Kornimate/medical-research-clean huggingface dataset:
impact of low frame rate fluoroscopy and cine-angiography on reducing operator and patient dose

Conditions: Stable Angina; Unstable Angina; Acute Coronary Syndrome

Summary: the investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (fps) and cine at 10 pulse per second (pps) vs. conventional (15 fps and 15 pps) on radiation dose to the patient and the operator during coronary angiography and intervention. in addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.

minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. patients undergoing diagnostic angiography +/- ad hoc pci or planned pci, will be randomised to conventional settings (15 fps and 15 pps) or low frame rate settings (7.5 fps and 15 pps) or low cine settings (7.5 fps and 10 pps). the patient radiation dose, patient radiation dose area product (dap), and fluoroscopy time will be measured. statistical analysis: demographic and procedural variables will be presented as percentage (categorical variable) or mean ± sd (continuous variable). patients will be randomized into three arms - a control arm and two intervention arms. the angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. the intervention arm will consist of two groups. group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second. sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. at 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.

Eligibility criteria:
inclusion criteria: * patients undergoing elective or urgent cardiac catheterisation with or without ad-hoc pci or planned pci in the pre-specified catheterisation laboratories. exclusion criteria: * patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures). * patients participating in other research study requiring higher cine angiography. * st-elevation myocardial infarction

Keywords: radiation fluoroscopy diagnostic
evaluation of metronidazole hydrogel 25% in stage ii and iii periodontitis

Conditions: Periodontitis

Summary: a randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.

a randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage ii and iii. at least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the srp. in half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered. the study will be carried out in accordance with the helsinki declaration and the protocol will be submitted to the internal review board of the university to obtain authorization. afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials. the protocol respects the spirit parameters for the compilation of protocols on clinical trials and the study will respect the parameters of consort sta-tement on randomized clinical trials.

Eligibility criteria:
inclusion criteria: * 10% of sites with survey depth 5 mm * comparable pockets in 4 mouth quadrants * health at systemic level exclusion criteria: * changes in oral mucosa * depth at the poll 5 mm * presence of removable prostheses or orthodontic equipment * allergies to even a single component of a product in testing• antibiotic-based treatments during the 6 months preceding the start of testing * history of previous periodontal treatments in the 12 months preceding the start of the study

Keywords: periodontitis periodontal disease
lens wear schedules and end-of-day comfort

Conditions: Myopia

Summary: the purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

this study was conducted in a cross-over design with two phases. each phase consisted of four cycles approximately 12 hours in length. during each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. a new pair of contact lenses was dispensed for each 2-hour interval of lens wear. a 12-hour lens-free wear period preceded each phase.

Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer. * is willing and able to follow instructions and maintain the appointment schedule. * has had an ocular examination in the last two years. * is an adapted soft contact lens wearer. * experiences a decrease in ocular comfort through a lens-wearing day. * has a current pair of spectacles. * has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses. * has astigmatism less than or equal to -1.00 dc. * achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles. * other protocol-defined inclusion criteria may apply. exclusion criteria: * has any ocular disease. * has a systemic condition that may affect a study outcome variable. * is using any systemic or topical medications that may affect ocular health. * has known sensitivity to the diagnostic pharmaceuticals to be used in the study. * other protocol-defined exclusion criteria may apply.
open-label extension study of ubenimex in patients with pulmonary arterial hypertension (who group 1)

Conditions: Pulmonary Arterial Hypertension

Summary: ubenimex is being developed for the treatment of pulmonary arterial hypertension (pah) (world health organization \[who\] group 1) to improve exercise capacity and delay clinical worsening. this study is a phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with pah (who group 1) who complete study eig-ubx-001.

this study is a phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with pah (who group 1) who complete study eig-ubx-001 (study eig-ubx-001 is a phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for study eig-ubx-002. the primary objective for this study is: - to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily \[tid\]) in patients with pah (who group 1).

Eligibility criteria:
inclusion criteria: * patients must have completed study eig-ubx-001 through week 24. * in the opinion of the principal investigator, has been generally compliant with study requirements during study eig-ubx-001. * agrees to use a medically acceptable method of contraception throughout the entire study period. * willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures. exclusion criteria: * is pregnant or lactating. * concurrent regular use of another leukotriene pathway inhibitor. * any reason that, in the opinion of the investigator, precludes the patient from participating in the study. 1. any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study 2. a serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy * an ongoing, drug-related, serious adverse event (sae). * significant/chronic renal insufficiency. * transaminases (alanine transaminase, aspartate transaminase) levels \>3 × upper limit of normal (uln) and/or bilirubin level \>2 × uln. * absolute neutrophil count \<1500 mm3. * hemoglobin concentration \<9 g/dl at screening.
comparison of 2 doses of temsirolimus (torisel) in patients with mantle cell lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this study will compare the effectiveness and safety of two different doses of temsirolimus (torisel).


Eligibility criteria:
inclusion criteria: * have confirmed mantle cell lymphoma diagnosis. * have measurable disease. * have received at least 2 prior treatment, which may include stem cell transplant. * have adequate organ and bone marrow function. * there are other criteria--please discuss with your doctor. exclusion criteria: * had any prior treatment with temsirolimus or mtor inhibitor. * had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy. * has active or untreated brain or central nervous system metastases. * there are other criteria--please discuss with your doctor.

Keywords: mantle cell lymphoma non-hodgkin's lymphoma temsirolimus
the expecting study

Conditions: Pregnancy; Obese

Summary: the purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.


Eligibility criteria:
inclusion criteria: * bmi \>30 * \>18 years of age * singleton pregnancy * less than 12 weeks gestation * sedentary * conceived without assisted fertility treatments * cleared by physician to exercise exclusion criteria: * women with pre-existing medical conditions as determined by the pi to affect the outcomes of interest * women who are using recreational drugs, tobacco, or alcohol during pregnancy * women with contraindications to exercise during pregnancy

Keywords: pregnancy obese
long-term persistence of immunity against hepatitis b in 7-8 years old children after hepatitis b vaccination.

Conditions: Hepatitis B Vaccine

Summary: the purpose of this study is to assess the persistence of immunity to hepatitis b in children who received three consecutive doses of hbv vaccine (engerixtm-b) in infancy. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * a male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment. * with documented evidence of previous vaccination with three consecutive doses of engerix™-b in germany * written informed consent obtained from the parents or guardians of the subject at the time of enrolment. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * evidence of previous hepatitis b booster vaccination since administration of the third dose of engerix™-b vaccine. * history of or intercurrent hepatitis b disease. * hepatitis b vaccination at birth. * planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before hbv vaccine challenge and ending 30 days after. * administration of immunoglobulins and/or any blood products within the three months preceding hbv vaccine challenge or planned administration during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hbv vaccine challenge. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

Keywords: hepatitis b vaccine challenge dose
collection of endometrial cancer-derived organoids to evaluate the efficacy of parp inhibitors: pendor pilot study

Conditions: Endometrial Cancer

Summary: this study comprises 3 stages: 1. collection of tumor and blood samples. 2. creation of organoid models based on tumor samples. 3. development of functional tests to predict clinical response to treatment.


Eligibility criteria:
inclusion criteria: * patient aged 18 years or more * patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment. * patient with localized endometrial cancer, presenting: * a high-grade endometrioid histological type and/or * p53 mutation and/or * a non-endometrioid histological type regardless of p53 status. * patient affiliated to a social security scheme * information and signature of informed consent prior to any specific study procedure exclusion criteria: * other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin). * patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.

Keywords: endometrial cancer organoide parp inhibitor
urotherapy vs. urotherapy with constipation treatment for children with lower urinary tract dysfunction

Conditions: Diurnal Enuresis

Summary: constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). this study aims to explore if treatment of patients without overt constipation (as defined by the rome iii criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. assessment of severity and response of lower urinary tract dysfunction will be based on the vancouver nultd/des questionnaire.


Eligibility criteria:
inclusion criteria: 1. aged 5-17 years at time of signing of informed consent. 2. lower urinary tract dysfunction (lutd)-daytime/daytime and nighttime urinary incontinence as defined by a score of \>11 on the vancouver questionnaire . 3. do not meet rome iii criteria for functional constipation. exclusion criteria: 1. inability to provide signed informed consent. 2. inability to comply with the study protocol. 3. neurogenic bladder 4. attention deficit disorder (add or adhd) on medical treatment. 5. known significant sacral, perineal, or other congenital or surgical defect. 6. known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis) 7. patient taking medicinal drugs which can cause urinary incontinence or constipation.

Keywords: lower urinary tract dysfunction constipation
the lyon real world evidence in metastatic neuroendocrine tumours

Conditions: Gastro-enteropancreatic Neuroendocrine Tumor; Health Care Costs; Metastatic Cancer

Summary: neuroendocrine tumours (nets) are rare and include a heterogeneous group of neoplasms derived from the endocrine system found in the gastrointestinal tract, pancreas and lung. gastroenteropancreatic (gep) nets represent the majority of neuroendocrine neoplasms (nen) and the annual incidence of all gep-nets has been estimated to 6.98 per 100,000 person-years in 2012 and is steadily rising. while data on the incidence of metastatic gep-net is limited, more than 50% of patients with gep-net have metastatic disease at the time of diagnosis. incorrect and delayed diagnoses are still common. treatment options include surgery, locoregional interventions, and systemic treatment. the lyon real world evidence in metastatic neuroendocrine tumours study (lyremenet) is a descriptive observational cohort study. the main objective is to assess the healthcare resources use and the corresponding costs for management of patients with metastatic gep and lung nets. the secondary objective is to describe the clinical characteristics, prognostic factors, treatment patterns, and the overall survival among patients with metastatic gep and lung nets.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of well-differentiated metastatic neuroendocrine tumour (either synchronous or metachronous) * diagnosis performed between 1 january 1990 and 31 december of 2017 * patients seen at least once at the oncologic department of hospices civils de lyon. exclusion criteria: * poorly differentiated neuroendocrine carcinoma * histologic mixed neuroendocrine tumour
removal of erroneous penicillin allergy labels: implementation study (repeal)

Conditions: Penicillin Allergy

Summary: to test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a uk hospital using the developed toolkit and a validated penicillin allergy decision support tool.

aim: to test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway. objectives: * to use the institute for health improvement (ihi) model for improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care) * to measure the number of patients meeting inclusion criteria (\>16 with a pena not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the ams team. * to measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / doc). to interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.

Eligibility criteria:
inclusion criteria: all adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use. exclusion criteria: none
change in coronary heart disease risk factors in young adults

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young adults who had been followed for sixteen years in the beaver county lipid study. the beaver county lipid study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.

background: epidemiologic studies of coronary risk factors have been performed primarily in populations of middle-aged adults, children, and adolescents. relatively little is known about these risk factors in men and women 20-29 years of age. this study provided important insights into the determinants of coronary heart disease risk factors in young adults and bolstered the argument of those who favor the early identification of and intervention in the young coronary candidate. design narrative: three cross-sectional examinations had been carried out: 1) 1972-1973; 2) 1980-1981; and 3) 1988-1989. the study examined the predictors of change in total cholesterol (from examination 1 to examination 3, and change in ldl-c, hdl-c, and triglycerides between examinations 2 and 3. it also investigated the stability in several health habits and behaviors such as cigarette smoking, alcohol use, adherence to a low fat/low cholesterol diet, and physical activity. weight gain and oral contraceptive use had been shown in previous analyses to be strong predictors of several lipids and lipoproteins. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
vinorelbine and gemcitabine versus capecitabine in pretreated metastatic breast cancer

Conditions: Breast Cancer

Summary: the combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.

this trial will compare the efficacy of combination treatment with vinorelbine and gemcitabine versus capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.

Eligibility criteria:
inclusion criteria: * age 19-75 years. * performance status world health organization (who) 0-2. * histologically confirmed breast adenocarcinoma. * clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (taxotere + mitoxantrone or taxotere + farmorubicine). * measurable disease. * no metastatic central nervous system (cns) disease. * less than 25% of myeloproductive bone marrow irradiated. * adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3). * adequate liver (bilirubin \< 1.5 times upper limit of normal and sgot/sgpt \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl). * informed consent. exclusion criteria: * pregnancy or nursing. * positive pregnancy test. * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness. * other invasive malignancy within the past 5 years except nonmelanoma skin cancer.

Keywords: breast cancer chemotherapy vinorelbine gemcitabine capecitabine
a study of tocilizumab in combination with disease-modifying anti-rheumatic drugs (dmards) in participants with moderate to severe active rheumatoid arthritis with an inadequate response to dmards

Conditions: Rheumatoid Arthritis

Summary: this open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with dmards in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to dmards. participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (iv) infusion every 4 weeks in addition to their current dmard therapy.


Eligibility criteria:
inclusion criteria: * moderate to severe active ra of ≥6 months duration * das28 \>3.2 * inadequate response to a stable dose of non-biologic dmard for ≥2 months * those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment exclusion criteria: * rheumatic autoimmune disease other than ra * history of or current inflammatory joint disease other than ra * previous treatment with alkylating agents or total lymphoid irradiation * intra-articular or parenteral corticosteroids within 6 weeks prior to baseline * previous treatment with any cell-depleting therapies * american college of rheumatology (acr) functional class iv