Kornimate/medical-research-clean huggingface dataset:
home-based exercise training for copd patients

Conditions: Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease

Summary: the aim of this study is to assess the effectiveness of a home-based exercise training program in copd patients who have completed a pulmonary rehabilitation.

exercise training is an important component of the management of chronic obstructive pulmonary disease (copd) and numerous trials have shown large improvements in health-related quality of life (hrqol) and exercise capacity in persons with copd. however, the great majority of patients who would benefit from pulmonary rehabilitation (pr) never follow such a program. moreover, many copd patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing pulmonary rehabilitation. this study evaluates an exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.

Eligibility criteria:
inclusion criteria: * signed informed consent after being informed * diagnosis of copd, defined as forced expiratory volume in 1s/forced vital capacity (fev1/fvc)\<70% predicted, fev1\<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a gold stage ii-iv * completion of an inpatient or outpatient pulmonary rehabilitation not longer than 1 months ago * male and female patients ≥40 years of age * knowledge of german language to understand study material and assessments exclusion criteria: * patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.

Keywords: exercise minimal equipment home-based copd
efficacy of protracted temozolomide in patients with progressive high grade glioma

Conditions: Glioblastoma; Astrocytoma; Oligodendroglioma; Brain Tumor, Recurrent

Summary: the purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.


Eligibility criteria:
inclusion criteria: * patient age \>18 years old * histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme) * progression after standard dose (d1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in magnetic resonance imaging * karnofsky performance status scale \>/=50 (due to brain pathology) * adequate hematological, renal and hepatic function * patients willing to participate in the study and signing the informed consent exclusion criteria: * karnofsky performance status scale \<50 * female patients with pregnancy or with suspicion of pregnancy. patients with fertility will be warned for appropriate contraception during the study * patients not suitable for follow-up

Keywords: temozolomide brain tumor, recurrent chemotherapy
frequent activity snacks breaks

Conditions: Obesity; Insulin Resistance; Sedentary Lifestyle

Summary: there is a growing health burden in sweden and europe arising from the interrelated sequelae of metabolic disorders comprising impaired glucose tolerance (igt), obesity and t2dm. obesity and inactivity are the main drivers of igt and t2dm and are responsible for up to 8% of health costs and 13% of deaths in europe, with the risk of co-morbidities rising in parallel with increasing body weight. igt and t2dm are the paradigm of inactivity-related disorders: the majority of people who have igt or t2dm are overweight and inactive, with up to 80% being obese. a recent meta-analysis of 42 studies concluded that sedentary time was independently associated with a greater risk of t2d, all-cause mortality, cardiovascular disease incidence and mortality, and cancer incidence and mortality (breast, colon, colorectal, endometrial and epithelial ovarian cancers) (ann intern med. 2015;162:123-32). a recent systematic review of trials published up to april 2014 identified 16 separate studies and concluded that there is considerable evidence of the positive effects of breaking up prolonged sitting time with light-intensity ambulatory physical activity and standing on postprandial metabolic parameters, including glucose, insulin and triglyceride levels (med sci sports exerc. 2015:47:2053-61). however, to date, all of the published experimental trials describing the beneficial effects of breaking up sitting time on metabolic risk markers have been restricted to acute exposure periods (1-5 days). we will perform a rct intervention study, which examines the efficacy (clinically relevant responses) and practical implementation of low-impact training in sedentary obese individuals during the day.


Eligibility criteria:
inclusion criteria: * sedentary lifestyle, * bmi 30-40 kg/m2 exclusion criteria: * unable to read swedish (for informed consent), * anticoagulant therapy, * unability to perform intervention
mrna expression as a biomarker of omalizumab response

Conditions: Asthma

Summary: objectives: 1. determine if mrna expression could be use as a biomarker to predict and monitor the response to omalizumab in patients with difficult control asthma 2. identify which genes are switched on and which are switched off by using omalizumab. methods: this study is an open label clinical trial, with six patients. the patients will receive omalizumab according to their age and weight (maximum dose: 375 mg every 15 days) for 4 months. there will be a run-in period of one month, when allergic asthma diagnosis will be confirmed and treatment will be optimized. patients will be evaluated and will have blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of the study. blood samples will always be collected one week after the last omalizumab dose. primary outcome will be rna expression of 20 genes measured by real time-pcr (high-affinity ige receptor, il-4, il-5, il-13, gama-ifn, quimokines, fc epsilon, between others). secondary outcomes will be act, acq and spirometry.

study rational: there is not a biomarker that can predict which patients will respond to omalizumab and those who will not respond. nowadays, the monitoring of therapeutic response to omalizumab is based on clinical and spirometric data. on the other hand, when a medication is administered, it has its main expected effect, but also acts on other targets with various direct and indirect effects. we do not know all the genes that are switched on and those that are switched off by the use of omalizumab. for example, anti-ige has been developed to block serum total ige and thereby improve control of allergic asthma. however, the studies noted that omalizumab also reduces the receptors fcepsilonri, which may have implications for the treatment of autoimmune urticaria.

Eligibility criteria:
inclusion criteria: * over 12 years * severe asthma not controlled despite medication * ige between 70 and 1300 iu/ml and evidence of allergy clinical history and/or skin test or blood. exclusion criteria: * previous use of omalizumab * smoke history

Keywords: asthma difficult-to-control asthma mrna expression biomarker real time pcr act acq
a study of the efficacy of gabapentin in neuropathic pain patients as measured by quantitative sensory testing

Conditions: Neuralgia; Neuralgia, Postherpetic

Summary: the purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.


Eligibility criteria:
inclusion criteria: * neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain * well-defined skin area of mechanical allodynia to punctate (von frey filament) stimuli * pain intensity score of ≥ 4/10 for von frey filament-evoked allodynia at the skin area exclusion criteria: * patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain * patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin * patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin
evaluate the safety, tolerability, and pharmacokinetics of icp-723 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: during this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and pk of icp-723


Eligibility criteria:
inclusion criteria: 1. patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with trk or ros1 inhibitors. 2. male or female patients with age ≥18 years old and ≤80 years old. 3. measurable lesion according to recist 1.1. 4. adequate organ functions that meet protocol requirement criteria. 5. patients with asymptomatic, stable primary central nervous system (cns) tumors or cns metastases (treated or untreated) 6. participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits. exclusion criteria: 1. other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured 2. received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives 3. major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug 4. clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption. 5. has evidence of uncontrolled heart disease 6. at the investigator's discretion, evidence of severe or uncontrolled systemic disease. 7. other conditions considered by the investigator to be inappropriate for participation in this study.
improvement of nutritional status in cancer patients and reduction of malnutrition

Conditions: Cancer

Summary: the european society for clinical nutrition and metabolism (espen) recommends assessing the nutritional status of each oncology patient early and in a multidisciplinary manner. this assessment should take into account physical activity and should allow for the patient to be provided with nutritional goals adapted to their new needs. these recommendations aim to combat malnutrition, which sometimes leads to treatment suspension and thus a loss of opportunity for the patient.


Eligibility criteria:
inclusion criteria: * newly diagnosed cancer exclusion criteria: * other cancer previously diagnosed * under 18 years old * pregnant and breastfeeding women
seminal tex101 as a predictor of recovery of spermatogenesis in azoospermic men with palpable varicocele

Conditions: Azoospermia, Nonobstructive; Varicocele

Summary: the aim of the study is to assess if seminal tex 101 can predict the restoration of spermatogenesis and appearance of sperms in the ejaculate after micro-surgical varicocelectomy among azoospermic patients.

male patients (40) cases attending the outpatient clinic of andrology at kasr el-aini university hospitals, all patients presented with azoospermia, age:18-43 years, complaining mainly of infertility or accidently discovered azoospermia during premarital check-up or chronic testicular pain caused by longstanding varicocele. infertile non obstructive azoospermia (noa) (n=40) subjected to varicocelectomy and patients evaluated 3 months after varicocelectomy by semen analysis, then according to results population divided into 2 groups: group a (responders): patients with positive semen analysis for sperms 3 months after varicocelectomy. group b (non responders): patients with no sperms in semen analysis in 3 and/or 6 months after varicocelectomy. method of estimation of human tex101 in semen: a 1 ml collected semen samples were centrifuged for 20 minutes at 1000xg at 4 o c, then supernatant of each sample was collected for estimation of tex101. the human tex101 (testis expressed 101) was assayed by commercially available elisa kit supplied by wuhan fine biotech co., ltd. china. principle of the procedure: this kit was based on sandwich enzyme-linked immune-sorbent assay technique. anti- tex101 antibody was pre-coated onto 96-well plate. the biotin conjugated antibody was used as detection antibodies. the standards, test samples and biotin conjugated detection antibody were added to the wells subsequently, and washed with wash buffer. hrp-streptavidin was added and unbound conjugates were washed away with wash buffer. tmb substrates were used to visualize hrp enzymatic reaction. tmb was catalyzed by hrp to produce a blue color product that changed into yellow after adding acidic stop solution. the intensity of yellow is proportional to the target amount of sample captured in plate.

Eligibility criteria:
inclusion criteria: * azoospermia in at least 2 separate semen analyses * palpable varicocele exclusion criteria: * obstructive azoospermia * abnormal karyotype * previous chemotherapy, radiotherapy and or diagnosed maligancy. * previous testicular of inguinal surgeries. * secondary azoospermia

Keywords: varicocele azoospermia tex 101
a research study to see how well different doses of cagrisema help people with excess body weight lose weight

Conditions: Obesity

Summary: this study will look at how well cagrisema helps people with excess body weight lose weight. cagrisema is a new medicine developed by novo nordisk that combines cagrilintide and semaglutide. cagrisema cannot yet be prescribed by doctors. in the study, participant will either get cagrisema or dummy medicine and which treatment participant get is decided by chance. the study will last for about 1½ years for each participant.


Eligibility criteria:
inclusion criteria: * male or female * age above or equal to 18 years at the time of signing informed consent 1. body mass index (bmi) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or 2. bmi ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease exclusion criteria: * glycated haemoglobin (hba1c) ≥6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening * history of type 1 or type 2 diabetes
single and multiple dose study of uprifosbuvir (mk-3682/idx21437) in healthy and hepatitis c virus (hcv)-infected participants (mk-3682-001)

Conditions: Chronic Hepatitis C

Summary: this is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (pk) of uprifosbuvir (mk-3682/idx21437) in healthy participants and in participants infected with hepatitis c virus (hcv) genotype (gt)1-gt6. the effect of food on the pk of uprifosbuvir will be evaluated. the antiviral activity of uprifosbuvir will also be assessed in hcv-infected participants.


Eligibility criteria:
inclusion criteria: all participants: * of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from screening through at least 90 days after the last dose of the study drug * must not have consumed grapefruit or grapefruit juice within 7 days of day -1 and throughout the study hcv participants: * documented clinical history compatible with chronic hepatitis c. * have not received direct-acting antiviral treatment for hepatitis c infection * has hcv genotype 1, 2, 3, 4, 5 or 6 exclusion criteria: all participants: * pregnant or breastfeeding * co-infected with hepatitis b virus (hbv) and/or human immunodeficiency virus (hiv). * decompensated liver disease * other clinically significant medical conditions or laboratory abnormalities.

Keywords: hepatitis c virus hcv
total knee replacement with duracon® and vanguard™ prostheses

Conditions: Degenerative Arthritis; Osteoarthritis; Rheumatoid Arthritis; Knee Arthritis

Summary: the purpose of this study is to compare range of motion, knee society scores, and duration of surgery for different total knee prostheses.


Eligibility criteria:
inclusion criteria: * patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * patients requiring correction of varus, valgus, or posttraumatic deformity. * patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. exclusion criteria: * patients with infection, sepsis, or osteomyelitis.
experimental studies of the effects of caffeine on glucose regulation

Conditions: Diabetes Mellitus, Type 2

Summary: this project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have type 2 diabetes. in our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. on separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. we measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. in a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo. these studies do not involve clinical treatment or disease management. however, we hope to learn whether a very popular drug impairs the clinical management of a common disease.

pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. this effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients. the experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers. the lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group. an ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. this study uses a double-blind placebo-controlled cross-over design. ambulatory glucose data are collected with a minimed cgms sensor and recorder worn for 72 hours. caffeine and placebo are administered on separate days. average glucose levels and glucose responses to meals are compared across treatment days within subjects.

Eligibility criteria:
inclusion criteria: * 6 months or longer history of type 2 diabetes * treatment by diet, exercise, or oral medication * current daily consumption of 2 or more cups of coffee * bmi \>21kg/m2 and \< 45kg/m2 exclusion criteria: * required use of insulin * current cigarette smoking * current use of medications that impact glucose metabolism * pregnancy * other major medical disorders

Keywords: caffeine coffee glucose insulin
ertapenem sodium vs. piperacillin/tazobactam in the treatment of complicated intra-abdominal infections (0826-037)

Conditions: Complicated Intra-Abdominal Infections

Summary: this study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.

original label approved november 2001

Eligibility criteria:
inclusion criteria: * male or female patients (greater or equal to 18 years of age) * intraoperative/postoperative enrollment: upon visual confirmation of an intra-abdominal infection. * preoperative enrollment: patients may be enrolled preoperatively if they meet certain criteria exclusion criteria: * failure to meet all inclusion criteria. * patients who are considered unlikely to survive the 6-8 week study period. * pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
michael method- fulfilling individual potential to attain excellence - as a tool for improving metabolic control and quality of life among adolescence with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: type 1 diabetes is the most common childhood disease. treatment of diabetes requires personal checks of blood sugar levels, injecting insulin, changing eating habits and physical exercise, which requires a real change in the life of the child \& adolescent and can cause significant damage to the quality of life as well. compliance to treatment is a major challenge for all patients and mostly to adolescence, which often worsen their diabetes control at that age. the michael method is a unique, holistic program to develop and realize an individual's emotional, intellectual and behavioral potential, which is based on the belief that every human being can excel in every field they choose. the method was developed in 1988 by a multi-disciplinary team of professional academic in israel. today the israeli education system implements the method in junior high schools and high schools in diverse educational sectors. the program is taught at many other various frameworks: teachers' continuing education programs, colleges, programs run by the ministries of defense and social welfare, the national insurance institute, the national electric corporation and in many other public and private frameworks. the proposed study is aimed to assess whether the michael method can be used as a tool for improving metabolic control and quality of life among uncontrolled adolescence with type 1 diabetes


Eligibility criteria:
inclusion criteria: * type 1 diabetes at least 1 year prior to study inclusion * 12-17 years old * hba1c \> 7.8% exclusion criteria: - incapability to comply with all study requirements

Keywords: type 1 diabetes metabolic control quality of life