Kornimate/medical-research-clean huggingface dataset:
behavior, biology and well-being study

Conditions: Depression; Psychological Distress

Summary: the central aim of this study is to test the efficacy of the healthy minds program (hmp) app, an intervention designed to promote well-being. the investigators plan to conduct a randomized controlled trial (rct) involving 1100 participants comparing 4-weeks of the hmp app with an active control (psychoeducation \[hmp without meditation practice\]), and a waitlist control in a sample of united states adults with elevated depression symptoms.

depression is highly prevalent and associated with extreme personal and societal costs. meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. research on neurocognitive and biological mechanisms of mediation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. this project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.

Eligibility criteria:
inclusion criteria: * elevated phq-8 or phq-9 ≥ 5 at screening and pre-baseline interview * proficient in english * able to provide informed consent * have access to a smartphone that can download apps from google play or the apple app store * for payment purposes, must be a us citizen or a permanent us resident exclusion criteria: * regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months * attended a meditation retreat or a yoga/body practice retreat with a significant meditation component - previous use of healthy minds program app * current suicidal intent and/or high self-injury risk (determined from the interview) * self-reported history of psychosis * self-reported history of mania * current psychopathology that interferes with study participation as assessed by interview * living or traveling outside the us during the whole study participation period (trips outside us after the interview phase is not an exclusion) * alcohol use disorders identification test (audit) score ≥ 13 for women and audit score ≥ 15 for men * drug use disorders identification test (dudit) score ≥ 8 for women and men
schema focused therapy for chronic depression

Conditions: Chronic Major Depressive Disorder

Summary: schema focused therapy (sft) is an innovative treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. this study will determine whether sft is a suitable and effective treatment for chronic depression in terms of acute effects and the prevention of relapse/recurrence. the secondary aim of this study is to identify the underlying mechanisms of change in sft that lead to recovery from depression and the prevention of future relapse/recurrence.

a single-case series design with multiple randomized baselines across participants will be used in this study. the study will last approximately 36 months and comprises three phases. the first phase is a 6-12 weeks waiting list/baseline phase during which participants will be repeatedly assessed with the main outcome measures and putative mediators. in the second phase participants will receive up to 75 individual sessions of sft for chronic depression depending on the individual progress in therapy. upon completion of the intervention phase, participants will have monthly follow-up assessments for the next 12 months.

Eligibility criteria:
inclusion criteria: * chronic mdd as defined by the dsm-iv (meeting full criteria of mdd for at least 2 years). * beck depression inventory ii (bdi-ii) score at screening \>=20 (moderate to severe depression) * can understand and speak the dutch language * has internet access at home exclusion criteria: * acute suicide risk * substance induced mood disorder * medical condition causes depression directly or through medication intake * mdd with psychotic features * dsm-iv bipolar disorder (current or past) * dsm-iv psychotic disorder (current or past) * dsm-iv alcohol or drug dependence * autism spectrum disorders (autistic disorder, asperger syndrome, pervasive developmental disorder nos, rett syndrome, childhood disintegrative disorder) * cluster a and cluster b personality disorders * started with antidepressant medication within three months prior to initial screening. patients who receive antidepressant medication for more than 3 months prior to the start of the study can keep taking their medication and will not be excluded from participation. * mri contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding.

Keywords: schema focused therapy chronic depression mechanisms of change
the therapeutic effect of betaine in syringomyelia

Conditions: Syringomyelia

Summary: purpose: this clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia. primary outcome measure: the primary endpoint is the change of asia at week 12. the clinical efficacy is defined as asia increase ≥ 1 at week 12, as compared with that before betaine usage.

the pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. although it is generally thought that syringomyelia is simply an accumulation of csf from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes. the investigators supposed that betaine might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(pts), and that betaine, as an osmotic homeostasis-related drug, would protect osmotic homeostasis in syringomyelia. primary objectives: this clinical trial aims to evaluate the indications, therapeutic effects and safety of betaine in refractory syringomyelia.

Eligibility criteria:
inclusion criteria: * contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects, * non-effective response to duraplasty and shunting treatment in 12 months prior to study entry. * estimated life expectancy must be greater than 12 months. * ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document. * must be able to swallow tablets exclusion criteria: * participants have a cardiometabolic disease for which they take prescribed medications * evidence of tumor metastasis, recurrence, or invasion; * history of psychiatric diseases ; * history of seizures; * history of arteriosclerotic cardiovascular diseases (ascvd), e.g. stroke, myocardial infaction, unstable angina, within 6 months; * new york heart association grade ii or greater congestive heart failure; * serious and inadequately controlled cardiac arrhythmia; * significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, -history of aortic dissection; * severe infection; * history of allergy to relevant drugs; * pregnancy, lactation, or fertility program in the following 12 months; * history or current diagnosis of peripheral nerve disease; * abnormal in liver and renal function; * active tuberculosis; * transplanted organs; * human immunodeficiency virus; * participation in other experimental studies.
allergy delabeling in antibiotic stewardship - evaluations

Conditions: Beta Lactam Allergy in Patients With a Hematologic Malignancy

Summary: the goal of this renew-eval project is to understand the potential barriers to implementation of the renew intervention into the routine clinical care of patients with a hematological malignancy.

the renew clinical intervention is designed to evaluate the impact of a comprehensive beta lactam (bl) allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (hm). hm patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies. the renew intervention will test the impact of a pharmacist-led bl allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with hm. the implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff. the renew-eval study is a concurrent mixed methods process evaluation of the renew intervention that aims to identify the social and behavioral factors that shape implementation of the intervention and to measure implementation outcomes including feasibility, acceptability, and fidelity. three types of data will be gathered by the research team as part of the renew-eval project: 1) semistructured interviews with patients and clinicians, (2) ethnographic observations of the delivery of the renew intervention, and 3) surveys assessing patient and clinician attitudes towards bl allergy delabeling, and implementation outcomes.

Eligibility criteria:
inclusion criteria: patient participants: * a diagnosis of a hematologic malignancy (lymphoma, leukemia, myeloma) * a prior label applied to their medical record to indicate a beta lactam allergy * hospitalized as an inpatient to an oncology service at the time the study is conducted clinician participants: * member of the primary inpatient care team exclusion criteria: patient participants: * meet one of the exclusionary criteria for the renew clinical intervention clinician participants: * no exclusions

Keywords: penicillin allergy hematologic cancer allergy delabeling
neurobiological effects of oxytocin in schizophrenia - imaging study

Conditions: Schizophrenia

Summary: to investigate whether 24iu oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fmri). the study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity


Eligibility criteria:
inclusion and exclusion criteria: schizophrenia subjects: inclusion criteria 1) males between 18 and 50 years 2) diagnosis of dsm-iv schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the macarthur competence assessment tool for clinical research exclusion criteria 1. general impairment in intellectual functioning 2. history of alcohol or substance dependence in the last 12 months (with the exception of nicotine) 3. contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma 4. past history of head injury resulting in loss of consciousness or neurosurgery 5. concomitant severe medical conditions 6. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the mri. healthy volunteers: inclusion criteria 1. males between 18 and 50 years 2. capacity to provide informed consent exclusion criteria 1) life-time diagnosis of psychiatric illnesses including substance abuse 2) general impairment in intellectual functioning 3) past history of head injury resulting in loss of consciousness or neurosurgery 4) concomitant severe medical or neurological conditions 5) metal implants or paramagnetic objects or claustrophobia 6) family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.
effect of tracheal tube fixation method on nasal pressure of patients with nasal tracheal intubation

Conditions: Nasotracheal Intubation

Summary: nasotracheal intubation (nti) is commonly used in operations of the mouth, pharynx, larynx and also the neck .various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.in clinical practice, nasal pressure sores caused by nti are not uncommon, but have failed to attract clinical attention.the investigators have observed that the surgeon fixed the nasal tracheal tube and threaded tube directly to the patient's head. the investigators suspect that this method can reduce the pressure between the nasal tube and the nose.

nasotracheal intubation (nti) is commonly used in operations of the mouth, pharynx, larynx and also the neck .various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.in clinical practice, nasal pressure sores caused by nti are not uncommon, but have failed to attract clinical attention.oral and maxillofacial surgery usually uses nasal endotracheal intubation to manage the airway. the tube fixation directly presses the skin of the patient's nose. due to the operation, the surgeon must stand on the head of the patient and there is not enough space to place the tracheal tube bracket. prolonged vascular compression on the nasal region may be caused by excessive tension and angulation of the nasotracheal tube against the nasal tissue.studies have proposed the use of nasal packing, hydrocolloidal dressing and modified nasal tracheal tube to reduce the direct contact between the nasal tube and the nose, relieve the pressure between the two, so as to prevent the occurrence of alar pressure ulcers, but there is no objective data to show the degree of pressure reduction.in clinical practice, the investigatorshave observed surgeons fixed the nasal endotracheal tube and threaded the tube directly to the patient's head. the investigators suspect that this method can reduce the pressure between the nasal tube and the nose, so the investigators want to use a pressure sensor to monitor the pressure between the two.

Eligibility criteria:
inclusion criteria: * age between 18-60 years old * asa physical status i and ii * requiring general anesthesia with nasal intubation exclusion criteria: * previous history of pressure ulcers * nasal trauma or defect * the need for emergency surgery * contraindications to nasal intubation * pregnancy

Keywords: nasotracheal intubation pressure injury
exercise and baseline respiratory functional tests among obese teenagers

Conditions: Obesity, Childhood

Summary: in obese adolescents, the severity of obesity should not influence the outcome of resting pft. the amplitudes of the rest pft should make it possible to predict the performance achieved while exercising on a cycloergometer. we wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.


Eligibility criteria:
inclusion criteria: * children aged \>12 y.o and \<18 y.o * bmi \> 30 * with a previous pulmonary function test (pft) available in the medical record
retrospective study of suture tape for soft tissue reconstruction in patients suffering from lateral ankle instability

Conditions: Lateral Ankle Instability

Summary: this study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for atfl repair (isolated or non-isolated) with suture tape augmentation. patients that have been treated at any of the participating institutions that have undergone an atfl reconstruction with arthrex internalbrace augmentation who have postoperative hospital or asc records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.


Eligibility criteria:
inclusion criteria: * patients between and including the age of 14-75 at the time of surgery * patients who were diagnosed with lateral ankle instability by physician clinical assessment * patients who underwent an atfl repair with arthrex internalbrace augmentation device (does not require an isolated repair) exclusion criteria: * significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (minor microfractures and ocd lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed) * any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an atfl reconstructive procedure. * patients undergoing a calcaneal osteotomy * patients with less than 6 weeks follow-up * patients with incomplete medical records * patients with worker's compensation cases * any patient with a history of infection of the ankle predating the ankle repair * any orthopedic issue outside of the ankle that the investigator feels may impede functional endpoint outcome measures. * patients who have a medical history that would likely make the patient an unreliable research participant

Keywords: atfl reconstructive procedure
a comfort study of brinzolamide 1% / brimonidine 0.2% fixed combination, brinzolamide 1% and brimonidine 0.2%

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to describe the ocular discomfort immediately upon instillation of brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, brinzolamide 1% ophthalmic suspension, and brimonidine tartrate 0.2% ophthalmic solution in subjects with open-angle glaucoma and/or ocular hypertension.


Eligibility criteria:
inclusion criteria: * sign informed consent document. * diagnosis of open-angle glaucoma or ocular hypertension * other protocol-specified inclusion criteria may apply. exclusion criteria: * females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * severe central vision loss in either eye. * any chronic or recurrent inflammatory eye disease. * ocular trauma within the preceding 6 months. * ocular infection or ocular inflammation within the preceding 3 months. * best-corrected visual acuity score worse than 55 letters using the early treatment diabetic retinopathy study chart. * any intraocular surgery within the preceding 6 months. * any ocular laser surgery within the preceding 3 months. * history or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension intraocular pressure brinzolamide brimonidine
elbow heterotopic ossifications associated with radial head prosthesis

Conditions: Radial Head Fracture

Summary: elbow heterotopic ossification (eho) is described as the formation of ectopic bone in tissues not supposed to around elbow. the eho physiopathology, yet not clarified, has been suggested to be a multifactorial process in which immune system, inflammatory response, cns and tissue expressed proteins after severe trauma boost hyperactive metabolically bone with no periosteal layer. consistent with that, eho has been widely related to elbow trauma, including bone, ligament, muscle or joint; iatrogenic trauma, including epicondylectomy or elbow arthroplasty; neural injuries or burns. clinical manifestations of eho has been reported as limited range of motion (rom), muscle, nerve or joint pain, stiffness and ankylosis all of them leading to upper extremity disfucntion. prevalence of eho can range from 3%-45% depending on degree of elbow injury. to our knowledge, prevalence of eho among radial head fractures had not been assessed previously.

prevention of eho has been proposed to be managed with a range of nonsurgical treatment options such as: radiotherapy, nsaids and biphosphonate. however, none of them had become clear effective above others, and only surgical excision of eho had become a reliable option to overcome its associated limitations in elbow motion. classic approaches suggested delayed surgery until maturity of heterotopic bone, however recent literature suggest early excisions of immature ossification to obtain favorable functional results. several studies have investigated risk factors of eho regarding the high patient burden and health costs to which is associated, however, few published data exists about prevalence and risk factors of eho after radial head arthroplasty. our aim is to assess the prevalence and predictor factors that can lead to eho after radial arthroplasty in order to be able to predict and apply early preventive treatment to improve postoperative functional outcomes among patients with severe radial head fractures.

Eligibility criteria:
inclusion criteria: * adults between 18-85 years-old * comminuted radial head fractures treated with radial head arthroplasty exclusion criteria: * younger than 18 years; older than 85 years * history of previous elbow injuries or operations. * pathologic fractures * infections
evaluate the efficacy of a global dental health promotion program on dental hygiene in patients with schizophrenia.

Conditions: Schizophrenia

Summary: there are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. the aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention. this is an interventional trial, randomized in clusters. the participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance). for each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. the follow-up will evaluate dental health and quality of life.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of schizophrenia according to the diagnostic and statistical manual of mental disorders 5th edition (dsm v) * managed at a specialized establishment * older than 18 years. * who have provided written informed consent to take part in the study exclusion criteria: * fully hospitalized patients * patients who are unstable from a psychiatric poit of view or who suffer from delirium. * subjects with less than one incisor, canine, premolar and molar on each hemi-arch * patients with a risk of infectious endocarditis or a major risk of superinfection * patients on long-term treatment with antibiotics (impact of antibiotherapy on oral flora) * patients treated with chemotherapy * pregnant or breastfeeding women * patients without national health insurance cover. * poor written and/or oral comprehension of the french language