Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study comparing the combination treatments of verteporfin therapy plus one of two different doses of intravitreal triamcinolone acetonide and the verteporfin therapy plus intravitreal pegaptanib

Conditions: Macular Degeneration; Choroidal Neovascularization

Summary: to evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. the combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.


Eligibility criteria:
inclusion criteria: * age \>50 * all types of untreated subfoveal choroidal neovascularization secondary to amd * lesion size \<5400 microns in greater linear dimension (gld) exclusion criteria: * have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy * known allergy to verteporfin, triamcinolone or pegaptanib * have received prior treatment with macugen, or other anti-angiogenic compound or any investigational treatment (e.g. ruboxistaurin, lucentis \[ranibizumab\], retaane \[anecortave acetate\], squalamine, sirna, vegf-trap etc.) for neovascular amd * have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the cnv lesion * have had previous pars plana vitrectomy in the study eye other protocol-specified inclusion/exclusion criteria applied.

Keywords: amd age-related macular degeneration choroidal neovascularization
efficacy of intra-articular corticosteroid injections on clinical outcomes in patients with operative distal radius fractures

Conditions: Wrist Fractures; Intraarticular Injection

Summary: the randomized controlled study which compare clinical outcomes (functional score) in patients with distal radius fractures who underwent open reduction with internal fixation and received intra-articular steroid injections to those who received placebo injections.

randomization of patients for intra-articular triamcinolone injection objective: to compare the effectiveness of intra-articular triamcinolone injection versus placebo in patients with distal radius fractures who underwent open reduction with internal fixation methods: patients: patients with distal radius fractures who need open reduction with internal fixation procedure randomization: patients will be randomly assigned to one of two groups using a block randomization procedure with a block size of 4. randomization will be performed using stata version 16.0 software. interventions: group 1: patients in this group will receive an intra-articular injection of 10 mg triamcinolone (1 ml) during surgery. group 2: patients in this group will receive an intra-articular injection of 1 ml normal saline solution during surgery. allocation concealment: a central randomization service will prepare sealed envelopes containing the assigned treatment for each patient. the envelopes will be labeled with the patient's name and study id. the envelopes will be kept in a secure location until the time of surgery. blinding: the study participants, surgeons, and assessors will be blinded to the treatment allocation. the syringes will be covered with an opaque glove material to further conceal the treatment allocation. outcome measures: pain scores function scores(prwe score : patient-rated wrist evaluation) wrist range of motion grip strength follow-up: patients will be followed up at 2 weeks, 6 weeks, 3 months, and 6 months after surgery. statistical analysis: demographic analysis analyze the differences in each demographic factor between the groups. for continuous data, use mean and standard deviation (s.d.). for categorical data, use number, percentage, and chi-square. inferential statistics compare the results of the study, including: postoperative pain scores wrist function score (prwe) wrist circumference (mm) wrist grip strength (kg) use mean and s.d. for continuous data. use mixed linear model for data analysis. use stata 16.0 software for statistical calculations.

Eligibility criteria:
inclusion criteria: 1. age more than 18 years old 2. closed unstable distal radius fracture unstable type which need surgical management 3. received procedure orif with plate and screws at injured wrist exclusion criteria: 1. history of corticosteroid allergy 2. poor diabetes controlled (hba1c) \> 8 3. who need ritonavir while enter this study 4. unable to follow up until the end of projects 5. unable to do questionnaires 6. infection around injured wrist 7. tear tendon at injured wrist 8. open fracture of injured wrist

Keywords: wrist fractures intraarticular injection corticosteroids
variation of aortic compliance related to exercise training with or without supervised sessions

Conditions: Cardiovascular Disease

Summary: many conditions and cardiovascular diseases (including stroke) are better managed with regular exercise training. the expected effects are partial reversal of adverse effects on heart and blood vessel structure and function, improved glycemic, tension and weight control. physiologically, the aorta maintains low left ventricular after-load, promotes optimal sub-endocardial coronary blood flow, and transforms pulsatile into laminar blood flow. increased aortic stiffness may ultimately contribute to left ventricular dysfunction. regular exercise training is likely to decrease the pulse wave velocity (a measure of the aortic compliance). some subjects seem more responsive than others, and they may not expect the same benefit of exercise training. to the best of our knowledge, this has not been explained yet.


Eligibility criteria:
inclusion criteria: * patients aged 50-69 years, with moderate or high cardiovascular risk exclusion criteria: * any physical or medical problem liable to limit the patient' ability to perform the cardiopulmonary exercise testing or the exercise training in safe conditions.

Keywords: moderate risk high risk
oral glucose in pain alleviation among term neonates

Conditions: Pain

Summary: background: it was long believed that newborns could not experience pain. as it is now documented that newborns have all the necessary systems to perceive pain, pain management can no longer be ignored. pharmacologic agents are not recommended in neonates for pain relief in minor procedures and still there is debate regarding the efficacy of oral glucose, in different strengths, on alleviation of pain among neonates. aim: the objective of this study is to assess the efficacy and safety oral administration of glucose, in different concentrations, on pain relief in full term neonates undergoing heel prick test. methods: the investigators will conduct a prospective, randomized, double blind placebo controlled trial to investigate the effect of glucose solution on alleviating the pain of heel prick test in 244 healthy full term newborns who will be randomly allocated to one of three groups: first group will receive 5% glucose, second group will receive 30% glucose and third group will receive sterile water as a placebo, 2 minutes prior to the procedure. specially trained nurses will take turns to carry out blood sampling. neonatal pain will be assessed by the neonatal infant pain (nips) as well as by duration of crying, changes in heart rate, respiratory rate and oxygen saturation.

the investigators will conduct a prospective, randomized, double blind, placebo controlled study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel prick test. they will be randomized to receive either 5% glucose, 30% glucose or sterile water as a placebo, 2 minutes prior to the procedure. the investigators will study the efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile water) in pain alleviation. all parents will receive an explanation of the study before participation, and informed written consent will be signed by the parents for voluntary participation

Eligibility criteria:
inclusion criteria: * estimated gestational age: 37 weeks-42 weeks * birth weight: 2500 grams- 4000 grams * mode of delivery: normal vaginal delivery * age: birth to 72 hours of life * apgar scores of at least 7 at 1 and 5 minutes * heart rate between 100 and 160 per minutes * blood o2 saturation ≥ 95% * no known congenital anomalies exclusion criteria: * they have history of birth trauma * they are admitted to neonatal intensive care unit (nicu) * they need respiratory support * their mothers are receiving sedatives or opioids during vaginal delivery
selinexor (nexpovio®) (svd) in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the non-interventional study seattle aims to answer open scientific questions regarding qol and tolerability/safety and ae management of selinexor as well as effectiveness and dosing in clinical routine. thus, seattle will provide real-world evidence complementary to pivotal studies.

multiple myeloma (mm) accounts for approximately 10% of hematological malignancies. since mm patients are elderly and often comorbid patients, risk-adapted treatment strategies to further improve outcome in is crucial.selinexor, a potent, oral, sine (selective inhibitors of nuclear exports) binds reversibly to xpo. this leads to nuclear localization and functional activation of tumor suppressor proteins, which further leads to suppression of nuclear factor κb activity, and reduction in oncoprotein mrna translation. all this induces apoptosis of tumor cells. since treatment options for mm are various and the most important factor is to keep or improve quality of life (qol) of the patients, there is an urge for real-world clinical data of mm patients treated with selinexor in clinical routine. the objective of this non-interventional study is to evaluate qol and tolerability/safety and ae management as well as effectiveness and dosing in adult patients with relapsed or refractory mm, which receive selinexor in combination with bortezomib and dexamethasone in the 2nd or later therapy line in a real-world setting.

Eligibility criteria:
inclusion criteria: * relapsed or refractory multiple myeloma * indication and decision for ≥2nd-line treatment with selinexor in combination with bortezomib and dexamethasone according to current selinexor smpc as assessed by the treating physician * treatment decision before inclusion into this non-interventional study * willingness and ability to participate in the electronic patient-reported outcome (epro) module and answering of questionnaires * age ≥18 years * signed and dated informed consent form * inclusion before start of treatment (prospective inclusion) exclusion criteria: * contraindications according to selinexor smpc for patients with mm * participation in an interventional clinical trial

Keywords: multiple myeloma selinexor bortezomib dexamethasone
nutritional intervention of type ii diabetes mellitus by vitamin d in qatar

Conditions: Insulin Resistance

Summary: there is an association between elevated type ii diabetes mellitus (t2dm) risk and low serum levels of vitamin d. it is important to examine whether vitamin d can enhance oral glucose tolerance in individuals at risk for developing t2dm. as such, the hypothesis suggested is that vitamin d supplementation (4,000 iu/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of t2dm.

epidemiologically, there is an association between elevated t2dm risk and low serum levels of vitamin d and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. although some of these effects were shown in clinical studies, no study permitted the inference that vitamin d can reduce blood glucose and attenuate inflammation. post-prandial glucose is the most sensitive to alterations in insulin sensitivity. therefore, it is rational to examine whether vitamin d can enhance oral glucose tolerance in individuals at risk for developing t2dm and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin d on the prevention of t2dm. identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin d dose to non-responders, leading to more effective and precise intervention protocols.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating females, aged 18-75 * volunteered to participate by signing the consent form * bmi ˂ 40kg/ m2 * serum 25(oh) vitamin d3 (25(oh)d) concentration ˂75nmol/l * fasting serum glucose \<7.0 mmol/l * homa insulin resistance index ≥1.3 * presence of any one or more of the following risk factors for type 2 diabetes: * high bmi (\>23) * high waist circumference according to idf ethnic specific values for non- caucasian (females \>80cm; males \>90cm) * family history of diabetes in first-degree relative (parent or sibling) * previous history of gestational diabetes * history of high blood glucose, high triglycerides and/or low hdl cholesterol exclusion criteria: * fasting serum glucose ≥7.0mmol/l * history of renal failure or liver disease * serum urea or creatinine \>1.8 times upper limit of normal (uln) * serum aspartate or alanine transaminase (ast,alt) \>1.5 times uln * current use of drug or drugs to treat diabetes or which influence glucose metabolism * medical or surgical event requiring hospitalization within 3 months of randomization * presence of any condition affecting nutrient absorption
pained: project addressing inequities in the emergency department

Conditions: Pain; Appendicitis; Bias, Racial; Fractures, Bone

Summary: racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. our overarching goal is to eradicate health care inequities through evidence-based interventions. the objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.


Eligibility criteria:
inclusion criteria: * all children's national hospital emergency department clinicians exclusion criteria: * none
genetic analysis of gray platelet syndrome

Conditions: Genetic Linkage; Myelofibrosis

Summary: this study will identify and characterize the gene or genes responsible for gray platelet syndrome (gps). platelets are small blood cells that stick on injured blood vessels to form a plug and stop bleeding. when a blood vessel is injured (like a cut on a finger), platelets release the proteins stored in their sacs to help form a blood clot. patients with gps bleed longer than other people because their platelets lack some of these protein-carrying sacs. platelets without sacs look pale gray under the microscope rather than pink, giving the syndrome its name. except for rare patients with severe hemorrhage, the bleeding tendency in gps is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and, in women, excessive menstrual bleeding. patients with gps and members of their family with gps may be eligible for this study. participants will provide a personal and family medical history and will have blood drawn. about 1 to 2 tablespoons of blood will be drawn in adults, and about 1 teaspoon in children. the blood will be analyzed for genes that cause gps

patients with gray platelet syndrome (gps) and their unaffected family members will be studied to identify the gene(s) involved in gps using linkage analysis and gene mapping strategies. up to 200 individual members of gps families will be investigated to identify candidate regions of the human genome, which will be further studied using fine mapping and sequence analysis. characterization of gene(s) involved in gps could provide important insight into the mechanisms of vesicle formation and protein sorting in human cells.

Eligibility criteria:
* inclusion criteria: enrollment in this study will be limited to patients diagnosed with gps and their unaffected relatives. the diagnosis will be based upon absence or marked reduction of platelet alpha-granules on electron microscopy. exclusion criteria: patients with reduction in both alpha and beta granules will be excluded, since this is probably a separate disease.

Keywords: gene identification linkage analysis homozygosity mapping gray platelet syndrome gps platelet function defect bleeding disorder
effect of physical activity program on sedentary of patients with upper aerodigestive tract cancer

Conditions: Upper Aerodigestive Tract Cancer; Head and Neck Cancer

Summary: apaorl2 study aims to evaluate the efficacy of a physical activity program on the sedentary and physical activity level during the 18-month program. apaorl2 study is a randomized, open label, controlled, monocentric, intervention study that will be conducted among 96 patients treated for localized upper aerodigestive tract cancer.

rationale: a sedentary lifestyle has been clearly shown to reduce survival in cancer patients, mainly through metabolic changes. while the notions of sedentary lifestyle and physical inactivity overlap, they are not entirely synonymous. the aim of this study is to examine the contribution of a physical activity program, during the treatment and post-treatment phases, in addition to the current care program, on behavior change (i.e. sedentary behaviors and physical activity levels), quality of life and fatigue in patients with upper aerodigestive tract cancer the primary objective is to show that the experimental group (combining the current care pathway + physical activity program) has lower levels of sedentary behaviour and higher levels of physical activity than the control group (following the classic care pathway with physical activity awareness) after the treatment phase. patients will be randomly assigned to one of the 2 arms of the study according to a 1:1 ratio: group a: control group: standard care with recommendations on physical activity. group b: experimental group: physical activity program

Eligibility criteria:
inclusion criteria: * patients ≥18 years * newly diagnosed, histologically proven upper aerodigestive tract cancer, non-metastatic, * life expectancy ≥18 months * having a smartphone, tablet or computer with an internet connection enabling remote physical activity sessions for the experimental group exclusion criteria: * presenting a contraindication to moderate physical activity * deprived of their liberty by court or administrative decision * unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,

Keywords: physical activity head and neck cancer
"effects of oral citrulline on protein metabolism in healthy humans: a prospective, randomized, double-blind , cross-over study" (citrugrêle)

Conditions: Healthy Subjects

Summary: the specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in healthy humans in the postabsorptive state. protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. the investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis .


Eligibility criteria:
inclusion criteria: * healthy adult between 18 and 45 years of age * absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol® * absence of any treatment with anabolic agents during the month prior to inclusion in the study- no current artificial feeding (enteral or parenteral) * no renal, cardiac, respiratory or hepatic insufficiency * no chronic inflammatory disease (intestinal or other * no current corticotherapy * fasting blood glucose below 6mmol/l (126 mg/dl) * body mass index between 19 and 24.9 * patient able to understand benefits and risks of protocol * not pregnant, taking oral contraceptive measure if able to procreate * subject affiliated to french health insurance (sécurité sociale) * informed consent form signed * no concomitant participation to another clinical trial, and compliance with the exclusion period required by law exclusion criteria: * subject not fulfilling inclusion criteria * subject mentioned in articles l1121-5 to l1121-8 of "code de la santé publique" * subject for whom the participation in this clinical trial would result, by cumulating stipends received for other clinical trials, in earning more than 4500 € within 12 consecutive months
benefits of peri-surgical physical therapy in the management of iii and iv grades of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: to find out the effectiveness of physical therapy associated with the surgical treatment over the simptoms and quality of life in iii and iv grades of pelvic organ prolapse, patients will be randomly assigned to one of these groups: experimental group: pre-surgical and post-surgical physical therapy + behavioral education + surgical therapy. control group: surgical treatment + behavioral education. in both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months post-surgery.

intervention in the experimental group, patients assigned to this group will receive: * pre-surgical physical therapy: 9 sessions of physical therapy aimed at correcting posture, to the awareness and the strengthening of the pelvic floor muscles. they will be also informed and instructed on hygienic and behavioral education to prevent pelvic organ prolapse and urinary incontinence. each session will be about 45 minutes and 3 sessions will be held a week for 3 weeks. * post-surgical physical therapy: 2. hospital discharge patients will receive the same fact sheet on sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence. 3. 6th weeks after surgery: 8 physical therapy sessions (2 per week for 4 weeks) about 30 minutes to review hypopressive exercises and contractions of the pelvic floor. intervention in the control group, patients assigned to this group will receive: after surgical correction of pelvic organ prolapse, at hospital discharge, patients will receive a fact sheet on the sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence (proper weight, prevent constipation, avoid weight bearing and cough and high impact exercise). no physical therapy intervention will be performed.

Eligibility criteria:
inclusion criteria: * consecutive women diagnosed with grade iii and iv pelvic organ prolapse, which would be operated for this reason at the asturias prince hospital (madrid-spain). exclusion criteria: * women diagnosed with different iii / iv grade of pop or a history of conservative treatment not from the subproject "physiotherapy in the pop grades i and ii", or a history of pop surgery, or concurrent conditions that would be affect the treatment (neurological, gynecological or urological), or recurrent urinary infection or hematuria, or those iii / iv grades in pop which is contraindicated or not possible to perform surgery. * pregnant women or women with a vaginal birth in the last six months. * women with cognitive limitations to understand the information, answer questionnaires, consent and / or participate in the study.