low level of toxicity, associated with tcrab/cd19 depletion usage, this strategy is planned to be used in the current study. to increase an immunoablative potential of conditioning regimen in scn, total lymphoid irradiation will be studied in combination with myeloablative agents and standardly used serotherapy.


Eligibility criteria:
inclusion criteria: * clinical indications for hsct in scn: clinical diagnosis of scn with (1) no adequate response to g-cst therapy or (2) with malignant transformation or (3) unfavorable mutations of known scn genes * gata2 deficiency * scn patients age at hsct 18 months - 21 years * gata2 deficiency patients age at hsct more than 10 years * signed informed consent to participate in the study * presence of hla-matched unrelated or hla-mismatched related donor exclusion criteria: * presence of hla matched related donor in absence of pathologic scn gene mutation * inability to perform tcrab/cd19 graft depletion * contraindications for hsct due to patients somatic condition
treatment adherence in substance users

Conditions: Substance-Related Disorders

Summary: this study evaluates the factors associated with treatment adherence in substance users. differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. the individual effect of each factor on treatment adherence is assessed.

introduction: treatment dropout is an unsolved problem in the addiction process which makes frequent the failure of the addiction therapy. research shows that the majority of dropouts occur during the first weeks of the treatment. these are the most serious ones because they have the worst prognosis. some factors, related to the patients and the therapy, have been associated with treatment dropout but the diversity of studied variables, the heterogeneity of patients and the sparse population of many studies, hampers external validity and comparison of results. objectives: analyze the treatment adherence of an outpatient treatment program for addicts. identify factors associated with treatment adherence in substance users. material and methods: observational, analytical, longitudinal and retrospective study in substance users who completed addiction treatment between november 2013 and january 2016. treatment adherence is measured in terms of medical discharge, regular attendance at activities and success in the noc indicators. differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. the individual effect of each factor on treatment adherence is assessed.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of substance-related disorders * treatment for drug dependency exclusion criteria: * admission for detoxification treatment.

Keywords: treatment adherence outpatient treatment drug dependence
aquacel® ag dressing and urgotul® silver dressing on healing of chronic venous leg ulcers

Conditions: Leg Ulcer

Summary: a prospective, comparative, randomised study to compare the effects on ulcer healing of aquacel® ag dressing when used for 4 weeks followed by treatment with aquacel® for 4 weeks to urgotul® silver dressing followed by urgotul® for 4 weeks on subjects with venous leg ulcers.


Eligibility criteria:
inclusion criteria: * subjects over 18 years, willing and able to provide written informed consent. * subjects who have an ankle to brachial pressure index (abpi) of 0.8 or greater. * subjects who have a venous leg ulcer (i.e. ceap classification of c6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 . * subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation. * subjects agree to wear compression therapy daily in combination with the trial dressing. exclusion criteria: * subjects with a history of skin sensitivity to any of the components of the study product. * subjects who have had current local or systemic antibiotics in the week prior to inclusion. * subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months. * subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids. * subjects who have participated in a clinical study within the past 3 months. * subjects who are pregnant or breastfeeding (in accordance with the urgotul® silver package insert).