Kornimate/medical-research-clean huggingface dataset:
closed-loop insulin delivery in pregnant women with type 1 diabetes

Conditions: Type1 Diabetes

Summary: multi-centric open-label randomized controlled trial (rct) with 11 belgian centers and one dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 minimed medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).

women will be recruited with a singleton pregnancy up to 12 weeks gestation. participants will be randomized 1/1 to 780 pump or standard of care (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections). participants will be stratified according to study center, baseline hba1c, and method of insulin delivery (pump or injections). participants will be followed-up till delivery. to account for differences in the type of continuous glucose monitoring (cgm) used between the intervention group and the control group, the same cgm system as in the 780 insulin pump group (guardian™ sensor 3 and once available the guardian 4 sensor) will be used in a blinded manner in the control group to collect cgm data during at least four different time points in pregnancy: at 14-17 weeks, 20-23 weeks, 26-29 weeks and 33-36 weeks.

Eligibility criteria:
inclusion criteria: * women with type 1 diabetes (t1dm), diagnosed with t1dm at least 1 year before pregnancy * age 18-45 years * a singleton pregnancy confirmed by b-hcg in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days. * treated with intensive insulin treatment (either mdi or insulin pump). a closed-loop system can only be used in manual mode. * have a booking hba1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%. * participants need to speak and understand flemish, french or english and have e-mail access. exclusion criteria: * the use of a closed-loop insulin delivery system in auto mode. * a twin (multiple) pregnancy * a physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician) * medications known to interfere with glucose metabolism * an insulin dose of ≥1.5 units/kg * known allergy to adhesives due to infusion set and/or cgm

Keywords: closed-loop insulin delivery
oxygen atomizing inhalation of egcg in the treatment interstitial pneumonia in cancer patients

Conditions: Interstitial Pneumonia; Neoplasms Malignant

Summary: epigallocatechin-3-gallate (egcg) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. in addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (egcg), including sars-cov-2. in previous studies, we found that egcg can prevent and cure radiation-induced normal tissue damage in tumor patients. in clinical studies, we found that egcg can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. thus, we designed this phase i-ii clinical study in order to investigate the possible role of egcg in the treatment interstitial pneumonia in tumor patients.

in this phase i study, subjects were divided into four dose groups according to the improved fibonacci method and were given different doses of egcg to evaluate adverse events. at the same time, the researchers conducted a phase ii study of egcg in tumor patients with interstitial pneumonia. the phase ii study was conducted with a randomized, controlled, placebo dose determined by phase i. the subjects were divided into two groups (experimental group and placebo group). to observe the effectiveness of egcg, the researchers will use both clinician assessment and patient self-assessment.

Eligibility criteria:
inclusion criteria: * diagnosed malignant tumors by pathology or cytology * covid-19 with a confirmed positive polymerase chain reaction or antigen test result for sars-cov-23 * moderate pneumonia, according to the diagnosis and treatment standard of covid-19 in peking union medical college hospital * pulmonary function of the patient can be treated with aerosol inhalation for 5-7 days exclusion criteria: * current or recent progresses rapidly and may develop into a critical illness with coronavirus in a short period of time * caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia * any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation * need systemic use of immune suppressive agents

Keywords: egcg
decompression versus heat and decompression in knee oa

Conditions: Knee Osteoarthritis

Summary: a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.

osteoarthritis (oa) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. the knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of oa worldwide. subjects having koa demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (rom), and declined functional status. except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability. interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. however, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients

Eligibility criteria:
inclusion criteria: * both sexes * age between 45 to 60 years. * normal and or overweight categories of bmi 19-30 kg/m2 * unilateral (grade 2 and 3) knee oa according to the kellgren-lawrence radiological rating scale exclusion criteria: * lower limb deformities as genu varum, valgus, flat foot * leg length discrepancy * previous trauma and or surgery to the knee joint * bone disease * inability to refrain from analgesic/anti-inflammatory medications for 6 weeks
economic assessment of starting endoscopic robotic groin hernia repair

Conditions: Inguinal Hernia

Summary: the material cost for robotic groin hernia repair is higher than for conventional laparoscopic surgery. in this study, this amount will be quantified and possible differences in early postoperative course, hospital stay and readmission rate that could influence the cost/benefit ratio for robotic groin hernia surgery will be analyzed.

robot-assisted groin hernia repair has been introduced in az maria middelares hospital since september 2016. in these procedures, the davinci robot is being used to perform minimal invasive repair of these hernias. at the moment, this technique is frequently being used for groin hernia repair. literature shows a clear benefit of robot-assisted versus open repair. hospital stay decreases and complications are less frequently observed in patients who underwent minimal invasive repair (henriksen na et al., 2018). on the other hand, the benefits of robot-assisted repair are less obvious compared to conventional laparoscopy. many robot-trained surgeons are in favor of robot-assisted repair, but current literature is still inconclusive about the economic feasibility of robot-assisted groin hernia repair as standard of care. this retrospective observational study is primarily designed to analyze the additional cost of robot-assisted groin hernia repair compared to conventional laparoscopic repair. a cost-benefit analysis will be carried out for groin hernia repairs performed by the same surgeon (dr. filip muysoms) in the period 2016-2019. as primary endpoint, direct costs related to the introduction of robot-assisted groin hernia repair will be analyzed. these are: material costs, costs related to hospital stay, honoraria and costs related to intrahospital complications. a comparison will be made between conventional laparoscopic and robot-assisted groin hernia repair. as secondary endpoint, indirect costs will be compared between both groups. these include costs related to late complications and readmissions related to the index operation.

Eligibility criteria:
inclusion criteria: * adult patients * underwent uni-or bilateral groin hernia repair in the period 2015- 2019 * surgery through minimal invasive repair exclusion criteria: * open surgery or conversion from minimal-invasive to open surgery * combined procedures * age below 18 years
safety and efficacy of posaconazole oral suspension in usual practice in korea (p08547)

Conditions: Fungal Infections

Summary: this study will examine the safety and efficacy of posaconazole in general use in korea. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * treated with posaconazole oral suspension within current local label exclusion criteria: * contraindication to posaconazole oral suspension according to current local label
safety study of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older

Conditions: Influenza

Summary: this study evaluates the safety of freeze-dried live attenuated influenza vaccine for intranasal administration in chinese adults aged 3 years and older.80 subjects will be divided into 2 groups, including 18 years and older and 3-17 years old. subjects in each groups will randomly receive one dose of influenza vaccine or placebo in a 3:1 ratio.


Eligibility criteria:
inclusion criteria: 1. healthy subjects more than 3 years 2. guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written informed consent form. 3. subjects, guardians and his family can obey the demands of the scheme . 4. axillary temperature less than 37℃ exclusion criteria: 1. subjects with flu or infected with flu within 3 months. 2. subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc. 3. subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain. 4. subjects have symptoms of acute infection within a week. 5. subjects have autoimmune disease or immune function defect, subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months. 6. subjects have congenital malformations, developmental disorder or serious chronic diseases( such as down's syndrome, diabetes, sickle cell anemia or nerve system disease) 7. subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years. 8. subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease. 9. alienia, functional asplenia, and alienia or splenectomy in any situation. 10. serious neurological disorders such as green barry syndrome. 11. subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated. 12. subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine. 13. the indicators of blood test or urine test do not conform to the inclusion criteria. 14. subjects have received allergy treatment in in the past 14 days. 15. subjects are receiving anti-tuberculosis treatment. 16. subjects have inoculated flu vaccine in the flu reason. 17. axillary temperature is more than 37℃ before vaccination. 18. subjects are pregnant or plan to become pregnant 19. subjects are participate in other clinical trials. 20. any factors unsuitable for clinical trail at the discretion of the investigator.

Keywords: vaccine safety intranasal administration
effects of taurine supplementation on repetitive sprint performance and exhaustion time in college students under high-temperature and high-humidity conditions

Conditions: Exercise Performance in Extreme Environments

Summary: this study is designed to evaluate the effects of acute pre-exercise taurine supplementation at different doses on the performance of college students during exhaustive exercise and subsequent repetitive sprint (rs) activities in a high-temperature, high-humidity environment. sixteen college students (8 male, 8 female) will participate in a single-blind, randomized, crossover-controlled trial. participants will be divided into four groups: high-dose taurine (6g), medium-dose taurine (4g), low-dose taurine (1g), and placebo. key performance metrics such as peak power (pp), mean power (mp), fatigue index (fi), exhaustion time (et), reverse vertical jump height, heart rate (hr), blood lactate (bla), and ratings of perceived exertion (rpe) will be measured. the objective of this study is to assess how taurine supplementation influences exercise performance under these challenging environmental conditions. this study will help to better understand taurine's potential effects on exercise performance and contribute to nutritional strategies for athletes exposed to extreme conditions.

this study is designed to evaluate the effects of taurine supplementation on exercise performance under extreme environmental conditions of high temperature and high humidity. the primary goal is to investigate whether taurine supplementation can enhance performance during exhaustive exercise and subsequent repetitive sprints (rs). sixteen college students (8 male, 8 female) will participate in a single-blind, randomized, crossover-controlled trial. participants will be divided into four groups receiving either high-dose (6g), medium-dose (4g), low-dose (1g) taurine supplementation, or placebo. the study will involve a protocol with exhaustive exercise followed by six repetitive sprints. performance metrics such as peak power (pp), mean power (mp), and fatigue index (fi) will be recorded. additionally, physiological parameters, including heart rate (hr) and blood lactate (bla), as well as subjective measures like ratings of perceived exertion (rpe), will be monitored. a standardized measurement protocol will be used to ensure consistency and accuracy across trials.

Eligibility criteria:
inclusion criteria: * school students * aged between 18 and 28 years * no exercise-related risk, as indicated by a "no" response to all questions in the physical activity readiness questionnaire (par-q) * no taurine-based supplements consumed in the last month. exclusion criteria : * individuals who do not meet the inclusion criteria * individuals with a history of cardiovascular issues, respiratory problems, or any condition that may impair exercise performance * participants who did not provide a "no" response to all questions in the physical activity readiness questionnaire (par-q) * participants who consumed taurine-based supplements in the month preceding the study.
g-tech feasibility study for early detection of a post-op ileus

Conditions: Post-operative Ileus

Summary: this feasibility study is for the purpose of determining if the g-tech device can differentiate between normal return of gi activity post-operatively and the myoelectric activity in patients who develop a poi.

while preventing the development of a poi is most important, pois still occur; therefore, it is important to definitively diagnose a poi as early as possible during the post-operative course for treatment to prevent patient discomfort, complications, and extended hospital stay. the purpose of the g-tech study is to determine if the g-tech device can detect a difference in the myoelectric signals from patients who develop a poi compared to those patients who do not develop a poi. it is anticipated that up to 20% of patients enrolled in this study and consented preoperatively, excluding screen failures, will show evidence of a post-operative ileus as detected by the g-tech gutcheck device and differentiate the myoelectric signals from the patients who do not develop a poi. patients who are known to have developed a poi may also be selected for the study.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent; 2. eighteen (18) years of age or older; 3. subject is willing and able to follow all study requirements; 4. subject who will undergo or has undergone open or laparoscopic gastrointestinal surgery or surgery not involving the abdominal cavity. exclusion criteria: 1. subject is pregnant or suspects pregnancy; 2. known allergy to medical grade adhesive; 3. weight \> 350 lbs (159 kg);
internet intervention for adolescents with chronic pain

Conditions: Chronic Pain; Abdominal Pain; Headache

Summary: the purpose of this study is to evaluate the efficacy of a web-based (i.e., internet) behavioral program to reduce pain and improve functioning in children and adolescents with chronic pain. we hypothesize that children and adolescents in families that receive the web-based behavioral program will report reduced pain levels and improved daily functioning compared to children and their parents who receive online patient education.

an estimated 15% to 30% of otherwise healthy children and adolescents suffer from recurrent or chronic pain such as headache, abdominal pain, and musculoskeletal pain. chronic pain has a significant impact on children's mood, daily functioning, and overall quality of life. effective behavioral interventions have been developed to increase positive coping behaviors. however, most children do not have access to these interventions due to a variety of barriers such as distance from pediatric pain treatment centers. we have developed an online behavioral intervention called web-based management of adolescent pain (web-map), and our preliminary findings indicated that children in families that received this intervention experienced significant improvements in their pain level and daily functioning compared to children who did not receive the intervention (palermo et al., 2009). the purpose of this study is to extend these findings by: 1) recruiting families from other medical centers, 2) determining whether the benefits of online behavioral intervention are maintained 6- and 12-months after the intervention has been completed, 3) evaluating additional outcomes such as parent responses to pain and child sleep quality, anxiety, depression, and health service use, 4) comparing results from online behavioral intervention to online patient education.

Eligibility criteria:
inclusion criteria: * literate in english * age 11-17 years * pain present for at least 3 months duration * pain occurs at least 1 time per week and interferes with daily functioning * pain is not related to a chronic disease * receiving evaluation or treatment in a pediatric pain clinic * has access to a computer, the internet, and a phone exclusion criteria: * a serious comorbid chronic condition in the patient (e.g., diabetes, arthritis, cancer). * non-english speaking * more than 4 sessions of cbt for pain management in the 6 months prior to the time of screening.

Keywords: chronic pain abdominal pain headache adolescents internet interventions behavioral interventions
per-oral endoscopic myotomy (p.o.e.m.) for treatment of primary esophageal motility disorders

Conditions: Achalasia

Summary: spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. per oral endoscopic myotomy (p.o.e.m.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. this study aimed to investigate the feasibility and safety of p.o.e.m. and translate the techniques from animal study to clinical practice in human.


Eligibility criteria:
inclusion criteria: * all patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. the primary motility disorders included: achalasia, hypertensive les, nutcracker esophagus and diffuse esophageal spasm. exclusion criteria: * patients will be excluded from this study with the followings - 1. pregnancy 2. informed consent not available 3. previous history of esophagectomy or mediastinal surgery 4. previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection 5. end-stage achalasia with dilated esophagus more than 6cm on barium swallow investigations before and after poem

Keywords: hypertensive les
cognitive-behavioral therapy for generalized anxiety disorder in primary care

Conditions: Generalized Anxiety Disorder

Summary: the feasibilty and preliminary comparative effectiveness of two methods of cognitive-behavioral therapy - metacognitive therapy and intolerance of uncertainty therapy - for primary care patients with generalized anxiety disorder is investigated in a pilot study using a randomized controlled design. purpose of the study is to examine the feasibility of a full-scale randomized controlled trial. research questions primarily concern recruitment, measurement, and adherence.


Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder * age 18 years or above * being able to understand and speak swedish without interpreter support exclusion criteria: * psychosis, bipolar disorder, severe depressive symptoms, risk of suicid, substance use disorder, intellectual disability * simultaneous psychological treatment * if pharmacological treatment, it needs to be stable prior to and during treatment
efficacy of combination therapy vs placebo for pediatric functional abdominal pain

Conditions: Functional Abdominal Pain; Irritable Bowel Syndrome; Functional Dyspepsia

Summary: ind application was submitted to fda on november 17th.


Eligibility criteria:
inclusion criteria: to participate in this study, the child/teen must be a patient of the fap clinic/gi clinic in the division of gastroenterology at the children's hospital of wisconsin, and have a parent or legal guardian who is willing to participate. children aged 8-18 years will be eligible for inclusion in the study. exclusion criteria: children or parents who are non-english speaking, or parents and/or children with cognitive delay that precludes comprehension and completion of questionnaires will be excluded from participating in this registry.

Keywords: functional abdominal pain irritable bowel syndrome ibs functional dyspepsia melatonin simethicone peppermint oil mentharil functional bowel disorders quality of life
special drug use investigation for paxil (paroxetine) social anxiety disorder (long-term)

Conditions: Social Phobia

Summary: the study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in japanese social anxiety disorder (sad) subjects.


Eligibility criteria:
inclusion criteria: * subjects who are diagnosed as having sad * subjects who are expected to use paroxetine tablets for the first time exclusion criteria: * subjects taking pimozide * subjects taking monoamine oxidase (mao) inhibitor or within two weeks after discontinuation of mao inhibitor * subjects with hypersensitivity to paroxetine