Kornimate/medical-research-clean huggingface dataset:
twelve -month study observing how insulin-naïve patients with type 2 diabetes mellitus manage diabetes using toujeo® after oral antidiabetic drug failure, the side effect of toujeo®, and the cost.

Conditions: Diabetes

Summary: primary objective: assess effectiveness of insulin glargine (u300) in achieving glycemic goal measured by hemoglobin a1c (hba1c). secondary objectives: * assess effectiveness in achieving glycemic goal measured by hba1c; * assess effectiveness on change in hba1c, fasting plasma glucose (fpg) and self-monitored plasma glucose (smpg) ; * assess requirement for intensification of therapy by additional antidiabetics. * assess incidence of hypoglycemia; * assess other safety endpoints: adverse events (aes), serious adverse events (saes); * assess change in body weight.

patients will be observed for one year

Eligibility criteria:
inclusion criteria : * signed patient informed consent; * type 2 diabetes mellitus; * treated with at least 1 oral antidiabetic drug (oad) for at least 6 months; * hemoglobin a1c (hba1c) \>7.0 % and ≤11% within 3 months of study baseline; * physicians' decision in accordance with the current local guidelines to add basal insulin glargine u300 to an existing oad regimen exclusion criteria: * diabetes mellitus other than type 2; * contraindication to insulin glargine u300 according to local product labelling; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the changes of coping with stressful events among adolescents under the covid-19 pandemic.

Conditions: Coping Behavior; Mental Health Issue

Summary: this study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.

under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.

Eligibility criteria:
inclusion criteria: * aged 14-25 * chinese nationality, who has lived in china since the outbreak of the covid-19 epidemic, and has experienced or is experiencing the epidemic and its normalization. * have the normal cognitive ability, expression ability, and social participation ability. exclusion criteria: * be diagnosed with psychological or mental illness. * incapacitated or unable to provide informed consent. * patients with severe diseases.

Keywords: adolescent pandemic coping behavior mental health stressful life event
dexamethasone in lower third molar surgery

Conditions: Impacted Third Molar Tooth

Summary: the aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.


Eligibility criteria:
inclusion criteria: * healthy patients (asa i) * bilateral symmetrically impacted lower third molars according to pel-gregory's and winter's classification exclusion criteria: * heavy tobacco smokers * drug and / or alcohol abusers

Keywords: dexamethasone lower third molar surgery
does a preoperative bowel regimen change time to first bowel movement after robotic sacral colpopexy

Conditions: Constipation; Post-Op Complication

Summary: the hypothesis is that starting a bowel regimen with polyethylene glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. the experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. the control group will not be given any intervention preoperatively. all patients will take polyethylene glycol postoperatively.

in order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. the patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. patients will record if they are taking their miralax as prescribed daily. they will also record their bowel movements and pain levels during evacuation. prior to surgery, in the pre-operative area, medication compliance will be assessed once again. post operatively all patients will take polyethylene glycol for seven days, once a day. they will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. the primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.

Eligibility criteria:
inclusion criteria: * patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures exclusion criteria: * age under 18 or over 90 * planned laparotomy * planned posterior colporrhaphy * regular pre-operative use of stool softeners/laxatives * presence of colostomy * inability to give informed consent * inability to take medication by mouth * chronic kidney disease (cr \> 1.2) * esophageal strictures * persistent nausea and vomiting * bowel obstruction * inflammatory bowel disease
effectiveness of a physical activity coaching intervention using e-health for copd patients in pulmonary rehabilitation

Conditions: COPD; Physical Activity

Summary: the goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an ehealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with chronic obstructive pulmonary disease (copd). all participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

this randomized controlled trial aims to evaluate the efficacy of a physical activity coaching intervention - delivered through an ehealth platform, both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with chronic obstructive pulmonary disease (copd). all participants will attend the pulmonary rehabilitation program for 10 weeks. at week 5 of the rehabilitation program, the experimental group will receive a physical activity coaching intervention, which will continue for 6 months following its completion. this intervention will include an ehealth platform divided into two applications (a mobile app for patients and a web app for researchers/healthcare professionals). goal setting and progression according to patients' performance and willingness to increase will occur every week, through phone calls. barriers to physical activity and strategies to overcome them will be identified between the patient and researcher, during the goal-setting moments. notifications about pa goals achievement and incentives will be sent to patients during the intervention. the assessment moments will be conducted at the beginning, midway, and end of the pulmonary rehabilitation program, as well as 3- and 6 months after its conclusion.

Eligibility criteria:
inclusion criteria: * age \> 40 years old * diagnosis of copd according to gold criteria, clinically stable (i.e., with no exacerbations in the previous month) * being enrolled in a pulmonary rehabilitation program * having a smartphone with access to the internet * being able to understand and provide informed consent. exclusion criteria: * simultaneous participation in another behavioural modification program * having any clinical condition that precludes participation in a pa intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease) * another primary respiratory disease * history of recent neoplasia (including last treatment) in the previous year.

Keywords: physical activity copd ehealth pulmonary rehabilitation
improving outcomes in autism: community implementation of stepped transition in education program

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to conduct the first community-based implementation of the steps program and test feasibility and preliminary impact. after first working with stakeholders to refine and optimize the program we will launch a hybrid type 1 open trial, targeting 25 transition-age youth (tay) with asd.

this community-engaged, applied research study will test the effectiveness of steps (stepped transition in education program for students with asd), a program designed to help transition-age youth (tay) with asd prepare for independence. adults with asd have worse outcomes, with respect to employment, education, and quality of life, than neurotypical peers. research-informed transition planning that addresses core impairments in skills needed for autonomous and independent living, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. in a prior trial, the investigators found steps to be feasible, acceptable, and efficacious. the proposed study is the first test of steps as implemented by community-based providers. through a series of implementation working group meetings with identified community partner agency and stakeholders (families, tay with asd) in the region, the study team will refine steps with the goal of optimizing program sustainability within community settings. following this, a hybrid type 1 open trial will be launched, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. with a sample of tay with asd (n=25) immediate and longer-term clinical outcomes of adult functional outcomes and vocational engagement will be assessed. this research will produce findings with the potential to shift clinical practice related to transition to adulthood for people with asd.

Eligibility criteria:
inclusion criteria: * ages 16-25 confirmed diagnosis of asd caregiver willing to participate stable medication exclusion criteria: * evidence of intellectual disability evidence of suicidal intent

Keywords: autism adult transition employment
evaluation of safety and efficacy of bf-200 ala for the treatment of actinic keratosis with photodynamic therapy

Conditions: Actinic Keratosis

Summary: the aim of the study is to evaluate the non-inferiority of bf-200 ala (ameluz) in the treatment of actinic keratosis (ak) with photodynamic therapy (pdt) compared to metvix.

this was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of bf-200 ala with the comparator metvix® (methyl-\[5-amino-4-oxopentanoate\]) and placebo, for the treatment of ak with pdt.

Eligibility criteria:
main inclusion criteria: * written informed consent. * men and women between 18 and 85 years of age. * 4-8 ak lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (olsen grade 1 and 2) in the face and/or on the bald scalp. lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study. * target ak lesions were to be discrete and quantifiable; adjacent ak lesions were to show a minimum distance of 1.0 cm from one another. * confirmation of ak by biopsy taken at screening. * free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation. * willingness to stop the use of moisturizers and any other topical treatments within the treatment region. * good general health condition. * healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type ii, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication. * no extensive sunbathing or solarium use during the trial. * negative pregnancy test at screening. main exclusion criteria: * known hypersensitivity to bf-200 ala, mal (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations * clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult * presence of photodermatoses * presence of other tumors in the treatment areas within the last 4 weeks * start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening * current treatment with immunosuppression therapy * hypersensitivity to porphyrins * presence of porphyria * presence of inherited or acquired coagulation defect * any topical treatment within the treatment area within 12 weeks before pdt1 (first pdt treatment) * topical treatment with ala or mal outside the treatment area during participation in the study * none of the specified systemic treatments within the designated period before pdt1
evaluation of the proximal femoral nail antirotation with cement augmentation in osteoporotic femoral neck fractures

Conditions: Proximal Femur Fracture

Summary: this is an open multicenter study, evaluating a new operative technique in femur neck fractures. the treatment consist of augmentated nails in cases of subtrochanteric or inter fracture due to osteoporosis.there two routine surgical techniques in femoral neck fractures: 1. insertion an intramedullary nail (without augmentation) to the bone. 2. insertion a nail and metal plateto the bone. the major disadvantage of these methods is the relative high rate (4-10 precentages) of failure because of the femur head bone which is very brittle and osteoporotic. this new approach enables the nail a better grip as a result of the cement augmentation which consists of pmma (polymethyl methacrylate). the investigators main goal is to evaluate the use of this surgical technique


Eligibility criteria:
inclusion criteria: * pfna augmentation is indicated for severe osteoporotic fractures (subtrochanteric or intertrochanteric) in the proximal femur. * men and women above 80 years old that fuffer from fracture in the proximal femur. exclusion criteria: * patient can not come to the follow up clinic visits.
safety and tolerability of vgr-r01 in patients with bietti crystalline dystrophy

Conditions: Bietti Crystalline Dystrophy

Summary: an open-label, non-randomized, uncontrolled, single-dose pilot study of vgr-r01 in patients with bietti crystalline dystrophy.

vgr-r01 is a novel aav vector carrying the human cyp4v2 coding sequence. this study is intended to evaluate the safety and tolerability of a single subretinal administration of vgr-r01. all subjects will undergo 365(±7) days of safety observation and will be encouraged to enroll in an extension study to evaluate the long-term safety of vgr-r01 for a total of five years.

Eligibility criteria:
inclusion criteria: 1. ≥18 years and \<80 years of age; 2. confirmed diagnosis of bietti crystalline dystrophy; 3. molecular diagnosis of cyp4v2 mutations (homozygotes or compound heterozygotes); 4. bcva ≤ 20/200 in the study eye; 5. -8 d \<diopters\< +8 d, 21 mm \< axial lengths ≤ 28 mm in the study eye; 6. normal liver function and renal function； 7. agree to use reliable barrier contraception for 1 year after administration of vgr-r01; 8. able to provide informed consent and comply with requirements of the study. - exclusion criteria: 1. have insufficient viable retinal photoreceptor cells based on investigator's decision; 2. have current ocular or periocular infections, or endophthalmitis; 3. have any significant ocular disease/disorder other than bcd, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc; 4. have intraocular surgery history except cataract surgery in the study eye; 5. prior medications which may interfere with the interpretation of study endpoints within six months before screening, eg. anti-vegf drugs; 6. have or potentially require of systemic medications that may cause eye injure; 7. live attenuated vaccines is expected to be required during the study; 8. participation in a clinical study with an investigational drug or medical device within three months before enrollment; 9. history of allergy or sensitivity to investigational drug, medications planned for use in the study; 10. use of anticoagulants, or after 10 days cessation of anti-platelet agents the platelet function does not recover; 11. use of any corticosteroids, other immunosuppressive drug(s) or antipsychotic drugs (eg. antidepressant, etc.) within 3 months prior to enrollment; 12. have contraindications for corticosteroids or immunosuppressant; 13. have complicating systemic diseases that would preclude the planned follow-up; 14. abnormal coagulation function or other clinically significant abnormal laboratory results; 15. have malignancies or history of malignancies; 16. history of immunodeficiency (acquired or congenital); 17. females in lactation period; 18. have a history of alcohol or illicit drug addiction; 19. unable or unwilling to comply with the schedule of visits. -
nk-orb expression of mu receptor on lymphocytes in rehabilitation

Conditions: Fibromyalgia

Summary: chronic pain is a serious disorder that causes physical suffering and emotional distress. nk cells are cytotoxic granular cells playing a crucial role in innate immunity. recent studies described modulation of the percentage of b lymphocytes and nk cells expressing the μ opioid receptor as a potential marker for measuring pain. neuropathic pain sufferers have decreased nk cell function, highlighting the need of further investigating the effect of opioid receptor expression on lympoid cells defining their potential relevance as a pain monitor marker. opioid receptors expressed on nk, b and t cells are a possible candidate for objective monitoring of pain in patients.

pain is a serious global problem based on the preliminary data, peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of mu-positive nk cells and to evaluate if they could be eligible as predictive markers of chronic pain. all patients in the experimental group will undergo three blood sample collections at specific time points to evaluate the percentage of mu-positive nk cells, and its modulation according to rehabilitation programs: the day of the enrollment (t0), at half part of the neuro rehabilitation programs (t1) and at the end of neuro-rehabilitation programs (t2). particularly, the two study groups involved will be in a experimental group (50 consecutive patients who have an nrs \>5); a control group (50 patients who have an nrs \<5). peripheral blood will be incubated with different fluorochrome-conjugated antibodies, specific for natural killer cells, in combination with anti-mu opioid receptor (mor) and the data will be analyze usin flow cytometer and flowjo. the level of statistical significance will be fixed at p \< 0.05. analyses will be carried out using graphpad prism software (v8.00; graphpad software). the results are expressed as mean ± sem the expected results from this study could support the hypothesis that modulation of the µ opioid receptor on nk cells is a valid method for pain measurement, helping to establish an innovative approach in a rehabilitation program.

Eligibility criteria:
inclusion criteria: irccs san raffaele roma patients who entered the neuro-rehabilitation program, aged 18 years older, able to sign a written informed consent. exclusion criteria: * patients with oncological or psychiatric diseases. * pregnant patients * patients with a severe psychiatric disorder (excluding mild depression) or mental/cognitive impairment

Keywords: chronic pain, nk cells, lymphocytes, mu opioid receptor
app-supported vestibular rehabilitation (rct)

Conditions: Vestibular Disorder; Vestibular Diseases; Vestibular Abnormality

Summary: a randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to vr and treatment outcomes

vestibular rehabilitation (vr) home exercises, prescribed by physiotherapists, are the main treatment for vestibular dysfunction. however, reports by clinicians indicate that patients do not fully comply with the treatment. advances in technology and tele-rehabilitation have the potential to facilitate adherence to home exercise, if they are designed to overcome the barriers for practice. we plan to continue and expand our previous feasibility study with the vestibular phone app, in order to examine the effects of an app-assisted vr program on adherence and treatment outcomes. the patients in this study will be randomly assigned to the intervention (app-assisted vestibular rehabilitation) or the control group (standard vestibular rehabilitation, no app). tests and measurements for both groups will be done at three time points: 1. preliminary assessment session (session 1)- an initial assessment test on the first visit; 2. secondary assessment session (session 2)- after 5-6 weeks; 3. follow-up evaluation session (session 3)- one month after the secondary assessment session.

Eligibility criteria:
inclusion criteria: * individuals aged 18 and over * diagnosis with any vestibular disorder that requires a vestibular rehabilitation exercise program * physical and cognitive ability to perform vestibular physiotherapy exclusion criteria: * a physical disability that does not allow for the performance of vestibular physiotherapy * a diagnosis of a central vestibular disorder caused by structural damage to the brain * individuals who are not qualified to give informed consent

Keywords: vestibular rehabilitation app-assisted rehabilitation rehabilitation technologies adherence compliance
extraperitoneal versus transperitoneal cesarean section

Conditions: Cesarean, Extraperitoneal

Summary: the aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.


Eligibility criteria:
inclusion criteria: * elective cesarean (primary or repeated up to four) exclusion criteria: * emergent cesarean * macrosomia (fetal weight \> 4500 g) * history of major abdominal surgery * suspected abnormal placentation * placenta previa

Keywords: cesarean, extraperitoneal cesarean pain