Kornimate/medical-research-clean huggingface dataset:
sjm masters hp 15mm rotatable mechanical heart valve as aortic valve replacement therapy

Conditions: Aortic Valve Disease

Summary: this pas is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the sjm™ masters series hemodynamic plus (hp) 15mm aortic mechanical heart valve (15 ahpj-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.


Eligibility criteria:
inclusion criteria: * inclusion criteria for prospectively enrolled subjects * subject's legal guardian must provide written informed consent prior to any clinical study related procedure. * subject requires aortic valve replacement and is intended to be implanted with a 15mm sjm15 ahpj-505 mhv as determined by the implanting physician in accordance with the instructions for use. * the legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study. * inclusion criteria for retrospectively enrolled subjects : in an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. for those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met: * echocardiography data at a time point greater than 90 days is available or may be acquired. * an implant was attempted with the 15mm mhv, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. * either: * for living subjects who already received the 15mm mhv, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable). or * for subjects who are deceased or explanted, an implantation with 15mm mhv was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device. exclusion criteria: * exclusion criteria for prospectively enrolled subjects: subject has a contraindication to anticoagulant/antiplatelet medication. * exclusion criteria of retrospectively enrolled subjects: none
a placebo-controlled study of volixibat in subjects with elevated serum bile acids associated with intrahepatic cholestasis of pregnancy (ohana)

Conditions: Intrahepatic Cholestasis of Pregnancy

Summary: part 1 is an open-label randomized study of volixibat in patients with intrahepatic cholestasis of pregnancy (icp) and elevated serum bile acid concentrations (sba) to evaluate safety and tolerability of two doses of volixibat. part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.


Eligibility criteria:
inclusion criteria: 1. female aged ≥18 and ≤45 years with a viable pregnancy. 2. provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements. 3. diagnosis of icp. 4. (part 2 only) qualified level of pruritus associated with icp, during screening. exclusion criteria: 1. at the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication. 2. known non-reassuring fetal status based upon antepartum testing (e.g., nst/ctg or bpp) at or within 7 days before the baseline visit. 3. known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life. 4. participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.

Keywords: pruritus itch itching cholestasis bile acid pregnancy pregnant intrahepatic liver icp
pedunculopontine nucleus stimulation for gait disorders in parkinson's disease

Conditions: Parkinson's Disease

Summary: the appearance of postural instability and gait disorders is a major turning point in the evolution of parkinson's disease (pd). these axial symptoms are usually unresponsive to l-dopa and represent a severe impairment for the patients due to frequent falls and reduced outside mobility. there is no effective pharmacological treatment available for these symptoms, and their pathophysiology is not well known : it is currently assumed that non-dopaminergic brainstem lesions participate to axial symptoms in pd. surgically, these patients cannot benefit from high frequency deep brain stimulation (dbs) of the subthalamic nucleus (stn) since this operation tends to even aggravate axial symptoms unresponsive to l-dopa in some patients. a dysfunction of the pedunculopontine nucleus (ppn) might be at the origin of these axial symptoms, since the ppn participates in the maintenance of posture and motion in primates. in pd patients, recent reports have suggested that low frequency stimulation of the ppn may equally improve gait and posture. however, these results are debatable due to methodological limitations, insufficient clinical evaluation and uncertain anatomical targeting. thus, our aim is to propose a low frequency ppn stimulation to six advanced pd patients according to the usual criteria for stn dbs who are, however, unsuitable for this operation due to gait and posture disorders. we will perform a randomized, double-blind and cross over design (two months periods with and without dbs randomly assigned to each patient). the targeting will be allowed by a a three-dimensional and deformable atlas of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (mri) of each patient. evaluations will comprise 1 month before surgery and in "off" and "on" stimulation condition: * clinical motor assessment in both "off" and "on" drug state, including cardinal parkinsonian signs, gait and balance * gait initiation physiological evaluation * cognitive and behavioral testing if our hypothesis is confirmed, low frequency ppn stimulation may well represent a substantial improvement of our therapeutic options for advanced pd patients suffering from debilitating gait and posture disorders unresponsive to l-dopa.


Eligibility criteria:
inclusion criteria: * parkinson's disease * age \ = 18 years * improvement \> or = 50 % during acute levodopa test * score \> or = 2 on item 29 of updrs part 3 score obtained in "off" drug state * no previous dbs * no evidence of atypical parkinsonism * no dementia (mattis \> 129) * no psychiatric disease * contraception if woman * informed consent exclusion criteria: * contra indication to surgery * contra indication to mri * severe life threatening comorbidity
multidimensional treatment foster care for adolescents

Conditions: Adolescent Behaviour; Family Functioning

Summary: the purpose of the study is to examine the effects of multidimensional treatment foster care compared to treatment as usual (tau) for adolescents in denmark in need of out-of-home placement.

it is difficult to treat adolescents with serious behaviour problems. although the number of adolescents displaying serious behaviour problems is limited, they are a serious concern to the society e.g. because of their frequent violent behaviour, criminal activities and lack of school adherence. multidimensional treatment foster care (mtfc)is a community-based treatment program developed in usa. the goal of the mtfc program is to decrease problem behaviour and to increase developmentally appropriate normative and prosocial behavior in adolescents who are in need of out-of-home placement. this study will evaluate the effect of mtfc on adolescents in out-of-home placement. participants will be recruited by caseworkers in the municipalities and randomly assigned to either mtfc or tau. tau will consist of other kinds of out-of-home placements. outcomes will be assessed for all participants at baseline, post-treatment (12 months), and 12 months post-treatment. parents and youth will be asked to fill out questionnaires on e.g. behaviour, parental stress, sense of cohesion, general health.

Eligibility criteria:
inclusion criteria: * 12-17 years old * in need of out of home placement * serious behaviour problems exclusion criteria: * severe psychiatric illness in youth or parent * risk of suicide in youth * acute psychosis in youth * sexual offence by youth * severe substance abuse in youth or parent

Keywords: multidimension treatment foster care adolescents disadvantaged families out-of-home placement conduct disorder family program denmark youth
amtolmetin gaucil in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study is conducted to study the efficacy and safety of niselat in patients with osteoarthritis.

osteoarthritis is the most common rheumatic disease. knee oa (koa), gonarthrosis (ga), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (nsaids) are actively used in clinical practice. it was revealed that nsaids may cause gastrointestinal adverse effects (aes), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. gastroprotection with misoprosol, н2-receptor antagonists and proton pump inhibitors (ppi) is not always effective. nsaids with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable. amtolmetin guacil (amg) is a new nsaid which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. amg does not have selectivity towards cox-2 or no. amg exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. to assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of nsaids intolerability.

Eligibility criteria:
inclusion criteria: 1. informed consent form for participation in the study; 2. koa (based on acr, 1987) 3. age between 30-60 years old 4. previous regular administration of nsaids for at least 4 weeks (at maximum therapeutic dose) 5. dyspeptic symptoms (according to soda questionnaire) 6. pain intensity in the investigated knee joint ≥ 40 mm according to vas 7. subjects with systolic blood pressure ≤ 140 mm hg and diastolic bp ≤90 mmhg against stable antihypertensive therapy. exclusion criteria: 1. contraindications to amtolmetin guacil (according to patient information leaflet) 2. subjects with sbp ≥140 mm hg and dbp ≥90 mm hg 3. signs of renal or hepatic failure; 4. pregnancy, lactation or planning for pregnancy. 5. one of the following changes in laboratory values at screening hgb, wbc, esr, alt, ast.
dural puncture epidural technique versus conventional epidural technique during vaginal surgeries

Conditions: Dural Puncture Epidural Technique

Summary: the study aims to evaluate whether the dural puncture epidural technique (group b) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group a).


Eligibility criteria:
inclusion criteria: age (25- 55) years. height (150 -170) cm. exclusion criteria: patient refusal. hypersensitivity to local anesthetic drugs. bleeding disorders and coagulopathy. severe mitral or aortic stenosis. local or systemic sepsis. uncooperative patients. sever spinal deformity. blood or csf in the epidural catheter during the procedure. failure of the block and need for general anesthesia.
involvement of archaea in carious disease

Conditions: Dental Caries

Summary: dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes. methanogenic archaea, mainly methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal. previous research has not really studied the archaea in carious lesions, hence the importance of our study. our study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. the aim is to improve understanding of the cavity microbiology to advance management of this pathology in terms of prevention or of treatment. our team is particularly competent in the field of archaea, especially in the cultivation of archaea methanogens since we have a dedicated platform. we also discovered the first human nanoarchaea, opening up a whole new possible search field.


Eligibility criteria:
inclusion criteria: * male or female of legal age. * patient who is a beneficiary or entitled beneficiary of a social security * patient under the care of the restorative and preventive dentistry of the promod - timone dentistry unit. * patients capable of giving written consent. exclusion criteria: patient in a period of exclusion from another research protocol at the time of signing the consent form, subjects covered by articles l1121-5 to 1121-8 of the public health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), a person who does not have a sufficient command of reading and understanding of the french language to be able to consent to take part in the research presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). antibiotics taken in the previous month. use of mouthwash in the previous 7 days.

Keywords: dental caries
a randomized, open-label study of daclatasvir and sofosbuvir with or without ribavirin for 8 weeks in treatment-naïve, non-cirrhotic subjects infected with chronic hepatitis c virus (hcv) genotype 3

Conditions: Hepatitis C

Summary: the purpose of this study is to determine if 8 weeks of daclatasvir plus sofosbuvir with or without ribavirin is safe and effective in the treatment of genotype 3 hepatitis c infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * genotype 3 * hcv rna \< 2000000 iu/ml * never taken hcv medication * absence of advanced fibrosis or cirrhosis * body mass index (bmi) 18-40 kg/m\^2 exclusion criteria: * infection with hcv other than genotype 3 (gt3); mixed infections of any genotype * previously taken hcv medication * liver cirrhosis * evidence of decompensated liver disease * hiv/ hepatitis b virus (hbv) coinfection
tranexamic acid for preventing postpartum hemorrhage after cesarean section

Conditions: Postpartum Hemorrhage， Cesarean Section

Summary: it is a multicenter randomized, double-blind and placebo-controlled trial. totally 6500 women to delivery by cesarean section will be recruited in this study. in addition to routinely oxytocin, the women in study group will receive txa 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. the incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.


Eligibility criteria:
inclusion criteria: * gestational week more than 37; * to delivery by cesarean section; * informed consent form signed exclusion criteria: * any known renal or liver disorders * history of venous or arterial thrombosis * any disease or history tend to increase thrombosis: opertion in 1 month; active smoker. * do cesarean section because of active bleeding

Keywords: postpartum hemorrhage， cesarean section， tranexamic acid
mental health, addictions and biomarkers in high athletes performance

Conditions: Mental Disorder; Anxiety; Depression; Substance Abuse; Pathological Gambling

Summary: sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. the concept of fair play is on which the development of those values pivots. from a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.

sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. the concept of fair play is on which the development of those values pivots. from a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice. since 2018, joint actions have been carried out with the villarreal de fútbol club, within the framework of the endavant agreement. within these actions, it is proposed to develop different lines of research on sport and health. within these lines, one of special relevance is that related to the risk of consumption of illicit substances and / or behavioral addictions, in elite athletes, since they are subjected to intense training days and stress situations derived from the demands of performance of professional competitive activity. on the other hand, recently published behavioral studies show that athletes who practice non-contact sports have a greater capacity to identify and assess emotions than athletes who practice contact sports and than those who practice contact sports show higher levels of physical aggression or verbal, and hostility or anger, than athletes who practice individual and non-contact sports.

Eligibility criteria:
inclusion criteria: * active athletes in the elite soccer competition from the villarreal cf, who agree to be included in the study by signing an informed consent and who have a health profile made by the club's medical service. exclusion criteria: * athletes who are transferred to other clubs during the study period.

Keywords: mental disorder gambling despression anxiety
nasal epithelium gene expression profiling in child respiratory allergic disease

Conditions: Allergic Rhinitis

Summary: using a human pangenomic microarray, the researchers established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct groups: 1. allergic rhinitis to dust mite (ar) isolated (n=12), 2. ar associated with bronchial hyperreactivity (n=12), 3. ar associated with asthma (n=14), 4. control (n=14).

context: asthma is the most frequent chronic disease in childhood. allergic rhinitis has been described as a risk factor to develop asthma. the objective of the study was to evaluate the contribution of the respiratory epithelium to development of allergic rhinitis and asthma and to identify the molecular mechanisms driving rhinitis toward asthma. methods: using a human pangenomic microarray, we established expression profiles of nasal epithelial cells, collected by brushing of patients belonging to one of four distinct children 2 to 18 years of age groups: 1. allergic rhinitis to dust mite (ar) isolated (n=12), 2. ar associated with bronchial hyperreactivity (n=12), 3. ar associated with asthma (n=14), 4. control (n=14).

Eligibility criteria:
inclusion criteria: patients: * patients between 6 and 17 years old * patients with allergic rhinitis witness: * patients between 6 and 17 years old * patients without allergic rhinitis and asthma exclusion criteria: * rhino-bronchitis infection dated from less than 15 days * patients younger than 6 or older than 17 years

Keywords: allergic rhinitis to dust mite allergic rhinitis associated with bronchial hyperreactivity allergic rhinitis associated with asthma
evaluation of galcanezumab in the prevention of chronic migraine

Conditions: Chronic Migraine

Summary: the main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.


Eligibility criteria:
inclusion criteria: main study: * have a diagnosis of chronic migraine as defined by international headache society (ihs) international classification of headache disorders (ichd)-3 beta guidelines (1.3) (ichd-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. israel addendum: * participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered. * participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine. exclusion criteria: * are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. * current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (cgrp) antibody. * known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab. * history of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by ihs ichd-3 beta.

Keywords: prevention prophylaxis headache