Kornimate/medical-research-clean huggingface dataset:
validity, reliability and minimum detectable changes of 2-minute walk , timed up and go, sit and stand test in patients with prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is a type of cancer that can occur in men, especially in the fifth and sixth decades of their lives, and various side effects occur depending on the treatments applied in the diagnosed patients. the treatments applied and the decreased level of physical activity also cause a decrease in the quality of life. recent studies have focused on treatment-related side effects. before treatment planning, there is a need for clinically validated clinical evaluations specific to prostate cancer patients in order to determine the current status of the patients or to measure the effectiveness of the treatment applied. in addition, tests with a minimal detectable amount of change will be guiding in order to understand that the effectiveness of the applied treatment is significant. the aim of our study is to investigate the validity, reliability and minimal detectable changes of the two-minute walk, sit up and time up and go tests validated in different disease groups for patients with prostate cancer.

performance-based outcome measures are gaining importance in terms of patients' health care. these tests are not specific for any disease or extremity. they are specific tests for walking and getting up from a chair. they evaluate what an individual can do rather than what they perceive the individual can do. performance measurement tests have a higher level of evidence than just self-reported evaluations. time up and go test, two-minute walk test, sit and stand test are the most frequently used tests in the clinic to evaluate functionality. the short duration of the tests and the fact that they do not require equipment provide advantages in the clinical setting. in the current literature, the validity and reliability of the time up and go, two-minute walk and sit-up test in elderly prostate cancer patients has not been established. the aim of our study is to investigate the validity and reliability of these tests in elderly prostate cancer patients and to determine their minimum detectable change. our second aim is to investigate the relationship of these tests we evaluated with the nottingham health profile questionnaire, which evaluates health-related quality of life in elderly cancer patients.

Eligibility criteria:
inclusion criteria: * receiving or continuing androgen deprivation therapy for at least 3 months * diagnosed with non-metastatic prostate cancer * in the process of radiotherapy or chemoradiotherapy * able to walk without assistive device * patients over 55 years of age exclusion criteria: * diagnosed with metastatic prostate cancer * uncontrollable cardiovascular disease uncontrollable insulin due to diabetes individuals with neuromuscular, metabolic disease that may effect physical tests
interactions of medicine and exercise with meal timing

Conditions: Metabolic Syndrome, Protection Against; Exercise Training; Metformin; Statins; Angiotensin-Converting-Enzyme Inhibitor; Fasting, Intermittent; Angiotensin Hypertension

Summary: to analyze the effects of altering the time of ingestion of participants' habitual medication (i.e., metformin, statins, araii/iace) and meals around the time of exercise training (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension, insulin sensitivity, dyslipidemia, and obesity). there will be a preliminary study of the effects of training "time-of-day" on the primary study outcomes.

objective: the purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of altering timing between exercise training, meals, and their habitual medication on the improvement in the factors that compose the metabolic syndrome (i.e., hypertension, insulin resistance, central obesity, and dyslipidemia). the main objective is to find the most productive combination between exercise training and the timing of their habitual pharmacological treatment, and meal ingestion for lowering those factors. methods and design: cross-over randomized double-blinded, pretest-posttest control group experimental design. the project will be developed in a single center with the collaboration of the regional public health system (secam). there will be a preliminary study of the effects of training "time-of-day" on three parallel groups of individuals. subjects: will be referred by their primary care physicians to our study unit or recruited by advertisements in local media. up to 180 subjects, all of them with metabolic syndrome will be recruited (\>25% women). measurements: specifically, we will study if the cardiovascular and metabolic adaptations to aerobic training that result in amelioration of metabolic syndrome factors are potentiated by correct timming of training, meals, and medicine around exercise training time.

Eligibility criteria:
inclusion criteria: * metabolic syndrome patients diagnosed according to the international diabetes federation consensus of 2009 (alberti, et al., circulation). exclusion criteria: * cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise. * respiratory failure * liver o renal disease * pregnancy

Keywords: cardiorespiratory fitness insulin sensitivity dyslipidemia hypertension
effectiveness of electro-acupuncture and manual therapy on pain and fucntion in patients with sciatica

Conditions: Sciatica; Electroacupuncture; Manual Therapy

Summary: the aims of the study are: to study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica. to study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.


Eligibility criteria:
inclusion criteria: * aged from 18 to 50 years old. * diagnosis of sciatica exclusion criteria: * pregnancy. * fear of needles. * coagulation disorders.
acute effects of aerobic exercise on motor memory consolidation in older people

Conditions: Elderly

Summary: scientific evidence suggests that an aerobic exercise session promotes improvements in the consolidation of motor memory in adults. in this sense, the main purpose of this study was to investigate if an aerobic training session could improve motor memory consolidation in older people.

the participants of this study were 33 subjects of both genders (m = 68 years old; sd = 4.2 years old) and were divided in two groups: a control group (n = 15; m = 67, 6 years old; sd = 4.1 years old) and an experimental group (n = 18; m = 67, 4 years old; sd = 4.4 years old). the participants performed a soda pop test before the aerobic training session (baseline). the training session lasted 45 minutes and was composed of running exercises. after the training session, the motor memory consolidation was held in three different stages: training; 1 hour after training; 24 hours after training.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * sensory abnormalities; * mental abnormalities; * motor abnormalities; * other atypical health problems.
clinical evaluation of the aptima® hpv assay and comparison with the hr hc2® test using lbc thinprep® specimens

Conditions: Human Papilloma Virus Infection

Summary: to assess and compare the performance of the hr hpv hc2® test (qiagen/digene) and the aptima® hpv assay (hologic) using lbc specimens (thinprep® pap test) for the detection of hpv infection and high-grade cin lesions in a screening population of women 30 years of age or older in germany.

the study is conducted in the areas of tuebingen, freiburg and saarbruecken in germany. in total, 10.000 thinprep® lbc cervical samples were collected from june 2009 to may 2012. liquid based cytology (lbc) was performed by a central laboratory in saarbruecken. human papilloma virus (hpv) testing with the hr hpv hc2® test and aptima® hpv assay were performed at the section of experimental virology, institute of medical virology, university clinic of tuebingen, germany (ukt). within a follow-up phase women who tested positive in any test at baseline will be monitored over a period of 10 years. study close out visit: in addition, approximately 5 years after baseline thinprep® lbc cervical samples will be collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (npv) and hpv related disease after a 5 year period. women who tested positive in any test will undergo colposcopy.

Eligibility criteria:
inclusion criteria: * women aged 30 - 60 years * women attending gynaecological practices for routine screening * women who gave informed consent to participation in the study exclusion criteria: * women with hysterectomy or known destructive therapy to the cervix * women who are pregnant * women with an abnormal cytology result during the previous 6 months * women with known hiv infection or history of transplants * women vaccinated against hpv * women participating in another research protocol

Keywords: cervical cancer screening high risk human papillomavirus aptima hpv assay
effects of the golo for life system diet with and without golo release supplement on glycemic control and insulin resistance

Conditions: Diabetes Mellitus, Type 2

Summary: this randomized, double-blind placebo-controlled study is intended to observe the short-term effects of the gfl system diet with release supplement versus gfl system diet with placebo on glycemic metabolism and insulin resistance in patients with type 2 dm.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 80 years * body mass index (bmi) ≥ 27 and ≤ 60 kg/m2 * have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking * a1c greater than or equal to 6.5% at screening * willing to comply with study procedures described herein exclusion criteria: * current diagnosis of type 1 diabetes * subjects with a history of hypoglycemia * a history of an eating disorder as defined by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * known allergy to any of the components in the release supplement * a history of prior surgery for weight loss within one year from screening * currently taking injectable medications to control diabetes, including insulin and glp-1 agonists * currently pregnant or breastfeeding or have had a baby within the last six weeks * planning to become pregnant in the next three months. women of child-bearing potential must be willing and able to use adequate and reliable contraception throughout the study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception). * uncontrolled hypertension at screening defined as systolic blood pressure greater than 180 mmhg or diastolic blood pressure greater than 110 mmhg * current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease. * current participation in any other weight loss or weight management program * currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain * has any condition that, in the opinion of the investigator, would make participation in this study not in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments. examples include: history of diabetic ketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, subjects predisposed to intestinal obstruction; chronic intestinal diseases associated with marked disorders of digestion or absorption
albumin infusion effects in mortality in patients with cirrhosis and hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Cirrhosis

Summary: to assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade ii) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).

to evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade ii) improves survival at 30, 90 and 180 days. * to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. * to analyze whether albumin administration reduces hospitalization requirement. * to study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones).

Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years. 2. liver cirrhosis defined by previous clinical data or liver biopsy. 3. presence of an episode of acute hepatic encephalopathy of grade\> 2. 4. sign the informed consent exclusion criteria: 1. pregnant or breast-feeding. 2. terminal illness. 3. presence of acute-on-chronic liver failure. 4. needing for intensive support measures. 5. active gastrointestinal bleeding. 6. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy. 7. clinical situations in which it is contraindicated to administer intravenous albumin. 8. meld score less than 15 or greater than 25 at the time of inclusion 9. any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.
natural history of patients with ph3 and a history of stone events

Conditions: Primary Hyperoxaluria Type 3

Summary: this is a natural history study of adults, adolescents, and children (starting at birth) with genetically confirmed primary hyperoxaluria type 3 (ph3) who have a history of stone events during the last 3 years and/or the presence of pre existing stones detected by renal ultrasound at screening.

the relationship between the level of uox and the incidence of kidney stones and/or nephrocalcinosis in patients with ph3 has not been established. the goal of this study is to record 24-hour uox levels and the incidence of new stone formation and/or the degree of nephrocalcinosis in patients with ph3 over time. potential participants are screened over an up-to-7 week period according to the eligibility criteria and will then be followed every 6 months over an up-to-2-year period to determine the annualized new stone formation rate (number of new stones being formed per year) and the change in the degree of nephrocalcinosis (if applicable). new stone formation is defined as occurrence of any of the following: * spontaneous stone passage in the absence of pre-existing stones * stone passage occurring without change in the number of pre-existing stones detected by renal ultrasound * appearance of new stones on renal ultrasound or 100% or more growth of a pre-existing stone (estimated area) * surgical removal of newly formed stones note: spontaneous passage or surgical removal of pre-existing stones does not meet the criteria for new stone formation. this is a non-interventional study that will last up to 2 years.

Eligibility criteria:
key inclusion criteria * genetically confirmed ph3 * for participants at least 2 years of age, history of stone events (defined as presence of calcifications in the urinary tract and/or kidney, their relative location, and the number and size of stones) during the last 3 years and/or presence of pre-existing stones detected by renal ultrasound at screening * uox ≥ 0.7 mmol/24 hours (adjusted per 1.73 m2 bsa in participants \< 18 years of age) or if not able to collect 24-hour urine, average spot uox to creatinine ratio at screening above the 95th percentile for age: * \> 220 mmol/mol in participants \< 6 months * \> 170 mmol/mol in participants from 6 months to \< 12 months * \> 130 mmol/mol in participants 12 months to \< 2 years * \> 100 mmol/mol in participants from 2 to \< 3 years and * \> 80 mmol/mol in participants from 3 to 5 years * egfr at screening ≥ 30 ml/min or for infants aged less than 12 months, serum creatinine below the 97th percentile of a healthy population key exclusion criteria: * prior or planned liver transplant within study period * currently receiving dialysis or anticipating dialysis during study period * unwillingness to comply with study procedures

Keywords: primary hyperoxaluria ph3 observational kidney stones nephrocalcinosis
astigmatism post-trabeculectomy

Conditions: Glaucoma

Summary: the aim of this project: 1. confirming the modification in corneal astigmatism after trabeculectomy with mmc and intracameral administration of bevacizumab. 2. medium-term follow up (6 months) of the induced corneal astigmatism. 3. investigating correlations between postoperative astigmatism, particularly with the postoperative iop.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * normal tension glaucoma * pseudoexfoliation glaucoma * pigment dispersion glaucoma exclusion criteria: * patients who refuse to sign the informed consent. * patients with primary angle closure glaucoma (pacg). * patients younger than 18 years old. * other ocular diseases besides glaucoma. * significant corneal opacities. * refractive error more than + or -6.00 diopters. * visual acuity less than 0.05 * previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy). * laser treatment for glaucoma within 6 months of the surgery.

Keywords: glaucoma trabeculectomy astigmatism intraocular pressure
perfusion ct monitoring to predict treatment efficacy in renal cell carcinoma

Conditions: Metastatic Renal Cell Cancer

Summary: this pilot clinical trial studies perfusion computed tomography (ct) in predicting response to treatment in patients with advanced kidney cancer. comparing results of diagnostic procedures done before, during, and after targeted therapy may help doctors predict a patient's response to treatment and help plan the best treatment.


Eligibility criteria:
inclusion criteria: * suspected or biopsy-proven renal cell carcinoma * treatment planned with sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, nivolumab alone or in combination with an investigational agent * ability to understand and willingness to sign a written informed consent document exclusion criteria: * serum creatinine greater than or equal to 1.7 mg/dl * severe allergy to contrast agent * any contraindication for undergoing a ct scan * pregnancy or unwillingness to use preventative measures if a woman of child-bearing potential
a study of an automated insulin delivery system in participants with type 1 diabetes mellitus (t1dm)

Conditions: Type1 Diabetes Mellitus

Summary: the automated insulin delivery (aid) system is an investigational insulin delivery device being developed for use for participants with diabetes. the purpose of this study is to assess the safety of the aid system and to test whether the aid system functions as it was designed to. this study will last approximately 12-18 days, not including screening. screening is required within 28 days prior to the start of the study.


Eligibility criteria:
inclusion criteria: * participants with t1dm for at least 2 years and who have used an insulin delivery system for at least 1 year * have a body mass index of 18.5 to 35 kilogram per meter squared * have a hemoglobin a1c level ≥6.0% and ≤9.0% exclusion criteria: * have known allergies or history of hypersensitivity to insulin lispro * have had an episode of severe hypoglycemia within the past 6 months * have had more than 1 episode of diabetic ketoacidosis in the past 6 months
evaluation and physical therapy for patients with degenerated cervical spine

Conditions: Degenerated Cervical Spine; Spinal Diseases

Summary: the specific aims are as follows: 1. to investigate the degree of impairment, such as range, proprioception, sensation, and electromyography (emg) pattern of healthy, older subjects. 2. to investigate the relationship of these impairment measurements, the functional outcome and disability in patients with cervical spondylosis. 3. to develop an exercise program with an emphasis on proprioception, stability and coordination for patients with neck-shoulder complaints to decrease the impairment and increase the functions of patients.


Eligibility criteria:
inclusion criteria: * group one: participants without degenerated disease in the cervical spine * group two: participants with degenerated disease in the cervical spine exclusion criteria: * grade iii, iv of degenerated cervical spine

Keywords: degenerated cervical spine assessment physical therapy
changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position

Conditions: Nephrectomy

Summary: the purpose of this study is to determine changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position.


Eligibility criteria:
inclusion criteria: * adult patients (asa physical status i and ii) aged between 20-65 yrs exclusion criteria: * cardiovascular, renal, hepatic disease, or communication failure

Keywords: to compare the change of cerebral oxygen saturation and blood flow between right and left side in lateral decubitus position during nephrectomy
validation of stroke volume measurement by a new noninvasive hemodynamic monitoring system (nexfin)in comparison to different invasive procedures as picco2, flotrac and tee

Conditions: Stroke Volume; Mean Arterial Pressure

Summary: main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (nexfin) and invasive hemodynamic monitoring systems as picco2-system, flotrac and transesophageal echocardiography

in high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. therefore invasive procedures as picco2-system, flotrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. disadvantage of this treatments is the need for a vascular access with all its complications. in this study the stroke volume measured by a new noninvasive finger cuff system (nexfin) should be validated in comparison to invasive hemodynamic monitoring systems as picco2-system, flotrac and tee.

Eligibility criteria:
inclusion criteria: * patients undergoing orthopedic surgery with need for invasive blood pressure measurements * age ≥ 18 years * signed informed consent * no participation on another interventional study exclusion criteria: * refusal of participation * patients who are not able to sign informed consent * atrial fibrillation with arrhythmia * peripheral arterial disease \> fontain iia * scleroderma * presence of an arterio-venous shunt on upper limb * contraindication for femoral arterial vascular access * contraindication for transesophageal echocardiography * stage iii heart valve defects * shunt heart defects * solitary regional anaesthesia * pregnant or breastfeeding women

Keywords: hemodynamic monitoring systems stroke volume