Kornimate/medical-research-clean huggingface dataset:
prevention of hemorhagic risk in upper myomectomy by use of misoprostol.

Conditions: Myoma;Uterus; Myomectomy; Surgical Blood Loss

Summary: in france, uterine fibroids or leiomyomas are the most common benign tumour in women of childbearing age. in 30% of cases, fibroids are symptomatic (menorrhagia, anaemia, pain), in which case surgical management is indicated. this is known as myomectomy, and can be performed by hysteroscopy, laparoscopy (laparoscopy) or laparotomy, depending on the number, size and position of the fibroids. intraoperative bleeding is the main surgical difficulty. for this reason, a number of studies have focused on ways of minimizing the risk of bleeding. a good surgical indication, prevention of anaemia (iron deficiency) and transient occlusion of the uterine arteries during surgery help to reduce this risk. there are also drugs available to reduce intraoperative bleeding, but few studies have been carried out to assess their real effectiveness. one such product is misoprostol, commonly used in gynecology. its muscle-contracting properties suggest that it could have a beneficial effect on bleeding during surgery. what's more, this treatment has been used for many years and is reputed to be very well tolerated. the most frequent side effects are digestive, with a risk of abdominal pain in the form of cramps, nausea or vomiting. the investigators therefore decided to set up the hemomyoc study to demonstrate a significant reduction in bleeding during laparotomy or laparoscopic myomectomy after taking oral misoprostol in combination with transient occlusion of the uterine arteries, compared with placebo. it would seem that the ease of use and good tolerance of misoprostol, in combination with transient occlusion of the uterine arteries, could be of real benefit in preventing intraoperative morbidity in myomectomies, whatever the surgical approach. to date, no studies have been carried out in this area.


Eligibility criteria:
inclusion criteria: * patient aged 18 to 43 * symptomatic myomas (bleeding, pain or infertility) * indication for laparoscopic myomectomy fibroma ≤ 10cm or number ≤ to 4 fibroids * indication for myomectomy by laparotomy fibroma \> 10cm, number \> to 4 fibroids * otau possible intraoperatively (clip on uterine artery and tourniquet placement) * speak and understand french * affiliated with a social security scheme. exclusion criteria: * previous abdominal surgery (excluding appendectomy) or myomectomy (excluding hysteroscopic myomectomy) * allergy to misoprostol and lactose * patients with hypersensitivity to misoprostol and/or other prostaglandins or to any of the product's excipients. * patients taking aspirin or anti-coagulants * patients with haemostasis disorders * malnourished patients * patients with hepatic or renal insufficiency * pregnancy, suspected ectopic pregnancy and breast-feeding women. * minors * guardianship, curatorship, deprived of liberty, safeguard of justice

Keywords: myomectomy surgical blood loss misoprostol
exercise capacity in non-cystic fibrosis bronchiectasis after a pulmonary rehabilitation home-based program

Conditions: Non-cystic Fibrosis Bronchiectasis; Pulmonary Rehabilitation

Summary: a number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-cf bronchiectasis), although little research exists on using the cardiopulmonary exercise test (cpet) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (prhp). in addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease. aims: to evaluate the exercise capacity of non-cf bq patients using cpet and physical activity after a pulmonary rehabilitation home-based program. methodology: our study describes a non-pharmacological clinical trial in non-cf bq patients at the virgen macarena university hospital (seville, spain). the patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).

a signed informed consent form was provided prior to inclusion in the study. the data evaluated was obtained under strict confidentiality rules. all patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (cpet) and 6mwt, stratification severity according to the e-faced scales, quality of life using the saint george respiratory questionnaire.

Eligibility criteria:
inclusion criteria: * certain diagnosis of non-cf bronchiectasis (chest hrct) * over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified medical research council (mmrc) dyspnea scale exclusion criteria: * less of 18 years * other airway disease ( asthma or copd) * physical inability to perform a physical training program (neuromuscular pathology or residual injuries). * smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year. * cystic fibrosis. * active infections (bronchopulmonary aspergillosis, pulmonary tuberculosis). * active tuberculosis. * medical illnesses that put the individual at risk of a decompensation due to the performance of any physical activity or cardiopulmonary stress test (unstable ischemic heart disease, acute myocardial infarction less than 1 month). * pregnancy * mental disorder that prevents the adequate interpretation of the indications or performance of the tests. * attended pulmonary rehabilitation within 1 year.
a study of cytotoxic t lymphocyte (ctl) therapy in hiv-infected patients

Conditions: HIV Infections

Summary: to define the safety of cytotoxic t lymphocytes (ctls) generated from sibling-supplied dendritic cells and lymphocytes and infused into an hiv-infected patient. to determine the efficacy of these ctls in helping the immune system to fight hiv. with lower cd4 counts, hiv-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate hiv-specific ctls. infusion of ctls generated from the dendritic cells and lymphocytes of an hiv-negative sibling may enable the body to recognize hiv more readily and increase immune response against the virus.

with lower cd4 counts, hiv-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate hiv-specific ctls. infusion of ctls generated from the dendritic cells and lymphocytes of an hiv-negative sibling may enable the body to recognize hiv more readily and increase immune response against the virus. dendritic cells and lymphocytes are obtained from an hiv-negative sibling. hiv-specific ctls are generated from these cells and then infused into the hiv-infected patient monthly for 6 months. siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. patients are screened over 3 months prior to study entry.

Eligibility criteria:
inclusion criteria patients must have: * hla a2+. * other hla matching with sibling. * cd4 count 100-350 cells/mm3. * no active opportunistic infection or malignancy (other than cutaneous kaposi's sarcoma). * current stable antiviral regimen. * normal lab values and chest x-ray. donor siblings must have: * hla a2+. * hiv negativity. * good venous access. * ability to donate on multiple occasions. * negative status for hepatitis b and c. exclusion criteria concurrent medication: excluded: * immunomodulators. * cytokines. * systemic steroids. * iv pentamidine. * investigational drugs.

Keywords: immunotherapy, adoptive t-lymphocyte subsets t-lymphocytes, cytotoxic dendritic cells
efficacy, safety, reactogenicity & immunogenicity of the rotarix vaccine in japanese infants

Conditions: Infections, Rotavirus; Rotavirus Vaccines

Summary: this study is undertaken to provide the regulatory authorities in japan with immunogenicity, efficacy, safety and reactogenicity data of gsk biologicals' human rotavirus \[hrv\] vaccine, given as a 2-dose primary vaccination, in healthy japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with hrv. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

combined diphtheria and tetanus toxoids and acellular pertussis (dtpa) and hepatitis b (hbv) vaccines are allowed to be co-administered along with rotarix vaccine/placebo.

Eligibility criteria:
inclusion criteria: * healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study * healthy subjects as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the parent or guardian of the subject. * born between a gestation period of 36 and 42 weeks inclusive. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the hrv vaccine within 30 days preceding the first dose of hrv vaccine, or planned use during the study period. * history of use of experimental rotavirus vaccine. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * 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 (pharmaceutical product or device). * uncorrected congenital malformation (such as meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * previous confirmed occurrence of rv ge. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). * a family history of congenital or hereditary immunodeficiency. * acute disease at the time of enrolment. * gastroenteritis within 7 days preceding the study vaccine administration. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
low-level laser therapy to prevent oral mucositis in head and neck patients

Conditions: Squamous Cell Carcinoma of Nasopharynx; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx

Summary: oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced om. this study was designed to assess the efficacy of low level laser therapy (lllt) in reducing the incidence and/or severity of oral mucositis.

assuming oral mucositis grade 3 for placebo 0.4 (p0); laser group 0.15 (p1) ; β=0.2; α=0.05, sample size was 94 pts. from jun 2007 to dec 2010, 47 laser group and 47 placebo patients bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase iii trial. chemoradiotherapy consisted of conventional radiotherapy 70.2 gray (gy) (1.8gy/d, 5 times/wk) + concurrent cisplatin 100 mg/m2 every 3 weeks. the primary end point was the incidence of grade 3-4 oral mucositis. the low-level laser therapy used daily, was a diode indium phosphide, gallium and aluminum (ingaalp), 660nm-100 milliwatts (mw)-4 joules (j)/cm²(dmc, são carlos, são paulo, brazil). oral mucositis evaluation was done by who and oral mucositis assessment scale (omas) scale.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx) * candidates for surgery or treatment for organ preservation * performance status (ps) of 0 or 1 according to the eastern cooperative oncology group (ecog) * indication for radiotherapy and concurrent platinum-based chemotherapy * oral mucosa intact * agree to follow the protocol of oral hygiene * informed consent. exclusion criteria: * patients using medication for treatment and or prevention of mucositis * patients incapable of treatment compliance or of performing the protocol of oral hygiene

Keywords: oral mucositis low level laser therapy head and neck cancer
a trial investigating the effect of nn5401 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the blood glucose-lowering effect of nn5401 (insulin degludec/insulin aspart (idegasp)) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index below or equal to 35.0 kg/m\^2 exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
association between inflammatory biomarkers in cvd patients on empagliflozin.

Conditions: Stable Angina; Heart Failure

Summary: the association of novel inflammatory biomarkers with cardiovascular diseases is still obscure. the present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (hf) and coronary artery disease (cad), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission. methods: we enrolled a total of 120 patients with hf, asymptomatic cad and 60 healthy controls (hc) without cardiovascular diseases.

* the present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (hf) and coronary artery disease (cad), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission in patients on empagliflozin 10 mg once daily for 6 months before the beginning of the study. * we enrolled a total of 60 patients with hf, 60 asymptomatic cad patients and 60 healthy controls (hc) without cardiovascular diseases. group i: 60 healthy subjects. group ii: 60 patients with stable angina (asymptomatic cad). group iii: 60 patients with heart failure. * clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity c-reactive protein, sortilin, homocysteine, troponin i, fetuin a and lipoprotein a levels were assayed. * patients will be followed up to assess all-cause 30- and -90 day of hospital readmission.

Eligibility criteria:
inclusion criteria: * either sex, aged 18 years or older. * new-onset ahf or acute decompensation of chronic hf, * cad (including previous myocardial infarction, previous percutaneous or surgical coronary revascularization, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more). * on empagliflozin 10 mg once daily for 6 months before the beginning of the study. exclusion criteria: * severe liver/ * kidney dysfunction; * severe systemic disease (such as the diseases of respiratory system/ digestive system/ nervous system etc.); * malignant tumor; * acute/ chronic infectious diseases; * autoimmune disease or connective tissue disease; * major trauma or surgical operation over the past three months.

Keywords: vaspin visfatin lipoprotein a high-sensitivity c-reactive protein sortilin homocysteine troponin i fetuin a
standard therapy or individualized immunosuppression for lowering adverse event risk

Conditions: Infection; Transplant;Failure,Kidney

Summary: infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. this study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.


Eligibility criteria:
inclusion criteria: * adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment * receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit exclusion criteria: * evidence of rejection on routine six month post-transplant biopsy * prior intolerance to mycophenolate mofetil necessitating drug discontinuation * are or are planning to become pregnant, due to inability to take mycophenolate * are marginally housed, due to concerns regarding routine follow-up * are actively participating in a different interventional trial that may affect immunosuppression dosing * are unwilling to consent to participate * institutionalized individuals or prisoners * are actively abusing illicit drugs or alcohol * have a history of poor or doubtful compliance (e.g., frequently missed appointments) * have cognitive impairment prohibiting participation in the study
a study of arry-334543 and gemcitabine in patients with advanced cancer and pancreatic cancer

Conditions: Advanced Cancer; Pancreatic Cancer

Summary: this is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug arry-334543 and gemcitabine. the study has 2 parts. in the first part of the study, phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. approximately 24 patients from the us will be enrolled in part 1 (completed). in the second part of the study, phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. approximately 42 patients from the us will be enrolled in part 2 (withdrawn).


Eligibility criteria:
key inclusion criteria (part 1): * histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine. * no more than 3 prior anticancer regimens for advanced disease. * measurable or evaluable, nonmeasurable disease. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. * able to take and retain oral medications. * additional criteria exist. key exclusion criteria (part 1): * uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days). * treatment with prior chemotherapy within 21 days of first dose of study drug. * requiring iv alimentation. * pregnancy or lactation. * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c. * history of being unable to tolerate gemcitabine or any of its components. * additional criteria exist.
gemcitabine, paclitaxel and oxaliplatin (gempox)

Conditions: CNS Germ Cell Tumor

Summary: this study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of gemcitabine, paclitaxel and oxaliplatin (gempox) followed by consolidation chemotherapy and autologous stem cell rescue.


Eligibility criteria:
inclusion criteria: * icgct including pure germinoma and mmgct. * patients with histologically proven germinoma and mmgct, including endodermal sinus tumor (yolk sac tumor), embryonal carcinoma, choriocarcinoma and mixed germ cell tumor will be eligible for the study. * patients with mature/immature teratoma who have tumor marker elevations are eligible on this study. * patient with only mature and/or immature teratoma are ineligible in the absence of the tumor marker elevations. exclusion criteria: * patients with icgcts who are newly diagnosed are excluded from the study. * patients with the diagnosis of mature or immature teratoma in the absence of tumor marker elevations are excluded from the study. * patients who are pregnant or breastfeeding are excluded from the study. * patients who have received previously a high dose chemotherapy regimen and autologous transplant are excluded from this study. * patients who have received gemcitabine, oxaliplatin and/or paclitaxel are excluded from this study.
leading healthy eating and activity promotion program

Conditions: Cancer Survivor; Cancer; Oncology

Summary: the goal of the leap project is to improve the health and well-being of cancer survivors and their co-survivors living in persistent poverty areas by providing healthy behavior change support. this will be done by engaging the community in adapting beneficial approaches for promoting healthy diet and regular physical activity into a program for cancer survivors and co-survivors that is appropriate for the persistent poverty context and social determinants of health.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 89 * english speaking * resident of birmingham area or surrounding community * history of any type of cancer or the friend or family with of a cancer survivor exclusion criteria: * serious difficulty hearing * history of dementia or organic brain syndrome * on primary treatment for cancer * no other other medical, psychological, or social characteristic that would interfere with participation in evaluation

Keywords: cancer survivor cancer oncology exercise nutrition diet healthy lifestyle behavior change
antioxidant functions of lipoic acid

Conditions: Hypercholesterolemia

Summary: the goal of this study is to determine whether a short treatment with lipoic acid, an antioxidant used in the treatment of diabetic neuropathy, improves blood vessel reactivity and decreases oxidant stress in persons with elevated blood cholesterol.

as per brief summary

Eligibility criteria:
inclusion criteria: * lipid criteria for inclusion are a plasma ldl between 160 and 190 mg/dl (total cholesterol usually 240-285 mg/dl) * less than 2 coronary risk factors, and already on a cholesterol-lowering diet. exclusion criteria: * overt or clinical atherosclerosis * diabetes * currently taking cholesterol-lowering medication. * subjects with other lipid disorders * subjects taking supplemental lipoic acid, vitamin c, or vitamin e.

Keywords: lipoic acid f2-isoprostanes endothelial dysfunction natural product