Kornimate/medical-research-clean huggingface dataset:
effectiveness of a pain science education programme in adolescent students.

Conditions: Chronic Pain; Pain; Pediatric ALL

Summary: the aim of this study is to analyze the effectiveness of a pain science education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of compulsory secondary education.

design: randomized controlled clinical trial. the primary endpoint of the study was pain conceptualization recorded by a questionnaire. setting: the participants were school-age children attending a different high school in the province of barcelona. participants: of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293

Eligibility criteria:
inclusion criteria: * to be schooled at the el cim school * to be between 10 and 16 years old (both included) * to have or have had pain in the last month; to be able to read and write in catalan and/or spanish. exclusion criteria: * had an intellectual disability and/or cognitive impairment that interfered with their participation * had not submitted the informed consent form duly completed and signed by their legal guardians
clinical performance study of the abtest card® device.

Conditions: Transfusion Reaction

Summary: the study aims to confirm the performance equivalence of the in vitro diagnostic device abtest card®ref with the abtest card®new device.

following some changes in the abtest card® raw materials, a new validation of the associated clinical performances is required. raw materials of the abtest card® are : triton, cleanis, tween, yellow, blue dye and the blood segment opener device. according to the regulatory text "common specifications for certain class d in vitro diagnostic medical devices in accordance with regulation (eu) 2017/746 of the european parliament and of the council", 90% of the results will be derived from the performance study carried out at the diagast laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside"). the regulation 2017/746 (ivdr) on ivdmd, has been effective since may 2022 with transitional periods. the ivdr replaces the current eu directive (98/79/ec) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the eu market. as the abtest card® is already ce marked under directive 98/79/ec as list iia product, this study is part of the device's post-marketing performance monitoring. the purpose of this study is to document and verify the clinical performance of the abtest card® device in combination with the new raw materials used for manufacturing (abtest card®new), by comparing the results obtained with the abtest card®ref, already commercialised and used routinely by the study sites.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old for the category marked with \*. * undergo capillary blood sampling ; * belong to one of the clinical categories: * patient in need of blood transfusion without any pathology known to have an impact on transfusion act\* ; * patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)\* ; * patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis\* ; * patient with cold agglutinin\* ; * premature patient with gestational age \< 37 weeks or newborn ≤27 days old in need of blood transfusion ; * newborn eligible for the guthrie test ; * newborn eligible for the glycaemic test. * have health care insurance ; * have given his/her written consent (or legal representative in the case of a newborn) ; exclusion criteria: * pregnant woman ; * person deprived of liberty ; * unconscious person ; * person under guardianship or trusteeship ; * for paediatric clinical category: age ≥28 days and \<18 years old.
clear procedure in myopia and astigmatism - registry study

Conditions: Myopia; Astigmatism

Summary: multicenter, prospective, single-arm, observational, non-interventional post market clinical investigation (registry study) with the overall objective to assess safety and performance of clear in a real world setting.


Eligibility criteria:
formal inclusion/exclusion criteria are not applicable to the study at hand, due to its observational and non-interventional nature. patients treated with the clear application using femto ldv z8, enrolled in the study are expected not to present with any of the market-approved device's contraindications: * residual thickness of stromal bed that is less than 250 microns from the corneal endothelium * abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration * ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) * irregular or unstable (distorted/not clear) corneal mires on central keratometry images * severe dry eye * active eye infection or inflammation * recent herpes eye infection or problems resulting from past infection * active autoimmune disease or connective tissue disease * uncontrolled diabetes * high iop fluctuations that are not controlled under medications and continuous visual field damage note 1: the above listed contraindications are a subject to change, as per pms, risk management or other regulatory feedback, and will be covered and communicated to the participating investigators in the prospective updates of the operator's manual. note 2: only eyes of patients treated bilaterally shall be included in the analysis covered by this registry study. note 3: patient's targeted for "monovision" shall not be included in the analysis covered by this registry study. note 4: clinical cases, that despite presenting any of the above listed contraindications, would still be enrolled in the study by the investigator, may be subject to a sub-group statistical analysis.

Keywords: clear ziemer femto ldv astigmatism myopia lenticule extraction
fms european long-term study

Conditions: Fibromyalgia Syndrome

Summary: investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * patient who completed the 3-month f02207 ge 302 study * patient with a diagnosis of fibromyalgia according to the 1990 acr criteria at entry of f02207 ge 302 study exclusion criteria: * known hypersensitivity to milnacipran * major depressive episode * significant risk of suicide * generalised anxiety disorder * substance abuse * clinically significant cardiac disease * pulmonary dysfunction * active liver disease * renal impairment * autoimmune disease * current systemic infection * epileptic * active cancer * severe sleep apnoea * active peptic ulcer * inflammatory bowel disease * unstable endocrine disease * (for men) prostatic enlargement or other genito-urinary disorders * (for women) pregnancy or breastfeeding
1-week dispensing evaluation of kalifilcon a daily disposable multifocal compared to ultra for presbyopia

Conditions: Presbyopia

Summary: experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. all subjects will be seen for a screening/dispensing visit at which informed consent will be obtained and eligibility will be assessed. if subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each investigator if vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.


Eligibility criteria:
inclusion criteria: * be 40 years or older on the date the informed consent form (icf) is signed and have the capacity to read, understand and provide written voluntary informed consent. * have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * have no active ocular disease or allergic conjunctivitis. * not be using any topical ocular medications. * be willing and able to follow instructions. * have signed a statement of informed consent. exclusion criteria: * participating in a conflicting study. * considered by the investigator to not be a suitable candidate for participation.
the effects of a ficus carica on improvement in bowl movements in female volunteer with functional constipation

Conditions: Functional Constipation

Summary: this trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation: to evaluate the improvement of the bowel to assess the quality of life and impact on female reproductive function to evaluate the influence on glucose, cholesterol, hdl-cholesterol, ldl-cholesterol


Eligibility criteria:
inclusion criteria: * subjects who are female volunteers (unmarried), 19\~40 years * subject who have functional constipation by rome iiii criteria * subject who have over 36 hour colonic transit time * subject must provide written informed consent to participate in the study exclusion criteria: * subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease * subjects who have a gastrointestinal (gi) disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a gi surgery excluding appendectomy and hernia surgery * subject with uterine fibroids at ultrasonography * subject is pregnant, planning to become pregnant, or breast-feeding * subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen * known history of moderate to severe hepatic impairment (i.e., serum alt\>1.5×uln, ast\>1.5×uln) * subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure ≤ 95 mmhg or diastolic blood pressure ≤ 60 mmhg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmhg or diastolic blood pressure≥ 95 mmhg measured) at vital sign measurement * subjects with significant hypersensitivity about ficus carica * subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration * subjects who participated in other clinical investigation within 2 months prior to first administration * subject who drink constantly (21 units/week over) * subject who have irritable bowel syndrome by rome iiii criteria * any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study (i.e., laboratory test and others)

Keywords: ficus carica functional constipation dietary supplement fig paste
brexpiprazole (opc-34712) as an adjunctive treatment in adults with major depressive disorder and anxiety symptoms

Conditions: Major Depressive Disorder; Anxiety

Summary: the purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (ssri)/serotonin norepinephrine reuptake inhibitor (snri) response.


Eligibility criteria:
main inclusion criteria: * have a diagnosis of a single or recurrent, nonpsychotic episode of mdd as defined by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) and confirmed by both the mini international neuropsychiatric interview (m.i.n.i.) and an adequate clinical psychiatric evaluation. * have a treatment history of an inadequate adt response to at least 1 adt (but not \> 3) for the current episode. * have received a single, trial-approved, ssri or snri at an adequate dose for ≥ 6 weeks prior to screening. * are 18 to 65 years old at the time of consent (inclusive, and outpatients only). * have a hamilton depression rating scale (ham-d)-17-item total score ≥ 18 at screening and baseline. * have a hamilton anxiety rating scale (ham-a) total score ≥ 20 at screening and baseline. main exclusion criteria: subjects with any of the following current axis i dsm-iv-tr diagnoses: * delirium * dementia * amnestic * other cognitive disorders * schizophrenia * schizoaffective disorder * other psychotic disorders * bipolar i disorder, * bipolar ii disorder * bipolar disorder not otherwise specified (nos) * eating disorders * anorexia nervosa * bulimia * obsessive compulsive disorder * post-traumatic stress disorder subjects with any of the following current axis ii dsm-iv-tr diagnoses: * borderline, antisocial * paranoid * schizoid * schizotypal * histrionic personality disorders * mental retardation.

Keywords: schizophrenia major depressive disorder anxiety symptoms mental disorders psychotic disorders emotional withdrawal antipsychotic
improving diabetes outcomes: a couples intervention

Conditions: Diabetes

Summary: research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. however, diabetes programs rarely involve the partner. this is a study to develop and test an intervention that helps partners and patients who have type 2 diabetes better support each other. the intervention will be delivered over the telephone to reach more people. our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.

research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. however, diabetes programs rarely involve the partner. this is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support. we believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes. the intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.forty-five couples will be recruited in which one partner has type 2 diabetes. after initial testing and basic diabetes education, they will be assigned to one of three comparison groups. for those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques. a manual will include readings, structured homework assignments, and self-monitoring logs. they will be re-tested 2 weeks and 3 months after the intervention.

Eligibility criteria:
inclusion criteria: * greater than 21 years of age. * diagnosed with type 2 diabetes for at least 1 year. * have no severe complications (on dialysis, blindness, amputations, history of stroke) * able to speak, read and hear english. * married or cohabiting for \> 1 year. * have a telephone. exclusion criteria: * have a diagnosed psychiatric disorder. * refuse audiotaping or other study procedures.

Keywords: diabetes relationship social support behavior change telemedicine
development of isthmocele symptom severity and quality of life scale

Conditions: Quality of Life

Summary: isthmocele, also known as cesarean scar defect (csd), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain. there is currently no quality of life scale that assesses isthmocele symptoms. a scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. this study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

patients with isthmocele symptoms three months after cesarean delivery will be included in the study.the study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Eligibility criteria:
inclusion criteria: * patients with isthmocele symptoms three months after cesarean delivery will be included in the study. exclusion criteria: * the study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps. * patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Keywords: isthmocele quality of life questionnaire abnormal uterine bleeding
3d ultrasound in women with vacuum or forceps deliveries

Conditions: Pelvic Floor Injury; Urinary Incontinence; Stool Incontinence

Summary: the purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (vavd) versus a forceps assisted vaginal delivery (favd) using three-dimensional ultrasound imaging. women within 1-5 years after first delivery who did not have an internal delivery will be included. the total number of subjects is forty. this will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.


Eligibility criteria:
inclusion criteria: * females age \>18 and \<45. * primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery. * birth weight \>2500g and \<4500g. * delivery should have occurred more than one year ago, but less than five years ago. pregestational bmi \<35kg40kg/m2. exclusion criteria: * presence of interim delivery. * presence of both vacuum and forceps use during delivery. * presence of pregestational or a2 gestational diabetes mellitus. * presence of neuromuscular disorder (i.e., spinal cord disease, multiple sclerosis, myasthenia gravis) or connective tissue disorder (i.e., lupus and sjogren's disease).

Keywords: pelvic floor injury levator ani muscle
effectiveness and safety of cream containing spent grain wax extract, argan oil, and shea butter post-tricholoroacetic acid 15% peel: randomized, controlled, double-blind, split-face clinical trial

Conditions: Aging Disorder

Summary: chemical peels are resurfacing procedures where chemical agent causes controlled exfoliation of the skin, followed by regeneration and remodelling of the epidermis and dermis layers. chemical peels can be used to treat various skin condition, such as skin aging, pigmentary disorders, and skin texture disorders. the use of moisturizer after chemical surgery can help speed up the wound healing process and repair the skin barrier. tca chemical peel has more side effects than other chemical peel solutions. the risk of complications after tca chemical surgery on fitzpatrick iv-vi skin types is also higher, especially post-inflammatory hyperpigmentation. there is no specific recommendations regarding the type of moisturizer that can be used after tca chemical peels. this study aims to assess the effectiveness of a cream containing spent grain wax, argan oil, and shea butter in reducing tca peel side effects.


Eligibility criteria:
inclusion criteria: women, 30 - 60 years old with facial skin aging underwent chemical peeling with tca 15%, have received priming with topical retinoic acid 0.05%, for at least 2 weeks and its use has been discontinued three days before chemical peel. exclusion criteria: pregnant or lactating women, patients who received hormonal therapy, immunosuppressants, allergic to any of treatment ingredients, had active skin diseases on the face (acne vulgaris, seborrheic dermatitis, dll), history of keloid/hypertrophic scar, open wound, active infection, or history of recurrent herpes simplex

Keywords: aging skin aging trichloroacetic acid chemical peel anti-inflammation moisturizer
chronicare for type 2 diabetes (chronicare-t2d)

Conditions: Type 2 Diabetes

Summary: this single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the chronicare disease management program in the management of subjects with t2d who are being treated with insulin glargine and metformin. the chronicare solution comprises connected devices (a bluetooth-enabled insulin pen sensor, a bluetooth-enabled medication container, and a bluetooth-enabled glucometer), a mobile smartphone app (crx health), an automated support system (intervention engine), and a remote care application (crx care) used by a team of clinicians to monitor and support patients.


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 75 years of age, inclusive, at screening. * diagnosed with t2d * have a baseline hba1c level between 7.5% and 10.0%, inclusive, while receiving insulin glargine and metformin. * prescribed insulin glargine and an oral diabetes medication for ≥ 6 months prior to screening. * the ability to follow an evening dosing schedule for insulin glargine. * have an egfr level \>30 l/min, inclusive, according to their most recent measurement. * if female, must be post-menopausal or surgically sterile, or be established on (≥ 3 months prior to screening) and agree to continue to use the same highly effective method of birth control throughout the study. females must agree to avoid pregnancy during their participation in the study. * able to comprehend and give informed consent. * able to comply with the requirements of the study, which include being able to speak and read english, and to complete the full sequence of protocol-related procedures. exclusion criteria: * females who are pregnant (positive pregnancy test at screening), lactating, or if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice. * have type 1 diabetes. * have had or have a malignant neoplasm within the past five years. * undergoing chronic or recurrent treatment with systemic corticosteroids or niacin treatment for hyperlipidemia. * use of one or more of the following agents affecting glycemic control: mifepristone, glp-1ra, or any insulin other than insulin glargine. * concurrent treatment with experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to study start. * unable or unwilling to follow the evening insulin glargine regimen required by the titration protocol (once daily dose must be scheduled between 5pm and 12am). * blood transfusions or severe blood loss in the last 3 months. * any other unspecified reason that, in the opinion of the investigator (or designee) or sponsor, makes the subject unsuitable for enrollment. * active diagnosis of hypoglycemic unawareness. * hypoglycemia (blood glucose \<70 mg/dl with or without symptoms) greater than one episode per week (on average)