Kornimate/medical-research-clean huggingface dataset:
daily, long-term intermittent fasting for the prevention of psa-recurrence in patients with localized prostate cancer after radical prostatectomy

Conditions: Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Summary: this early phase i trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (psa) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. psa is a protein produced by both normal and cancer cells. following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' psa level rising above 0.4 ng/ml, which is also called psa-recurrence. a psa-recurrence can sometimes mean that the disease has returned and/or progressed.

primary objectives: i. to determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen. ii. to measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer. outline: beginning when patients' psa is detectable up to 24 months after surgery, patients follow a daily intermittent fasting routine consisting of restricting the daily eating period to 8 hours (e.g. between 1pm-9pm) followed by 16 hours of prolonged nightly fasting for up to 1 year or until secondary therapy commences.

Eligibility criteria:
inclusion criteria: * biopsy-proven histological diagnosis of localized prostate cancer (pt2 or specimen confined pt3) * having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection * negative surgical margins on final specimen * men that decline adjuvant therapy * detectable serum psa of 0.1 ng/ml or \> * 24 months or less since radical prostatectomy at time of study screening exclusion criteria: * unable or unwilling to provide informed consent * treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy * treated prior to surgery with any form of chemotherapy or radiotherapy * medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to: * diabetes mellitus * on hormone therapy (casodex, gonadotrophin releasing hormone \[gnrh\] agonist/antagonist)
early digi-physical support during breastfeeding initiation

Conditions: Breastfeeding; Self Efficacy; Breastfeeding Duration; Depression

Summary: the purpose of this randomized controlled trial is to develop and evaluate a digi-physical intervention within primary health care lactation counselling and breastfeeding support to promote exclusive breastfeeding rates during the first 6 months after birth and to prevent depressive symptoms. the project addresses parents during pregnancy week 20 and 32 and will continue during the infant's first year of life. all participants will get access to an evidence-based information package (theory and practical advises) during pregnancy. study aim is to develop and evaluate digital evidence-based information materials and continuous support for both parents in order to increase prevalence of exclusive breastfeeding and duration as well as decreasing the risks of symptoms of post-partum depression.

the project design is a single-blind randomized controlled trial. the intervention group will receive: * digital support by chat with a lactation consultant for immediate breastfeeding support two-three weeks after delivery * extended home visits by pediatric nurses providing extra knowledge and support about lactation * extra support by health care providers educated in lactation counseling when needed. more specific purposes are: * compare the prevalence of exclusive breastfeeding until 6 months and duration of breastfeeding up to one year between the intervention and the control group. (primary outcome) * compare prevalence of depression symptoms between the intervention and control group. (secondary outcome) * strengthening parents' self-efficacy in breastfeeding their child.

Eligibility criteria:
inclusion criteria: * being pregnant or partner of a person who is pregnant in pregnancy week 20-32 * all parents with language skills enabling them to fill out questionnaires, participate in interviews and read information. * being resident in stockholm region exclusion criteria: * parents without adequate swedish language skills * parents resident outside the stockholm region

Keywords: breastfeeding depression primary healthcare digi-physical self-efficacy
the effect of exercise intervention on the community's older adults

Conditions: Metabolic Disease

Summary: osteoporosis is a serious global health problem, second only to cardiovascular disease. osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (bmd) and continuous destruction of bone microstructure, especially in postmenopausal women. it gives rise to bone fragility and fracture risk. moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year. osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life. here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and tai chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.


Eligibility criteria:
inclusion criteria: * being \>45 years-of-age, * healthy and physically independent. exclusion criteria: * the exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.
acute effects of cryotherapy on muscle properties

Conditions: Cryotherapy Effect

Summary: the main aim of this study is to investigate the acute effects of cryotherapy on muscle mechanical properties, muscle strength, and activation changes in healthy subjects.

what changes occur in muscle stiffness following cryotherapy application? how does cryotherapy affect muscle strength? how does cryotherapy impact muscle activation? are there differences in muscle mechanical properties, muscle strength, and muscle activation between different cryotherapy methods (ice massage and cold spray)? how do the effects of cryotherapy on muscle mechanical properties, muscle strength, and muscle activation change over time?

Eligibility criteria:
inclusion criteria: * being willing to participate in the study * being between the ages of 18 and 35 exclusion criteria: * having undergone orthopedic surgery involving the lower extremity

Keywords: cryotherapy muscles acute effect muscle strength electromyography
charm: chronic hepatitis b antihepadnaviral resistance mutation study

Conditions: Chronic Hepatitis B

Summary: this study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis b receiving antihepadnaviral therapy.

this is a naturalistic cross-sectional study of chronic hepatitis b subjects receiving nucleoside or nucleotide antihepadnaviral therapy. it is anticipated approximately 800 subjects will be recruited at 20 australian sites. data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in australian patients with chronic hepatitis b.

Eligibility criteria:
inclusion criteria: * aged 18 years and over * provided informed consent * diagnosis of chronic hepatitis b (hbsag documented for at least 6 months) * currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis b management * been taking current antihepadnaviral therapy for at least 6 months prior to recruitment * negative tests for hiv ab, hepatitis c ab and hepatitis d ab within the previous 2 years exclusion criteria: * known or suspected co-infection with hiv, hepatitis c or hepatitis d * concomitant immunosuppression / immunomodulatory therapies * diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months * current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial * current child pugh class c classification (current child pugh score \> 9) * other known or suspected cause of chronic liver disease * any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.

Keywords: chronic hepatitis b
functional outcome of urethral reconstructive surgery

Conditions: Urethral Stricture

Summary: the analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.

urethroplasty is the surgical repair of a urethral stricture. depending on the location, severity and length of the stricture, various techniques can be performed. the first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. the results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery. the purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.

Eligibility criteria:
inclusion criteria: * male * urethral stricture surgery * informed consent exclusion criteria: * loss of follow-up * not willing to participate
bioequivalence study of sertraline 100 mg tablet and zoloft following a 100 mg dose in healthy subjects under fed conditions

Conditions: Healthy

Summary: * objective: * to compare the rate and extent of absorption of torrent pharmaceuticals limited, india, sertraline and pfizer, inc., usa (zoloft) sertaline, administered as a 1x100 mg tablet, under fasted conditions. * study design: * single-dose, open-label, randomized two-way crossover.


Eligibility criteria:
inclusion criteria: * male or female, smoker or non smoker, 18 years of age and older. * capable of consent. * bmi\>= 19.0 and \<30.0 kg/m2 exclusion criteria: * clinically significant illness or surgery within 4 weeks prior to the administration of the study medication. * positive testing for hepatitis b, hepatitis c, or hiv at screening. * ecg abnormalities or vital sign abnormalities(blood pressure). * history of significant alcohol or drug abuse within one year prior to the screening visit. * history or allergic reactions to heparin, sertraline or other related drugs. * use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication. * clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease. * history of seizures, suicide attempt, bipolar disorder or manic episodes. * depot injection or an implant of any drugs with in 6 months prior to administration of study medication. * breastfeeding subject. * positive urine pregnancy test at screening. * female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. acceptable methods of contraception: 1. intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration) 2. condom or diaphragm + spermicide.
a system and process to improve the satisfaction with hearing health products

Conditions: Hearing Loss

Summary: innovative design labs inc. (idl) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from health and wellness coaching (hwc) into the hearing aid (ha) fitting and trial process.

as of 2015, 28.8 million u.s. adults could benefit from using hearing aids and the prevalence of hearing loss in the united states is predicted to rise significantly due to an aging population and the growing use of personal listening devices. however, only 28.5% of individuals who could benefit from a ha actually wears one. the non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. as the market moves towards a, direct-to-consumer distribution model following the 2017 fda directive, more patients will be receiving therapy for hearing loss. while in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. hypothesis: the investigators hypothesize that the integration of health and wellness coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. specific aims: 1) create patient/coach interaction protocol and training; 2) develop a cloud-based health coaching interface; 3) evaluate system effectiveness through a clinical trial.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * significantly reduced cognitive ability (assessed using the montreal cognitive assessment moca) * lack of proficiency communicating in english
genetics of middle ear disease

Conditions: Otitis Media

Summary: the goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. a blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.

using the twin study approach, the investigators demonstrated that time with middle ear effusion (mee), number of episodes of mee and numbers of episodes of acute otitis media (aom) have a strong genetic component. the point estimate of heritability of time with mee was 0.73. while there is significant evidence that susceptibility to recurrent/persistent om is largely genetically determined, the specific genes which confer susceptibility are unknown. the overall research strategy to identify genes underlying om is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power. five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. a blood sample will be obtained from each subject for genotyping.

Eligibility criteria:
inclusion criteria: * families: 2 or more full sibs who had tympanostomy tubes inserted exclusion criteria: * major congenital malformations * medical conditions with a predisposition for om (e.g. cleft palate, down syndrome, or other craniofacial malformations * cared for in the intensive care unit as neonate * been on assisted ventilation * known sensorineural hearing loss

Keywords: middle ear otitis genetics
perioperative temperature management

Conditions: Hypothermia

Summary: the investigators aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

hypothermia, defined as a core temperature below 36 degrees celsius, is commonly seen in patients undergoing surgery. intraoperative hypothermia is related to postoperative patient discomfort, impaired wound healing, increased blood loss, anxiety and disturbances in glucose and insulin levels. prewarming of patients prior to surgery may result in maintenance of intraoperative temperature and reduce postoperative complications. we therefore aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels. objective of the study: does preoperative heating of patients undergoing elective orthopedic surgery reduce the incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative glucose and insulin blood levels? study design: multi-center, prospective, randomized clinical trial. study population: patients undergoing an elective orthopedic hip- or knee replacement

Eligibility criteria:
inclusion criteria: * patients undergoing an elective orthopedic knee- or hip replacement * participation based on informed consent * \> 18 years old and \< 85 years old exclusion criteria: * bmi 18.5 \> x \< 40 * pregnancy * non elective trauma patients * infectious or febrile patients (\> 37.5oc) * diabetes mellitus * combined surgery * anemia (hb \< 4.0 mmol/l)

Keywords: surgery anesthesia hypothermia temperature perioperative temperature management
a research study investigating safety and concentration in the blood after one dose tablet of the new medicine monlunabant in healthy weight japanese and caucasian men

Conditions: Obesity

Summary: the study is testing a new study drug in healthy normal weight japanese and caucasian participants after a single dose. the aim of this study is to see if the new medicine is safe and how it works in the participants body. oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. the participant will either get monlunabant or placebo or a combination of both. which treatment the participant get is decided by chance. the study will last for about 49 days in total.


Eligibility criteria:
inclusion criteria: * male. * age 18-55 years (both inclusive) at the time of signing the informed consent. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * for japanese participants, both parents of japanese descent and both paternal and maternal grandparents of japanese descent. * for caucasian participants, self-reported european descent or white latin-american descent. * bmi 18.5-24.9 kg/m\^2 (both inclusive) at screening. exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products. * previous randomisation in this study. * previous rescreening for this study. * history of major depressive disorder within the last 2 years from screening. * presence or history of any psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression, and anxiety) as judged by the investigator. * suicidal ideation corresponding to type 4 or 5 or suicidal behaviour on the columbia-suicide severity rating scale (c-ssrs) as assessed at screening or any history of suicidal attempts. * a patient health questionnaire 9 (phq-9) score greater than 9 as assessed at screening.
pain and anxiety reducing during dental treatment in children using video game on tablet device with joystick.

Conditions: Pulpotomy; Dental Caries; Primary Teeth

Summary: the aim of this study is to evaluate the effectiveness of two different distraction techniques (audio video distraction /video game distraction) in the management of anxious pediatric patients during dental treatment. group a: pulpotomy in temporary inferior molar will be treated with using video game on tablet device with wireless joystick and wireless headphone group b: pulpotomy in temporary inferior molar will be treated with using av tablet and wireless headphone. group c (control group): pulpotomy in temporary inferior molar will be treated with basic behavior guidance techniques and without using any type of distraction aids. all of the children who experienced a pulpotomy in temporary inferior molar with/without distraction will be assessed by using a combination of measures: simplified wong-baker faces(self-report), and "houpt" behavior rating scale for movement - crying - overall behavior (nonself-report).

this study will evaluate the effectiveness of two types of distraction aids that contain video game on tablet device with wireless (joystick and headphone) along with audio video distraction using tablet device and wireless headphone. pain and anxiety will be evaluated during pulpotomy in temporary inferior molar using two behavioral scales, simplified wong-baker faces (self-report), and "houpt" behavior rating scale for movement - crying - overall behavior (nonself-report). the behavior rating scale "houpt" will be measured four times: directly when the patient seated comfortably on the dental chair, after anesthesia, after pulpotomy, and when the treatment completed. all child patients will ask to choose a face that describe their status from one of the simplified wong baker faces scale in the same four times.

Eligibility criteria:
inclusion criteria: 1. age between 6 and 10 years. 2. no previous dental experience. 3. definitely positive or positive ratings of frank scale. 4. need of pulpotomy in temporary inferior molar. exclusion criteria: 1. previous dental experience 2. systematic or mental disorders. 3. definitely negative or negative ratings of frankel scale 4. don't need of pulpotomy in temporary inferior molar

Keywords: children's dental anxiety video game