Kornimate/medical-research-clean huggingface dataset:
evaluation of brain opioid receptor activity in anorexia nervosa : a pet [11c]diprenorphine study

Conditions: Body Dysmorphic Disorders; Anorexia

Summary: the place of opioid system in anorexia nervosa (an) physiopathology is still unclear. conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. however, no data have been reported on opioid cerebral activity. diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.


Eligibility criteria:
inclusion criteria: * an patients dsm iv criteria including amenorrhea bmi \ 2 yrs) group 2 (n=15) : recent weight loss (6 to 12 months) * recovered an patients history of an weight recovery and bmi \> 18.5 kg/m², stable for at least 12 months normal nutritional markers group 1 (n=15) : menses recovery after bodyweight stabilization group 2 (n=15) : long persistence of amenorrhea (\> 12 months) despite weight recovery * healthy volunteers (n=15) bmi between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology * for all subjects women 18-35 yrs written and sign consent affiliation to health insurance exclusion criteria: * history of heart failure * psychotropic treatment , antiepileptics * ongoing or suspected pregnancy, positive beta hcg test before brain imaging * intense physical activity * constrains for mri (ferromagnetic implants or claustrophobia) * refusal to be informed in case of incidentaloma revealed by brain imaging * refusal for written consent

Keywords: anorexia nervosa opioid receptors positron emission tomography (pet) diprenorphine
make my day - primary prevention of stroke

Conditions: Non-Communicable Diseases; Stroke; Cardiovascular Risk Factor

Summary: the purpose of this study is to evaluate the feasibility of a digital, person-centered stroke prevention program with a focus on primary prevention. the program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke.

the study is a randomized controlled pilot trial evaluating the feasibility of a digitally augmented person-centered stroke prevention program with a focus on primary prevention. the program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke. with activity patterns (individual actions and behaviour) in everyday life we mean a persons overall lifestyle that may or may not contribute to health. the prevention program is a theoretically grounded, complex intervention tested against a control-group that are receiving usual care. the prevention program is based on activities in people's everyday lives and integrates health and well-being with what people do, as well as with what they want or need to do, in order to thrive and live well. lifestyle change refers to a conscious change of behaviour and everyday activities in order to promote health. the process of changing behaviour results from an interaction between the person (eg, self-efficacy), the environment (support and material) and the action. in the project, the key behavioural change technique is incorporating engaging everyday activities (eeas) that contribute to a healthy lifestyle. this might include changing the form of current eeas or finding new health-promoting eeas.

Eligibility criteria:
inclusion criteria: * persons with increased risk for stroke according to stroke risk score card * persons motivated for participating in an intense digital lifestyle prevention (including the use of a mobile phone with the function to download and use apps), exclusion criteria: * persons having had a stroke or tia * persons with a diagnosis of dementia or cognitive impairment * drug abuse

Keywords: life style primary prevention modifiable risk factors mhealth engaging occupation
patient-centered communication about healthy weight in early breast cancer

Conditions: Breast Cancer

Summary: comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. this study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.

the overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "patient-center communication about healthy weigh in clinical practice primary objective: 1. understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups secondary objective 2. understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.

Eligibility criteria:
inclusion criteria for breast cancer cohort: * age 21 or older * diagnosed with early breast cancer, stages i-iii * completed primary treatment (surgery, chemotherapy, radiation) within past 2 years * body mass index of equal or greater than 30 exclusion criteria: * cannot understand and speak english inclusion criteria for oncology provider cohort: * breast cancer oncology provider in north carolina with md/do/pa/np/rn * associated with community-based practices
urinary retention after arthroplasty

Conditions: Urinary Retention Postoperative; Arthroplasty Complications

Summary: arthroplasty increases the risk of postoperative urinary retention. treatment of postoperative urinary retention is indwelling or intermittent catheterization. the need for catheterization is most commonly determined with an ultrasound scanner. catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. there is no evidence of an optimal way to monitor the onset of spontaneous urination. the aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.

adult patients undergoing knee arthroplasty will be recruited to this study. participants will be randomized to the ultrasound monitoring group or the symptoms alone group. in the symptoms alone group, urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis or if spontaneous voiding has not started 10 hours after the spinal anesthesia. symptoms that indicate catheterization are lower abdominal pain or need to void. in the ultrasound group, urinary retention is monitored according to current practice with an ultrasound scanner and the patient is catheterized if residual urine exceeds 800 ml or if the patient is symptomatic. the primary outcome variable is the change in ipss score from the baseline to 3 months after the procedure. the baseline score is evaluated preoperatively.

Eligibility criteria:
inclusion criteria: * elective total knee arthroplasty exclusion criteria: * previous surgery for urologic cancer * fracture as indication for surgery * lack of co-operation * untreated urinary retention * nephrostoma * general anesthesia
periodontal therapy in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid; Periodontitis

Summary: aim: a prospective randomized, controlled clinical trial comparing two groups of a cohort of rheumatoid arthritis (ra) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (lda)-remission. methods: 42 patients with ra and periodontitis from the ra almenara cohort will be included (acr 1987 and or acr/eular 2010 criteria with more than 16 years old at diagnosis); those with \ =5mm, probing depth \>=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria. two ra patients groups will be follow up by monthly visits. patients will be divided into two groups (intervention and no intervention treatment). pd treatment will be performed by a qualified periodontist. no intervention group will receive pd treatment after 6 month visit because ethical principles. disease activity will be determined according with das 28index, clinical disease activity index (cdai) and simple disease activity index (sdai) scores, c-reactive protein (crp), the erythrocyte sedimentation rate (esr), and rheumatoid factor levels will be registered before and after pd treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. periodontal parameters including probing depth (pd), clinical attachment loss, and sulcus bleeding index (sbi) will be correlated with the factor levels.


Eligibility criteria:
inclusion criteria: * patients of both sexes * age ≥16 years at the time of diagnosis and who do not meet criteria of overlap with any other autoimmune disease. * presence of six or more permanent teeth in the mouth, excluding third molars. * presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss \>=5mm, probing depth \>=5mm and bleeding on probing according to tonetti et al.\[35\]. * willingness to attend all visits for the duration of the study. exclusion criteria: * patients with sjogren's syndrome * - severe ongoing systemic infection. * - associated dental infection * - history of oral cavity cancer or precancerous lesion. * - use of local or systemic antibiotics in the last 3 months (including tetracyclines or other medication that could change the periodontal evaluation in the investigator's opinion, such as heparin alendronate, antivitamin k). * - medications that induce gingival hyperplasia (such as phenytoin, warfarin or cyclosporine). * - pregnant or breastfeeding women * - participation in another intervention study. * patients with a history of pd treatment in the last 6 months or previous dental surgery)

Keywords: c-reactive protein periodontal diseases periodontitis rheumatoid arthritis scaling and root planning
ete interventions in the dental setting

Conditions: HIV Infections

Summary: the purpose of this study is to use information technology (it) to support the delivery of hiv prevention and care best practices in the dental care setting to meet the department of health and human services (dhhs) ending the hiv epidemic (ete) goals.

routine hiv screening in all health care settings is considered a best practice by the centers for disease control and prevention (cdc), dhhs ending the epidemic initiative, the new york state blueprint to end the aids epidemic, and is mandated by law in new york for all individuals over the age of 13 who receive hospital or primary care. despite this, many patients are not screened for hiv during routine care, including in dental care settings, resulting in missed opportunities for identifying undiagnosed hiv infections, providing education for and linkage to prep, and linking and re-engaging hiv-positive patients into hiv care. the investigators will use information technology in the following two ways to support the delivery of hiv prevention and care best practices in the dental care setting to meet the dhhs ending the hiv epidemic (ete) goals. first, dental teams will receive a best practice (bpa) alert whenever they have a patient who should be offered hiv testing. this bpa is linked to an order set to simplify ordering hiv tests and reporting results. second, dental teams will be contacted whenever they have a patient who is known to have hiv and is out of hiv care. a critical knowledge gap for implementing these ete activities in the dental setting is whether comprehensive ete efforts could be integrated into existing dental teams consisting of practitioners, dental assistants and hygienists or require augmentation by a dedicated care navigator. therefore the investigators will pilot the dental team and care navigator models at two different dental sites (nyp-columbia and nyp-weill cornell) using a cross-over design to evaluate acceptability and feasibility of providing hiv prevention and treatment services supported by these health it strategies in the dental setting under these two care delivery models. if the strategies are found to be acceptable and feasible for both dental care patients and providers, then the study will expand to 4 sites and examine the effectiveness of these strategies for delivering hiv prevention and care best practices in the dental setting.

Eligibility criteria:
inclusion criteria: dental team/patient navigator: to be eligible, members of the dental team or patient navigator need to have direct contact with patients at a participating dental clinic site during the months of the pilot study. patient: to be eligible, patients must: * be 18 years or older * have at least one visit during the months of the pilot study at a participating dental clinic exclusion criteria: * not meeting inclusion criteria

Keywords: health information technology care navigation acceptability feasibility dental setting
surgical stabilizer assisted rvc with rtpa for crvo

Conditions: Central Retinal Vein Occlusion

Summary: this phase ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue plasminogen activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.

investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase ib trial. in line with the previous phase i trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative oct-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).

Eligibility criteria:
inclusion criteria: * patients aged over 18 years * recent diagnosis (\<8 weeks) of crvo * recent onset of symptoms (\<12 weeks) * visual acuity \< 5/10 in study eye * visual acuity \>1/10 in fellow eye * central macular thickness \>250µm * signed informed consent prior to inclusion exclusion criteria: * fluorescein allergy * active neovascularization * eye disease other than crvo or cataract decreasing central vision * history of retinal surgery * high myopia (\> -10d) * contraindication for the use of systemic anticoagulant medication * extensive macular ischemia noted on fluo-angiography
group-based psychoeducation for relatives of patients with bipolar disorder, a randomized controlled trial

Conditions: Bipolar Disorder

Summary: relatives of patients with bipolar disorder (bd) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. the effects of group-based psychoeducation have not been investigated in large-scale real-world settings. the investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (rct) to test whether group-based psychoeducation for relatives to patients with bd improves mood instability and other critical outcomes in relatives and the corresponding patients with bd. the trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. the group sizes for psychoeducation is between 20-40 relatives.the primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about bd.


Eligibility criteria:
inclusion criteria: * relatives of patients with bipolar disorder who are affiliated with the copenhagen affective disorder clinic. exclusion criteria: * insufficient danish language. * age below 18 years.

Keywords: relatives caregivers family psychoeducation randomized controlled trial
lansoprazole in preterm infants with reflux

Conditions: Preterm Infants; Gastrointestinal Reflux

Summary: this study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr ph impedance monitoring


Eligibility criteria:
inclusion criteria: * preterm infant * documented gastrointestinal reflux by 24hr ph monitoring exclusion criteria: * unstable vital sings * congenital anomaly in upper gastrointestinal tract incuding esophagus * drug history of h2 blocker during last 1 week * medication of warfarin, carbamazepine, phenytoin, rifampin * renal or hepatic dysfunction * inappropriate clinical conditions judged by researchers

Keywords: preterm infants reflux impedance ph monitoring lansoprazole
genetic sources of variability of the adaptation of the ventricular repolarisation

Conditions: Healthy Volunteers

Summary: the main objective is to research for genetic factors involved in the extreme modifications of the qt interval of the electrocardiogram in answer to a pharmacological stimulation (sotalol) and physiological stimulation in the apparently normal general population. the phenotypic characterization, based on the ventricular repolarisation dynamics will be used aiming at term of the predictive genetic factors of the acquired long qt syndrome

study of 1000 apparently healthy subjects which will receive an unique dose of sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of dna.

Eligibility criteria:
inclusion criteria: * both sexes * age between 18 and 60 years * european or north african origin * body mass index between 19 and 29 kg / m ² * obtaining informed and written consent exclusion criteria: * asthma * heart rate \< 50 bpm * systolic blood pressure \< 100 mm hg * atrioventricular block * known chronic illness with chronic treatment * raynaud phenomenon * qt prolonging drug * family or personal history of the congenital long qt syndrome * qt/qtc fridericia (qtcf) \> 450 ms * pregnancy

Keywords: long qt syndrome cardiac repolarisation genome-wide association electrophysiology drugs/adverse effects
fingolimod (fty720) in acute demyelinating optic neuritis (adon)

Conditions: Acute Demylelinating Optic Neuritis

Summary: to evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (adon) receiving standard steroid treatment


Eligibility criteria:
inclusion criteria: * clinical signs and symptoms of adon in one eye (loss of vision, pain on movement, impairment of color vision) * first episode of adon * able to undergo treatment with iv steroids exclusion criteria: * history of any unexplained eye or neurological symptoms lasting longer than 48 hours * optic neuritis in both eyes * concomitant condition in either eye, other than optic neuritis * history of heart condition/disease * patients with uncontrolled diabetes mellitus * patients with liver conditions/disease * inability to undergo mri * pregnant or nursing women * women of childbearing potential who are not using highly effective method of birth control * other protocol-defined inclusion/exclusion criteria may apply

Keywords: acute demyelinating optic neuritis optic neuritis
a trial to evaluate dr-2021 in women with secondary amenorrhea

Conditions: Amenorrhea

Summary: this is a multicenter trial to compare the effectiveness of 4 doses of dr-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

in this multicenter trial patients will be randomized to receive dr-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. patients will be treated for 10 days and study participation will be approximately 24 days. patients will undergo a physical exam including a pelvic and breast exam. patients will be required to complete bleeding and spotting information daily in a diary.

Eligibility criteria:
inclusion criteria: * not pregnant * secondary amenorrhea or oligomenorrhea of at least 50 days duration * not currently on any hormonal medication * not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom) exclusion criteria: * use an injectable or implantable estrogens, progestins, or androgens within the last 6 months * use of any hormonal birth control within the last 3 months * any contraindication to the use of progestins

Keywords: secondary amenorrhea progesterone
clinical investigation of eno/teo/oto pacing system under mri environment

Conditions: Bradycardia

Summary: the interest of the capri study is to confirm the safety and the efficacy of the eno/teo/oto pacing system when used under 1.5 or 3 tesla mri environment and in accordance with the mri solutions guideline.

the purpose of capri study is to confirm the safety and the efficacy of the ce marked mr conditional pacing system composed of the eno, teo or oto pacemaker with vega pacing lead(s). conditions to undergo an mri scan are provided in the mri solutions guideline. the primary objective is to confirm the clinical safety of the eno/teo/oto pacing system when used under 1.5 and 3 tesla specific mri conditions without scan exclusion zone. the study secondary main objectives are aiming to assess the performance of the mr conditional pacing system in the right atrium and ventricle at 1 month following the mri scan: * stability of the pacing capture threshold * stability of the lead sensed amplitude

Eligibility criteria:
inclusion criteria: subjects who meet all the following criteria at the time of inclusion visit may be included: * already implanted in the left or right pectoral region for at least 6 weeks with: * eno, teo or oto single chamber rate response (sr) pacemaker with a vega pacing lead, or * eno, teo or oto dual chamber rate response (dr) pacemaker with two vega pacing leads. * implanted pacing system must fulfill the following parameters: * battery impedance is \< 5 kilo ohm (kω) * pacing capture threshold value is ≤ 2 volts (v) at 0.35 millisecond (ms) * lead impedance value between 200ω and 3000ω * no diaphragmatic or pectoral stimulation at 5v/1ms * p-wave minimum sensed amplitude ≥ 1mv for patients with sinus rhythm * r-wave minimum sensed amplitude ≥ 4mv for patients with spontaneous conduction rhythm * must agree to undergo a non clinically-indicated mri scan without intravenous injection and without sedation; * have reviewed, signed and dated informed consent. subjects who meet any of the following criteria are not eligible to be included in the study: * included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device; * have other active or abandoned cardiac implants already implanted; * have other active or passive non mr conditional devices implanted such as metallic foreign body; * have a history of brain aneurysm with ferromagnetic clipping; * have a planned cardiac surgery within the 3 months of inclusion; * have a medical mri examination prescription planned within the 3 months of inclusion; * age less than 18 years old or under guardianship or kept in detention; * known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ; * be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.