Kornimate/medical-research-clean huggingface dataset:
effect of repaglinide and metformin combination tablet or rosiglitazone and metformin in fixed dose combination on blood glucose control in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). this trial compares the changes in hba1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 3 months * hba1c between 7.5-11.0% on monotherapy or * hba1c between 7.0-10.0% on dual therapy * bmi maximum 45 kg/m2 exclusion criteria: * any clinically significant disease history in the opinion of the investigator * severe heart disease * pregnancy
intraligmentary dexamethasone in lower first molars with irreversible pulpitis and apical periodontits

Conditions: Pulpitis - Irreversible

Summary: using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation

aim :asseing the effect of intraligmentary dexamethasone on anesthetic efficacy of inferior alveolar nerve block and buccal infiltratation in lower first molar with irreversible pulpitis and apical periodontits, dexamethasone has antiinflammatory effect so it will improve the efficacy of anathesia and reduce postoperative by inhibition the production of phosopholipase and reduction of prostaglandins synthesis methods: diagnose the case clinically and readiographically patients will divide into 3 groups first group will be given inferior alveolar nerve block 4%articaine hcl1:100 epinephrine second group will be given inferior alveolar nerve block 4%articaine with intraligmentary dexamethasone third group will be given buccal infiltratation 4%articaine with intraligmentary dexamethasone after anathesia ,make access cavity and reduce the occulsa surface and make it out of occulsion . working length determination will be done by apex locator and confirm it by x ray . mechanical preparation will be done by fanta files and apply edta on files irrigate the canal by naocl 2.5٪ complete the root canal preparation through single visit. obturate the canal by single cone technique and bioceramic sealer. during procedures , record pain intensity on hp visual scale follow up the patient after 6,12,24 and 48 hours describe ibuprofen 200mg in case of sever pain conclusion : it's predictable that the intraligmentary dexamethasone will reduce the pain during and after root canal procedures

Eligibility criteria:
inclusion criteria: 1. age between 20-45 years old. 2. systemically healthy patient (asa i or ii). 3. lower first molar with: * preoperative sharp pain. * slight widening in the periodontal ligament (pdl). * vital response of pulp tissue to cold pulp tester (ethyl chloride spray). exclusion criteria: 1. patients allergic to anesthetics, or dexamethasone (other corticosteroids). 2. pregnant or nursing females. 3. patients having significant systemic disorder (asa iii or iv). 4. hemostatic disorders or anti-coagulant therapy during the last month. 5. consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment. 6. retreatment cases.

Keywords: " irreversible pulpitis with apical periodontitis"
a study of cyclophosphamide/methotrexate/5-fluorouracil (cmf) with pegfilgrastim in subjects with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the relative dose intensity (rdi) of intravenous (iv) cmf on a day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage i-iii breast cancer.


Eligibility criteria:
inclusion criteria: - histologically confirmed breast cancer stage i, ii or iii - candidate for iv cmf chemotherapy (every 4 weeks) for a total of 6 cycles - chemotherapy naïve (prior treatment with hormone therapy or with anti-her2 monoclonal antibody therapy is permitted as long as treatment has been stopped prior to enrollment into the study) - absolute neutrophil count (anc) greater than or equal to 1.5 x 10\^9/l - platelet count greater than or equal to 100 x 10\^9/l - eastern cooperative oncology group (ecog) performance status of 0-2 - written informed consent before any study specific procedure exclusion criteria: - ast and/or alt greater than 1.5 x upper limit of normal (uln) concomitant with alkaline phosphatase greater than 2.5 x uln according to institutional standard - bilirubin greater than 2 x uln according to institutional standard - inadequate renal function (creatinine greater than 1.5 x uln according to institutional standard) - any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemias) - history of prior malignancy other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy - prior radiotherapy - scheduled concomitant radiotherapy (e.g., radiotherapy administration while on study) - documented active infection at the time of enrolment requiring use of systemic anti- infectives - documented positive test for human immunodeficiency virus (hiv) infection - known hypersensitivity to e coli derived products \[e.g., filgrastim (neupogen®), pegfilgrastim (neulasta®), humulin® insulin, l-asparaginase, humatrope® growth hormone, intron a®\] - subject is currently enrolled in or 30 days have not passed since completing other investigational device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented) - pregnant or breast-feeding (for subjects of child bearing potential) - not using adequate contraception (for subjects of child bearing potential) - previous participation in this study - inability or unwillingness to comply with the protocol procedures

Keywords: clinical trial pegfilgrastim haematopoietic growth factor neutropenia cmf cancer
reducing skin cancer risk in childhood cancer survivors

Conditions: Skin Neoplasms

Summary: the objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. this randomized controlled trial uses a three-group design. our specific aims are to: (1) determine the impact of a patient activation and education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) determine the impact of the intervention on time to diagnosis, and (3) estimate the cost and cost-effectiveness of the intervention as a secondary outcome.

there are currently more than 420,000 americans who are long-term survivors of childhood and adolescent cancer. while these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. it is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (nmsc) and increased risk of melanoma. early detection is crucial to reduce the morbidity caused by nmscs and the morbidity and mortality incurred due to melanoma. both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists. the objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. all participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. to reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the us can take weeks or months to schedule.

Eligibility criteria:
inclusion criteria: * treated with radiation for a childhood cancer * have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year * have a phone that can receive text messages * have access to a dermlite compatible smartphone or tablet exclusion criteria: * personal history of a skin cancer diagnosis

Keywords: skin neoplasms radiation screening self-examination comparative effectiveness research dermoscopy
st. john's wort photodynamic therapy

Conditions: Acne

Summary: the investigators aimed to evaluated the efficacy and safety of sjw-pdt compared to indole-3-acetic acid (iaa)-pdt in the treatment of acne. the investigators also investigated the skin rejuvenating effects of sjw-pdt.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate facial acne * between 25 and 60 years old exclusion criteria: * history of oral retinoid treatment with the past 6 months * history of oral antibiotics, topical acne treatment, or skin rejuvenation treatment such as lasers and chemical peeling within the month before the start of the study
efficacy of resistive capacitive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain: rct

Conditions: Pelvic Pain; Pelvic Pain Syndrome; Chronic Pain; Chronic Pain Syndrome; Chronic Pelvic Inflammatory Disease; Physical Therapy

Summary: this study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.

it is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. but there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.

Eligibility criteria:
inclusion criteria: * have an age equal to or greater than 18 years * having chronic pelvic pain of six or more months of evolution. exclusion criteria: * failure to grant informed consent. * have fibromyalgia. * present a pacemaker or other type of electronic implant. * suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions). * previous treatment with chemotherapy and / or radiotherapy in the pelvic area. * suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy). * have myelopathy and osteomyelitis. * have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia ... * have an alteration of the central nervous system (traumatic or spinal vascular injury) * suffer oncological processes with sacral involvement. * have a severe mental disorder. * have vulvodynia * be pregnant. * have undergone surgery in the last 3 months in the pelvic area. * have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact. * inability to correctly complete the questionnaires or understand the study protocol. * having initiated other pelvic physiotherapy treatments during the study intervention.
placing preterm infants in polyethylene bags immediately after birth

Conditions: Newborn; Infant; Hypothermia; Premature

Summary: primary objective: to determine if placing preterm infants in a polyethylene bag (pb) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on admission to the neonatal intensive care unit (nicu).

newly born preterm infants that develop abnormal temperature after birth have higher morbidity and mortality. placing infants \< 32 weeks' gestation in a polyethylene bag (pb) in the delivery room (dr) reduces the rate of hypothermia on admission to the neonatal intensive care unit (nicu). since 2012, the rate of admission hypothermia in preterm infants, placed in a pb in the dr at the national maternity hospital (nmh), has increased significantly. this may be as a result of heat loss while the infant remains attached to the cord. our primary objective is to determine if placing preterm infants in a pb immediately after birth, before the umbilical cord is clamped will increase the number of preterm infants with a normal temperature on admission to the nicu.

Eligibility criteria:
inclusion criteria: infants who are inborn at the national maternity hospital at \< 32 (up to 31+6) weeks' gestation by best obstetric estimate will be included in the study. exclusion criteria: * infants with a large abdominal wall or neural tube defects * infants with an imperforate anus * infants to whom resuscitative measures are not initiated in the dr

Keywords: cord clamping hypothermia hyperthermia polyethylene bag
rofecoxib efficacy and safety evaluation trial in hemophilic arthropathy

Conditions: Hemophilic Arthropathy

Summary: this is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of trm-201 (rofecoxib) versus placebo in the treatment of patients with hemophilic arthropathy (ha) over a 12-week period (part i) that is followed by a year-long (52 week) open-label extension (part ii) to further evaluate the safety and maintenance of efficacy of trm-201.


Eligibility criteria:
inclusion criteria: * diagnosis of hemophilia a or b * either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) or currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial * diagnosis of hemophilic arthopathy for at least 6 months prior to screening * chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening. * able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to randomization including: acetaminophen (paracetamol), nsaids, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain * primary source of pain is due to hemophilic arthropathy exclusion criteria: * taking opioids for greater than 4 days per week prior to screening * has a history of advanced renal disease or severe liver disease (within the last 6 months) * receiving emicizumab while also receiving activated prothrombin complex concentrate (feiba) * uncontrolled or poorly controlled hypertension * history of major cardiac or cerebrovascular disease * history of an upper gi perforation, obstruction, or major gi bleed or current evidence of gi bleeding * has active hepatitis c or hepatitis b infection or uncontrolled hiv. note: patients who are hiv positive are allowed to participate if considered to be controlled. * has a positive drug screen for all prohibited drugs of potential abuse at screening * has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening

Keywords: hemophilia pain ha joint pain
endurant™ stent graft system in the treatment of infra-renal abdominal aortic aneurysms (endurant france)

Conditions: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Summary: the purpose of this study is to assess the benefits of endovascular repair with endurant stent graft system by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in france.

data regarding the use under routine practice of abdominal aortic stent grafts in france are expected by the french national authority for health (has). therefore, in its opinion report from july 13, 2010, has makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the french population treated under real-life conditions of use. this prospective cohort study must involve at least 150 patients implanted after registration on the lppr (list of products and services qualifying for reimbursement). the results of the follow-up study must be forwarded to the national committee for evaluation of medical devices and health technologies (cnedimts) for examination once a year. the assessment of this follow-up could lead to the recommendation by cnedimts to continue or stop the reimbursement of the concerned stent graft. in france, the endurant™ stent graft system is registered on the lppr for a period of 3 years since september 13, 2011. in order to comply with has expectations, medtronic bakken research center is setting up this long term non-interventional study on the endurant stent graft.

Eligibility criteria:
inclusion criteria: * patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release. * any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm. * patient not opposed to the collection and release of his/her personal information * intention of physician to implant electively the endurant™ stent graft system exclusion criteria: * patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)

Keywords: endurant stent graft abdominal aortic aneurysm
study of solifenacin succinate and tamsulosin hydrochloride ocas in males with lower urinary tract symptoms

Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Summary: clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with luts associated with bph with a substantial storage component.


Eligibility criteria:
inclusion criteria: * voiding and storage symptoms diagnosed as luts associated with bph for ≥ 3 months * a total international prostate symptom score (ipss) of ≥13 * a maximum urinary flow rate of ≥4.0 ml/s and ≤12.0 ml/s, with voided volume of ≥120 ml during free flow * a micturition frequency of ≥8 and at least 2 episodes of urgency with patient perception of the intensity of urgency scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization) exclusion criteria: * any significant post void residual volume (\>150 ml) * a prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound * evidence of a symptomatic urinary tract infection

Keywords: ec905 solifenacin succinate tamsulosin hydrochloride ocas treatment benign prostatic hyperplasia vesomni lower urinary tract symptoms
fasturtec tls treatment / prophylysis

Conditions: Tumor Lysis Syndrome

Summary: an open-label study to determine the efficacy and safety of rasburicase used for the prevention and treatment of tumor lysis syndrome


Eligibility criteria:
inclusion criteria: * chemotherapy planned for at least 3 cycles * undergoing cytoreductive chemotherapy for all, multiple myeloma or burkitt's lymphoma stage iii or iv * with a minimum life expectancy of 3 months * uric acid \> 8 mg% * negative pregnancy test \< or =to 2 weeks and efficient contraceptive method. * negative hiv serology \< or =to 4 weeks * patient or legal guardian has signed a written informed consent exclusion criteria: * hypersensitivity to uricases or any of the excipients * known history of g6pd deficiency. * previous treatment with rasburicase or uricozyme® * pregnancy or lactation * treatment with any investigational drug within 30 days before planned first rasburicase administration
effect of the cycloergometer in patients undergoing hematopoietic stem cell transplantation

Conditions: Fatigue; Leukemia; Lymphoma; Multiple Myeloma; Hematopoietic Stem Cell Transplantation

Summary: physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. currently, randomized studies have shown that physical exercise can contribute to improve quality of life of these patients. in this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (hsct).

the sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma, undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be randomized into two groups. the results of muscle strength in the lower limbs, general mobility, fatigue and clinical symptoms will be compared between the control group and the experimental group. the control group will perform an exercise program based on the standard protocol of the physiotherapy service, where exercises are performed to gain strength in muscle groups of the upper and lower limbs, range of motion, balance and functional movements. the experimental group will perform the same exercises as the control group, added to a training program using a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for 20 minutes.

Eligibility criteria:
inclusion criteria: * adult patients (18-70 years) scheduled to perform the first hsct; * be with a preserved neurological function and full cognition; * have clinical conditions that allow participation in the motor physiotherapy program; * be agreed with a study proposal and sign the free and informed consent form (icf). exclusion criteria: * develop clinical complications that contraindicate the performance of motor physiotherapy including the practice of the cycle ergometer; * present a previous musculoskeletal alteration that interferes with the performance of physical performance assessment tests; * recent cardiovascular or pulmonary disease; * psychiatric or neurological disorder; * need for gait assistance or presence of bone metastasis * adherence below 50% of the total motor physiotherapy protocol.

Keywords: autologous transplant allogeneic transplant physiotherapy exercise fatigue