Kornimate/medical-research-clean huggingface dataset:
randomized comparison of radiological exposure with triptable® in patients with acute coronary syndromes

Conditions: Acute Coronary Syndromes; Angioplasty, Transluminal, Percutaneous Coronary

Summary: excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access. the study hypothesis is that the use of radial access device dedicated radioprotective triptable ® (transradial intervention table protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.

this study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated triptable ® device. the triptable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images.

Eligibility criteria:
inclusion criteria: * unstable angina with an indication for invasive stratification * acute coronary syndrome without st-segment elevation * acute coronary syndrome with st-segment elevation * patient informed of the nature of the study and have signed the informed consent * patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral exclusion criteria: * below 18 years of age * pregnancy * chronic use of vitamin k antagonists, or direct thrombin inhibitors or antagonists of factor xa, * active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance \<30 ml / min, platelet count \<100,000 mm3); * uncontrolled hypertension; * cardiogenic shock; * previous coronary artery bypass graft surgery with the use of ≥ 1 graft * patients not candidates for the use of any of the specified vascular access * concomitant severe disease with life expectancy less than 12 months life; * medical, geographical, or social conditions that impede study participation * refusal or inability to understand and sign the informed consent form.

Keywords: cardiac catheterization radiation protection radial artery femoral artery
effects of black tea intake on serum lipids

Conditions: Hypercholesterolemia

Summary: a diet-controlled clinical trial which attempts to provide estimates of the effect of black tea consumption on serum lipids under tightly controlled conditions, including a controlled diet. mildly hypercholesterolemic individuals (total cholesterol levels between 4.9 and 6.7 mmol/l, 190 and 260 mg/dl), non-smoking, chronic disease-free individuals were enrolled in a 15-week, double blind, randomized crossover trial, during which they consumed a controlled low-flavonoid diet plus 5 cups of black tea or a tea-like placebo over two 4-week treatment periods.


Eligibility criteria:
inclusion criteria: * between 45-65 years old * mildly hypercholesterolemic (total cholesterol levels between 4.9 and 6.7 mmol/l, 190 and 260 mg/dl) * high-density lipoprotein cholesterol (hdl-c) between 0.9 and 1.6 mmol/l (35 and 65 mg/dl) * triglyceride (tg) concentrations below 6.8 mmol/l (600 mg/dl) * habitually consumed a typical american diet with low dietary flavonoid intake (\<4 one-half cup servings of fruits and vegetables/day) and low intake (\<1 serving/day) of soy-rich foods, nuts, herbs, and spices (besides salt and pepper) * aspartate aminotransferase (ast) between 0 and 55 mg/l * creatinine between 70.7 and 150.3 mmol/l (0.8 and 1.7 mg/dl) * glucose between 3.3 and 6.4 mmol/l (60 and 115 mg/dl) exclusion criteria: * current smoker * usage of high amounts of antioxidant vitamin supplements (\>3 times the recommended dietary allowance (rda) of vitamins e, c, and selenium, or \>10 mg/day of beta carotene) * had been diagnosed with diabetes, coagulation disorders, chronic pulmonary disease, current active malignancy, renal disease requiring dialysis, malabsorption, or gastrointestinal disorders, or had a history of cardiovascular disease. * antihypertensive, immunosuppressive, cholesterol lowering, or anticoagulant medications * consuming \>3 servings of alcohol daily * pre-menopausal (women)

Keywords: serum lipids cholesterol serum cholesterol black tea flavonoids crossover trial randomized control trial diet controlled
comparison of physical fitness, physical activity level in patients with bipolar disorder and schizophrenia

Conditions: Bipolar Disorder; Schizophrenia

Summary: according to the world health organization; bipolar disorder ranks in the top 20 causes of disability among all medical conditions and 6th among mental disorders worldwide. bipolar disorder is noted as a serious mental illness involving emotional ups and downs.

schizophrenia is a chronic mental disorder characterized by the appearance of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills, and disorganization. in this study, it was aimed to compare physical fitness, physical activity level, depression and quality of life in bipolar disoder and schizophrenic patients with healthy individuals.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with bipolar disorder and schizophrenia by a physician according to dsm-5 criteria * individuals with bipolar and schizophrenia between the ages of 30-55 * patients without any other accompanying psychiatric disorder * patients who can communicate * patients who agreed to participate in this study and gave informed consent exclusion criteria: * patients with a psychiatric diagnosis other than bipolar and schizophrenia. * pregnancy condition * those who did not consent to participate in the study
hepatitis b vaccine clinical trial

Conditions: Hepatitis B; Hepatitis, Viral, Human; Liver Diseases

Summary: to determine the efficacy of a hepatitis vaccine in preventing hepatitis b.

background: although most carriers of hbsag are asymptomatic, a substantial proportion eventually develop chronic active hepatitis and cirrhosis. there is also overwhelming evidence that the hepatitis b virus is the single most important causative factor of hepatocellular carcinoma. thus, mass immunization programs against hbv infection may ultimately affect not only the incidence of acute hepatitis b and the pool of chronic carriers but may also reduce the morbidity and mortality from chronic active hepatitis, cirrhosis, and hepatocellular carcinoma. krugman and his co-workers laid the groundwork for active immunization against hepatitis b in 1970 to 1973. they discovered that a 1:10 dilution of hepatitis b infective serum lost its infectivity when boiled for one minute but retained its antigenicity and prevented hepatitis b in 70 percent of vaccinated subjects. hilleman and his colleagues at the merck institute of therapeutic research developed a more sophisticated vaccine consisting of highly purified, formalin-inactivated hbsag particles derived from the plasma of chronic carriers of the antigen. by 1978, data were sufficient to permit testing in a clinical trial. the first subject was inoculated in november 1978, and by october 1979, recruitment had ended. in may 1980, all trial events were reviewed and classified by an expert panel. in june 1980 the code of vaccine and placebo allocation was broken. design narrative: randomized, double blind, fixed-sample. a total of 549 subjects were allocated to the vaccine group in which they were treated with highly purified formalin-inactivated virus subunits derived from the plasma of chronic carriers of hepatitis b. a total of 534 were allocated to the placebo group. both groups received injections at 0, 1 month, and 6 months unless evidence of infection developed before the series was completed.

Eligibility criteria:
men at high risk for hepatitis b virus infection, 36 years of age or younger, no recent symptoms of hepatitis, blood specimen negative for hbsag, anti-hbs and anti-hbe.
healing efficacy of isobutyl cyanoacrylate high viscous solution in treatment of traumatic ulcer in children

Conditions: Ulcer

Summary: 30 children with traumatic oral ulcer that will be divided into equal three groups. group a (isobutyl cyanoacrylate) includes children will be treated with isobutyl cyanoacrylate high viscous solution only once during the treatment episode, group b (control positive) includes children will be treated chlorohexidine gel (0.2%) twice daily and group c (control negative) includes children will be treated with normal saline five times per day. clinical follow up will be done by assessment of pain perception, photographs of the ulcer will be recorded by using digital camera and measurement of ulcer size in the 1st ,5th and 9th days after treatment

thirty children will be randomly and equally allocated into three groups, by throwing a dice (1\&4 for group a, 2\&5 for group b and 3\&6 for group c). 10 for each group as follows: - * group a (isobutyl cyanoacrylate): 10 children will be treated with isobutyl cyanoacrylate high viscous solution will be applied on the ulcer site. * group b (control positive): 10 children will be treated with chlorhexidine (0.2%) gel twice daily for 9 days. * group c (control negative): 10 children will be treated with normal saline will be applied on the ulcer site 5 times per day. * children will be examined before treatment to assess pain by using children's international mucositis evaluation scale (chimes) and measure ulcer size by periodontal probe. then apply different treatments of each group * all patients in both groups will be instructed to avoid eating or drinking for at least half an hour after oral administration of the oral gel. * all patients can be given oral analgesics (paracetamol) if needed to decrease pain severity. * the size of the ulcers, change in pain severity will be assessed on the 1st, 5th and 9th days after using isobutyl cyanoacrylate high viscous solution and chlorhexidine (0.2%) gel. assessment of pain will be performed using children's international mucositis evaluation scale (chimes) will be used for pain assessment 1. photographs of the ulcers will be recorded with a digital camera at 1st, 5th and 9th days. 2. measurement of ulcer size by using a periodontal probe

Eligibility criteria:
inclusion criteria: apparently healthy cooperative children free from any systemic diseases that may predispose oral ulceration. development of pain/ulceration in the oral mucosa, surrounded by light red areola less than 1 cm. diameter. child with good oral hygiene. parents willing to participate in the study and have a good likelihood of recall availability exclusion criteria: taking of drugs that may influence the pattern of oral ulceration oral ulcerations with unknown etiology that are not traumatic in nature. allergic or who have suffered adverse reactions to isobutyl cyanoacrylate gel or chlorhexidine gel

Keywords: ulcer chlorhexidine isobutyl cyanoacrylate
relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance

Conditions: Lumbar Spine Instability; Balance; Physical Performance; Foot; Ankle Deformity

Summary: it has been shown that foot and ankle postural disorders can alter the biomechanic of lower extremity and pelvis. this situation can affects balance, postural control and phsical performance of individual adversely. however, it is unknown whether the muscles that control lumbopelvic are affected or not affected. the aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.

a healthy load distribution at the foot depends on the ability of the foot to fulfill both the task of stabilization and mobilization. studies related foot movement disorders usually focus on subtalar joint. the reason for this is that subtalar joint transmits the rotations which in leg to the foot. one of the deformities affecting the foot and subtalar joint is pes planus. kosashvili et al. have shown that grade 2 and 3 pes planus can affect the lower limb biomechanical alignment, resulting in an increase in perceived pain associated with the knee, hip and pelvic region. problems related to foot and ankle can affect the balance of individuals as well as affect the pelvic region. sung et al. have shown that the postural stability and balance of individuals with pes planus are worse than those without pes planus. studies showing that foot-ankle postural disorders negatively affect physical fitness and motor performance of individuals are also present. akaras et al. have stated that the increase in pronation in the hindfoot affects individuals' leap and agility performance negatively. it has shown that leg-related problems can affect upper. however, there is no objective study of ultrasonographic imaging of core muscles in foot-ankle problems. the aim of this study is to investigate the relationship between foot-ankle characteristics and lumbopelvic control, balance and physical performance in healthy young adults.

Eligibility criteria:
inclusion criteria: * volunteering to participate. * be between the ages of 18 and 25 * being a normal weighted individual with a body mass index from 18.5 to 24.9 exclusion criteria: * presence of any systemic, locomotive or foot related problem * undergone any surgical operation related to the foot * to have loss of sense, diabetic or peripheral neuropathy * the presence of any problem with the spine (back pain, scoliosis, past surgeons) * presence of any neurological problem

Keywords: foot-ankle characteristic lumbopelvic control balance physical performance
a clinical study to evaluate the use of a cryopreserved formulation of otl-103 in subjects with wiskott-aldrich syndrome

Conditions: Wiskott-Aldrich Syndrome

Summary: this is an open-label, single arm study to evaluate the cryopreserved formulation of otl-103 gene therapy. otl-103 consists of autologous cd34+ hematopoietic stem cells in which the gene encoding for the wiskott-aldrich syndrome is introduced by means of a third generation lentiviral vector.


Eligibility criteria:
inclusion criteria: * age: up to 65 years * diagnosis of was defined by genetic mutation and at least one of the following criteria: * severe wiskott-aldrich syndrome (was) gene mutation, defined by literature data (genotype/phenotype studies).; * absent wasp expression, assessed by flow cytometry; * severe clinical score (zhu clinical score ≥ 3); * no human leukocyte antigen (hla)-identical related donor available for hematopoietic stem cells transplant (hsct). exclusion criteria: * end-organ dysfunction, severe active infection not responsive to treatment or other severe disease or clinical condition which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * malignant neoplasia (except local skin cancer) or a documented history of hereditary cancer syndrome. * myelodysplasia, cytogenetic alterations characteristic of myelodysplastic syndrome and acute myeloid leukaemia , or other serious haematological disorders * documented human immunodeficiency virus (hiv) infection * prior allogeneic hematopoietic stem cell transplantation, with evidence of residual cells of donor origin * symptomatic herpes zoster, not responsive to specific treatment * evidence of acute tuberculosis * acute or chronic stable hepatitis b * presence of positive hepatitis c rna test result at screening * patients not eligible for mobilization protocols in order to obtain cd34+ cells * previous gene therapy
effects of interscalene brachial plexus nerve blocks on the hand and forearm

Conditions: Shoulder Surgery; Interscalene Nerve Block

Summary: research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.

this is a research study to prospectively determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. the investigators will investigate this issue in patients having shoulder and not hand/forearm surgery. we will test hand grip strength and sensation to determine if the hand and forearm are responding to the anesthesia.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * unilateral orthopedic shoulder surgery * already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine exclusion criteria: * any known contraindication to study medications or testing hand grip strength pre/post-op * insulin-dependent diabetes mellitus * neuropathy of any etiology in the affected extremity * any anticipated incision site apart from the shoulder * obesity * pregnancy * incarceration * inability to communicate with the investigators and hospital staff

Keywords: ucsd perineural nerve block shoulder surgery pain grip strength sensation interscalene nerve block
use of knotless suture for closure of total hip and knee arthroplasties

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. it use is gaining increased acceptance across many of the other surgical disciplines at this time. the purpose of this study is to evaluate the use of quill as part of our layered closure compared to using our traditional sutures. the study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit. primary objectives: * to evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a traditional layered (vicryl) wound closure. secondary objectives: * establish the all around (intra-operative and post-operative) cost-savings potential in using a knotless wound closure compared to that of a layered vicryl closure (our standard suture protocol). * assess the overall cosmesis of the wound/scar as well as perceived presence of subcutaneous surgical knots, when using the knotless wound closure versus our traditional layered suture closure.

we performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. complications, time to closure, and length of surgery were evaluated. closure was noted to be significantly faster (9.3 vs 13.6 minutes, p b .005) in the barbed suture group. wound-related complications were similar (3 cases) in both groups at 3-month follow-up. although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.

Eligibility criteria:
inclusion criteria: * patients must be male or female of any race * ages 18-80 years old * patients must be undergoing a primary hip or knee arthroplasty * patients must be able to understand and willing to cooperate with study procedures * able to provide written and verbal informed consent exclusion criteria: * allergy or intolerance to the study materials * surgical intervention during the past month for the treatment of the painful joint or its underlying etiology * history of previous surgeries on the affected joint other than arthroscopy (open surgeries) * history of any substance abuse or dependence within the last 6 months

Keywords: safety efficacy cost-savings cosmesis safety and efficacy of wound closure cost-savings potential cosmesis of the wound/scar
zd 1839 in treating patients with stage iv or recurrent kidney cancer

Conditions: Kidney Cancer

Summary: rationale: biological therapies such as zd 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer. purpose: phase ii trial to study the effectiveness of zd 1839 in treating patients who have recurrent or stage iv kidney cancer.

objectives: * determine the response rate in patients with progressive stage iv or recurrent renal cell cancer treated with zd 1839. * determine the median time to objective progression in these patients receiving this drug. * determine the toxic effects of this drug in this patient population. * determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients. outline: this is a multicenter study. patients receive oral zd 1839 daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 8 weeks. projected accrual: a total of 21-45 patients will be accrued for this study within 11-23 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iv or recurrent renal cell carcinoma not amenable to potentially curative surgery * evidence of disease progression * measurable disease * at least 20 mm with conventional techniques or * at least 10 mm with spiral ct scan * no brain metastases * malignant tissue available patient characteristics: age: * 18 and over performance status: * ecog 0-2 or * karnofsky 60-100% life expectancy: * more than 2 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin normal * ast/alt no greater than 2.5 times upper limit of normal (uln) renal: * creatinine no greater than 1.5 times uln cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other: * no prior allergy to compounds of similar chemical or biologic composition to zd 1839 * no ongoing or active infection * no other uncontrolled illness or psychiatric condition that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunotherapy chemotherapy: * no more than 1 prior chemotherapy regimen * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * no concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy surgery: * see disease characteristics other: * no prior therapy for metastatic disease * no other concurrent investigational agents * no concurrent oral retinoids

Keywords: stage iv renal cell cancer recurrent renal cell cancer