Kornimate/medical-research-clean huggingface dataset:
clinical study new gel for xerostomia

Conditions: XEROSTOMIA

Summary: at present, there is no single consensus protocol for the treatment of oral dryness, although the main objective is to improve the quality of life of patients. current therapy for the control of xerostomia is based on the following measures: 1. general measures ; review and control of drugs,hydration and dietary advice: the main recommendations are found in the following scheme. 2. saliva stimulants( topics and sistemic )the option of using chewing stimuli by chewing gum with non-cariogenic sweeteners helps to improve symptoms. the investigators can also use gustatory stimuli, such as citric acid that is a potent stimulator of salivary secretion. among the most commonly used pharmacological agents are: pilocarpine, bethanecol, civemiline 3. saliva substitutes or artificial saliva. saliva substitutes can provide a moisture retention layer in the oral mucosa and can be administered by liquids, spray, pills or gels. topical treatments have few adverse effects and improve the quality of life of patients with xerostomia; in addition, they maintain oral health.

randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability in patients with a non-commercialized gel and property of the promoter to treat xerostomia.

Eligibility criteria:
inclusion criteria: * subjects of both sexes 2. over 18 years. 3. adequate cultural level and understanding of the clinical study. 4. agree to voluntarily participate in the study and give their informed consent in writing 5. present xerostomia of more than three months of evolution / sialometry less than 0.2ml / 5 min. exclusion criteria the presence of at least one of the following criteria will be grounds for exclusion from the clinical trial: 1. presence of health problems that may compromise adherence to the study protocol. 2. pregnant or breastfeeding women. 3. present hypersensitivity to any component of the product under study.

Keywords: dry mouth
paricalcitol in fabry disease

Conditions: Fabry Disease; Proteinuria

Summary: proteinuria is the predominant risk factor for renal disease progression in fabry disease (fd). when urine protein excretion is controlled to \ 0.50 g/24 hr persisting despite the ert and anti-ras therapy titrated to maximum tolerated dosage.


Eligibility criteria:
inclusion criteria: * genetically proven fd * stable dose of ert for at least 12 months * stable dose of acei or arb titrated to maximum tolerated dosage for at least 6 months * persistent proteinuria \>0.50 g/24 h despite the use of ert and acei/arbs in 2 consecutive samples within 12 weeks exclusion criteria: * steroid/immunosuppressive treatment or glomerular filtration rate change \>30% in the past 3 months * pth levels \<20 pg/ml * serum phosphorus \>5.0 mg/dl * serum calcium (adjusted for albumin) \>10.0 mg/dl * active malignancy.
adjuvanted influenza vaccine evaluation in kidney transplant recipients

Conditions: Influenza

Summary: influenza is an important public health problem. organ transplant patients are particularly susceptible to severe disease. also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. therefore, improved strategies to prevent influenza in this population is an important public health concern. standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. recently seasonal influenza vaccines containing adjuvants have become available in canada but have only limited information in transplant patients. this randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.


Eligibility criteria:
inclusion criteria: adult kidney transplant recipients greater than 3 months post-transplant exclusion criteria: has already received influenza vaccination for 2012-2013 season egg allergy previous life-threatening reaction to influenza vaccine (i.e. guillain barre syndrome) ongoing therapy for rejection febrile illness in the past two weeks unable to provide informed consent unable to comply with study protocol

Keywords: kidney transplant recipients
food product for management of gestational diabetes

Conditions: Gestational Diabetes; Glucose Tolerance Impaired in Pregnancy; Glucose Tolerance Impaired; Pregnancy Related; Insulin Sensitivity/Resistance

Summary: the goal of this pilot open pre-post clinical trial is to test effects of a wholegrain product in patients with newly diagnosed gestational diabetes. the main question it aims to answer is: does the wholegrain product improve glucose tolerance and insulin sensitivity during a 75 g oral glucose tolerance test (ogtt). participants will consume product on two consecutive evenings shortly after the first ogtt and will then perform a second ogtt. researchers will compare the results of the first and second ogtt to see if glucose tolerance improved after consumption of the test product.


Eligibility criteria:
inclusion criteria: 1. pathological fasting glucose or ogtt according to who-criteria for the diagnosis of gestational diabetes (see table 1). 2. agree to maintain consistent dietary habits and physical activity levels for the duration of the study. 3. willingness to complete questionnaires and follow instructions associated with the study and to perform another ogtt at the clinic in a second visit. 4. has given voluntary, written, informed consent to participate in the study. exclusion criteria: 1. type 2 diabetes prior to pregnancy 2. psychiatric disease 3. acute infections 4. alcohol or drug abuse 5. acute diverticulitis 6. malignant tumors or hematologic disorders 7. heart failure stages iii-iv according to new york heart association (nyha) 8. acute coronary syndrome 9. chronic kidney disease \> stage 3 (kidney disease outcomes quality initiative - kdoqi) 10. celiac disease 11. diagnosed inflammatory bowel diseases (mainly crohn´s, ulcerative colitis) 12. allergy to ingredients included in the investigational product. 13. use of antibiotics within 2 weeks of enrollment 14. use of probiotics within 2 weeks of enrollment

Keywords: wholegrain dietary intervention gestational diabetes impaired glucose tolerance insulin sensitivity/resistance
clinical study on the accuracy of real-time ai-assisted endocytoscopy in the diagnosis of colorectal diminutive polyps

Conditions: Colorectal Polyp

Summary: colorectal cancer (crc) is the third most common malignant tumor in the world and the second largest cause of cancer-related death \[1\]. colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resectable detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. in recent years, with the continuous development of endoscopic diagnostic techniques and the standardization and strengthening of endoscopist training, the detection rate of colorectal polyps has increased year by year. as the number of endoscopic excisions increases, the costs associated with endoscopic excision and pathological diagnosis of excised specimens increase year by year. research results showed that about 90% of the detected polyps were small polyps (6-9 mm) and diminutive polyps (≤5 mm), and nearly half of them were non-neoplastic polyps, so endoscopic resection and histopathological examination were not required \[2, 3\]. in order to reduce unnecessary pathological examination and endoscopic treatment, the american society of digestive endoscopy proposed pivi strategies: "excise and discard" and "diagnose and do not excise" strategies. endocytoscopy is a kind of ultra-high magnification endoscopy. combined with chemical staining and narrow-band imaging technology, endoscopists can observe and judge the nuclear morphology, glandular duct morphology and microvascular morphology of colorectal lesions by naked eye, thus realizing the purpose of real-time biopsy in vivo. however, it takes a lot of experience accumulation to improve the judgment accuracy of endoscopy images, and endoscopy doctors have certain subjective judgments and errors in the process of judging results. therefore, in order to solve this problem, artificial intelligence (ai) is proposed clinically. our center has developed an artificial intelligence assisted diagnosis system based on endocytoscopy to assist endocytoscopy in judging the nature of colorectal lesions. however, whether this artificial intelligence assisted diagnosis system is accurate in judging the nature of colorectal diminutive polyps and is suitable for widespread promotion and application of pivi strategy lacks relevant clinical data. this study intends to carry out this clinical study to verify the diagnostic accuracy of this artificial intelligence in the diagnosis of colorectal diminutive polyps.


Eligibility criteria:
inclusion criteria: * colorectal lesions exclusion criteria: * lesions lacking high-quality images; * inflammatory bowel disease, familial adenomatous polyposis and other special diseases; * submucosal tumors; * pathological diagnosis of inflammatory polyps, peutz-jeghers polyps, juvenile polyps, lymphoma and other pathological types.
evidence-based pain intervention for veterans: atease for chronic pain

Conditions: Chronic Pain

Summary: this study is a randomized controlled trial to test the efficacy atease, a pain self-management app in a sample of veterans with chronic musculoskeletal pain. the primary outcome is changes in peg scores from baseline to final follow-up (12 months).

the primary objectives of this project are to develop and examine the effectiveness of a mobile app (atease) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 veterans with chronic pain. veterans will be recruited from va connecticut healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for veterans, student veterans of america, and social media). eligible veterans will be randomized to receive access to atease or the comparison intervention (a mobile-optimized adaptation of chronic pain education for veterans) for a total of 6 months. atease is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. chronic pain education for veterans is a free va-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials. between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access atease or the chronic pain education for veterans program. all participants will complete follow-up assessments at 6 months and 12-months post-baseline. the primary outcome will be a comparison of peg scores at 12 months follow-up. secondary outcomes will include pain,global impression of change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and post traumatic stress disorder checklist scores.

Eligibility criteria:
inclusion criteria: * male or female veteran * chronic musculoskeletal pain defined as (numeric rating scale of \>4) (10 point scale) for \> 3 months.43 * internet connectivity via tablet or mobile phone. exclusion criteria: * life-threatening condition or acute medical conditions that precludes participation * psychiatric conditions that could impair participation * suicidal ideation or intent * inability to read or speak english * unwilling or unable to provide informed consent

Keywords: chronic pain stage of change pain self management mobile applications transtheoretical model
diabetes telemonitoring of patients in insulin therapy

Conditions: Type 2 Diabetes Treated With Insulin

Summary: the trial is an open-label randomized controlled trial. patients with t2d on insulin therapy will be randomized to a telemonitoring group (intervention) and a usual care group (control). the telemonitoring group will use various devices at home. hospital staff will monitor their data for a period of three months.

the diamont trial is an open-label randomized controlled trial with a trial period of three months conducted. the trial will be conducted in two sites in denmark: steno diabetes center north jutland and steno diabetes center zealand. patients with t2d on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). the telemonitoring group will use an insulin pen, an activity tracker, a cgm, and a smartphone application throughout the trial period. hospital staff (lab technicians and nurses) will monitor the telemonitoring groups' data and contact the subjects by telephone repeatedly throughout the trial period. the usual care group will use a blinded cgm the first and last 20 days of the trial and will use a blinded insulin pen for the entire period. the usual care groups' data will not be monitored during the trial.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * t2d diagnosis for ≥ 12 months * residence in region north denmark or region zealand * in treatment with insulin * being able to use a smartphone along with the other devices to be used in the trial * able to understand and read danish. exclusion criteria: * pregnancy or breastfeeding, * major surgery planned during the trial period * participation in other trials * terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate

Keywords: diabetes insulin telemedicine telehealth telemonitoring cgm adherence
a dose finding and safety study of oral leq506 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors; Recurrent or Refractory Medulloblastoma; Locally Advanced or Metastatic Basal Cell Carcinoma

Summary: this first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of leq506 given orally on a daily dosing schedule in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma) * protocol defined laboratory parameters * performance status ≤ 2 * patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy exclusion criteria: * history of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients) * impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea * impairment of cardiac function or significant cardiac disease * pregnant or lactating women * other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors recurrent or refractory medulloblastoma locally advanced or metastatic basal cell carcinoma hedgehog pathway inhibitor
motion coaching technology for physical therapy in low back pain.

Conditions: Low Back Pain

Summary: in this study, we will compare exercise execution between two groups of patients: (1) individuals who undergo instruction session by a pt and then perform exercises with a written handout at home and (2) individuals who use the mhealth motion coach at home. participants will perform the same 4 exercises. both groups will be instructed to exercise at home, supported either by the handouts or the motion coach technology and then return after 1 week for assessment. for the assessment, standardized videos will be used to capture pose during exercise execution. group 1 will perform the exercises with the written handout; group 2 will perform the exercises with the motion coach. rating will be performed by a panel of pt professionals on the overall assessment of each exercises and on the three segments mentioned below that are exercise specific. the first group with pt instruction and written handout portion will be compared to the second group with the motion coach.


Eligibility criteria:
inclusion criteria: * age 22 - 65 * english speaking * absence of neurologic deficits as assessed by the clinician, with 5/5 strength in all muscle groups in the lower extremities and no sensory deficits in the lower extremities * pain located in the low back or posterior pelvic region * self-reported mean pain score \>4 in the past 1 week as assessed by vas pain score from 0-10 * pain duration \>1 month to 5 years * ambulatory w/out assist prior to enrollment exclusion criteria: * red flag signs including fevers, unexplained weight loss, personal history of cancer, tuberculosis exposure, history of spinal infection, history of thoracolumbar spine fracture in the past year as assessed by the clinician. * use of assistive ambulatory device * pregnancy * formal physical therapy within the past 6 months * neurologic symptoms including weakness or sensory changes in the bilateral lower extremities as assessed by the clinician. * pain radiating below the posterior pelvic region into either lower extremity * unwilling or unable to commit to study procedures * physically incapable of completing pt exercises safely as determined by clinician
managing diabetes to gain opportunities for a more active life

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.

the purpose of this novel patient-facing disease management intervention, my diabetes goal, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). this application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.

Eligibility criteria:
inclusion criteria: * 65 years and older * diagnosis of type 2 diabetes * enrolled in mychart (university of chicago patient portal) * outpatient clinic visit in the prior year exclusion criteria: * under 64 years of age * no type 2 diabetes * not enrolled in mychart * no outpatient clinic visit in the prior year

Keywords: geriatrics
online cbt intervention for students with adjustment disorder

Conditions: Adjustment Disorders

Summary: the aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on unified protocol and mediators of obtained changes among polish students with adjustment disorder. the intervention is fully self-helped and based on unified protocol principles. control conditions contain of online progressive muscle relaxation group and waiting list.

adjustment problems are highly prevalent among students around the world (conley et.al., 2013). unfortunately only half of students in need receive psychological help (eisenberg et al., 2018). for these reasons, there is a need to develop and evaluate new, more scalable forms of treatment for students with adjustment disorder - such as internet therapeutic programs. therefore the aim of the present research is to evaluate the effectiveness of online cognitive-behavioural therapy intervention. mediators of obtained changes will also be evaluated. the present study has a potential for the development of a scalable, well researched treatment option for students experiencing adjustment disorder - internet psychological intervention.

Eligibility criteria:
inclusion criteria: * having a student status * 18 years old or older, * having access to the internet and using computer or smartphone, * meeting the diagnostic criteria of adjustment disorder based on a total sum score \> 47,5 in adnm-20 questionnaire * meeting diagnostic criteria for ajd in mini interview. exclusion criteria: * an increased risk of suicidality intent or ideation (at least moderate scores on the mini and/or a score \> 2 on item 9 from the phq-9), * psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the mini * receiving another psychological treatment at the start of the study * having no time for participation in program * receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study

Keywords: adjustment disorder students internet psychological interventions cognitive behavioural therapy
vr education in arterial hypertension

Conditions: Arterial Hypertension

Summary: the aim of this study is to compare standard education with vr augmented education in patients with arterial hypertension

to demonstrate the technical and organizational feasibility of patient education about arterial hypertension in virtual reality. demonstrate the non-inferiority of education conducted in virtual reality to traditional face-to-face education by a physician. to define the cost-effectiveness of education in virtual reality in the reality of progressing shortage of human resources. patients diagnosed with arterial hypertension as part of a routine examination in an internal medicine outpatient clinic will be randomized to education about the disease directly by a physician in one arm or using a 3d movie in vr glasses filmed by a physician in an identical outpatient clinic setting. it will be concluded by questionnaire method to compare the outcome of both education namely subjective satisfaction and objectively by using questions to evaluate the success of the education.

Eligibility criteria:
inclusion criteria: * all consecutive patients with arterial hypertension exclusion criteria: * visual impairment

Keywords: virtual reality education