Kornimate/medical-research-clean huggingface dataset:
to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension for 112 weeks

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (pah) and to the patients who completed the a1481142 study for the treatment of pah in poland. only safety and tolerability data will be collected in these patients.


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 and over who have any of the following conditions: * idiopathic pulmonary arterial hypertension. * pah associated with connective tissue disease (ctd). * pah with surgical repair, at least 5yrs previously, of atrial septal defect (asd), ventricular septal defect (vsd) patent ductus arteriosis (pda) or aorta-pulmonary window. 2. subjects with a mean pulmonary artery pressure (mpap) \> 25mmhg and a pulmonary artery wedge pressure (pawp) \< 15mmhg at rest, assessed via right heart catheterization. 3. subjects whose baseline 6-min walk test distance was \> 100m and \< 450m. exclusion criteria: 1. pah secondary to any etiology other than those specified in the inclusion criteria. 2. subjects with congenital heart disease (other than those specified in the inclusion criteria), pah due to thrombo-embolism, hiv, chronic obstructive airways disease, congestive heart failure. 3. subjects whose 6-minute walk test might have been limited by conditions other than pah, associated dyspnea or fatigue.
neoadjuvant therapy with docetaxel and ketoconazole in patients with high-risk prostate cancer: a pilot study

Conditions: Prostate Cancer

Summary: eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection. a cycle of therapy is defined as 21 days (three weeks). pharmacokinetic analysis will be performed with the first and second cycle of therapy. all patients will be evaluated for toxicity, tumor response, and recurrence.


Eligibility criteria:
inclusion criteria: * patients must have histologically proven adenocarcinoma of the prostate. * patients must meet at least one of the following high risk criteria: * psa \> 20 * gleason score 8 or greater * presence of pathological gleason grade 4 or higher as the majority sum on biopsy core * greater than 50% of cores at time of biopsy positive for cancer * clinical stage t3 disease * patients must have ps of 0-1(ecog) and medically deemed a surgical candidate for radical prostatectomy. * age \> or = to 18. * patients with a pre-existing peripheral neuropathy of equal to or greater than grade two are ineligible. * serum creatinine must be \< or equal to 2.0mg/dl. * patients must currently not receiving any drug which is metabolized by cytochrome p450-3a4 including the statins, cyclosporin, terfenadine and erythromycin. * prior to receiving any dose of docetaxel, patients should have absolute neutrophil counts \> 1,500, hemoglobin \> 8.0 g/dl and platelet counts \> 100,000/mm3. * patients with bilirubin elevated above institutional upper limit of normal (uln)must be excluded. transaminases (sgot and/or sgpt) may be up to 5.0 x institutional upper limit of normal (uln) if alkaline phosphatase is \ 1.5 x uln and alkaline phosphatase \> 2.5 x uln are not eligible for this study (due to decrease clearance of docetaxel and increased risk of toxicity). * patients receiving concurrent warfarin are eligible but require monitoring of protime on a weekly basis. * patients with clinical stage t4 disease are not eligible. * patients must not had have received prior treatment with surgery, radiation or hormone deprivation. * patients with other primary malignancies previously treated with chemotherapeutic agents are not eligible. * patients must not have had a history of peptic ulcer disease requiring treatment with surgery or endoscleral. * patients requiring corticosteroids for other systemic diseases are not eligible. * patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are not eligible. * all patients must sign informed consent. * men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Keywords: prostate cancer neoadjuvant
a study of mk0140 in diabetic patients with macular edema (0140-001)

Conditions: Macular Edema

Summary: this study will evaluate the treatment effect of three doses of the i-vation ta implant (mk0140) in diabetic patients with clinically significant macular edema.


Eligibility criteria:
inclusion criteria: * patient has clinically significant macular edema as a result of their diabetes (type i or type 2) * patient has in the study eye, 20/40 - 20/160 vision * patient has type 1 or type 2 diabetes * patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control exclusion criteria: * patient has had any active ocular infection in either eye * patient has intraocular pressure \> 22 mmhg or a diagnosis of glaucoma * patient has cystoid macular edema in the study eye * patient has a history of elevated iop in response to ocular steroid therapy in either eye * patient has had intraocular surgery in the study eye within 6 months prior to visit 1 * patient has an hbaic value \> 10% at visit 1 * patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months * patient has a history of cancer within 5 years prior to signing informed consent * patient has clinically-relevant chronic renal failure * patient has high blood pressure * patient has coronary heart disease * patient has known allergies to steroids
compliance to vaginal dilation therapy in patients who have undergone radiation therapy for stage ib, stage iia, stage iib, stage iiia, or stage iiib cervical cancer or stage ia, stage ib, stage iia, or stage iib endometrial cancer

Conditions: Cervical Cancer; Endometrial Cancer; Radiation Toxicity; Sexuality and Reproductive Issues

Summary: rationale: understanding how well patients comply with their treatment regimen may help doctors determine best treatment and ongoing care for future patients. purpose: this phase i study is looking at compliance with vaginal dilation therapy in women who have undergone radiation therapy for stage ib, stage iia, stage iib, stage iiia, or stage iiib cervical cancer or stage ia, stage ib, stage iia, or stage iib endometrial cancer.

objectives: primary * to determine adherence to vaginal dilation therapy after radiotherapy in patients with early-stage ib grade 2-iiib cervical cancer or stage ia grade 3-iib endometrial cancer. * to identify demographic, medical, and psychosocial factors associated with adherence to recommendations for vaginal dilation in these patients. * to describe the sexual, marital, and non-marital dyadic functioning of these patients. outline: patients from the impac registry in radiation oncology at the university hospitals case medical center, ireland cancer center complete questionnaires online or by mail. questionnaires include the vaginal dilation adherence questionnaire, the sexual function-vaginal changes questionnaire, the dyadic satisfaction questionnaire, and the physician/nurse recommendation of vaginal dilation questionnaire.

Eligibility criteria:
disease characteristics: * history of early-stage ib grade 2-iiib cervical cancer or stage ia grade 3-iib endometrial cancer * meets the following criteria: * received radiotherapy for this disease * treated within the last 3 years and followed for at least 6 months patient characteristics: * able to read and understand english * currently with or without a sexual partner * no history of other cancers * no other potentially life-threatening disease prior concurrent therapy: * see disease characteristics

Keywords: radiation toxicity sexuality and reproductive issues stage i endometrial carcinoma stage ii endometrial carcinoma stage ib cervical cancer stage iia cervical cancer stage iib cervical cancer stage iii cervical cancer
exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue

Conditions: Anemia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: exercise may decrease anemia-related fatigue, improve strength, and build up lost muscle tissue. epoetin alfa may help improve cancer-related anemia, energy levels, and quality of life. exercise plus epoetin alfa may be effective treatment for anemia-related fatigue. purpose: phase ii trial to study the effectiveness of exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue.

objectives: i. determine the effect of progressive resistance training and epoetin alfa on lean body mass, fatigue, exercise tolerance, functional capacity, and total body weight in cancer patients with anemia related fatigue. outline: patients undergo progressive resistance training (prt) consisting of 3 sets of 8 repetitions of concentric (lifting) and eccentric (lowering) exercises over 4-6 seconds each using bench press, arm pull, knee extension, knee flexion, and double leg press followed by 1-2 minutes of rest between sets. patients undergo warm up and cool down periods over 10 minutes prior to and following prt. patients perform prt 3 times a week for 12 weeks. patients also receive epoetin alfa subcutaneously once weekly over 4-12 weeks in the absence of unacceptable toxicity. projected accrual: a total of 30 patients will be accrued for this study over 15 months.

Eligibility criteria:
disease characteristics: diagnosis of nonmyeloid malignancy with cancer related fatigue anemia (hemoglobin less than 10 g/dl) no clinical or radiographic evidence of lytic bone metastases patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: greater than 4 months hematopoietic: see disease characteristics hepatic: not specified renal: not specified other: no dementia or evidence of mental incompetence no physical handicap precluding aerobic or resistance exercise no clinical abnormality that would render exercise a risk hiv negative no contraindications to epoetin alfa not pregnant or nursing negative pregnancy test prior concurrent therapy: biologic therapy: at least 8 weeks since prior epoetin alfa chemotherapy: concurrent chemotherapy allowed endocrine therapy: not specified radiotherapy: concurrent radiotherapy allowed surgery: not specified other: concurrent anticancer therapy allowed at least 1 month since prior strength training of greater than 3 hours a week

Keywords: unspecified adult solid tumor, protocol specific anemia fatigue
delirium detection during routine patient care

Conditions: Delirium

Summary: despite the presence of validated tests, there are still drawbacks to implementing delirium diagnosis tests in hospital wards. we developed a new, simple, easy to implement user friendly delirium diagnostic test that is likely to facilitate implementation in many departments. the present study will compare the new test to a well validated older test - 4at.

delirium is characterized by an acute onset altered mental status and/or a confusional state. although delirium has been known since ancient times, the condition is often not diagnosed, documented, evaluated, and managed. early detection of delirium in hospitalized patients may be critical, particularly on internal medicine wards, as mental deterioration in the elderly can be the first sign of preventable diseases and disorders that precipitate delirium. nevertheless only 15%-35% of cases of delirium in hospitalized patients are identified by the treating staff and documented in the medical records. the main reasons for this shortcoming are insufficient awareness to emerging delirium, and excessive work load. we have recently developed and implemented in our department of internal medicine a new diagnostic tool for delirium. this test, designated r\&m, is based on a combination of radar (recognizing acute delirium as part of your routine), performed by the nurses during medication dispensing, and moyb (months of the year backwards), performed by residents during the routine rounds in patients with positive radar. both tests are online and saved in the patients' electronic records. the purpose of this study is to demonstrate non-inferiority of r\&m compared to 4at (attention, abbreviated mental test, alertness, acute onset test), an old and well validated delirium recognition test. the sample size required for a sensitivity of 95% and a 95% confidence interval was calculated to be n=365, assuming delirium prevalence of \>20% in elderly patients hospitalized in internal medicine wards.

Eligibility criteria:
inclusion criteria: - patients \>70 yrs old, hospitalized in the department of internal medicine exclusion criteria: * severe dementia

Keywords: delirium diagnosis 4at
multi-variable prediction model of total knee replacement outcome

Conditions: Knee Osteoarthritis; Joint Disease; Total Knee Replacement; Arthroplasty Complications

Summary: total knee arthroplasty (tka) is a surgical procedure applied as a common solution to overcome limitations produced by advanced stages of severe gonarthrosis. the procedure has high prevalence, high associated costs, and is considered to be cost-effective. rehabilitation is essential to optimize outcomes. however, in clinical practice, the length of rehabilitation for each patient may be highly variable, and the programmed times may lack the necessary objectivity. current limitation of resources and increasing prevalence make essential to generate strategies to optimize surgical results, so that the use of resources of the health system is efficient without detriment to the patient's benefit. for this purpose, objective and pragmatic information must be available, and should be based on scientific evidence in order to assist in making clinical decisions. indeed, a number of demographic, biomedical and psychosocial factors have been identified as predictors of tka results (i.e weight, age, expectations...). some of them have been associated with the need for hospital resources after surgery. however, most researches base their predictions in retrospective studies, which are limited in the type of variables that can be used (clinic history), quality of registries, and limitations of retrospective designs. on the other hand, most of prospective researches base their predictions in a limited number of outcomes. to overcome this limitations, this project has been designed as a prospective observational study with two observations of each patient. * the primary goal is to implement a multi-variable prediction model of tka outcome, so that the procedure become optimal in two aspects : patient recovery (social and economic benefit) and use of health system resources (economic benefit). the implementation requires a processing of the information sampled through various algorithms and innovative data processing in this field, based on data mining and machine learning techniques. this will be used in search of the model with the greatest predictive capacity. * as a secondary objective, information extracted from patients both in the final stages of the condition, and in the medium term after the intervention will allow to study the functional and psychosocial reality of the subjects with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * over 60 years old * severe knee osteoarthritis * in the surgery waiting list for undergoing total knee replacement surgery exclusion criteria: * lobo mini-mental state examination \< 20 (not able to properly understand the tests and study) * vestibular affection that prevents to perform the tests
influence of an inspiratory muscle fatigue protocol on healthy youngs on respiratory muscle strength and heart rate variability

Conditions: Healthy

Summary: respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. the aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability. according to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function. in this study, subjects will be divided into three groups: the experimental group , the activation group and the control group. measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted.

this is a randomized control trial. the experimental group (eg) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their maximum inspiratory pressure (mip) through a threshold valve device. the participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts. the activation group (ag) will perform the protocol of 2 sets of 30 repetitions at 40% of their mip, one-on-one, and in a single session, using a threshold valve device. the control group will do a seat and wait. the interventions will be supervised by a physiotherapist. the primary outcomes will be respiratory muscle strength will be assessed using a respiratory pressure meter or manometer designed, and with ultrasound image measuring the cross sectional area of the diaphragm at 8-9th rib level and speed of contraction with a deep and fast inspiratory manoeuver. this will be done immediately before intervention and immediately after intervention heart rate variability (hrv) will be assessed using a heart rate sensor polar h10.

Eligibility criteria:
inclusion criteria: * aged between 18-45 years. * non-smoker. * engaged in sports activity at least 3 times a week for a minimum of one year. exclusion criteria: * having a medical condition that impedes engaging in physical activity. * individuals with compromised cognitive capacities. * subjects with any chronic disease (cardiorespiratory, neurological, metabolic, oncological, etc.). * subjects with tympanic perforation or middle-inner ear pathology. * subjects who have undergone lower limb surgery within the past 12 months. * subjects experiencing an active episode of lower limb pain.
topic ketorolac added to panphotocoagulation in proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy; Macular Edema

Summary: the purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. this treatment reduces the incidence of severe visual loss in the long term. nonetheless, it induces macular thickness that delays the conclusion of the treatment. this delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation. topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * proliferative diabetic retinopathy * without macular edema * adequate quality 6 mm fast macular map on the day of treatment * visual capacity under subjective refraction before treatment * signed of inform consent exclusion criteria: * ocular surgery in the last 4 months * myopia over -6.00 diopters * allergy to ketorolac or non-steroids antiinflammatory * previous selective photocoagulation * using non-steroids antiinflammatory or immunomodulators * intraocular inflammatory * any retinal disease different from diabetic retinopathy * pregnancy * actual corneal disease * inadequate quality 6 mm fast macular map after the second visit * inconsistency after the second visit * adverse event of the drug * remove of the inform consent

Keywords: proliferative diabetic retinopathy macular edema panphotocoagulation topic ketorolac efficacy treatment
the effect of dairy and non-dairy alternatives on satiety and post-meal glycemia in healthy young adults

Conditions: Diabetes; Obesity

Summary: this study investigates the effects of commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal blood glucose. each participant will receive every treatment in this crossover design study.

regular consumption of dairy is associated with better body composition and lower incidences of type 2 diabetes and obesity. this may be due to dairy's ability to increase satiety and decrease post-prandial glycemia. however, most clinical studies have only investigated isolated dairy proteins (whey and casein) and the effects of whole dairy products remains unclear. additionally, as non-dairy alternatives are becoming more popular there is interest to see if they can elicit similar benefits as dairy. therefore, this study will test the effects of commercially-available dairy and non-dairy beverages when consumed with cereal at breakfast time. thirty healthy young males and females (20-30 years, bmi 20.0-24.9 kg/m2) will be recruited for the randomized, unblinded, crossover study. participants will fast overnight, and at baseline will consume 250 ml of 1% milk, soy beverage, almond beverage, yogurt beverage, or water with 54 g of cheerios cereal. at 0 (baseline), 15, 30, 45, 60, 75, 90, 120 minutes (pre-meal period) 140, and 170 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. insulin will be analyzed every 30 minutes and for the last two timepoints. between 120-140 minutes, an ad libitum lunch will be provided to assess food intake.

Eligibility criteria:
inclusion criteria: * healthy bmi (20.0 - 24.9 kg/m2) * females with regular monthly menstrual cycles exclusion criteria: * diabetes * fasting blood glucose higher than 5.8 mmol/l * pregnancy * medications * smoking * lactose intolerance or allergies to milk, soy, or almonds * elite athletes * those trying to lose or gain weight * breakfast skippers and those on an energy-restricted diet * score equal to or higher than 11 on eating habits questionnaire

Keywords: dairy breakfast cereal postprandial glycemia satiety food intake milk yogurt soy almond