Kornimate/medical-research-clean huggingface dataset:
a research study of how nnc0174-0833 taken with semaglutide works in people who are overweight or obese

Conditions: Obesity; Overweight

Summary: the aim of this study is to find out how nnc0174-0833 taken with semaglutide works in people who are overweight or obese. both study medicines have been investigated on their own. the study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: semaglutide (a new medicine) and nnc0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). participants will get 2 injections per week for 20 weeks. a study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. the study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. participants will have 28 clinic visits with the study staff and some will be overnight visits. participants will be asked about their health, medical history and habits including mental health questionnaires.


Eligibility criteria:
inclusion criteria: * male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. exclusion criteria: * any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. * male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (pearl index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product.
plaque reduction sesame-based oil

Conditions: Dental Plaque; Gingivitis; Oral Microbial Colonization

Summary: the goal of this clinical trials to learn about potential additives in reducing dental plaque. the main questions it aims to answer is: • is there a difference in the plaque reducing effect of oil pulling with sesame-based oil compared to rinsing with distilled water? participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks. researchers will compare sesame-based oil against distilled water to see if there is a difference in the plaque reducing effect.


Eligibility criteria:
inclusion criteria: age ≥ 18 years contractual capability the presence of ≥ 10 teeth, community periodontal index of treatment needs (cpitn) grade 1 or 2 exclusion criteria: missing consent community periodontal index of treatment needs (cpitn) grade 0, 3 or 4 pregnancy or breastfeeding systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment mental and behavioral disorders that impede (verbal) communication allergy against sesame(oil) intake of antibiotics 6 months prior to or during study duration intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone) infectious diseases (e.g. hiv, hepatitis b or c) fixed orthodontic appliances ongoing oil pulling or mouth rinsing adult guardianship insufficient nasal breathing
electromyography in patients on chronic pyridostigmine therapy

Conditions: Muscle Weakness

Summary: we intend to measure evoked emg at two sites in subjects who are chronically taking pyridostigmine.

the investigators are intending to enroll patients who are chronically treated with pyridostigmine for the treatment of any medical condition and presenting at the investigators' outpatient clinics for follow up appointment. subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded. both adults and children older than 12 years of age will be approached. those subjects that agree to participate will be asked to sign an informed consent. for the participation of minors a parental (or guardian) consent and subject assent will be obtained. those that participate will answer a few questions pertaining to their medical history and will then undergo electromyograph (cmap) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). evoked electromyogram will be recorded on a computer hard drive. eight percent or greater decrement in the cmap response on repetitive stimulation will be considered positive.

Eligibility criteria:
inclusion criteria: * subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis exclusion criteria * subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.
creactive - collaborative research on acute traumatic brain injury in intensive care medicine in europe

Conditions: Brain Injuries, Traumatic

Summary: creactive is a large-scale observational cohort study concerning traumatic brain injury (tbi) care in the icu setting

traumatic brain injury (tbi) is among the leading causes of death and disability and the main cause of death among the under-45s. most patients with moderate to severe tbi are admitted to intensive care units (icus). the 'promoting patient safety and quality improvement in critical care' icu network was recently established in 6 european countries through european union funding (phea 2007331), and has continued to collect high-quality data beyond the grant duration. in 2012, 242 icus had joined 'promoting patient safety and quality improvement in critical care', recruiting a total of 85,965 patients. of these icus, 180 admitted at least one tbi patient, totaling more than 3,300 cases. hence, the network is expected to enroll 7-9,000 moderate-to-severe tbi patients in 4 years, in about 125 participating icus. the 'promoting patient safety and quality improvement in critical care' consortium has already focused attention on tbi and has just started collecting additional information on this condition in order to develop a prognostic model to identify centers of excellence in tbi management. aims of the creactive project are to consolidate the existing network in order to better describe the epidemiology of moderate-to-severe tbi in 7 countries (cyprus, greece, hungary, israel, italy, poland, slovenia); establish centralized repositories of biological samples (blood and derived fluids, csf) and clinical imaging data, to be exploit for prognostic purposes; build a prognostic model based on clinical and biological data to predict short- and long-term outcome; identify most effective clinical interventions for optimally treating tbi patients; recognize the determinants of optimal vs. suboptimal performance. all patients admitted to the participating icus with a diagnosis of traumatic brain injury, regardless of their severity, will be recruited. centralized repositories of imaging data and biological samples for the analysis of phenotypic and genotypic biomarkers will be established for approx. 2,000 adult tbi patients. follow-up will be performed six months after the trauma event, and will be two-tiered. the first level will be administered over the phone and constituted of the extended version of the glasgow outcome scale (gose) and a health-related quality of care questionnaire. the second level will encompass a patient's full examination that, for children, will include a dedicated sleep disturbances study. the second level follow-up will be performed in a selected subgroup of icus.

Eligibility criteria:
inclusion criteria: all patients admitted to the participating icus with a diagnosis of traumatic brain injury, regardless of their severity,will be recruited. exclusion criteria: absence of informed consent

Keywords: tbi icu comparative effectiveness research
using attention training to reduce adolescents' anxious symptoms

Conditions: Attentional Bias; Anxiety

Summary: during adolescence, youth undergo rapid developmental change and in some cases experience increases in worries and fearfulness, although the mechanisms that underlie this change are unclear. previous studies indicate that heightened attentional bias (ab) toward threat-related cues may increase fearfulness, and it may be possible to change ab using a computerized, attention bias modification task (abm). this study will recruit healthy youth with elevated anxious symptoms to index attentional tendencies toward threat-related stimuli using cutting-edge techniques, and to test the effect of a computerized attention training task in altering attention to threatening cues. the investigators will also examine the role of abm in changing youth's attention-related resting-state functional connectivity (rsfc), a neural marker of at-rest cognition.

adolescence is a critical period for increases in anxious symptoms, potentially due to etiologically significant attention biases (ab) favoring threatening cues. however, the specific facets of ab that drive this vulnerability as well as their neurocognitive correlates are unclear, due in large part to the poor psychometric properties of the traditional assessment of ab in this field. by using both a standard behavioral task and a novel eye-tracking task, this study aims to unpack the nuanced facets of ab related to anxiety risks. additionally, well-controlled attentional bias modification (abm) tasks designed to train attention away from threatening cues can be used to experimentally manipulate the causal mechanisms of interest, and to test whether abm reduces symptoms and alters patterns of resting-state functional connectivity (rsfc, the intrinsic brain activity that occurs outside specific tasks) that characterize anxiety risks. this study will recruit 60 11-13-year-old healthy adolescents with heightened anxious symptoms but without clinically significant anxiety disorders. they will be randomized to a six-session abm training or a placebo task. both before and after the training, the investigators will assess their anxious symptoms, ab, and rsfc. by examining the risk processes prior to the onset of clinically significant anxiety disorders, our work will make important new contributions to our understanding of how ab eventuates in anxiety and will have direct implications for early identification of youth at highest risk for anxiety disorders, and the targets that should be focused on in preventative efforts.

Eligibility criteria:
inclusion criteria: * english-speaking 11-13-year-old youth without significant medical, psychological, cognitive, or language impairments. exclusion criteria: * adolescents with clinically significant anxiety disorders or conditions in conflict with mri scanning (e.g., orthodontics) will be excluded.

Keywords: attentional bias anxiety risk adolescence eye-tracking resting-state functional magnetic resonance imaging
treatment of non-gestational acute uterine bleeding: a randomized trial

Conditions: Uterine Hemorrhage; Menorrhagia

Summary: to determine the relative efficacy of multidose medroxyprogesterone acetate (mpa, provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes many reproductive-aged women to requite emergent medical and/or surgical intervention. although the traditional approaches have generally been surgical in nature, many practitioners utilize medical methods to arrest the bleeding. however, despite widespread use, there exists a paucity of information regarding the effectiveness, side-effects, and patient satisfaction associated with the commonly-used medical regimens. (b) the purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational, acute uterine bleeding. (c) non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of is, who present either to the emergency area or to kp practitioner's offices with acute uterine bleeding, will be considered for eligibility. if, following a full exam and medically appropriate investigations medical management is deemed appropriate, they will be approached by a member of the investigating team for possible inclusion into the study. following informed consent, patients will be randomized to receive either medroxyprogesterone acetate (20 mg three times daily for 7 days) or monophasic oral contraceptive containing i mg of norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). following the seven days of therapy, those randomized to mpa will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks, each completing a total of four weeks of therapy. the primary outcome will be the number of days until cessation of bleeding. other outcomes measured will include pad and tampon counts, and hemoglobin levels. chi square tests and student t will be used to evaluate differences between the two treatment groups. the hope is that this study will elucidate on the efficacy of the two regimens.

Eligibility criteria:
inclusion criteria: non-pregnant hemodynamically stable reproductive-aged women \>18 years present with acute uterine bleeding exclusion criteria: pregnant non-hemodynamically stable \<18 years

Keywords: acute uterine bleeding
early post-operative pain control following wrist operations

Conditions: Pain

Summary: the purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, exparel, when compared to the use of the standard local anesthetic, marcaine.


Eligibility criteria:
inclusion criteria: * age \> 18 years * asa physical status 1-3 * undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation * physically and mentally able to participate in the study and complete all study assessments * able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required. exclusion criteria: * history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics * any patient whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful local administration of exparel * patients who have received any investigational drug within 30 days prior to exparel administration, or planned administration of another investigational product or procedure during their participation in this study * any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more * confirmed pregnancy at time of enrollment * patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf

Keywords: carpalmetacarpal arthroplasty proximal row carpectomy post-operative pain control exparel marcaine
a phase 1 study of abt-869 in subjects with solid tumors

Conditions: Solid Tumor

Summary: the objective of this study is to evaluate the pharmacokinetics, safety and tolerability of abt-869 in japanese patients with solid tumors up to the recommended phase two dose that was determined in a previous the m04-710 study.


Eligibility criteria:
inclusion criteria * subjects aged from 20 to 75 years and ecog ps of 0-2 at screening. * subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist. * the subject must have adequate bone marrow, renal and hepatic function. * women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy. * the subject must voluntarily sign and date an informed consent. exclusion criteria * the subject currently exhibits symptomatic or intervention indicated cns metastasis. * the subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment. * the subject with the following conditions during screening assessment. 1. proteinuria ctc grade \> 1 as measured by urinalysis and 24 hour urine collection 2. diastolic blood pressure (bp) \> 95 mmhg; or systolic blood pressure (bp) \> 150 mmhg 3. a history of or currently exhibits clinically significant cancer related events of bleeding 4. lv ejection fraction \< 50% 5. received a cumulative dose of anthracycline \> 360 mg/m2 for treatment of cancer 6. receiving therapeutic anticoagulation therapy 7. having fractures except for chronic bone lesion due to bone metastases * the subject exhibits evidence of other clinically significant uncontrolled condition(s).
periodontal initial treatment combined with glucocorticoid therapy for erosive oral lichen planus

Conditions: Oral Lichen Planus; Periodontal Diseases

Summary: the purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. it will also understand the safety of this treatment regimen. this study is a single-center, parallel-group, randomized self-controlled trial. the researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus. participants will: one side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy clinical examination at 2, 4, 8, and 12 weeks after treatment note down the size of their erosion lesion area and periodontal clinical parameters


Eligibility criteria:
inclusion criteria: * existence of erosive oral lichen planus that lasts for more than 2 months * erosive lesions are located in the buccal mucosa and gingival buccal sulcus of the bilateral mandibular posterior teeth area * the erosive lesions are mild to moderate (single or multiple small area erosions; 3mm ≤ longest diameter ≤ 10mm; 9mm2 ≤ total area of erosions ≤ 100mm2), and the degree of erosion on both sides is similar (the difference in the size of erosion on both sides does not exceed ± 25%) * the plaque index in the area of erosive lesions is ≥ 3; dental calculus index ≥ 2; gingival index ≥ 2; * accompanied by stage ii-iv extensive periodontitis exclusion criteria: * pregnant women, lactating women, or women planning to conceive during the trial period * patients with coagulation dysfunction or other uncontrolled systemic diseases who cannot undergo periodontal treatment * has undergone basic periodontal treatment within the past 6 months * individuals with a history of allergy to local anesthetic drugs such as articaine * individuals with contraindications to glucocorticoids * patients with lesion area erosion caused by trauma or chemical stimulation * patients with mental disorders who are difficult to cooperate with treatment

Keywords: periodontal initial therapy erosive oral lichen planus local anesthesia
the effect of binaural sound on the occurrence of emergence delirium in children undergoing strabismus surgery

Conditions: Emergence Delirium

Summary: the hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. to test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.


Eligibility criteria:
inclusion criteria: * children under the age of 7 receiving a strabismus surgery under general anesthesia. * american society of anesthesiologists physical status classification 1-2. exclusion criteria: * pediatric patients with hearing impairment or those who are currently using a hearing aid * pediatric patients with neurological disorders * pediatric patients with respiratory disorders
risk-targeted behavioural activation for the management of treatment-resistant depression.

Conditions: Treatment Resistant Depression (TRD)

Summary: depression is the leading cause of disability worldwide. major depressive disorder (mdd) is the most common diagnosis made for individuals seeking treatment for depression. although a wide range of treatments have been developed for the treatment of mdd, a significant proportion of patients fail to respond. this study examined the effectiveness of a 10-week behavioural activation intervention for individuals with treatment-resistant depression.

objective: the purpose of the present study was to examine the acceptability and impact of a standardized 10-week risk-targeted behavioral activation (rtba) intervention as an augmentation strategy in the clinical management of treatment-resistant depression (trd). methods: the study sample consisted of 118 individuals with trd, who were currently absent from work and referred to an occupational rehabilitation service. the rtba intervention was a 10-week standardized program consisting of weekly visits with a trained clinician. the objectives of treatment included symptom reduction, resumption of important life activities (including return to work) and improvement in quality of life. measures of depression, perceived injustice, and catastrophic thinking were completed pre-, mid- and post-treatment.

Eligibility criteria:
inclusion criteria: * a diagnosis of major depressive disorder * the date of diagnosis of mdd preceded referral by at least 12 months * at least one previous prescription of an antidepressant failed to yield therapeutic response * currently taking an antidepressant * a phq9 score in the moderate to severe range of depression at the time of enrolment exclusion criteria: - participating in another psychotherapeutic intervention.

Keywords: treatment resistant depression catastrophic thinking perceived injustice behavioural activation