Kornimate/medical-research-clean huggingface dataset:
naturalistic monitoring and treatment of chronic insomnia

Conditions: Chronic Insomnia

Summary: 90 individuals with chronic insomniacs and 30 healthy normal sleepers will have their sleep monitored by the sleepscore max for 10 weeks. individuals with chronic insomnia will be randomized into one of three groups (30 subjects in each): a test intervention group, a passive control group, and an active control group. the purpose of the study is to examine if the sleepscore max provides a accurate measurement of sleep relative to a validated, wrist-worn sleep monitor and if a integrated coaching feature within the sleepscore max facilitates improvement in sleep relative to other gold standard treatment methods.

90 chronic insomniacs, carefully screened using the criteria of chronic insomnia disorder according to the international classification of sleep disorders 3 (icsd-3), will be studied. additionally, 30 healthy normal sleepers will be included as controls. the duration of study participation will be 10 weeks. all subjects will wear an actigraph during week 1 to record baseline sleep patterns, followed by 8 weeks of recording with the sleepscore max. during week 10, the subjects will wear the actigraph again to measure post intervention sleep. the healthy subjects will be used as a control to test if the sleepscore max can track sleep well as compared to actigraphy. the subjects with chronic insomnia will be randomized into one of three groups (30 subjects in each). one of these groups is the test intervention group, in which subjects will track their sleep with the sleepscore max device and will receive feedback and coaching from the smartphone app associated with the device. the other two groups will serve as passive and active controls. the passive control group will track their sleep using the sleepscore max device, but without any feedback or coaching. the active control group will also be tracking their sleep with the device, without feedback or coaching, but they will also undergo online cbti which is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.

Eligibility criteria:
inclusion criteria: * age 18-65 * physically and psychologically healthy (except for chronic insomnia for the insomnia participants) as assessed by questionnaires and history * no sleep disorders other than chronic insomnia (for insomnia participants only) as assessed by questionnaires and history * has daily access to an iphone exclusion criteria: * non-english speaking
validation of acs nsqip risk calculator for predicting complications after thoracic surgery at university hospital basel

Conditions: Thoracic

Summary: this single-center retrospective research project aims to evaluate whether and what is the significance of the national surgical quality improvement program of the american college of surgeons (acs nsqip) risk score in thoracic surgery at the university hospital basel.

advances in medical and surgical therapies have enabled treatment for polymorbid patients, who often have multiple chronic conditions. this has increased the need to accurately assess the risks of postoperative complications and mortality. due to their complex health status, these patients are more susceptible to adverse outcomes following surgery, necessitating precise risk prediction to guide clinical decision-making and optimize outcomes. this single-center retrospective research project compares the preoperative risk assessments by the national surgical quality improvement program of the american college of surgeons (acs nsqip) risk calculator with actual complications (graded according to the clavien-dindo classification) observed in patients who underwent thoracic surgery at the university hospital basel between may 1, 2021, and march 1, 2022. the acs nsqip risk calculator, a web-based tool, uses 21 preoperative risk factors to predict 13 perioperative outcomes, including serious complications, infections, and mortality. by evaluating these predictions against real patient outcomes, this research project aims to validate the calculator's accuracy specifically in the context of thoracic surgery. the results of this research project could optimize patient care by better identifying high-risk patients and improving preoperative preparation.

Eligibility criteria:
inclusion criteria: * patients with signed general research consent * patients who underwent surgery in our department for the period from 01.05.2021 to 01.03.2022 * patients with preoperative acs nsqip risk score exclusion criteria: * patients who have clearly stated that they would not agree in providing their clinical data for scientific purposes

Keywords: thoracic surgery predicting complications national surgical quality improvement program of the american college of surgeons (acs nsqip)
family telemental health intervention for veterans with dementia

Conditions: Dementia Family Caregiver Burden and Conflict

Summary: dementia impacts veterans, their families, and other veterans who serve as caregivers. one of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (pwd). existing va caregiver treatments for caregiver stress and behavioral problems are often ineffective. many caregivers do not realize their interactions with pwd contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. the aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of pwd who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. this project, will develop and test (1) a video assessment of caregiver/pwd interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.

study temporarily suspended due to covid risk associated with at risk population of veterans with dementia and often older caregivers.

Eligibility criteria:
inclusion criteria: either the caregiver or the care-recipient must be a veteran. the caregiver must: * be the primary unpaid family or friend who helps or supports an individual with dementia * be involved in the care of the person with dementia (at least 4 hours of care per day) * report that the care-recipient exhibits behavioral problems that are distressing * not be currently receiving the reach va protocol additionally, the care-recipient must: * must have a documented diagnosis of dementia * have cognitive impairment (mmse\<23 or slums\<20 or diagnosis of dementia based on chart review) * be out of bed and able to respond to a caregiver's instructions or interventions exclusion criteria: * caregiver severe cognitive impairment * caregiver inability to meet study demands * caregiver psychosis
opioid use and criminal justice: intervening to improve the outcomes of women

Conditions: Opioid Use Disorder

Summary: opioid-related overdose deaths and incarceration rates have skyrocketed and have disproportionately affected women. despite having a higher burden of substance use disorders and hiv/aids than criminal justice-involved (cji) men, cji women are less likely to have access to substance use and hiv treatment. the planned research aims to improve how women in the criminal justice system connect to and stay in drug treatment. this will be done by creating and putting into practice a well-researched program specifically designed for women, considering their experiences with trauma. the program incorporates several best practices in substance use treatment such as the use of certified peer recovery specialists (crs) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare. in addition, half of the women will be randomly selected to participate in a 12-session trauma support group led by crs which uses the evidence-based curriculum, beyond trauma, which was specifically designed for women who use drugs. the aforementioned components are rarely offered in tandem with substance use treatment, and as such, this research is assessing if having this comprehensive program is linked with better substance use and social outcomes. the overall goal is to reduce the problem of opioid addiction and overdoses among women who have recently been involved in the criminal justice system and to reduce the barriers to opioid addiction treatment.


Eligibility criteria:
inclusion criteria: 1. female 2. 18+ years of age 3. pennsylvania resident and intends to remain in or near harrisburg, carlisle, york or lancaster areas for the duration of the study 4. use opioids illicitly 5. interested in starting drug treatment that uses medication to stop opioid use or are currently in a drug treatment program for opioid use that uses medication but feel that without additional support they won't be able to continue with the program 6. not currently pregnant, planning to become pregnant, or breastfeeding during the study period 7. released from a jail or prison within the past 12 months or have other criminal justice involvement (arrests, probation, or parole) within the past 12 months. exclusion criteria: 1. not female 2. under 18 years of age 3. not a pennsylvania resident or no intention to remain in or near harrisburg/carlisle/york or lancaster areas for the duration of the study 4. do not use opioids illicitly 5. not interested in moud to stop opioid use 6. no arrests, probation or parole, nor released from a jail or prison within the past 12 months 7. pregnant, planning to become pregnant, or breastfeeding during the study period

Keywords: women criminal justice substance use opioid use disorder
awareness based stress reduction program applied to breast cancer patients receiving chemotherapy

Conditions: Breast Cancer Patients Receiving Chemotherapy

Summary: implementation of awareness-based stress reduction program in breast cancer patients receiving chemotherapy and examining its effects on psychological resilience, symptom management and quality of life.

the conscious awareness-based stress reduction program is a program that lasts eight weeks, each session lasting 2-2.5 hours and including a 6-hour silence day. in order to apply the mindfulness stress reduction program to the experimental group, the 'conscious awareness stress reduction program day and time were determined for 30 breast cancer patients receiving chemotherapy who met the inclusion criteria and were sampled. it was applied to the patients in the experimental group, once a week for 150 minutes, lasting 8 weeks, and consisting of 8 times in total. then, an intermediate test was applied to the patients. after the interim test, patients were asked to repeat the it applications individually for 8 weeks (between weeks 8-16). in addition, after it was applied to the patients in the experimental group by the researcher, the 'conscious awareness stress reduction program booklet prepared by the researcher was given to the patients in order to provide a guide for the patients in the experimental group. during the implementation of the research, no intervention was applied to the control group.

Eligibility criteria:
inclusion criteria: * being over 18 years of age * ability to communicate adequately * no psychiatric problems * implementation of the awareness-based stress reduction program is an obstacle * volunteering to participate in the research exclusion criteria: * those who have communication problems * those with psychiatric problems * not agreeing to participate in the study.

Keywords: life quality mindfulness psychological resilience symptom management
cosmetic fat transplantation using expanded asc enriched fat grafts

Conditions: Breast Hypoplasia and Facial Ageing

Summary: the purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded asc injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.

the cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects. the cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.

Eligibility criteria:
criteria breast augmentation: inclusion criteria 1. age 18 - 50 years 2. healthy females 3. bmi 18 - 30 kg/m2 4. 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs 5. desire for breast augmentation 6. speaks and reads danish or english 7. signed informed consent exclusion criteria 1. smoking 2. previous breast surgery 3. previous cancer or predisposition to breast cancer 4. pregnancy or planned pregnancy within one year after the procedure 5. breastfeeding less than 6 months prior to inclusion 6. weight gain or loss above 2 bmi point 7. known chronic disease associated with metabolism malfunction or pour healing 8. pacemaker or other implanted foreign objects 9. allergy towards necessary anaesthesia 10. intention of weight loss or weight gain within the trial period criteria fascial filling inclusion criteria 1. age 25 - 65 years 2. healthy females 3. bmi 18 - 30 kg/m2 4. 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs 5. desire for facial wrinkle treatment and facial augmentation (rejuvenation) 6. speaks and reads danish or english 7. signed informed consent exclusion criteria 1. smoking 2. previous facial surgery 3. previous cancer 4. pregnancy or planned pregnancy within one year after the procedure 5. known chronic disease associated with metabolism malfunction or poor healing 6. allergy towards necessary anaesthesia 7. intention of weight loss or weight gain within the trial period
valproic acid in treating cyanotic breath holding spells

Conditions: Breathhold

Summary: breath holding spells (bhs) are common non-epileptic paroxysmal behavioral involuntary episodes occurring in up to 5.9% of healthy children. the attacks occur in early childhood (0.5-3 years) but are self-limited by school age (4-5 years old) (90%). classically, bhs were classified as cyanotic (blue), pallid (pale) and mixed based on the color change of the child during the spell. in general, cyanotic spells have been classically described in a toddler with excessive temper tantrums \[stubborn, easily frustration or annoyed. the mechanisms of bhs are controversial. the most suggested cause of bhs is instability of the autonomic nervous system, inhibition of respiratory effort and cyanosis in cyanotic bhs and bradycardia or a brief asystole and cerebral hypoperfusion in pallid bhs. iron deficiency anemia (ida) has been widely regarded as a risk factor for bhs in nearly 50% of children due to reduced brain oxygenation \[4\]. it is generally agreed that the long-term prognosis is considered good \[1\]. there is no definite therapy for bhs. in children with low frequency spells, parental reassurance are just enough; however, high frequency spells may result in anxiety to the parents or fear from sudden death of the child or development of mental subnormality. treatment of iron has been reported to result in reduction of the frequency of spells or its stoppage. some reported improvement of bhs with piracetam \[a nootropic drug known to increase brain oxygenation\]. we did not find systematized published reports evaluating the effectiveness of antiepileptic drugs (aeds) in reduction of spells frequency of cyanotic bhs or their stoppage.


Eligibility criteria:
inclusion criteria : 1. children with high frequency spells (≥ 4/week) of cbhs. 2. children with parents who were wishing to provide treatment to their children. 3. failure of alternatives modalities of treatment (e.g. iron supplements, piracetam, non-specific vitamins, etc) (tried for ≥ 3 months) to reduce the frequency of spells or stop them. 4. follow-up for 6 months after starting treatment with valproic acid. exclusion criteria: 1. primary neurologic disease, history of epilepsy or febrile convulsions, abnormal neurological examination and abnormal eeg. 2. primary cardiac disease or presence of long qt syndrome in the ecg. 3. presence of a hematologic (other than ida) or other medical disease, electrolyte disturbance, hypoglycemia, hypocalcemia, impaired kidney or liver function tests. 4. those with a doubtful diagnosis.

Keywords: breath holding spells cyanosis valproic acid
quantified mobile sensing for improving diagnosis and measuring disease progression

Conditions: Depression; Bipolar Disorder

Summary: the purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.


Eligibility criteria:
inclusion criteria: * age 18 or older * have a smartphone and cell service plan, including voice and data, that meets the device requirements of the mobile sensing platform. * enrolled in the moodnetwork exclusion criteria: * report positively on the qids-sr suicide item during study intake * total score greater than 15 on the qids-sr during the screening process
a phase i/ii study of gx15-070ms in untreated cll

Conditions: Chronic Lymphocytic Leukemia

Summary: this protocol is being run to determine the best phase ii dose and schedule of obatoclax in patients with previously untreated cll.

both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed b-cll * previous standard systemic chemotherapy, including fludarabine. there are no limitations on additional, allowable type and amount of prior therapy. acute toxicities from prior therapy must have resolved to ≤grade 1 * age ≥18 years * ecog performance status ≤1 * life expectancy of \>8 weeks exclusion criteria: * patients receiving any other investigational agents (e.g., under another ind) or commercial agents or therapies administered with the intent to treat their malignancy * patients with history of seizure disorders * pregnant women and women who are breast feeding * hiv-positive patients receiving combination anti-retroviral therapy

Keywords: cll obatoclax
clinical study on the effect of a synbiotic on body fat mass

Conditions: Type 2 Diabetes; Metabolic Syndrome; Obesity, Abdominal; Obesity, Visceral

Summary: in this trial the effect of a synbiotic consisting of the three different strains of lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors for cvd and diabetes in overweight type 2 diabetics is investigated.

the effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. some probiotic species/strains, however, seem to be more efficacious. the lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity. the combination of these lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut and, hence, are supposed to promote their propagation and, hence their effects. the dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial.

Eligibility criteria:
inclusion criteria: 1. overweight or obese (bmi ≥ 25) 2. type 2 diabetes 3. age ≥ 18 4. written informed consent exclusion criteria: any of the following is regarded as a criterion for exclusion from enrollment into the study: 1. subjects currently enrolled in another clinical study 2. subjects having finished another clinical study within the last 4 weeks before inclusion 3. hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum) 4. condition after implantation of a cardiac pacemaker or other active implants 5. antidiabetic drugs except metformin 6. any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria 7. history of hepatitis b, c, hiv 8. history of or present liver deficiency as defined by quick \< 70% 9. regular medical treatment including otc, which may have impact on the study aims (e.g. probiotics containing supplements etc.) 10. major cognitive or psychiatric disorders 11. subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations 12. simultaneous study participation by members of the same household 13. pregnancy and lactation 14. any diet to lose body weight 15. eating disorders or vegan diet 16. anorexic drugs and laxatives 17. present drug abuse or alcoholism 18. legal incapacity

Keywords: synbiotic body fat mass metabolic syndrome diabetes
continuous glucose monitors to regulate glucose levels in type 2 diabetics

Conditions: Type2 Diabetes

Summary: this study allows type 2 diabetics to receive feedback from a continuous glucose monitor (cgm) as part of an educational program designed to help them better manage their glucose levels. subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. the educational program will involve calls from coaches to check subjects' progress and answer questions.


Eligibility criteria:
inclusion criteria: * be diagnosed with type 2 diabetes * currently take a dpp4 inhibitor, sglt2 inhibitor, glp-1 agonist, and/or basal insulin * be able to read and understand english * have access to a telephone * have a medicare health plan exclusion criteria: * pregnant * blind * deaf * currently receiving chemotherapy or radiation therapy to treat cancer * addicted to any drugs (including alcohol, painkillers, hallucinogens, or others) * critically ill * diagnosed with or experiencing: * kidney disease stages 4 and 5 * end stage renal disease * severe liver disease * dementia * schizophrenia * bipolar disorder * autism * an intellectual or learning disability * arrhythmias other than atrial fibrillation * congestive heart failure * has had a: * myocardial infarction within the last 6 months * stroke within the last 6 months * stroke that resulted in significant disability (e.g., unable to write clearly or walk)