Kornimate/medical-research-clean huggingface dataset:
breathing retraining for asthma trial of home exercises for teenagers

Conditions: Adolescent Behavior; Asthma

Summary: this trial will address the impaired quality of life of young people with asthma, despite appropriate medicines. research shows that young people report needing to calm themselves down during an asthma attack to control their breathing. although physiotherapist- delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. the investigators have redesigned an adult training package to make it appropriate for young people and will now assess how effective such an intervention would be in this population. this study will include young people (12-17 years) with physician diagnosed asthma. the repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in stages 1 and 2 of the breathe 4 teens (breathe4t) project. a self-guided, breathing retraining digital intervention has been developed, delivered via a mobile friendly, online platform. the current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. participants with access to the intervention will be compared to a usual care group. asthma and quality of life of both groups will also be assessed at baseline, 2-month and 6-month time points. at the end of the 6 months, the control group will also be given access to the website. the online nature of this study allows recruitment from across the united kingdom. recruitment methods would include primary care, hospital clinics, social media and posters. asthmauk will also provide publicity to assist recruitment.

the trial will aim to assess the acceptability, uptake and success in collecting follow up data and variance in asthma-related outcome measures. a parallel group design will be used with participants being randomised to intervention or normal management. the intervention will be a self-guided, breathing retraining digital intervention, delivered via a mobile-friendly, online platform. the intervention will continue to be used for 6 months after which both groups will be reassessed. the usual management control group will then have access to the intervention (delayed access).

Eligibility criteria:
inclusion criteria: * young people aged 12-17 years * physician diagnosed asthma * impaired quality of life (\<85) * under the care of a general practitioner, community or hospital practitioner for their asthma exclusion criteria: * co-existent respiratory conditions such as bronchiectasis * already using breathing techniques * already enrolled in another interventional study * lack of informed consent * learning difficulties * previously involved with stages 1 and 2 of the study
psilocybin-assisted psychotherapy in adults with alcohol use disorder (aud)

Conditions: Alcohol Use Disorder

Summary: the goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with alcohol use disorder (aud). the main question\[s\] it aims to answer are: * does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? * is treatment with psilocybin and therapy safe for participants? participants will * attend 13 study visits * take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo * record their daily alcohol consumption on study specific device researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.


Eligibility criteria:
inclusion criteria: * moderate to severe diagnosis of aud as measured by diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria using structured clinical interview for dsm-5 by the investigator. * expressed a wish to reduce or stop alcohol consumption. * generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology. exclusion criteria: * diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. recent (within last 12 months) diagnosis of a major depressive disorder (mdd) (ham-d score \>19), treatment resistant depression (trd), post-traumatic stress disorder (ptsd), panic disorder, or eating disorders. * subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session. * history of hallucinogen use disorder, or any use in the past 1 year, or \>25 lifetime uses.
ischia spinous fascia fixation surgery for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse is a common problem. the primary treatment is surgery. ischia spinous fascia fixation procedure is developed in china for vaginal apex fixation with native tissue. this study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage iii. patients enrolled into the study will be followed up for up to 3 years after surgery. evaluation will take place during surgery and postoperative visit. stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.

pelvic organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. an ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function. ischia spinous fascia fixation procedure is developed in china. it is a transvaginal procedure used for restoring the vaginal apex support with native tissue. clinical practice showed that it was safe, efficient and cost-effective. recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline. the purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.

Eligibility criteria:
inclusion criteria: * candidates with symptomatic pelvic organ prolapse of pop-q stage ii or more, suitable for surgical repair. * vaginal hysterectomy and anti-incontinence procedures could be performed concurrently. * agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires. exclusion criteria: * previous repair of pelvic organ prolapse involving insertion of mesh. * experimental drug or experimental medical device within 3 months prior to the planned procedure. * active genital, urinary or systemic infection at the time of the surgical procedure. surgery may be delayed in such subjects until the infection is cleared. * coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. * history of chemotherapy or pelvic radiation therapy. * systemic disease known to affect bladder or bowel function (e.g. parkinson's disease, multiple sclerosis, spinal cord injury or trauma). * current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia). * nursing or pregnant or intends future pregnancy. * chronic cough not well-controlled. * bmi \&#8805; 30. * in the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.

Keywords: pelvic organ prolapse
study of myfortic in combination with tacrolimus and thymoglobulin in early corticosteroid withdrawal

Conditions: End Stage Renal Disease (ESRD)

Summary: to determine the safety and efficacy of a new formulation of myfortic in combination with tacrolimus and thymoglobulin.

evaluate the safety and efficacy of myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of myfortic in a corticosteroid withdrawal protocol.

Eligibility criteria:
inclusion criteria: * males and females between 18 and 75 years of age. * patients who are primary or repeat cadaveric, living unrelated or non-hla identical living related donor renal transplant recipients. exclusion criteria: * patient previously received or is receiving an organ transplant other than kidney. * primary or re-transplant from human leukocyte antigen (hla)-identical living donor. * recipient or donor is known to be seropositive for hepatitis c virus (hcv), hepatitis b virus (hbv), or human immunodeficiency virus (hiv). * uncontrolled concomitant infection or other unstable medical condition. * patients that received an investigational drug in the 30 days prior to transplant. * known hypersensitivity to tacrolimus, mycophenolate mofetil (mmf), enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids. * receiving chronic steroid therapy at the time of transplant. * history of malignancy in last 5 years. * pregnant or lactating.

Keywords: kidney transplant corticosteroid myfortic
cytosponge protocol irb 11-006429

Conditions: Eosinophilic Esophagitis

Summary: this study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy. exclusion criteria: * patients for whom clinically indicated endoscopy is not safe. patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule. * vulnerable populations, such as those with diminished mental acuity, will be excluded. * patients with known lidocaine/acetylcysteine allergies
phase ii: scalable digital delivery of craft training for professionals to maximize treatment rates of oud in families

Conditions: Community Reinforcement And Family Training; Family Health; Substance-Related Disorders

Summary: the goal of this project is to demonstrate digital training efficacy at scale and commercial readiness. this pilot project will advance piloted digital training programs for craft and maximize scalability. in this project, investigators will: aim 1: optimize the digital craft training product based on data and feedback from the pilot and commercialization advisors. aim 2: conduct a fully powered randomized control trial of 3 levels of digital training (level 1 - digital tutorial only \[t\]; level 2 - tutorial \& digital training materials for self-study \[tm\]; level 3 - tutorial, digital materials, feedback and coaching \[tmc\]) to examine the effects of training on craft knowledge, fidelity, and plus ip treatment entry/retention and counselor skill pre- and post-tutorial, at 12 weeks and at 6 months.


Eligibility criteria:
inclusion criteria: * be over 19 * live in the us * work in a counselor-related profession * have counseling work that involves clients * work with csos impacted by oud, or could work with this type of client * have not been certified in craft * have not participated in the 2023 wtv counselor training pilot study * be able to provide at least 45-minute individual counselor sessions to at least one cso (cso) * be able and willing to complete intervention activities over the course of the 12-week study as determined by the random assignment including: participating in the tutorial and training and submitting the required session audiotapes * report having access to a computer and smartphone with internet access, email, and word processing capability * demonstrate complete understanding of the requirements for participation in the study by reading and signing the consent form and completing the online consent quiz or confirmation call * provide valid locator information to allow research and craft training staff to contact them to schedule study-related appointments * complete the first assessment mock session with our standardized patient (sp) and pre-tutorial surveys exclusion criteria: * does not agree to participate * does not complete the baseline assessment requirements * is not english-speaking * participated in the qualitative review aspect of the study
med-south lifestyle study: phase 1

Conditions: Healthy Lifestyle

Summary: the purpose of this study is to determine the processes by which a previously proven lifestyle intervention (the med-south lifestyle program) can most effectively and efficiently be translated into public health and clinical practice to positively impact chronic disease risk reduction among mostly minority, rural, and medically underserved populations.

purpose: although lifestyle behavior change interventions are widely recommended to improve health, they are not being implemented sufficiently or equitably on a national scale, particularly in rural communities. the research team has developed and tested multiple lifestyle interventions, which have culminated in the med-south lifestyle program (mslp), an evidence-based behavior change intervention that translates the predimed (mediterranean) dietary pattern for a southeastern us population and includes support for increased physical activity. in this research the investigators propose to identify the most effective and efficient way to scale-up the mslp for use in public health and clinical practices settings so that it reaches minority, rural, and medically underserved populations. in phase 1, the investigators will develop, pilot test, and refine implementation strategies that will be used to take the mslp to scale. participants: phase i participants include up to 80 participants who will receive the mslp and for whom the study team will collect baseline and follow-up data. procedures (methods): an evidence-based framework for scaling-up health interventions will be used to guide phase i activities. the initial phase involves refining the "scalable unit" which includes the lifestyle program (mslp), implementation strategies for the sites that will give the program, and strategies unc will use to train sites on implementing the program. to refine the scalable unit the investigators will apply a descriptive, qualitative design to assess the feasibility and acceptability of the mslp's intervention and implementation strategies (i.e., what the investigators will scale-up in phases 2 and 3). in phase 1, the study team will recruit 2 local health departments and 2 federally qualified health centers as participating sites. each site will form an implementation team of 2-4 individuals who will go through training on intervention delivery and implementation. sites will be randomized to receive training either through a distance (webinar) or in-person/collaborative format. each site will recruit up to 20 participants (for a total of 80 across all sites) to receive the intervention.

Eligibility criteria:
inclusion criteria: * male or female * english speaking * ages 18-80 exclusion criteria: * malignancy * advanced kidney disease (estimated creatinine clearance \< 30 ml/min)
evaluation of 123i-iodometomidate for adrenal scintigraphy

Conditions: Adrenal Tumor; Adrenocortical Carcinoma

Summary: the improvement of conventional imaging techniques has led to an increased detection rate of different adrenal tumors. since those tumors can belong to a variety of entities the therapeutic consequences also show considerable variation. in order to definitely determine the type of tumor, invasive procedures like ct guided biopsies are often required, which could be avoided by a tumor specific imaging method. the presently available scintigraphic procedures are either time consuming and lead to high radiation exposure or are technically demanding. the steroidogenic enzymes cyp11b1 (11ß-hydroxylase)and cyp11b2 (aldosterone synthase)are expressed exclusively in the adrenal cortex and therefore represent suitable targets for a specific imaging technique. in our project we evaluate 123i-iodometomidate which binds to both cyp11b enzymes as radiotracer for adrenal scintigraphy.


Eligibility criteria:
inclusion criteria: 1. adrenal tumor seen by ct or mrt-scan with diameter of at least 2 cm or patient with adrenocortical carcinoma and suspected metastasis or local recurrence or patients with primary hyperaldosteronismus and adrenal tumour \> 1 cm 2. hormonal work up of of the adrenal tumor according to ens@t (european network for the study of adrenal tumours)-criteria 3. age ≥ 30 jahre 4. effective contraception (pearl index \<1%) 5. written informed consent exclusion criteria: 1. pregnancy or breast feeding 2. renal insufficiency (serum creatinine \> 2,0 mg/dl or mdrd \< 60 ml/min) 3. known allergy to etomidate or constituents of the test drug

Keywords: adrenocortical carcinoma (acc) adrenal tumor metastastic adrenocortical carcinoma
study to assess efficacy of risedronate in preventing bone loss in postmenopausal women treated for breast cancer

Conditions: Breast Cancer; Menopause; Osteopenia

Summary: aromatase inhibitor therapy is in france the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. this treatment induces bone loss and a higher risk of fractures. this study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer


Eligibility criteria:
inclusion criteria: * postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means) * operated for an invasive breast cancer (histologically proven) * surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed * treated with aromatase inhibitor * osteopenic (-2.5\<t score\<-1) without osteoporotic fracture * with written informed consent signed * with social security exclusion criteria: * women presenting a history of osteoporotic fracture or a t score less than -2.5 at at least one measure site * women presenting clinical signs of metastases * having received other hormonal treatment in the last 3 months * having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year * presenting a known and untreated hyperthyroid * presenting a known hyperadrenocorticism * patients treated and followed for paget's disease of bone * presenting a untreated primary hyperparathyroid * presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min) * patients presenting malabsorption syndrome for glucose/galactose * person participating in another clinical trial concerning a medicine susceptible to influence bone mass

Keywords: aromatase inhibitor treatment osteoporosis breast cancer bisphosphonates
virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety

Conditions: Nurse's Role

Summary: aim this study aimed to determine the effect of virtual reality distraction versus positive pre-visit imagery intervention on children's dental fear and anxiety during local anaesthesia injection. research hypotheses 1. children who receive virtual reality distraction or positive pre-visit imagery intervention exhibit less dental fear and anxiety levels during la injection than those who do not. 2. children who receive virtual reality distraction exhibit less dental fear and anxiety levels during la injection than those who receive positive pre-visit imagery intervention.

promoting children's health is a crucial nursing role. dental health and psychological well-being are basic components of the health promotion for young children. dental procedures especially local anesthesia injection is one of the most unpleasant experiences for young children. dental fear and anxiety are considered pervasive psychological problems accompanied with strong negative feelings among a large portion of young children. basically, dental fear and anxiety have been reported as one of the most important reasons for avoidance of dental treatments among young children, thereby results in an adverse effects on their oral and psychological health. nurses face a great challenge to minimize dental fear and anxiety and stabilize young children psychologically during restorative dental procedures. such stabilization is the cornerstone of successful local anaesthesia injection and facilitating dentist's mission. virtual reality refers to a human-computer interface that completely immerse the child in a simulated environment. it integrates multiple perceptual senses including; the visual, auditory and kinaesthetic stimulation modalities. virtual reality diverts children's attention away from the negative feelings associated with unpleasant experience. positive pre-visit imagery is one of the superior cognitive- behavioral interventions. it is kind of psychological preparation that is designed to provide children with a step-by-step explanation of the dental local anaesthesia injection in an attractive approach. it helps them to anticipate, deal with, and be empowered to gain mastery over the events they will experience. it also plays a role in counteracting the distorted beliefs that invading the children's conscious awareness.

Eligibility criteria:
inclusion criteria * age ranged from 4- 6 years. * had a previous experience of dental local anaesthesia injection. * had carious mandibular primary molar and planned for restorative dental treatment. exclusion criteria: * age more than 6 years. * visual or auditory deficits. * chronic or mental disabilities that affect their understanding.

Keywords: virtual reality positive pre-visit imagery dental fear dental anxiety
mindfulness training versus low (fodmap) fermentable oligosaccharides, disaccharides, monosaccharides and polyols diet

Conditions: Irritable Bowel Syndrome (IBS)

Summary: the study aims to compare the effect of mindfulness-based awareness training in irritable bowel syndrome (ibs) (mb-ibs-eat) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (fodmap) diet) on patient's ibs symptoms

this pilot study will be a randomized parallel trial comparing mb-ibs-eat done over an 8-week period to a standard low fodmap diet. the low fodmap diet is currently employed by clinicians as a treatment for ibs, but response rates are poor, without documented long-term benefit. this finding supports the need for better, longer lasting interventions.

Eligibility criteria:
inclusion criteria: * aged 18 and over * meets rome iv criteria for diagnosis of irritable bowel syndrome (ibs) * has legal and mental capacity to understand and sign an informed consent document * access to a computer or smart device with internet exclusion criteria: * pregnancy * active malignancy in the previous five years * current or prior history of alcohol or drug abuse as defined by clinician * any history of eating disorder such as anorexia or bulimia * taking yoga or with prior history of mindfulness therapy within 3 months of enrollment * currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (fodmap) diet * psychiatric illnesses other than depression or anxiety disorder * nausea or vomiting

Keywords: irritable bowel syndrome (ibs) mindfulness fodmap