Kornimate/medical-research-clean huggingface dataset:
tamoxifen to prevent bone loss and heart disease in premenopausal women receiving chemotherapy for stage i or stage ii breast cancer

Conditions: Breast Cancer; Osteoporosis

Summary: rationale: tamoxifen may be able to increase bone density and decrease cholesterol in women who are undergoing chemotherapy for breast cancer. purpose: clinical trial to study the effectiveness of tamoxifen in preventing bone loss and heart disease caused by chemotherapy treatment in premenopausal women who have stage i or stage ii breast cancer.

objectives: * compare the bone density in the femoral neck and lumbar spine and cholesterol levels in premenopausal women with stage i or ii breast cancer treated with adjuvant chemotherapy with or without tamoxifen. * collect information regarding breast cancer risk factors, treatment, pathology, diet, activity levels, weight, and smoking in these patients. outline: patients are stratified according to type of treatment (adjuvant chemotherapy plus tamoxifen vs adjuvant chemotherapy alone). patients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of the treating physician. prior to starting chemotherapy, patients undergo blood draw to measure baseline levels of follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and low-density lipoproteins. patients undergo baseline bone densitometry of the femoral neck and lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of the first drug treatment. laboratory studies and bone densitometry are repeated at years 1 and 2. a comparison is made between the study findings at baseline and at years 1 and 2. projected accrual: a total of 80 patients (40 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven stage i or ii breast cancer * must be scheduled to receive adjuvant chemotherapy with or without tamoxifen * hormone receptor status: * not specified patient characteristics: age: * 35 to 50 sex: * female menopausal status: * premenopausal by follicle-stimulating hormone and estradiol levels performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * see disease characteristics radiotherapy: * not specified surgery: * not specified

Keywords: osteoporosis stage i breast cancer stage ii breast cancer
effect of omega 3 supplementation on the heart rate variability in obese children

Conditions: Obesity, Childhood

Summary: evidence shows that omega-3 fatty acids lower blood triglyceride levels, lower blood pressure, enhance insulin sensitivity, and improve heart rate variability (hrv) measures, all of which may be indicators of cardiovascular health.as a result, omega-3 fatty acid supplementation may be a low-cost strategy with little adverse effects for obese youngsters, perhaps delaying the development of chronic cardiovascular illnesses.

this is a two-armed study , the interventional group will be given omega 3 and the control group will be given a placebo and both will be examined for the heart rate variability

Eligibility criteria:
inclusion criteria: * children (5-12 years) whose parents or caregivers will agree to be enrolled in the study * obese children (simple obesity ) * both males and females exclusion criteria: * patients are known to have cardiac disease * patients with associated chronic systemic illness * patients with 2ry obesity : (endocrine /metabolic/genetics/drug intake) * patients on medications affecting heart rate :structural or arrhythmic
intravenous micronutrient therapy (ivmt) for fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to determine if intravenous micronutrient therapy (ivmt) is effective in the treatment of fibromyalgia, as assessed by validated functional and pain measures.

as per brief summary

Eligibility criteria:
inclusion criteria: * meet the american college of rheumatology criteria for fibromyalgia diagnosis; * on no medication for fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study * willing to stop all fms medication for the duration of the study or be on a stable dose of such medication for at least 3 months exclusion criteria: * other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding problems * allergy to thiamin * unwilling to stop vitamin supplementation for the duration of the study * please note: travel to and accomodations at the study site can not be compensated. anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense.

Keywords: fibromyalgia intravenous micronutrient therapy ivmt alternative medicine complementary medicine vitamins vitamin supplements
surgery and intrapleural docetaxel in treating patients with malignant pleural effusion

Conditions: Metastatic Cancer

Summary: rationale: giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again. purpose: this phase i trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.

objectives: primary * determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion. secondary * determine the toxicity profile of this drug in these patients. * determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients. * determine the response in patients treated with this drug. outline: this is a dose-escalation study. patients undergo thorascopic surgery to drain the malignant pleural effusion. an intrapleural catheter (pleurx catheter) is then inserted for subsequent docetaxel instillation. approximately 24 hours after surgery, patients receive docetaxel intrapleurally over 3 minutes via the pleurx catheter. the pleurx catheter is then clamped for 4 hours and the patient is placed in several different positions to ensure uniform distribution of docetaxel throughout the pleural cavity. cohorts of 3-6 patients receive escalating doses of intrapleural docetaxel until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. after completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter. projected accrual: approximately 8-24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed malignant pleural effusion (mpe) * symptomatic disease * candidate for thoracoscopic surgery for treatment of mpe * no known or suspected ipsilateral pleurodesis that would preclude surgery * no bilateral mpes * no progressive extrapleural disease that is untreatable and/or resistant to systemic treatment patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 8.0 g/dl hepatic * alt and/or ast ≤ 1.5 times upper limit of normal (uln) (if alkaline phosphatase normal) or * alkaline phosphatase ≤ 2.5 times uln (if alt and/or ast normal) * bilirubin normal * inr ≤ 1.5 renal * creatinine ≤ 1.8 mg/dl other * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment * no history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * no peripheral neuropathy \> grade 1 prior concurrent therapy: biologic therapy * not specified chemotherapy * no concurrent systemic chemotherapy endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: malignant pleural effusion
safety and efficacy study of a recombinant and protein-free factor viii (rahf-pfm) in hemophilia a patients undergoing surgery

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate whether rahf-pfm is safe and effective in the treatment of hemophilia a patients undergoing surgery.


Eligibility criteria:
inclusion criteria: * age \>= 5 years * the subject has severe or moderately severe hemophilia a defined by a baseline factor viii level \<= 2% of normal documented at screening or historically (e.g., at hemophilia diagnosis) * subjects may enroll regardless of their serologic status for human immunodeficiency virus (hiv-1) and hepatitis c virus (hcv) * the subject requires a surgical, dental or other invasive procedure--either elective or emergency * the subject has a history of at least 150 exposure days for all other factor viii products (as estimated by the study site investigator) prior to study entry * the subject has a life expectancy of at least 28 days from the day of surgery * the subject has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate irb/iec and baxter bioscience exclusion criteria: * the subject has a detectable inhibitor to factor viii in the local hemostasis laboratory at the investigative site at the time of enrollment * the subject has a history of inhibitor to factor viii \> 1.0 bu. note: if the subject has a history of an inhibitor titer \> 1.0 bu at any time prior to enrollment but demonstrated expected clinical responses to conventional doses of factor viii therapy, the subject may enroll * the subject has known hypersensitivity to recombinate * the subject is currently participating in another investigational drug study, or has participated in any clinical trial involving an investigational drug within 30 days of study entry * the subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia a (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura, disseminated intravascular coagulation) * the subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
the diabetes and aquatic training study (dats)

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the effects of the combined exercise training (aerobic more resistance) and of the aerobic exercise training isolated compared to control group, which performed only stretching and relaxation, in the treatment of type 2 diabetes (t2dm). the two exercise interventions and the control procedure are performed in aquatic environment.

the fact that aquatic training can provide similar benefits to land training has important clinical implications, because the aquatic environment provides some interesting advantages to this population, such as no impact on walking and running in deep water or reduced, as in water-based exercises. this minor impact and consequent reduced chance of injury allows consider the aquatic environment favorable to the principle of continuity with progression of physiological stimuli and metabolic benefits. from these peculiarities of the training in aquatic environment, and of the association between t2dm with obesity and hypertension, conditions that create difficulties for individuals performing exercise supporting their own body mass and need both benefits from aerobic and resistance training, is believed to be necessary to carry out physical training programs of the same duration, differing in training mode (aerobic or combined) in the aquatic environment in order to answer of in a adequated duration of training, the diabetes control through training differs between the different mode of exercise.

Eligibility criteria:
inclusion criteria: * type 2 diabetes; * be under medical treatment with oral hypoglycemic agents and / or insulin; * not engaged in regular exercise (regular exercise was defined as performing any type of physical training for at least 20 minutes three or more days a week). exclusion criteria: * severe autonomic neuropathy; * severe nonproliferative and proliferative diabetic retinopathy; * decompensated heart failure; * limb amputations; * severe foot injuries; * chronic renal failure (modification diet in renal disease-mdrd, glomerular filtration rate-gfr \< 30 ml/min); * body mass index (bmi) \> 45.0 kg/m2; * any muscle or joint impairment which prevented individuals from engaging in physical exercise.
efficacy of double fortified salt (dfs) to improve work productivity in women in india

Conditions: Anemia; Iron Deficiency

Summary: the main objective of the present study is to assess the impact of double fortified salt containing iron and iodine on work performance (productivity) of women plantation workers in india. efficacy studies have shown that salt double-fortified with iodine and iron can significantly reduce the incidence rates of iron-deficiency anemia (ida) and iodine-deficiency disorders. double-fortified salt (dfs) can be prepared by mixing microencapsulated iron compounds into conventionally iodated salt (yuan et al, 2008). iron deficiency anemia affects the work productivity and physical activity. many studies have shown that when the individuals with low hb received iron supplement, their work performance improved markedly. animal studies have demonstrated that iron deficient anemic rats had a lower work tolerance as measured by oxygen consumption than the adult rats with normal hb levels (ohira et al, 1981). several human studies have demonstrated the effect of iron supplementation on endurance capacity and work productivity in women (zhu and haas, 1997, 1998; edgerton et al., 1979). many human studies have also examined the possible linkages between iron deficiency and concurrent cognitive or behavioral outcomes. iron supplementation effective in reducing iron-deficiency anemia would also result in better behavioral and developmental outcome. many studies found that ida had a great influence on cognitive functions in infants and school children (lozoff et al., 2003, 1998 and friel et al., 2003). however, studies of ida and cognitive function in adults are few and controversial. this study will assess iron status and physical and mental performance at 2 time points, before and after approximately 10 months during which a controlled intervention will take place on tea estates at the panighatta tea garden near siliguri, west bengal. subjects will be women between 18 and 50 years of age who are actively employed as full time tea pickers. the study requires that 2 experimental groups of subjects be identified: a) an experimental group that consumes double fortified salt (dfs) containing iron + iodine, and b) a control group that consumes only iodized salt (is).


Eligibility criteria:
inclusion criteria: * experienced, permanent, full-time tea pickers who plan to work for at least 2 picking seasons exclusion criteria: * pregnant and lactating women * women with physical or mental disabilities that inhibit their ability to understand the study procedures or conduct their usual work (tea picking)
pet/mri/eeg imaging study in epilepsy

Conditions: Epilepsy

Summary: this study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. the study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography \[fdg-pet\], and blood flow, measured by functional magnetic resonance imaging \[fmri\]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography \[eeg\]). the study will also compare how the three imaging modalities localize regions of abnormal function in the brain.


Eligibility criteria:
inclusion criteria: * age 18 or older additional inclusion criteria for subjects with epilepsy: * diagnosed with epilepsy with abnormal interictal eeg exclusion criteria: * contraindications to pet, mri, or eeg imaging * history of severe brain disease such as stroke and head trauma * history of brain surgery * history of type i or ii diabetes mellitus * fasting plasma glucose level \>200 mg/dl * employed under direct supervision of the pi conducting the research additional exclusion criteria for healthy subjects: * current use of drugs that modulate brain function * current or past history of major medical, neurological, or psychiatric conditions

Keywords: functional pet fdg-pet functional mri eeg epilepsy neuroimaging multimodal imaging
preoperative radiotherapy and chemotherapy in patients with locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: the aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with folfox chemotherapy regimen.


Eligibility criteria:
inclusion criteria: * previously untreated and pathologically proven adenocarcinoma of the rectum. * mri staged t3 or t4, any n. * lower border of tumour must be within 12 cm of anal verge. * age greater than or equal to 18 years. * ecog performance status 0-1 (appendix 2) * absolute neutrophil count greater than or equal to 1.5 x 109/l, haemoglobin greater than or equal to 90 g/l, and platelets greater than or equal to 100 x 109/l. * adequate renal function: gfr greater than or equal to 55 ml/min (derived from serum creatinine e.g. using the cockcroft-gault formula or measured by radioisotopic techniques). * bilirubin and alt less than or equal to 1.5 x upper limit of normal. * no symptomatic peripheral neuropathy greater than or equal to grade 2. * male or non-pregnant, non-lactating female. patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive. * has provided written informed consent for participation in this trial exclusion criteria: * presence of metastatic disease. * prior pelvic radiotherapy * febrile intercurrent illness or infection. * previous history of unstable angina * cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment * acute coronary syndrome even if controlled with medication * myocardial infarction within the last 12 months * concurrent treatment with other anti-cancer therapy. * significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities. * locally recurrent rectal cancer.

Keywords: rectal cancer chemotherapy radiotherapy
premature coronary atherosclerosis in scleroderma

Conditions: Scleroderma

Summary: the purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

coronary calcium scores will be obtained from a group of patients with scleroderma and a group of controls. comparison of the calcium scores will be made.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years. 2. fulfillment of the american college of rheumatology (acr) criteria for the classification of scleroderma.

Keywords: scleroderma sclerosis atherosclerosis
effectiveness of oral antibiotics in the treatment of severe acute malnutrition

Conditions: Kwashiorkor; Marasmus

Summary: the need for oral antibiotics as part of the case management of severe acute malnutrition (sam) in the outpatient setting has not been studied in a prospective trial. this study will compare the recovery rates of children with sam treated at home with locally-produced ready-to-use therapeutic food (rutf) with and without prescribed antibiotics as part of their outpatient case management. the investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.


Eligibility criteria:
inclusion criteria: * 6 months - 5 years old * kwashiorkor or marasmus * qualifies for home-based therapeutic feeding with rutf exclusion criteria: * obvious congenital or other malformation that makes child a poor candidate for home-based feeding with rutf * unable to consume test-dose of rutf in clinic * parent refusal to participate and return for follow-up
trabeculectomy with mitomycin c associated with sub-conjunctival injection of ranibizumab

Conditions: Glaucoma

Summary: trabeculectomy with mitomycin c remains the standard surgery for glaucoma. this surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. however, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. the failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. furthermore, they have shown promise when used during trabeculectomy. ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes. the investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin c by decreasing scarring. the aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin c compared to eyes having undergone trabeculectomy with mitomycin c alone.

prospective, randomized, unblinded clinical trial. two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with mmc between march 2009 and september 2012. the ranibizumab group (ran) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.

Eligibility criteria:
inclusion criteria: * to have uncontrolled glaucoma * to have accepted to undergo a primary trabeculectomy with mitomycin c * to have one of the following types of glaucoma: * normal tension glaucoma * chronic open-angle glaucoma * chronic angle-closure glaucoma * mixed mechanism glaucoma * steroid-induced glaucoma * neovascular glaucoma exclusion criteria: * to be less than 18 years old * to be unable to observe the study protocol * to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases * a history of thromboembolic events and cerebrovascular accidents * congenital glaucoma * uveitic glaucoma * to be pregnant * to be breastfeeding * surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages * to have undergone a previous conjunctival surgery * to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging * to present an active or suspected intraocular or periocular inflammation * to have a kidney failure * to have a liver failure

Keywords: trabeculectomy vascular endothelial growth factor a wound healing angiogenesis inhibitors