Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy of nexalin trans-cranial electrical stimulation stimulation for the treatment of depression

Conditions: Depression

Summary: the purpose of this research study is to determine whether nexalin trans-cranial electrical stimulation (tes) is an effective treatment for depression among patients who are candidates for ect. a secondary aim to assess whether nexalin can be used as an alternative to ect. although nexalin has been approved for use in the us, using nexalin to treat depression in this way is investigational and experimental. if nexalin is found to be an alternative to ect, it could offer a safer treatment for depression with less side-effects and a lower cost. !!! note !!! post script / post study. the ect arm (profiling subjects as ect accepters vs. rejecters) was dropped owing to site objections by referring clinicians. accordingly, the study was framed as a simple comparison between tes and sham tes.

a 2x2 factor randomized controlled trial with block randomization. inpatient subjects at the carrier clinic who are referred for ect will be recruited, typed regarding their acceptance of ect, and randomized to either treatment with tes or to a sham condition. treatment non-responders in either condition will continue as in patients at the carrier clinic until they reach acceptable levels of functioning to be discharged.

Eligibility criteria:
inclusion criteria: 1. in-patients at the carrier clinic 2. adults over age 18 and under age 65 3. able to speak, read and write fluently in english, assessed by the study coordinator at carrier clinic 4. screened negative for alcohol abuse and/or dependence 5. able to provide informed consent, assessed by the study coordinator at carrier clinic 6. referred for ect 7. not currently taking hypnotics or be prescribed hypnotics during the nexalin trial 8. not pregnant or intending to become pregnant during the study 9. committed to completion of the study exclusion criteria: medically or psychiatrically unstable, where the severity of the illness prohibits the subject from engaging in study procedures.
interacting together everyday: recovery after childhood traumatic brain injury (tbi) "i-interact

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (tbi). previous interventions were not designed to address the needs of young children with tbi, and feedback revealed a desire for more examples and materials appropriate for families of younger children. this project builds upon the investigators previous research by modifying the online intervention content to address the needs of young children with tbi. the goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following tbi. the investigators hypothesize that the intervention group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.

five million young children suffer from traumatic brain injury (tbi) each year resulting in new child behavior problems, parental distress, and family dysfunction. recent studies provide evidence that online skill building interventions can reduce caregiver distress and improve child adjustment following tbi. the investigators hypothesize that the i-interact group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the irc group. the investigators overarching goal is to reduce the risk of long-term behavioral problems and disability in young children following tbi by equipping parents with increased coping and parenting skills in a cost effective fashion. findings will be disseminated via presentations and peer-reviewed publications, a website and newsletter, workshops with advocacy groups, and technical assistance to interested parties

Eligibility criteria:
inclusion criteria: * moderate to severe tbi that occurred within the last 24 months * overnight hospital stay * english-speaking * parent must be willing to provide informed consent exclusion criteria: * child does not live with parents or guardian * child or parent has history of hospitalization for psychiatric problem * diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

Keywords: tbi intracranial edema brain edema craniocerebral trauma head injury brain hemorrhage, traumatic subdural hematoma brain concussion head injuries, closed epidural hematoma extra-axial hemorrhage cortical contusion additional relevant mesh terms: nervous system diseases wounds and injuries disorders of environmental origin central nervous system diseases trauma, nervous system brain diseases brain injuries
impact of topical pentoxifylline and tocopherol in treatment and prevention of medically-related osteonecrosis of the jaws

Conditions: Medically Related Osteonecrosis of the Jaws

Summary: while there is no doubt about the benefits of antiresorptives, it is known that patients using these drugs are at increased risk of developing osteonecrosis of the jaws (mrnoj), especially after oral procedures such as tooth extraction. the management of osteonecrosis has remained a controversial topic within the oral and maxillofacial surgery community. the aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of mrnoj.

a double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical pentoxifilline and tocopherol in the prevention and treatment of mrnoj and determine the statistical significance of the outcome variables. 48 subjects with mrnoj, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5% and tocopherol 75%.

Eligibility criteria:
inclusion criteria: * correspondence to the updated sipmo criteria for mronj diagnosis * need for tooth extraction exclusion criteria: * recent use of antibiotics and anti-inflammatories in the last 4 weeks * oral lesions of hard and soft tissues not related to mronj
study of zanubrutinib in japanese participants with b-cell malignancies

Conditions: Mature B-cell Malignancies

Summary: this is a phase 1/2 study of zanubrutinib in japanese participants with mature b-cell malignancies. this study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for japanese participants with b-cell malignancies. no formal hypothesis testing will be performed given the small sample size.


Eligibility criteria:
key inclusion criteria: * participants with confirmed diagnosis of mature b-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and waldenström's macroglobulinemia * relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy * meeting at least one of criteria for requiring treatment * measurable disease by computed tomography (ct)/ magnetic resonance imaging (mri) for mantle cell lymphoma (mcl), marginal zone lymphoma (mzl) and follicular lymphoma (fl) participants and by serum immunoglobulin (ig) m level \> 0.5 g/dl for wm participants * eastern cooperative oncology group performance status of 0, 1, or 2 * life expectancy of \> 4 months key exclusion criteria: * known central nervous system involvement by lymphoma/leukemia * known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected richter's syndrome * prior allogeneic stem cell transplant * systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib * active fungal, bacterial, and/or viral infection requiring systemic therapy * prior therapy with b-cell receptor inhibitor (eg, bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or b-cell lymphoma 2 inhibitor (eg, venetoclax/abt-199) * pregnant, lactating, or nursing women * autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: relapsed/refractory chronic lymphocytic leukemia relapsed/refractory small lymphocytic lymphoma treatment-naïve chronic lymphocytic leukemia treatment-naïve /small lymphocytic lymphoma relapsed/refractory mantle cell lymphoma relapsed/refractory marginal zone lymphoma relapsed/refractory follicular lymphoma relapsed/refractory waldenström macroglobulinemia treatment-naïve waldenström macroglobulinemia
impact on risk stratification of overlap syndrome phenotype in patients with e1784k mutation in scn5a

Conditions: Long QT Syndrome; Brugada Syndrome; Cardiac Conduction System Disease; Arrhythmias, Cardiac

Summary: in patients expressing the scn5a-e1784k mutation (glu1784lys), cardiovascular risk is difficult to define as the stratification of these patients is challenging. from our experience, major cardiovascular events (mce) tend to occur more frequently in patients expressing overlap syndrome phenotype (brugada syndrome and long qt syndrome type 3)than in patients expressing a single phenotype (whether brugada syndrome or long qt syndrome type 3). this trials is led on the impact on risk stratification of overlap syndrome phenotype in patients with e1784k mutation in scn5a ( riskover )

study design: this study will compare the occurrence of mce between patients with overlap syndrome phenotype and patients with a single phenotype (whether brugada syndrome or long qt syndrome type 3) in a cohort of patients 12 years of age and older with the scn5a-e1784k mutation. eligible patients will be identified nationwide and included retrospectively and prospectively. occurrence of mce between the group " overlap syndrome " and the group " single phenotype " will be compared.

Eligibility criteria:
inclusion criteria: * genotype e1784k (glu1784lys) in scn5a gene exclusion criteria: * none

Keywords: long qt syndrome type 3 brugada syndrome scn5a gene e1784k mutation cardiac arrhythmias cardiac conduction system disease phenotypic overlap overlap syndrome sodium channelopathie
swiss spinal tumor registry (swiss-str)

Conditions: Spinal Tumors; Surgical Treatment

Summary: the swiss spinal tumor registry is a prospective redcap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine.

tumors of the vertebral column consist of primary spinal tumors and malignancies metastasizing to the spine. while primary spine tumors represent a rare condition, metastases to the spine have gradually increased over past decades because of increases in aging population and continued advances in cancer therapy with improved survival times across multiple cancer subtypes. metastases to the vertebral column are found in up to 70% of cancer patients, with 10% of patients demonstrating epidural spinal cord compression. therefore, many cancer patients may face spinal surgical intervention at some point of their chronic illness. numerous surgical treatment options are currently available, ranging from simple cement augmentation over decompression of neural elements to extended instrumentation or reconstruction of the spine, including hybrid procedures that combine these techniques. however, precise surgical treatment guidelines do not exist, likely due to the absence of robust, long-term clinical outcomes data in these patients, and the overall heterogeneous nature of spinal tumors. the primary goal of swiss-str is to inform on the effectiveness of current practice in spinal oncology and its impact on patient outcomes. furthermore, it will help to better categorize the different clinical presentations of spinal tumors, thereby facilitating treatment recommendations, assessing the socio-economic burden of this condition to the healthcare system, and improving the quality of care. in cases of rare tumors, multicenter data pooling will fill significant data gaps, allowing a better understanding of these entities. finally, the approach is to first build and implement a high-quality registry with efficient electronic data capture strategies across hospital sites in switzerland, with the potential to later expand internationally, providing opportunities for future international scientific collaboration to push the envelope in cancer research further.

Eligibility criteria:
inclusion criteria: * diagnosis of primary spinal tumor * diagnosis of secondary (metastatic) spinal tumor * indication for surgical treatment is present * patient age: =/\>18 years exclusion criteria: * withdrawal of consent * withdrawal from initially planned surgical procedure * patient age: \<18 years

Keywords: spinal tumor spinal metastasis
effects of multidomain training of health with aging (train-old)

Conditions: Sarcopenia; Memory Loss; Muscular Atrophy; Cardiovascular Diseases; Frailty

Summary: the current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.


Eligibility criteria:
inclusion criteria: 1. subject has provided written and dated informed consent to participate in the study. 2. subject is a male or female between 55 and 90 years of age, inclusive. 3. subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician. 4. subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week). 5. ability to walk independently without any gait aid exclusion criteria: 1. perform high-intensity aerobic exercise on a consistent basis (\>180 min-week). 2. be performing some other regular and systematic strength training program during the intervention in the first half of 2022. 3. have a body mass index greater than 35. 4. have a diagnosis of ischemic heart disease. 5. have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis. 6. possess uncontrolled blood pressure (tas \>180 and tad \>110). 7. stroke. 8. severe peripheral arterial disease. 9. other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe copd, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause. 10. other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.

Keywords: older adults healthy aging resistance training cognitive training cardiovascular training
medical and surgical treatment of mronj (medication-related osteonecrosis of the jaw bones)

Conditions: Osteonecrosis Due to Drugs, Jaw; Osteonecrosis of the Jaw, Bisphosphonate Related; Osteonecrosis of the Jaw, Bisphosphonate Induced

Summary: mronj is an acronym used to describe medication-related osteonecrosis of the jaw bones. it has been reported by the aaoms that bisphosphonates or denosumab can cause this condition. the management of medication-related osteonecrosis of the jaw (mronj) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. the aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of mronj and comparatively evaluate their outcomes.

this study analyzed 116 mronj lesions in 102 patients, divided into medical and surgical treatment groups. sixty patients in medical treatment group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures.the systemic antibiotherapy spanned 3 weeks. once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. forty-two patients were treated surgically. during follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. outcomes after 12 months were categorized into four healing response groups. (h1) complete healing: complete healing with a total coverage of previously exposed bone by the oral mucosa, (h2) partial healing: healthy progress for clinical outcomes and downstaging of the lesion according to the aaoms criteria, (h3) stable disease: no clinical alterations without any change for the clinical stage of the lesion, (h4) progressive disease: deteriorated clinical outcomes following lesion upstaging. associations between variables and outcomes were assessed using chi-square and fisher's exact tests.

Eligibility criteria:
inclusion criteria: * use of antiresorptive and/or antiangiogenic drugs and consequent development of mronj. * absence of head and neck radiotherapy. * presence of necrotic bone in the maxillofacial region for at least 8 weeks. exclusion criteria: * having undergone head and neck radiotherapy. * presence of active radiotherapy and/or chemotherapy. * missing information in treatment and follow-up records

Keywords: antibiotics bisphosphonate bronj mronj osteonecrosis
understanding non-radiotherapy-based development of trismus

Conditions: Trismus; Oral Cancer

Summary: a limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. the enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics. the aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. there is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus. the investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.


Eligibility criteria:
inclusion criteria: * all patients with a newly diagnosed oral cancer. * cases with a limited mouth opening secondary to oral tumour resections exclusion criteria: * minors. * deceased cases within the follow-up period of one year. * other malignancies than oral squamous cell carcinomas.
prevention of diabetes progression trial (pdpt)

Conditions: Newly Diagnosed With Type 1 Diabetes

Summary: the primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type i diabetes. additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy. * ages 2 to 40 years at diagnosis * enroll within 3 months of diagnosis * test positive for at least one of the biochemical autoantibodies (ica-512, gad 65 or iaa) prior to enrolling exclusion criteria: * previous treatment with an anti-il-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab. * other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine. * active significant infection * limited life expectancy because of disease other than diabetes * pregnancy
cognitive enhancement and relapse prevention in cocaine addiction

Conditions: Cocaine Addiction

Summary: for this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. this study will combine a medication called d-cycloserine (dcs) and weekly cognitive behavioral therapy (cbt) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time. one of the greatest risks for drug relapse is drug craving. oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. dcs has been shown to enhance the learning of new information. by administering dcs prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time. in addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. a technique called mri (magnetic resonance imaging) will be used to identify areas of the brain that are being activated during an attention task. areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.

primary hypothesis: enhancing glutamatergic neurotransmission with dcs facilitates cbt-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues. specific aims: 1. determine if the short-term oral administration of dcs relative to placebo prior to cbt sessions facilitates cocaine abstinence and functional recovery, and reduces cocaine craving in treatment-seeking cocaine addicts. 2. determine if dcs administration relative to placebo facilitates cbt-related decreases in the behavioral and neural response to conditioned cocaine cues.

Eligibility criteria:
inclusion criteria: * eligible subjects must be cocaine-dependent persons between 18 and 65 years exclusion criteria: * any current axis-i psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use * any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications * positive history of loss of consciousness of greater than 10 min * significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable * history of hospitalization within the previous six months for a medical illness * deafness, blindness or other significant sensory impairment. * contraindications for d-cycloserine and magnetic resonance imaging.

Keywords: cocaine dependence relapse prevention computerized cognitive behavioral therapy (cbt) d-cycloserine (dcs)