Kornimate/medical-research-clean huggingface dataset:
comparison of gastric by-pass and optimized medical treatment in obese diabetic patients

Conditions: Obesity; Diabetes

Summary: the objectives are to compare the results of the gastric by-pass (gbp) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

optimizing the management of type 2 diabetes (t2d) will remain a major public health concern for decades to come. t2dm has already affected 4% of the french population and generates each year over 12 billion euros of expenditure. by combining therapies, oral and/or injectable (insulin or analogues of glp-1), the current management of t2dm provides two thirds of patients with a satisfactory metabolic control (hba1c \< 7%) and reduced incidence of cardiovascular complications. its effect on mortality, however, remains more limited, presumably because of the persistence of other cardiovascular risk factors. a recent study has confirmed that french patients with t2dm present an overall mortality risk significantly higher than the general population. in france, this group registered a mortality of 32 deaths per 1000 persons. bariatric surgery is now a recognized method for the treatment of severe obesity. it allows for the permanent loss of at least 50% of initial excess weight. in obese patients, this surgery is also associated with a significant reduction in cardiovascular risk factors and particularly t2d. a recent meta-analysis of retrospective studies available suggests that surgery results in remission of t2dm in over 75% of cases. the only prospective randomized study showed that gastric restriction by placing a gastric band, provides better glycemic control than just medical treatment in obese patients with recently discovered t2dm. the gastric by-pass (gbp) which also includes an intestinal by-pass, seems to have an even higher metabolic efficiency than gastric bypass alone. in patients with t2dm, the gbp restores postprandial insulin secretion independently of weight loss. despite the significant morbidity of the intervention, long-term results seem broadly supportive of the gbp. in a large case-control study, gbp was associated with a decrease of 90% of deaths related to diabetes. in a controlled study conducted in surgical candidates obese diabetics, the gbp decreased the overall world mortality by 75% after 6 years. despite these very encouraging data, the gbp is now proposed to only a small proportion (\< 1%) of patients likely to benefit from the procedure.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus with hba1c \> 7.5 % * body mass index \> 35 and \< 50 kg/m2 * candidate for gastric by-pass * treatment with glp1 (glucagon-like peptide) analogue or insulin exclusion criteria: * contraindication to bariatric surgery * pregnancy * affiliation of health care assurance * psychiatric disorders

Keywords: obesity diabetes bariatric surgery
misoprostol versus oxytocin infusion on reducing blood loss during abdominal myomectomy

Conditions: Myoma;Uterus

Summary: uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. they can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion. various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative gnrh agonist administration, and preoperative ascorbic acid injection. however, these strategies may have complications, be ineffective, expensive, or require extra steps. oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. however, caution is needed in its use, especially in women with heart disease or hypovolemia. misoprostol, a prostaglandin e1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. it can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.


Eligibility criteria:
inclusión criteria: patients aged between 20 to 48 years old. bmi less than 35 kg/m2 symptomatic uterine myomas. intramyometrial myoma staging from (3 to 6) according to figo staging through trans vaginal ultrasonography (tvusg) or magnetic resonance imaging (mri) according to figo classification. maximum diameter of the largest myoma is 15 cm. uterine size between 14 to 28 weeks of pregnancy. exclusion criteria: 1. history of previous myomectomy 2. allergy to misoprostol, carbetocin, txa, ethamsylate, oxytocin, vasopressin, bupivacaine and epinephrine. 3. hypertension. 4. cardiac and pulmonary diseases. 5. patients who have bleeding disorders. 6. patients on antiplatelets or anticoagulant before surgery. 7. anemia (hb \< 10g %). 8. chronic endocrine or metabolic diseases such as diabetes. 9. renal and hepatic impairment. 10. moderate and morbid obesity (body mass index \> 35 kg/m2). 11. cases that will require intraoperative conversion of myomectomy to hysterectomy. 12. intracavitary, submucosal, pedunculated subserosal and adnexal myoma figo staging 0,1,2,7,8. 13. history of gynecological infections (pid), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause. -

Keywords: misoprostol oxytocin myomectomy blood loss
individualized duration of antibiotic treatment in early onset infection in newborns.

Conditions: Early-Onset Neonatal Sepsis; Antibiotic Side Effect

Summary: a nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. the study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.

there is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. the study aims to evaluate the effect of individualized treatment duration in early-onset infection. the study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. the investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of crp is non-inferior to the standard care being seven days of treatment. in the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of crp, with an absolute threshold of crp ≤ 30 mg/l. the investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.

Eligibility criteria:
inclusion criteria: * gestational age ≥ 35 weeks * birth weight ≥ 2000 * probable or possible infection according to the structured infection risk assessment * sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment * negative blood culture after 48 hours exclusion criteria: * infants with positive blood culture * blood culture volume prior to antibiotics of \< 0.2 ml * site-specific infection as for example, meningitis or osteomyelitis * infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; low suspicion of sepsis initially including few and vague symptoms, crp maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment

Keywords: neonatal early-onset infection antibiotic
a co-designed physical activity intervention in fabry disease

Conditions: Fabry Disease

Summary: currently, treatments for fabry disease are pharmacological and predominantly focus on the physical symptoms of the disease. in the general population and individuals with disabilities, increasing physical activity levels and reducing sedentary time can be an effective, non-pharmacological treatment to improve mental health and quality of life. such interventions have not yet been developed or evaluated in people with fabry disease. the aim of this study is to co-design a physical activity and sedentary behaviour intervention tailored to the needs of adults with fabry disease. the study will seek to gain the expertise of adults with fabry disease, specialist stakeholders (physicians, cardiologists and clinical nurse specialists) and lay specialist stakeholders (family and friends of adults with fabry disease and members of staff and volunteers at the society for mucopolysaccharide diseases). a range of views and experiences of physical activity and sedentary behaviour will be explored via focus groups (with individuals with fabry disease and lay specialist stakeholders) and semi-structured interviews (with specialist stakeholders). the information gathered from the focus groups and interviews will then be utilised to inform participatory workshops (with individuals with fabry disease) to test intervention concepts. data from these activities will inform the design of a future intervention.


Eligibility criteria:
individuals with fabry disease will be eligible to participate in the study if they meet the following inclusion criteria: * have been diagnosed with fabry disease. * aged ≥ 18 years old. * able to independently ambulate with or without the use of a walking aid. * lives in the united kingdom. * deemed eligible to participate following screening by a clinician (for participatory workshops). the circumstances in which an individual may be deemed ineligible to participate in the participatory workshops based on the clinician's assessment are as follows: * severe neuropathic pain. * stage 4 heart failure or other condition resulting in breathlessness to a level they cannot participate. * other clinical condition which dominates the clinical picture to the extent that it dominates the symptoms and biases the results. exclusion criteria for all participants will be as follows: * incapacity to provide written informed consent. * unable to communicate in english to a sufficient level to permit engagement in the study. specialist stakeholders will be members of staff at nhs specialist centres for fabry disease who are directly involved in the healthcare of adults with fabry disease. lay specialist stakeholders will be individuals who have been involved in supporting adults with fabry disease, such as family, friends and members of staff at the society for mucopolysaccharide diseases.
silymarin cream versus combined silymarin cream and microneedling in treatment of melasma

Conditions: Melasma

Summary: melasma is an acquired pigmentary disorder, occurring most commonly on the face. it is more prevalent in females and darker skin types. melasma is mainly a clinical diagnosis consisting of symmetric reticulated hypermelanosis in three predominant facial patterns: centrofacial, malar, and mandibular. melasma, though benign, can be extremely psychologically distressing and has been shown to have a significant impact on quality of life, social and emotional wellbeing. multiple factors are implicated in the pathogenesis of melasma; however, the definite underlying mechanisms are not yet completely established. ultraviolet exposure is one of the leading etiological factors, besides genetic and hormonal factors.

many studies examined multiple treatment options for melasma, but none of them is completely satisfactory with recurrence in most cases. silymarin (sm) is a standardized extract from silybum marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. lately, sm is utilized in dermatological and cosmetic preparations for its antioxidant effect, anti-inflammatory and immunomodulatory properties. silibinin, the main component of silymarin, has been found to have antioxidant properties. it decreases the hazardous effects of solar ultraviolet radiation and significantly prevents melanin production in a dose-dependent manner without effect on cell viability. skin microneedling, or percutaneous collagen induction by needles, is a minimally invasive procedure that uses short fine needles to puncture the skin and stimulates fibroblast proliferation, release of growth factors and collagen production. long-term improvement of melasma after microneedling was reported , however, the exact mechanism that promotes skin lightening is not known.

Eligibility criteria:
inclusion criteria: * age: 18-50 years old. * pattern of melasma: bilateral symmetrical facial melasma of any pattern. * fitzpatrick skin phototypes: types iii, iv and v exclusion criteria: * pregnancy and lactation. * patients taking oral contraceptive pills, hormonal replacement therapy or treatment for chronic illness at the time of the study or during the past 6 months. * coexistance of diseases associated with hyperpigmentation such as addison disease. * scarring and keloid tendency, active skin infections as active hsv. * previous history of post inflammatory hyperpigmentation.
impact of combined hormonal contraceptives on upa

Conditions: Contraception

Summary: the purpose of this research study is to determine if taking a birth control pill effects how well an emergency contraceptive pill called ulipristal acetate (upa) works. this type of emergency contraceptive is the most effective oral method available. however, this medication is an anti-progestin and most regular forms of birth control contain progestin (a female hormone). it is unknown if taking the two close together may make the emergency contraceptive not work well. the overall goal of this research is to improve the effectiveness of contraception for women and to better counsel women.

emergency contraception (ec) provides women with an additional line of defense against unintended pregnancy during an act of unprotected intercourse. an antiprogestin, ulipristal acetate (upa; ellatm), has emerged as one of the most effective oral options. however, there is currently a lack of information regarding the practical use of upa. basic science studies have shown that upa binds to and prevents progesterone receptor from working, leading to the possible concern that hormonal contraceptives, like the birth control pill, would prevent upa from working. ideally, women should start their regular method of birth control soon after ec use but by doing this, they may prevent the upa ec from working. a woman could just delay starting her regular method of birth control but then she is still at risk for pregnancy. this proposal has been designed to address this gap in knowledge and will focus on the impact of the birth control pill on upa's ability to delay ovulation (or the release of an egg). subjects will undergo a referent cycle upa only (cycle 1, 1 month), followed by a washout cycle (cycle 2, 1 month) and finally upa with combined oral contraceptives (cocs) dosed 2 days later (cycle 3, 1 month treatment cycle). the hypothesis is that starting the birth control pill shortly after upa adversely impacts upa's ability to delay ovulation.

Eligibility criteria:
inclusion criteria: * generally healthy women aged 18 to 35 with regular menses (every 21-35 days). * normal bmi * proven ovulation with a screening serum progesterone of \>3ng/ml * willing to use condoms (if sexually active with a male partner), willing to not have sex with men during the study, or have had a tubal ligation (or have a partner who has had a vasectomy) or have a copper intrauterine device (iud). exclusion criteria: * known intolerance or allergy to any of the study medication * known metabolic disorders including polycystic ovarian syndrome or uncontrolled thyroid disorder * overweight or obese bmi * any centers for disease control and prevention (cdc) medical eligibility criteria category 3 or 4 for combined oral contraception (coc) use 12. * pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception * current use of drugs that interfere with metabolism of sex steroids * smokers.

Keywords: emergency contraception birth control pills
effect of a posture adapter for 12 to 24-month children with zyka virus syndrome

Conditions: Zika Virus

Summary: congenital zika virus syndrome (sczv) has been gaining attention in studies due to changes in the central nervous system and in the motor development of children. these changes resulted in an unexpected picture and without future predictability, with the appearance of several functional impairments and also on orthostatic posture. in this context, the protocol of orthostatism proposed here is a 10-week program of the use of a postural adjuster, the standing frame, made of its own with alternative material to the commercial models (cardboard). the use of low cost materials allows these devices to be made in the desired size without cost high, individually adapted, easy to be transported as it is light and can still be colored. it is an equipment that offers the opportunity to experience the orthostatic posture and mainly benefits children with little economic resources that enable the acquisition of traditional devices made of iron or wood and even imported equipment. the postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in standing positioning, feasible for home use, besides being useful for performing functional activities. thus, the objective will be to analyze the repercussions of the use of the standing frame on body alignment, muscle tone, gross motor function and gastrointestinal functions of children with sczv. an uncontrolled intervention study will be conducted with children between 12 and 24 months of age, who will undergo an evaluation before use and after the use of the adjunct along with the proposed orthostatism protocol. the postural alignment will be evaluated through photogrammetry and the evaluation of muscle tone will be performed through the modified tardieu scale. the gross motor function measure (gmfm) scale will be used to assess the gross motor function of the children involved in the study. questionnaires will be applied for the collection of maternal socio-demographic data, the child's data, the type and time of therapy that the child already participates, and the gastrointestinal functions. evaluations will occur in four moments: initial / before use, on the first day of placement in the adjuster, after the first month after use and after the second month of use. for statistical analysis, the shapiro wilk test will be applied to evaluate the normality of the data, and the friedman or anova tests for repeated samples, to analyze intra-group time factor for the dependent variables of each individual.


Eligibility criteria:
inclusion criteria: * children between 12 and 24 months old; * children with confirmed zika virus infection diagnosis; * children with storch + for zika virus (blood test) exclusion criteria: * children with no medication for controlling zika virus infection symptoms; * children with musculoskeletal disorders or limitation to standing position
virtual surgery of the upper airways

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is a sleep related breathing disorder caused by repetitive collapses of the upper airways resulting in impaired breathing, oxygen desaturation and sleep disturbances. osa has a massive impact on global health contributing directly to cardiovascular diseases, insulin resistance, metabolic syndrome and daytime fatigue and is repeatedly associated with an increase in motor vehicle accidents. the mainstay of treatment is still the use of positive airway pressure or surgery of the upper airways, but the success rate is persistently low. surgery may be of help, but there is a lack of patient-specific options in both diagnostics and treatment. mathematical and computational modeling is expected to provide significant insight into the airway function and onset of osa. this study is part of a project that will rely on biomedical engineering to obtain the required insight to produce software tools for computer-aided diagnostics and treatment of osa.

this study is the clinical part of a project that contains 4 work packages (wp 1-4). the clinical study (work wp 1) will ensure the inclusion of up to 30 patients with verified sleep apnea that will be in need of either structural nasal surgery, pharyngeal surgery or orthognathic surgery. studies of nasal airflow and pressure as well as a detailed conebeam ct scans of the upper airways will be performed before and after surgery. wp 2, 3 and 4 deals with the mathematical modeling, structural mechanic modeling and the patient-specific airflow modeling.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnea * need either functional septorhinoplasty or oropharyngeal/orthognathic surgery in order to establish adequate airway patency * have undergone sleep registration using polysomnography and ultrawideband radar * on the subsequent clinical evaluation presenting either 1) intranasal obstruction, due to malalignment of the nasal septal cartilage or the nasal outer framework; and/or 2) oropharyngeal obstruction or retrognathia. exclusion criteria: * previous nasal or oropharyngeal surgery * previous use of nasal decongestant or nasal topical steroids over the last 3 months

Keywords: surgery rhinoplasty nasal obstruction soft tissue biomechanics
edwards evoque eos miscend study

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Summary: study to evaluate the safety and performance of the edwards evoque eos mitral valve replacement system

the study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the edwards evoque eos mitral valve replacement system.

Eligibility criteria:
inclusion criteria: * clinically significant, symptomatic mitral regurgitation * high risk for open-heart surgery * meets anatomical criteria exclusion criteria: * unsuitable anatomy * patient is inoperable

Keywords: mitral regurgitation insufficiency degenerative functional primary secondary organic transcatheter tmvr tmvi heart valve mitral valve transseptal trans-septal transeptal severe