Kornimate/medical-research-clean huggingface dataset:
vaccine therapy in treating patients with acute myeloid leukemia in complete remission

Conditions: Leukemia

Summary: rationale: vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells. purpose: this phase i trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

objectives: primary * assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission. secondary * evaluate the emergence of an immune response. * determine the relapse rate. * assess the occurrence of residual disease. outline: patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 iv) every 3 weeks for up to 5 doses.

Eligibility criteria:
disease characteristics: * diagnosis of acute myelogenous leukemia (aml) * myelomonocytic (m4) or monocytic (m5) subtype * in second complete remission (cr) or later following cr1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation * no (15;17) translocation * no aml m3 * hla-a2 positivity * cd14 ≥ 20% on peripheral blood mononuclear cells * circulating blasts ≥ 10 x 109/l (collected prior to chemotherapy) available * must not be eligible for hla-matched allogeneic transplantation * no progressive disease patient characteristics: * karnofsky performance status 70-100% * not pregnant or nursing * fertile patients must use effective contraception * no contraindication to cytopheresis or chemotherapy * no hiv or htlv positivity * no hepatitis b or c activation * no prior psychological disease * not deprived of liberty and able to give consent * must be able to speak and read french * no other cancer except for basal cell or cervical prior concurrent therapy: * see disease characteristics * no concurrent participation in another clinical study

Keywords: adult acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22)
neck fat accumulation and its relationship to cardiovascular risk and metabolic syndrome

Conditions: Obesity

Summary: accumulation of fat in the neck using tape measures has been linked to increased cardiovascular risk. the investigators' hypothesis is that detailed measures of neck fat using computed tomography will show that specific fat compartments in the neck contribute differently to cardiovascular risk.


Eligibility criteria:
inclusion criteria: * no history of malignancy at the time of image acquisition * fasting glucose measured immediately prior to pet/ct exclusion criteria: * history of neck cancer, radiation therapy, and/or surgery
risk factors and outcomes in coronary chronic total occlusion

Conditions: Chronic Total Occlusion; Coronary Artery Disease

Summary: this study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (cto) treated with percutaneous coronary intervention or medical treatment.

coronary artery disease (cad) is still one of the major contributors to global mortality. cto is a special lesion type of cad, defined as complete occlusion of at least one major epicardial coronary artery more than 3 months. compared to non-cto patients, those with cto have worse prognosis. the prognosis of cto patients is related to many factors including the baseline characteristics, modality of treatment and the degree of coronary collateral formation. figuring out the factors which can indicate the outcomes of cto is essential to clinical decision making. in this single center, observational study, we collect patient's clinical characteristics and blood samples to investigate potential factors associated with the development of coronary collateral formation and outcomes in patents with stable coronary artery disease.

Eligibility criteria:
inclusion criteria: * age ≥18 years; patients with angina or silent ischemia and documented ischemia; patients with cto ≥ 3months exclusion criteria: * egfr\<15ml/(min·1.73m2); chronic heart failure with nyha grade ≥3; had a history of coronary artery bypass grafting; had received a percutaneous coronary intervention within the prior 3 months; malignant tumor or immune system disorders; pulmonary heart disease
a study to evaluate the efficacy and safety of an experimental solution for peritoneal dialysis

Conditions: End Stage Renal Disease

Summary: objective: the purpose of this study is to demonstrate: -the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (esrd) in peritoneal dialysis patients.


Eligibility criteria:
inclusion criteria: * patients who have given written informed consent after the nature of the study has been explained. * patients who are at least 18 years of age. * patients who have been treated with capd using specific solutions for at least 60 days before the baseline visit. exclusion criteria: * patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit. * patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection. * patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit. * patients who have severe malnutrition (serum albumin \< 25 g/l by bromocresol green method). * patients who are participating in another study that requires ethics committee approval. non-interventional studies are permitted. * patients who have received an investigational product within 30 days preceding the screening visit. * patients who are pregnant or lactating. (nb: female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study). * patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.
gonadotrophin dosage using a threshold nomogram for ovulation induction in who group ii anovulatory infertility

Conditions: Anovulation; Infertility

Summary: ovulation disorders are a common cause of infertility in women. most of these women can be classified as world health organization (who) group ii anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (fsh) and estradiol. the purpose of this study is to optimize the low-dose-step-up protocol traditionally used for ovulation induction with follicle-stimulating hormone (fsh) in women with anovulatory infertility who group ii. previous studies have established that menstrual cycle history, mean ovarian volume and bmi are significant predictors of fsh threshold dose in women with anovulatory infertility who group ii undergoing ovulation induction (nyboe andersen et al., 2008). a fsh dosage nomogram has been constructed based on these variables. the aim of this study is to evaluate the clinical use of the nomogram in order to test the use of the variables to determine whether an individualized starting dose of fsh can be used for ovulation induction in anovulatory patients. it is the hypothesis that an individualized starting dose of gonadotrophin will minimize the disadvantages of the treatment and that the stimulation period of the individualized nomogram-based treatment will be 25% shorter than observed in the standard protocol. the primary endpoint is the proportion of patients who reach the criteria for hcg-administration within 14 days of menopur stimulation. the results of the study will be compared with the data obtained in the menopur ovulation induction trial (platteau et al., 2006).


Eligibility criteria:
inclusion criteria: 1. anovulatory infertility 2. age 18 - 39 years 3. anovulation with oligomenorrhoea (\> 35 days of mean cycle length) or amenorrhoea 4. normal serum fsh (\< 10 iu/l) 5. two ovaries 6. bmi \< 35 7. first fsh/hmg cycle at the fertility clinic. 8. a sperm sample compatible with conception or semen from a donor. 9. tubal patency documented by either hysterosalpingography (hsg) or hysterosalpingography by ultrasound (hsu) in cases where the woman has had a pelvic infection or pelvic surgery. exclusion criteria: 1. a history of \>12 ovulation induction cycles without achieving pregnancy. 2. more than three earlier gonadotropin cycles at other clinics or earlier treatments with threshold doses below 75. 3. known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney. 4. undiagnosed vaginal bleeding. 5. acute or chronic infection with hiv or hepatitis. 6. persistent ovarian cysts or endometriomas detected by ultrasound. 7. tumors of the hypothalamus, pituitary gland, breast, adrenal gland or ovary. 8. pregnancy or lactation. 9. current or past alcohol or drug abuse. 10. a history of chemo- or radiotherapy. 11. malformations of reproductive organs incompatible with pregnancy. 12. hypersensitivity to any trial medication.

Keywords: infertility anovulation ovulation induction
botulinum for chronic exertional compartment syndrome

Conditions: Chronic Exertional Compartment Syndrome

Summary: we will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of chronic exertional compartment syndrome (cecs). we think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.

the study will be a prospective cohort pilot study designed to compare active duty patients, 18 years of age or older, with chronic exertional compartment syndrome (cecs) undergoing two different treatment interventions. the first arm will be patients receiving investigational botulinum toxin injections. the second arm will be patients who undergo the standard of care surgical fasciotomy. both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (lefi) surveys at pre-treatment and again at one, three, and six months post-treatment. clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, lefi and pain on the universal pain assessment tool.

Eligibility criteria:
inclusion criteria: * adult ages 18-65 * active duty military * unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb * failed conservative treatment over a period of 2 months, including trial of rest, nsaids, icing, and stretching routine * meets standard of care clinical diagnostic intramuscular compartment pressure criteria for cecs, based on standardized imp needle testing. see below for testing protocol and criteria. exclusion criteria: * prior botulinum toxin injections into the affected limb * prior compartment release of the affected limb * pregnant or becomes pregnant during the study * standard of care clinical exams indicating other more likely causes of leg pain
the impact of pharmacist recommendations on quality of care in diabetic patients

Conditions: Diabetes Mellitus

Summary: the goal of this study is to investigate a comprehensive provider-focused intervention to improve the quality of care for diabetic patients in a large primary care practice at brigham and women's hospital. this will be accomplished through pharmacist recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

type ii diabetes mellitus is an increasingly common condition among adults in the united states and is associated with substantial morbidity and mortality. the microvascular and macrovascular complications of diabetes lead to significant disability and early mortality, in addition to tremendous costs to the healthcare system. it has been clearly demonstrated, that both microvascular and macrovascular complications can be reduced through specific interventions that can be carried out by office-based primary care physicians. despite the accumulation of evidence regarding specific interventions that can reduce diabetes-related morbidity and mortality, multiple studies have shown that the care provided for diabetic patients frequently falls short of recommended standards. the researcher's goal is to investigate a comprehensive, provider-focused intervention to improve the quality of care for diabetic patients in a large, primary care practice at brigham and women's hospital. this will be accomplished through pharmacist-delivered recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients. adult diabetic patients age 18 years and older receiving primary care in the brigham internal medicine associates (bima) practice will be randomized to intervention and control groups, based on the practice subset (suite) within bima in which they receive their ongoing care. patients who receive care from providers in suites a, b, e, and f will be assigned to the intervention group, while patients who receive care from providers in suites c, d, g, and h will be assigned to the control group. patients will not be contacted regarding the study; providers who practice in the intervention suites will receive specific written recommendations regarding optimal diabetes care parameters from our study pharmacist prior to each patient's visit. providers who practice in the control suites will not be contacted. pre- and post-intervention compliance with multiple diabetes quality-of-care measures (eg, hemoglobin a1c measurement, ldl cholesterol measurement, pneumococcal vaccination, etc.) will be assessed in the intervention and control groups.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes * age 18 years or older * identifiable primary care physician (pcp) * attendance at index appointment with pcp exclusion criteria: * no assigned pcp * non-attendance at pcp appointment

Keywords: diabetes quality of care pharmacist recommendations
a phase 4 study to determine dosing of hectorol® capsules when converting from zemplar® injection

Conditions: Secondary Hyperparathyroidism

Summary: protocol hect00306 aims to determine clinically appropriate doses of hectorol (doxercalciferol capsules) when converting from zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in stage 5 chronic kidney disease on hemodialysis.


Eligibility criteria:
inclusion criteria: * the subject must be receiving hemodialysis three times per week for a minimum of six months. * the subject must have been receiving zemplar injection for a minimum of 3 months. the subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks. * the central laboratory assessment must be within the following ranges: serum ipth between 150-600 pg/ml, inclusive; corrected calcium \< 10.0 mg/dl; phosphorus \< 7.0 mg/dl. exclusion criteria: * in the opinion of the investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, hiv infection, or any other clinically significant, unstable medical condition. * abnormal liver function as measured by alt/ast greater than two times the upper limit of normal (uln). * the subject currently has malabsorption, severe chronic diarrhea, or ileostomy. * any evidence of active malignancy except for basal cell carcinoma of the skin. a history of malignancy is not an exclusion.

Keywords: hectorol (doxercalciferol capsules) zemplar (paricalcitol injection)
assessment of performance of [18f]-fes for endometriosis diagnosis

Conditions: Endometriosis

Summary: endometriosis is a benign chronic disease responsible for infertility and pelvic pain. one of the main problem of endometriosis is the significant delay of diagnosis.this delay has significant consequences for patients. currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (er). \[18f\]fes (16α-\[18f\]fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (pet), and a specific tracer of er. we propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis. the aim of this multicenter, prospective, open study is to assess sensitivity of pet with \[18f\] -fes for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.


Eligibility criteria:
inclusion criteria: * first planned coelioscopy (therapeutic indication) for suspected endometriosis * patient aged from 18 to 50 years * absence of treatment with gnrh (gonadotropin-releasing hormone) analogue for at least 3 months * patient affiliated to a social security system * no hormonal treatment for at least 3 months exclusion criteria: * history of abdominal pelvic surgery for endometriosis * current treatment with gnrh (gonadotropin-releasing hormone) or stopped for less than 3 months * hormonal drug ongoing * patient pregnant, may be or during lactation * patient under guardianship or trusteeship * patient unable to understand the purpose of the study * patient already included in another clinical trial with an experimental molecule.
characterization of lung function profile of inhaled tiotropium + olodaterol fixed dose combination compared to fluticasone propionate + salmeterol fixed dose combination in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol fdc \[2.5/ 5µg and 5/ 5µg\] delivered by the respimat with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol fdc \[250/50µg and 500/50µg\] delivered by the accuhaler® after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of chronic obstructive pulmonary disease 2. relatively stable airway obstruction with a post-bronchodilator 30% \</= forced expiratory volume in 1 second (fev1)\<80% of predicted normal and a post-bronchodilator fev1/(forced vital capacity)fvc \<70% 3. male or female patients, 40 years of age or older 4. smoking history of more than 10 pack years 5. ability to perform technically acceptable pulmonary function tests and maintain records 6. ability to inhale medication in a competent manner from the respimat inhaler, accuhaler and from a metered dose inhaler (mdi) exclusion criteria: 1. significant disease other than copd 2. copd exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months. 3. clinically relevant abnormal lab values 4. history of asthma 5. diagnosis of thyrotoxicosis 6. diagnosis of paroxysmal tachycardia 7. history of myocardial infarction 8. unstable or life-threatening cardiac arrhythmia 9. hospitalization for heart failure within the past year 10. known active tuberculosis 11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 12. history of life-threatening pulmonary obstruction 13. history of cystic fibrosis 14. clinically evident bronchiectasis 15. history of significant alcohol or drug abuse 16. history of thoracotomy with pulmonary resection 17. oral or patch ß-adrenergics 18. oral corticosteroid medication within 6 weeks prior to visit 1 19. regular use daytime oxygen therapy for more than one hour per day 20. pulmonary rehabilitation program in the six weeks prior to the screening visit 21. investigational drug within one month or six half lives (whichever is greater) prior to screening visit 22. known hypersensitivity to ß-adrenergic drugs, bac, edta 23. pregnant or nursing women
malnutrition screening in acute aged care

Conditions: Malnutrition

Summary: the purpose of this study is to determine the impact of malnutrition screening and nutrition intervention on acute aged care patient outcomes.


Eligibility criteria:
inclusion criteria: * admitted under a geriatrician into one of 2 acute geriatric medicine wards of the hospital exclusion criteria: * expected length of stay less than 72 hours * palliative (not for active treatment) * unable to be nutritionally assessed (non english speaking, severe dementia/confusion and non cooperative/refused) * already seen by dietitian during current admission * enrolled in the study during previous admission
a study to treat small cell lung cancer with a combination of cisplatin, pemetrexed, and radiotherapy

Conditions: Small Cell Lung Cancer; Carcinoma, Small Cell; SCLC

Summary: the purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with small cell lung cancer.


Eligibility criteria:
inclusion criteria: * measurable disease with diagnosis of small cell lung cancer. * performance status of 0 to 1 on the eastern cooperative oncology group performance status schedule. * patients must be at least 18 years of age and have at least a 12-week life expectancy. * no prior chemotherapy and/or prior thoracic radiotherapy. * adequate pulmonary function and organ function. exclusion criteria: * patients with myocardial infarction within the preceding six months. * diagnosis of a serious concomitant systemic disorder. * prior radiotherapy to the lower neck or abdominal region. * significant weight loss. * concurrent administration of any other antitumor therapy.