Kornimate/medical-research-clean huggingface dataset:
combined conventional speech therapy and functional electrical stimulation in dysphagia following stroke

Conditions: Dysphagia, Oropharyngeal; Stroke, Ischemic

Summary: this study will evaluate the effectiveness of conventional speech therapy associated with functional electrical stimulation in patients with dysphagia after ischemic stroke. included patients will be divided into two groups, where in the intervention group the speech therapy is associated to functional electrical stimulation, and in the control group, the patients will receive the conventional speech therapy with electrical stimulation placebo with intensity 0hz.

since the 1980's, electrical stimulation has been used for therapeutic purposes in brazil, and, since 1990's, it has been used as a relevant therapeutic tool in the cases of oropharyngeal dysphagia in addition to speech therapy. positive results have been observed in the treatment of swallowing disorders, including in patients that carry neurological diseases. however, there is no substantial evidences for this interventions. in this study, the electrotherapy will be used as a complement to conventional speech therapy and performed the application of electrical stimulation protocol in dysphagia, through the apparatus neurodyn portable tens/fes (transcutaneous electrical neurostimulation/ functional electrical stimulation), which is a transcutaneous neuromuscular stimulator flow tens/fes from two channels with independent intensity adjustment. it is about a non-invasive technique with no systemic effect, causing no dependence or undesirable side effects, and consists by gentle application in electrical stimulation, through electrodes placed in body areas affected by pain or to activate skeletal muscles and produce movements. a channel of electrodes will be placed in the submental region and the other channel on the thyroid cartilage., in formation of a t. the explication of the procedure in the patient treatment, is describing the sensations that he should expect that happened during the stimulation. the intensity of necessary flow to apply in the treatment, will depend in the sensation of the patient, therefore, it is applicable until the tolerance level or desirable muscular contraction. thus, the treatment should be initiated with minimal levels of intensity, by being carefully raised if appropriate effects are achieved on the procedure and according to the patient report.

Eligibility criteria:
inclusion criteria: * stroke - ischemic type; * dysphagia following stroke; * 40 to 70 years old; * exclusive enteral feeding; * glasgow \> 11. exclusion criteria: * pregnants; * febrile condition; * neoplasia; * pacemaker; * cochlear implant; * anxious patient; * degenerative neurological diseases.
peginterferon and til therapy for metastatic melanoma

Conditions: Metastatic Melanoma

Summary: adoptive t cell therapy with tumor infiltrating lymphocytes (til) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. the tils are isolated from the patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. before til infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. after til infusion interleukin-2 are administered to support t cell activation and proliferation in vivo. in this trial the therapy is combined with peginterferon (the pegylated form of interferon alpha 2b). interferon alpha has immunomodulatory effects and is known to upregulate hla expression on melanoma cells and are hypothesized to synergize with til therapy.


Eligibility criteria:
inclusion criteria: histologically confirmed unresectable stage iii or stage iv metastatic melanoma metastasis available for surgical resection (about 2 cm3) and residual measurable disease after resection ecog performance status 0-1 life expectancy ≥ 3 months no significant toxicity from prior treatments adequate renal, hepatic and hematologic function women of childbearing potential (wocbp) and men in a sexual relationship with a wocbp must be using an effective method of contraception during treatment and for at least 6 months after completion af treatment. able to comprehend the information given and willing to sign informed consent - exclusion criteria: other malignancies, unless followed for ≥ 5 years with no sign of disease, except squamous cell carcinoma or adequately treated carcinoma in situ colli uteri. cerebral metastasis. patients with previously treated cns metastases can participate if cns metastases are surgically removed or treated with stereotactic radiosurgery and stable ≥ 28 days after treatment measured by mri. patients with asymptomatic, stable and untreated cns metastasis can in be included according to investigators and sponsors decision. patients with ocular melanoma severe allergies, history of anaphylaxis or known allergies to the administered drugs. serious medical or psychiatric comorbidity creatinine clearance \< 70 ml/min acute or chronic infection with e.g. hiv, hepatitis, tuberculosis severe and active autoimmune disease pregnant and nursing women need for immunosuppressive treatment, e.g. corticosteroids or methotrexate concomitant treatment with other experimental drugs patients with uncontrolled hypercalcemia less than four weeks since prior systemic antineoplastic treatment at the time of treatment. -
lifestyle intervention for prevention of gastric neoplasm

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection * have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep. exclusion criteria: * patients who refuse to change lifestyle according to the trial plan

Keywords: early gastric cancer lifestyle
studies to gain insight how the drugs pcsk9-inhibitors and statins affect cholesterol and bile acid metabolism

Conditions: Acute Metabolic Effects of Evolocumab and Atorvastatin

Summary: eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.


Eligibility criteria:
inclusion criteria: * male * \>18 years of age exclusion criteria: * cardiovascular disease * cerebrovascular disease (e.g. stroke, prior aneurysm) * pulmonary disease (e.g. pulmonary hypertension, copd) * metabolic disease (incl. but not limited to cushing disease, diabetes) * renal disease (by chronic kidney disease criteria) * active inflammatory bowel syndrome * cancer * pregnancy * smoker * any chronic medication use * steroid treatment for the last six months or hormone replacement therapy * coagulopathy * musculoskeletal or neurologic disease * know allergy against any of the studied substances * inclusion in any other concurrent medical research study
auricular acupressure (aa) for insulin resistance in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Insulin Resistance

Summary: the present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with pcos.a total of 100 subjects will be enrolled into this study and will be randomized into two groups. auricular acupressure or sham auricular acupressure will be treated for three months. the primary outcome is the whole body insulin action assessed with homa-ir.


Eligibility criteria:
inclusion criteria: * women aged between 15 and 40 years. * diagnosis of pcos according to the modified rotterdam criteria. * 2 years after menarche. * body mass index (bmi) equal to or greater than 23 kg/m2. * ir is defined by the homeostaticmodel assessment (homa-ir: (fasting insulin (μu/ml)×fasting glucose (mmol/l))/22.5). a value ≥2.14 will be considered to be indicative of ir. * with no desire of children within 3 months. exclusion criteria: * administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, gonadotropin-releasing hormone (gnrh) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers. * patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected cushing's syndrome. * patients with known severe organ dysfunction or mental illness.

Keywords: polycystic ovary syndrome insulin resistance
comprehensive cohort study of bracing for adolescent idiopathic scoliosis (ais): a feasibility study

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).

the study has been completed.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ais 2. age ≥10 years 3. risser sign 0-2 4. cobb's angle 20 deg to \<25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to \<30 deg exclusion criteria: 1. history of treatment of ais 2. \>= 1 year postmenarchal (for girls only) 3. physical or mental disability to adhere to bracing 4. diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature 5. structural thoracic scoliosis with apex above t7 (note these patients are not suitable for under-arm brace) 6. difficulty to read, understand, and complete the study questionnaires 7. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Keywords: ais
randomized study designed to look at disease progression using 2 currently fda approved drugs for the treatment of rrms

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: randomized study designed to look at the difference in relapse rates between patients remaining on their current interferon medication and those switched to copaxone®


Eligibility criteria:
inclusion criteria: 1. patients must have a diagnosis of clinically definite ms with a relapsing disease course as determined by the poser criteria 2. patients must be on high dose interferon therapy (betaseron® 250 µg or rebif® 44 µg) for at least 1 year prior to study entry 3. patients must have experienced at least one documented relapse during the past year prior to screening. pseudo-relapses must be ruled out. a gadolinium enhancing lesion is not required. 4. patients must be ambulatory, with a kurtzke edss score between 0-5 inclusive 5. patients must be between the ages of 18 and 50 years inclusive 6. women of childbearing potential must practice an acceptable method of birth control. acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or iud with spermicide), or partner's vasectomy 7. patients must be relapse-free and off corticosteroids (iv or oral) for at least 30 days prior to the screening visit 8. patients must be relapse-free and off corticosteroids between the screening and baseline visits 9. patients must be willing and able to give written informed consent exclusion criteria: 1. use of experimental or investigational drugs, and/or participation in an investigational drug study within 6 months prior to study entry 2. previous treatment with glatiramer acetate (injectable) 3. previous treatment with immunomodulators (except ifnβ), immunosuppressive agents, ivig, or plasma exchange in the 6 months prior to screening; previous treatment with cladribine in the past 2 years 4. previous total body irradiation or total lymphoid irradiation 5. chronic corticosteroid (iv, im, and/or po) treatment (more than 30 consecutive days) in the 6 months prior to study entry 6. pregnancy or breastfeeding 7. life-threatening or other clinically significant disease 8. any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse 9. a known sensitivity to gadolinium (gadolinium acid) 10. a known history of sensitivity to mannitol 11. inability to successfully undergo mri scanning
study of an investigational vaccine in pre-adolescents and adolescents (gardasil)(v501-016)

Conditions: Cervical Cancer; Genital Warts

Summary: the primary purpose of the study is to determine if an investigational vaccine gardasil (v501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.


Eligibility criteria:
inclusion criteria: * healthy adolescents and pre-adolescents with no prior sexual history * healthy women who have an intact uterus with lifetime history of 0-4 sexual partners exclusion criteria: * prior human papillomavirus (hpv) vaccination * prior abnormal paps * prior history of genital warts
biomarkers of ovarian reserve and correlation with ivf treatments

Conditions: Pregnancy, Ovarian

Summary: retrospective study to evaluate the correlation between afc, fshb, amh and ivf outcomes of 347 cycles performed with three different protocols.

347 ivf cycles (236 patients) analyzed for a retrospective study to evaluate the correlation between the biomarkers of ovarian reserve (antral follicles count, antimullerian hormone, basal follicle stimulating hormone) and number of oocytes and mature oocytes (mii) retrieved during the pick up. for the stimulation were used three different protocols: long luteal, antagonist with daily administration of gonadotropins and antagonist with depot administration of gonadotropins.

Eligibility criteria:
inclusion criteria: * women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization. exclusion criteria: * women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.

Keywords: mature oocytes antral follicles count follicle stimulating hormone antimullerian hormone
impact of diabetes mellitus on retinal microvasculature in patients without clinical retinopathy using optical coherence tomography angiography

Conditions: Diabetic Retinopathy, DR

Summary: the aim of this study is to assess the impact of duration of dm on octa parameters in diabetic patients without clinical diabetic retinopathy.


Eligibility criteria:
inclusion criteria: 1. age : above 40 years old 2. type of dm: type 2. 3. fundus examination: no macular edema or other signs of clinical retinopathy exclusion criteria: 1. age : below 40 years old 2. ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical octa changes \[13, 14\]. 3. fundus examination: macular edema or any other signs of clinical retinopathy
global hemostasis monitoring by using sonoclot signature in traumatic patients

Conditions: Study of Hemostatic Profile in Traumatic Patients

Summary: 1. analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy . 2. assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests

coagulopathy is a physiological response to massive bleeding that frequently occurs after severe trauma and is an independent predictive factor for mortality\[2\]. . there are two of the major causes of coagulopathy in trauma patients 1. coagulopathy secondary to hemorrhagic shock due to massive bleeding and 2. coagulopathy secondary to severe head injury\[3\] which results in release of tissue factor from damaged brain tissue. therefore, it is very important to grasp the coagulation status of patients with severe trauma quickly and accurately with objective indicator in order to establish the therapeutic strategy . the importance of viscoelastic devices in understanding the disease condition of patients with traumatic coagulopathy has been widely recognized in europe. viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile . also in the usa, massive transfusion in trauma guidelines proposed by the american college of surgeons in 2013 presented the test results obtained by the viscoelastic devices, as the standard for transfusion or injection of blood plasma, cryoprecipitate, platelet concentrate, or anti-fibrinolytic agents in the treatment strategy for traumatic coagulopathy and hemorrhagic shock . however, some studies have reported limitations of these viscoelastic devices

Eligibility criteria:
inclusion criteria: * -patients \>18 years. * both sexes will be included. * recent trauma exclusion criteria: * -patients \<18 years. * patients with documented evidence of coagulopathy or bleeding diocese . * patients with liver disease. * pregnant women
vascular effect of tibolone versus placebo evaluated by flow-mediated dilatation of brachial artery

Conditions: Flow-mediated Dilation Evaluation of the Brachial Artery

Summary: the aim of this study is to evaluate the vascular effects of tibolone on climateric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.


Eligibility criteria:
inclusion criteria: * women without menstrual cycles whithin the last 12 months and fsh\>30iu/l * healthy women * women that were not using drugs with potential vascular effect whithin the last 1 year * women that never used hormone replacement therapy exclusion criteria: * smoking * blood pressure \> 160/90 mm hg. * breast and or endometrial cancer * history of acute myocardial infarction * diabetes * vaginal bleeding of any origin * hepatic disease * thrombophlebitis or thromboembolic disorders

Keywords: hormone replacement therapy; dopplervelocimetry; flow-mediated dilation; menopause; tibolone
the effect of mid-urethral sling on the urethral dynamic shape and motion

Conditions: Stress Urinary Incontinence

Summary: the purpose of this prospective cohort study is to investigate the effect of sling on urethral dynamic shape and motion using static and dynamic pelvic floor ultrasound and additionally compare the findings among women with successful vs failed surgical outcome.

this study is designed as a prospective cohort study. our hypothesis is that mid-urethral sling provides backstop for excessive "swing motion" of distal urethra and helps with urethral compression along its luminal axis. aim 1: investigate the effect of mid-urethral sling on the urethral shape at rest and maximum valsalva, in other words dynamic urethral shape. aim 2: compare the effect of mid-urethral sling on urethral dynamic shape in women with successful surgical outcome (absence of stress urinary incontinence at 3 and 12 months after the surgery) and women with surgical failure (presence of stress urinary incontinence at 3 and 12 months after the surgery).

Eligibility criteria:
inclusion criteria: * stress urinary incontinence interested in treatment with mid-urethral sling * able to consent in english and come to post-operative and research visits exclusion criteria: * contraindication to mid-urethral sling * detrusor overactivity \> 40cm h2o * post-void residual \> 150ml * maximum urethral closure pressure \< 40 cm h2o
multimodal pain therapy after hernia repair

Conditions: Hernia, Abdominal; Pain

Summary: investigating the effect of multimodal pain treatment after hernia repair

this is a randomized, non-blinded study comparing the effects of multimodal pain management (ibuprofen, tylenol, and narcotics/oxycodone as needed) for relief of post-operative pain in patients who undergo hernia repair. patients who present for elective hernia surgery will be randomized in a 1:1 fashion by pre-operative pain score into a multimodal pain treatment group or conventional opiod treatment group for post-operative pain management. they will be followed up after their surgery to evaluate their pain scores and narcotic use.

Eligibility criteria:
inclusion criteria: * healthy adult patients \>18 years of age to 90 years of age who are eligible for a hernia repair (ventral or inguinal) by a surgeon in the medical faculty associates department of general surgery at the george washington university hospital. exclusion criteria: * patients with allergies to sulfa or any of the medications being evaluated in this study (ibuprofen, tylenol, oxycodone) * patients with a history of gastric ulcer or gastrointestinal bleeding * patients with kidney disease * patients with cardiovascular disease * patients with a co-morbid condition that would prohibit them from taking narcotics * patients with known or suspected narcotic abuse * patients who do not wish to participate
efficacy of an acceptance-based group behavioral therapy for generalized anxiety disorder.

Conditions: Generalized Anxiety Disorder

Summary: generalized anxiety disorder (gad) shows the weakest treatment response among anxiety disorders. the present study aimed at examining whether an acceptance-based behavioral treatment, combining mindfulness and exposure strategies, would improve clinical outcome compared to a standard, non-directive, supportive group therapy (ndst) for clients at a brazilian anxiety disorders program.

ninety-two individuals diagnosed with gad were randomized to receive 10 sessions of either an acceptance-based behavior therapy (abbt) or a non-directive support therapy (ndst). assessments were at pretreatment, mid term, post-treatment, and 3-month follow-up.data were analyzed using the mixed effect regression models comparing both groups in primary outcome measures. secondary outcome measures and putative process variables were assessed and also analyzed. the latter were tested as mediators of efficacy.

Eligibility criteria:
inclusion criteria: * literate, * gad-diagnosed * 18-65 years old exclusion criteria: * bipolar disorder (or any past maniac episodes), * psychosis, * substance dependence (apart from those abstemious for 3 months or more, considered as initial remission by dsm 5 - apa, 2015), * high suicide risks according to the mini - international neuropsychiatric interview (mini; sheehan et al., 1998). * participants under pharmacological treatment for gad whose medication dosage had not been stable for a minimum of three months prior to the beginning of the study.