Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of suvorexant (mk-4305) for reducing incidence of delirium in japanese participants at high risk of delirium (mk-4305-085)

Conditions: Delirium

Summary: the goal of this study is to evaluate the efficacy and safety of suvorexant (mk-4305) for reducing the incidence of delirium in japanese participants who are at high risk of delirium. the primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria.


Eligibility criteria:
inclusion criteria: * is hospitalized for (1) acute disease with severe disease state or decreased daily living function or (2) elective surgery requiring general anesthesia scheduled on the day after or 2 days after admission/day 1 * has (1) mild cognitive impairment or mild dementia and/or (2) a history of delirium in any prior hospitalization * requires hospitalization for 6 days for acute disease, with treatment starting on day of admission; or 7 days, with treatment starting the day after admission or * requires hospitalization for 6 days for elective surgery scheduled on the day after admission; or for 7 days for elective surgery scheduled 2 days after admission * is able to take study medications orally exclusion criteria: * has moderate or severe dementia * has a history of epilepsy or parkinson's disease * currently uses psychotropic agents or has a mental condition including schizophrenia, other mental disorders, bipolar disorder and major depression * has a history of drug or alcohol abuse in the 5 years prior to start of study or has alcoholic disease such as alcoholic liver disease or gastritis alcoholic * has a history of narcolepsy or cataplexy * has used hypnotics, antipsychotics, mood stabilizers, antidepressants, anxiolytics, psychostimulants, anticonvulsants or tiapride within 2 weeks prior to randomization * has delirium as assessed by dsm-5 or drs-r-98 (total score ≥14.5) before the first dose of study medication
spine procedures assisted with robotics and navigation

Conditions: Spine Deformity; Idiopathic Scoliosis; Adolescent Idiopathic Scoliosis; Spondylolisthesis; Congenital Scoliosis; Neuromuscular Scoliosis

Summary: creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. eventually, an educational and informative framework for this technology will be established.


Eligibility criteria:
inclusion criteria: * diagnosis of a spine deformity * scheduled for surgery using robotics and navigation and/or patient-specific rods * up to and including 21 years of age * speak and read english or spanish exclusion criteria: • none

Keywords: pediatric spine surgery registry robotic navigation
the effect of calcium dobesilate on non dialysis patients with ckd

Conditions: Chronic Renal Failure

Summary: to investigate the feasibility of calcium dobesilate in the treatment of microvascular injury provides new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

the deterioration of renal function is closely related to microvascular damage, calcium dobesilate is known as microcirculation protective agent, the investigators will further study its effect of non dialysis patients with chronic renal failure and explore the feasibility of calcium dobesilate in treatment of renal microvascular injury, the investigators will provide new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Eligibility criteria:
inclusion criteria: * enroll the non dialysis patients with chronic renal failure hospitalized in the department of nephrology of the affiliated hospital of xuzhou medical university. * according to the glomerular filtration rate, the patients who were not required to be dialysate were at ckd3-5 (gfr between 10 and 59ml/min). exclusion criteria: * exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis. * eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).

Keywords: calcium dobesilate non dialysis patients with ckd(3-5) glomerular filtration rate serum creatinine
protective factors against elderly suicide

Conditions: Suicide, Attempted; Suicide Gesture

Summary: suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. the suicide of an older adult is a situation that often leads to helplessness feelings. analysis of the literature reveals two types of major interventions in order to reduce suicide rate: reducing risk factors and increasing protective factors. risk factors are well documented, particularly from studies using psychological autopsies. however, protective factors are much less studied for the elderly. yet the identification of relevant and available protective mechanisms in a suicidal crisis is essential to effectively guide nurses and health professionals in therapeutic commitment and intervention.

france has a suicide rate (16.2 per 100 000 inhabitants) well above the european average rate (10.2 per 100 000 inhabitants). the poitou-charentes region is in a situation of excess mortality by suicide compared to france (+ 25%). while the ratio of suicide attempts per suicide is about 200/1 before 25 years, it is estimated to be 4/1 after 65 years, or even 1/1 in elderly men. in france, suicide attempts are not systematically recorded and the frequency of suicidal ideation is poorly understood. the consensus conference on suicidal crisis highlights a number of clinical points specific to the elderly population (suicidal ideas are not always clearly expressed or unidentified, there are various manifestations of the psychic crisis, greater vulnerability of this population), but the complexity of interactions between suicidal risk factors limits our predictive capabilities of suicidal intention in an elderly person. analysis of the literature reveals two types of major interventions in order to reduce the suicide rate: those aimed at reducing risk factors and those aimed at increasing protective factors. the objective of our research is to determine the effect of protective factor methodical search on post-crisis patient care.

Eligibility criteria:
inclusion criteria: * attempted suicide and / or suicidal ideas * informed and agreed to participate exclusion criteria: * cognitive disorders * refusal to participate
acceptance and commitment therapy with and without enhanced mindfulness training for chronic pain

Conditions: Chronic Pain

Summary: as non-pharmacological alternatives, psychosocial treatments have been recommended for chronic pain management. one such treatment is acceptance and commitment therapy (act). act is a cognitive behavior therapy based on relational frame theory, a comprehensive theory about language and cognition. this treatment intends to help patients identify values ("what is truly meaningful to them") and to set goals and take action according to their values. act has research support in the treatment of several mental health problems. moreover patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so that these will have less impact on functioning and action. among patients with chronic pain, several small clinical trials have shown that act is more effective than other treatments in terms of increasing function and improving mental health. act in combination with mindfulness training has not been tested so far. further methodologically robust trials are required. this study will therefore examine whether act is more effective for chronic pain than an education program, and whether adding daily mindfulness training will improve the outcome, in a large sample of patients from four multidisciplinary pain centers.


Eligibility criteria:
inclusion criteria: * referred to one of the pain clinics in oslo (200), trondheim (200), bergen (100) or tromsø (100) * primary diagnosis of chronic pain lasting for at least 6 months exclusion criteria: * severe somatic disease * severe mental disorder (ongoing mania, psychosis, suicidal ideation, substance abuse/addiction * not able to communicate in norwegian * needing 24-hour personal assistance

Keywords: mindfulness psychotherapy, group behavior therapy
impact of repeatedly-administered thc-cannabis on experimental pain and abuse liability in humans

Conditions: Cannabis; Pain; Tolerance; Hyperalgesia

Summary: chronic pain is a significant public health concern in the u.s., for which prescription opioids have historically been the standard treatment. this has resulted in striking rates of opioid use disorders and fatal overdoses. identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. more than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. however, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. carefully controlled research is needed. the proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (n = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) if so, is tolerance reversed during the 7 days of abstinence from active-thc cannabis; 3) does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep? two distinct modalities of experimental pain will be assessed: the cold pressor test (cpt) and quantitative sensory testing thermal temporal summation (qst-tts). throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.


Eligibility criteria:
inclusion criteria: * males/non-pregnant females, 21-60 years old * current cannabis user * able to perform all study procedures exclusion criteria: * use of other illicit drugs * if medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation * insensitivity to the cold-water stimulus of the cold pressor test or the heat stimulus of quantitative sensory testing
evaluation of vidiac scores of obese and morbid obese patients intubated by videolaryngoscopy

Conditions: Vidiac Score; Videolaryngoscopy; Obesity, Morbid

Summary: the aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between obese and morbid obese patients and to reveal the differences, if any.


Eligibility criteria:
inclusion criteria: * all obese and morbidly obese patients to be operated under general anesthesia and endotracheal intubation exclusion criteria: 1. under 18 years old 2. the patient's refusal 3. difficult airway story before 4. congenital or previous airway anatomical disorder 5. patients who have undergone airway surgery 6. patients with a mass in the head and neck region 7. body mass ındex \< 30 kg/m2
implant placement with simultaneous gum grafting

Conditions: Edentulous

Summary: this study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. the objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. the hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.


Eligibility criteria:
inclusion criteria: * one edentulous site bordered by 2 teeth needing a dental implant exclusion criteria: * systemic diseases that affect the periodontium * previous head and neck radiation * smoking more that 1/2 pack per day * requires prophylactic antibiotics * allergy to meds used in study * previous chemotherapy * pregnancy

Keywords: soft tissue thickness dental implant soft tissue recession implant exposure
pacap38 induced headache, migraine and flushing in patients with migraine

Conditions: Migraine Without Aura

Summary: the aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (pacap38) with and without treatment with sumatriptan in patients with migraine

pituitary adenylate cyclase-activating peptide-38 (pacap38) plays a role in migraine pathophysiology. infusions of pacap38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. we are investigating whether treatment with sumatriptan has an effect on the pacap38-induced flushing and on whether headache and migraine is induced. the purpose of this study is to investigate pacap38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. the study will be conducted with a double-blind, placebo-controlled crossover study design.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine, according to ihs criteria * weight between 50 - 100 kilograms * women in fertile age must not be pregnant and must use adequate contraception exclusion criteria: * migraine more than 5 days per month in average over the past year * any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month * headache \< 48 hours before experimental day * migraine \< 72 hours before each experimental day * daily / frequent use of any medication apart from contraceptive medication * use of any drug less than 5 times the half-life of the drug at the time of the experiment * women who are pregnant or breast-feeding at the time of the experiment * anamnestic or clinical signs of hypertension (systolic blood pressure \> 150 mmhg and/or * diastolic blood pressure \> 100 mmhg) or hypotension (systolic blood pressure \< 90 mmhg and/or diastolic blood pressure \< 50 mmhg) * anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs * patients with glaucoma or prostate hyperplasia * anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
hypofractionated radiosurgery for localised prostate cancer (hypostat-iii)

Conditions: Prostate Cancer

Summary: hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. the investigators initiated this multicenter phase ii prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late gu and gi toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.

experimental radiosurgery of the prostate with 3 fractions each with 9.5 -10.5 gy (total application rate of 28.5-31.5 gy) based on risk grading. planned visits are: baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Eligibility criteria:
inclusion criteria: * localised, histopathologically confirmed prostate cancer (ct1-t2c n0 m0) * gleason-grade ≤7, isup grade group 1-3 * guideline-based staging * age ≥ 18 years * psa \< 20 ng/ml * volume of the prostate \< 80 cm³ * ipss-score ≤ 12 * written informed consent exclusion criteria: * history of prior pelvic radiotherapy * previous transurethral resection, laser enucleation or prostate ablation * contraindication to mri or fiducial marker implantation (e.g. gold allergy) * relevant comorbidity thought to adversely affect treatment compliance * legal incapacity or lack of informed consent

Keywords: prostate cancer sbrt cyberknife radiosurgery hypostat
open trial to improve retention in care for persons with hiv who use substances

Conditions: Substance Use Disorders; Hiv

Summary: the open trial will examine the feasibility and acceptability of a brief, empirically-supported acceptance-based behavioral therapy intervention to promote retention in care for out-of-care people with hiv who use substances.

the proposed study will adapt a brief, 2-session acceptance-based behavioral therapy (abbt) intervention to help people with hiv (pwh) who use substances tolerate fears of stigmatization, increase acceptance of hiv status and substance use problems, and increase engagement in care. by conducting an open trial with 15 adults recruited from an hiv primary medical care clinic, the study will focus on the feasibility of recruiting out-of-care pwh and determine the acceptability of the refined abbt protocol.

Eligibility criteria:
inclusion criteria: 1. hiv+ 2. meet dsm-5 criteria for one or more of the following substance use disorders, at any severity level: cocaine, methamphetamine, and/or opioid 3. ≥18 years old 4. poorly retained in care, defined as no attended medical appointment in the past 9 months 5. able to speak and read english at a level sufficient to complete the study procedures 6. have telephone access exclusion criteria: (a) patients who are cognitively impaired, which will be determined by chart review during screening

Keywords: acceptance and commitment therapy acceptance-based behavioral therapy behavioral intervention acceptability and feasibility stigma
hiv engagement and adolescent depression support (heads-up)

Conditions: Depression; Anxiety; Adolescent Behavior; HIV Infections; Immune System Diseases

Summary: this pilot study will individually randomize 105 adolescents living with hiv 1:1:1 to standard of care, adapted intervention, or enhanced intervention. the intervention is called the friendship bench intervention is a counseling intervention for depression and engagement in hiv care.

sub-saharan africa is home to the largest population of adolescents living with hiv (alwh). engaging alwh in hiv care is challenging and reflected in lower rates of viral suppression and higher rates of loss to follow-up as compared to adults in the region. depression has been identified as a significant barrier to initiating and remaining in hiv care. indeed, this is the case for alwh in malawi where estimates of viral suppression range from 40%-78% and estimates of depression range from 18-26%. resource-appropriate interventions that improve depression and address engagement in hiv care for alwh are urgently needed. the friendship bench (fb) is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. it is proven to reduce depression in the general population in low-resource settings but has not been adapted to be youth-friendly or enhanced with peer support to facilitate engagement in hiv care among alwh. fb is based on problem-solving therapy, which offers an ideal framework for youth-friendly adaption and integration of retention peer support into a proven depression treatment model. the long-term goal of the study team is to adapt, test, and scale up resource-appropriate interventions to reduce depression and improve engagement in hiv care amongst alwh. the specific aims are: 1) to conduct formative research for youth-friendly adaptation and peer support enhancement of fb; 2) to adapt the evidence-based fb protocol to meet the developmental and contextual needs of alwh and enhance this adapted fb protocol with peer support to facilitate hiv care engagement among alwh; and 3) to determine the feasibility, fidelity, and acceptability of the adapted and enhanced fb protocols to improve depression and engagement in hiv care among alwh. for the latter, a 3-arm individually randomized pilot study will be conducted to compare the adapted fb and the enhanced fb to standard care. the proposed aims pave the way for a r01 application to test the adapted and enhanced friendship bench interventions in a cluster randomized controlled trial and represent an important step forward towards improving depression among alwh.

Eligibility criteria:
inclusion criteria: * age 13-18 * diagnosed with hiv (vertically or horizontally) * scored ≥ 13 on the self-reported and previously used bdi-ii * living in the clinic's catchment area with intention to remain for \> 1 year * willing to provide consent (age 18 or 16-17 years old and married (emancipated minors per malawi law) or assent with parental consent (age 13-17) exclusion criteria: * less than 13 or greater than 18 years of age
semi-quantification of her2/neu protein expression in formalin fixed, paraffin-embedded normal and neoplastic tissue

Conditions: Breast Cancer

Summary: the purpose of the study is the identification and quantification of protein expression level in breast cancer tissues. the imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (ihc) stained samples.

the anti her2/neu kit is a semi-quantitative immunohistochemical (ihc) assay to identify the human epithelial growth factor receptor (her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. results from the her-2 test is indicated as an aid in the assessment of patients for whom herceptin® (trastuzumab) treatment is being considered. while the her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the her2 protein expression through a brightfield microscope, the genasis gopath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility criteria:
inclusion criteria: * women having breast cancer aged 21 and up * borders of tumor nuclei are distinguishable * nuclei should have good integrity * background should not contain particles that interfere with the analysis exclusion criteria: * slides that cannot be analyzed manually by pathologist

Keywords: immunohistochemical (ihc) her2/neu breast cancer