Kornimate/medical-research-clean huggingface dataset:
the effect of prednisone on physical exercise in copd patients

Conditions: Exercise Performance in Copd Patients

Summary: the objective of this study is to investigate if there is an effect on exercise performance og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic obstructive pulmonary disease(copd)

rct study with 4 days of steroid

Eligibility criteria:
inclusion criteria:fev1\< 60% fev1/fvc ratio \<70 % * able to use a ergometer bike exclusion criteria: haemodynamicaly unstable heart conditions * exacerbations before 6 week entry of the study exacerbation during the study period treatment with beta blockers malignancy the last 5 years allergi toward imp

Keywords: copd exercise inflammation prednisone
proteases in patients with prostate cancer that has spread to the bone

Conditions: Anemia; Metastatic Cancer; Myelodysplastic Syndromes; Precancerous Condition; Prostate Cancer

Summary: rationale: collecting and storing samples of bone marrow and tissue from patients to test in the laboratory may help the study of cancer. purpose: this laboratory study is comparing proteases (enzymes that break down protein) in patients with prostate cancer that has spread to the bone with patients who do not have cancer that has spread to the bone.

objectives: * examine the roles of proteases and protease-associated molecules in bone metastases in patients with metastatic prostate cancer. outline: patients undergo bone marrow aspiration and core bone biopsies. tissues are analyzed by immunohistochemistry methods, in situ hybridization assays, gelatin zymography and/or western blot analysis, and gene profiling analysis in order to visualize and quantitate protease or protease-related levels. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * diagnosis of metastatic prostate cancer * patients with documented bone metastases on radiologic imaging studies must undergo bone marrow biopsy * male patients ≥ 50 years of age without cancer who are scheduled to undergo bone biopsy for other clinically indicated reasons, including any of the following: * myelodysplasia * anemia * monoclonal gammopathy of undetermined significance * male or female patients ≥ 40 years of age without metastatic bone cancer who are scheduled to undergo an orthopedic procedure involving removal of bone specimen patient characteristics: * see disease characteristics prior concurrent therapy: * not specified

Keywords: stage iv prostate cancer bone metastases anemia monoclonal gammopathy of undetermined significance de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes
statins in children with type 1 diabetes and hypercholesterolemia

Conditions: Diabetes Mellitus, Insulin-Dependent; Hypercholesterolemia

Summary: children with type1 diabetes (t1dm) have increased risk for cardiovascular disease (cvd) due to chronic increase in the blood sugars and inflammation. if there is also increased in cholesterol, it creates a highly abnormal environment not fully corrected by improved control of the blood sugars. cvd remains the principal risk of mortality in t1dm, and its prevention and treatment, compelling in children. this grant proposal encompasses 3 separate, yet interrelated projects addressing different aspects of cvd risk in children with t1dm. project #1: a randomized controlled trial on the safety and efficacy of a class of drugs called "statins", which lower bad cholesterol in the body, in children with diabetes and elevated bad cholesterol. we will measure changes in concentration of blood inflammatory markers and for the 1st time, correlate levels of these markers with changes in blood sugar as measured by continuous glucose sensors, instruments that measure the blood sugar continuously through a small needle under the skin. project #2: is a laboratory study to investigate the genetics and concentration of key molecules that participate in the inflammatory cascade and atheromatous plaque formation that causes cvd. expression levels in children with t1dm will be compared with those in healthy controls for the 1st time. project #3: examines the use of abdominal aortic mri to measure damage to the arteries in children with t1dm and healthy age-matched controls. the results of these studies will likely provide important new data on the use of statins in children with diabetes.


Eligibility criteria:
inclusion criteria:project 1 * t1dm diagnosed clinically for \> 1 year * any hba1c * on stable insulin therapy * ages: 10 - 20 years * both genders * bmi \< 85th percentile * fasting ldl-c\>100mg/dl * normal thyroid function inclusion criteria:projects 2 and 3 * t1dm diagnosed clinically for \> 3 year * hba1c \> 8% * on stable insulin therapy * ages: 12- 20 years * both genders * bmi \< 85th percentile * fasting ldl-c\>100mg/dl * normal thyroid function exclusion criteria:projects 1,2 and 3 * severe dyslipidemia (ldl-c \>160, tg \> 400 mg/dl) * smoking * pregnancy * current use of anti-inflammatory or immunomodulatory drugs, lipid lowering, antidiabetic drugs * patients with hypertension and/or microalbuminuria will be allowed using balanced randomization and standardized treatment

Keywords: type 1 diabetes children statins hypercholesterolemia lipoproteins c reactive protein continuous glucose monitors adolescence abdominal magnetic resonance imaging toll like receptors receptors of advanced glycation end products nutrition
bioequivalence study of gabapentin 400 mg capsules under fed conditions

Conditions: Healthy

Summary: to compare the single-dose oral bioavailability of metformin hci liquid 500 mg/5 ml of ranbaxy with glucophage® 1000 mg tablets of bristol-myers, usa following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fasting conditions

this was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult volunteers and 2 alternates. all 26 subjects completed the clinical phase of the study. in each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. single oral 400 mg doses were separated by a washout period of 7 days a total of 24 healthy adult volunteers and 2 alternates (17 males and 9 non-pregnant females) enrolled in and completed the clinical phase of the study

Eligibility criteria:
inclusion criteria: 1. healthy adult male or female volunteers, 18-55 years of age 2. weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of "desirable weights of adults", metropolitan life insurance company, 1983) 3. medically healthy subjects with clinically normal laboratory profiles 4. females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods: * surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum * iud in place for at least 3 months * barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and throughout the study * surgical sterilization of the partner (vasectomy for 6 months minimum) * hormonal contraceptives for at least 3 months prior to the start of the study other birth control methods may be deemed acceptable. postmenopausal women with amenorrhea for at least 2 years will be eligible. 5. voluntarily consent to participate in the study. exclusion criteria: subject candidates must not be enrolled in the study if they meet any of the following criteria: 1. history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease 2. in addition, history or presence of: * alcoholism or drug abuse within the past 2 years * hypersensitivity or idiosyncratic reaction to anticonvulsants 3. female subjects who are pregnant or lactating 4. subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose 5. subjects who, through completion of the study, would have donated in excess of: * 500 ml of blood in 14 days, or * 500 - 750 ml of blood in 14 days (unless approved by the principal investigator) * 1000 ml of blood in 90 days * 1250 ml of blood in 12 days * 1500 ml of blood in 180 days * 2000 ml of blood in 270 days * 2500 ml of blood in i year 6. subjects who have participated in another clinical trial within 28 days prior to the first dose

Keywords: bioequivalence gabapentin fed conditions
instrumental soft tissue mobilization in patients with chronic neck pain

Conditions: Neck Pain

Summary: in this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (iastm) in patients with chronic neck pain. forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. individuals were randomly divided into two groups as combined therapy (ct) (n = 24) and exercise therapy (et) (n = 24) groups. all exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. et which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities. ct in addition to the et applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of iastm on the days they came to the treatment twice a week, before the et. as soon as the participants came to the session, iastm was applied first. following the iastm application, et was applied in the same protocol and under the same therapist supervise with the et group. before and after treatment, deep neck flexor muscle endurance (dnfme), pain severity with visual analogue scale (vas) and brief pain inventory (bpi), functional status with neck disability index (ndi), quality of life with nottingham health profile (nhp) treatment and treatment satisfaction was evaluated.


Eligibility criteria:
inclusion criteria, exclusion criteria: individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included. individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
long-term longitudinal imaging of presynaptic terminals in pd

Conditions: Parkinson Disease

Summary: aim: to investigate whether sv2a loss spreads from brainstem to cerebral cortex with progression of parkinson's disease (pd) and to determine whether longitudinal cortical sv2a loss correlates with cognitive decline in pd. study design: we will re-invite participants (both patients with pd and healthy controls) of a previous longitudinal study (nct04243304, s61477) to undergo evaluation approximately 7 years after the initial baseline study visit (i.e. on average 10 years since the first motor symptoms). all participants will undergo clinical assessment of motor and non-motor symptoms (including cognitive testing), as well as 11c-ucb-j pet-ct (targeting synaptic density marker sv2a), 18f-fe-pe2i pet-ct (targeting dat) and brain mri.


Eligibility criteria:
inclusion criteria: * participation in study s61477 (nct04243304) exclusion criteria: * neuropsychiatric diseases (unrelated to pd for pd patients) * major internal medical diseases * history of alcohol or drug abuse * relevant abnormalities on mr brain * contraindications for mr * pregnancy or breastfeeding * previous participation in other research studies involving ionizing radiation with \> 1 msv over past 12 months.

Keywords: parkinson disease pet ucb-j pe2i positron emission tomography
manual lymphatic drainage versus standard treatment for the prevention of breast cancer-related lymphoedema in patients who undergo axillary node clearance

Conditions: Breast Cancer Related Lymphoedema

Summary: axillary lymph nodes are the main site of metastasis in breast cancer. if positive axillary lymph nodes are present, an axillary lymph node dissection (alnd) is usually performed. this procedure improves disease-free survival but comes with the risk of lymphoedema as a result of disrupted lymphatic channels. breast cancer-related lymphoedema (bcrl) is associated with considerable morbidity, which is why proven measures to reduce its incidence would improve patient outcomes. we aimed to investigate whether a regime of manual lymphatic drainage and exercise, supervised by a manual lymphatic drainage therapist compared to standard care would reduce the incidence of breast cancer-related lymphoedema in patients undergoing alnd.

eligible patients were those in whom a primary operable breast cancer is diagnosed and in whom surgery is planned to include alnd. patients with recurrent carcinoma, previous axillary surgery/radiotherapy or any previous arm/axillary pathology leading to arm volume changes will be excluded. eligible participants will be identified at the breast multidisciplinary meeting and will be informed of the study and given a written information sheet. patients who choose to participate will be asked to fill in a written consent form. patients allocated to the decongestive lymphatic therapy group will undergo intervention for a total period of 3 months. this will consist of 2 visits to a qualified practitioner in dr vodder manual lymphatic drainage therapist, one at the start of the 3-month period and again 6 weeks later. patients in both groups will also be instructed to perform self-mld on a daily basis and will be taught a series of exercises to be performed on a daily basis. compression hosiery will be fitted to be worn during the exercises.

Eligibility criteria:
inclusion criteria: * patients with a new diagnosis of primary operable breast cancer * surgery will involve axillary lymph node clearance exclusion criteria: * patients with recurrent breast cancer * patients with previous axillary surgery * patients with previous axillary radiotheraphy * patients with previous arm/axillary pathology leading to arm volume changes

Keywords: breast cancer lymphoedema manual lymphatic drainage decongestive lymphatic therapy
9 minutes for tandem colonoscopy withdrawal

Conditions: Colon Polyp; Colorectal Adenoma

Summary: a mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. however, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. it is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.


Eligibility criteria:
inclusion criteria: * patients whose age is between 40-75. * patients who have indications for screening * patients who have signed inform consent form. exclusion criteria: * patients who have undergone colonic resection or polypectomy * patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination * patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days * patients with inflammatory bowel diseases * patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests * patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis). * patients with pregnancy, severe chronic cardiopulmonary and renal disease. * patients with failed cecal intubation * patients with poor bpq that necessitated a second bowel preparation * patients with therapeutic colonoscopy for existing lesions * patients refusing to participate or to provide informed consent

Keywords: withdrawal time adenoma miss rate tandem colonoscopy adenoma detection rate
evaluation of innovative ultrasonic techniques for non-invasive diagnosis of liver fibrosis in patients with chronic viral hepatitis b or c

Conditions: Liver Fibrosis

Summary: the non-invasive assessment of liver fibrosis in chronic viral hepatitis b and c is now entering clinical practice. it is based on blood tests, especially fibrometre® and fibrotest® and on elastography with the fibroscan®. despite the overall satisfactory diagnostic performance for all of these tests (auroc ranging from 0.80 to 0.90 depending on the study) for the discrimination of f≤1 versus f≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. with these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. it would be particularly useful to have new generation techniques with a better diagnostic performance. in this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.


Eligibility criteria:
inclusion criteria: * patient with an ac-hcv positive and rna hcv positive or aghbs-positive, * naive to treatment or not receiving treatment for viral eradication in six months, * patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion, * patient affiliated to social security or similar regime, * patients who signed consent for participation in the study. exclusion criteria: * patient with anti-hiv ac positive (latter result not older than 12 months and in the absence of risk factors) * chronic liver disease due to other causes than hcv (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...) * chronic alcohol consumption \>30g/day in men and \>20g/day in women * history of severe systemic disease, * hcv treatment with anti-viral or anti-fibrotic referred to within the last 6 months, * immunosuppressive therapy: corticosteroids, imurel, cyclosporine, tacrolimus, cellcep, * patient with an active implantable medical device, * protected person referred to in articles l1121-5 to l1121-8 of the code of public health

Keywords: hepatitis fibrosis elastography
letrozole pretreatment with misoprostol versus misoprostol alone in missed abortion

Conditions: Missed Abortion

Summary: this study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

according to the american college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week letrozole administration with misoprostol raises the rate of complete abortion

Eligibility criteria:
inclusion criteria: * gestational age less than 64 days gestation (\<9 wks). * hemoglobin \>10 g/dl. * bmi between 18.5 kg/m2 and 25 kg/m2. * missed abortion. exclusion criteria: * molar pregnancy. * fibroid uterus. * uterine anomalies. * coagulopathy. * medical disorder that contraindicate induction of abortion (e.g. heart failure). * previous attempts for induction of abortion in the current pregnancy. * allergy to misoprostol or letrozole. * scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
mechanical alternans study

Conditions: Ischemic Cardiomyopathy; Nonischemic Cardiomyopathy; Heart Failure

Summary: the purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate icd therapies, and to predict progression of heart failure and death.


Eligibility criteria:
inclusion criteria: * structural heart disease * ischemic or non-ischemic cardiomyopathy exclusion criteria: * pregnancy * age \< 18 years old
a study of baricitinib in participants from 1 year to less than 18 years old with juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of jia in participants ages 1 to 17. this study is for participants that have been enrolled in studies i4v-mc-jahv (nct03773978) or i4v-mc-jahu.


Eligibility criteria:
inclusion criteria: * participants must have completed a previous study of baricitinib for the treatment of jia. exclusion criteria: * participants must not have had a permanent discontinuation of baricitinib in the prior study. * participants must have not developed an allergy to baricitinib.

Keywords: polyarticular jia oligoarthritis juvenile psoriatic arthritis (jpsa) enthesitis-related juvenile idiopathic arthritis (era) systemic jia with and without systemic features
convalescent plasma in hospitalized covid-19 patients

Conditions: COVID-19

Summary: the study assesses the efficacy and safety of administration of hyperimmune plasma in hospitalized covid-19 patients. efficacy was measured as 28-day mortality following convalescent plasma transfusion. safety was measured as the rate of adverse reactions. to plasma infusion.

inclusion criteria: adult inpatients with a severe form of covid-19 have been enrolled, with at least one of the following inclusion criteria: 1) tachypnea with respiratory rate (rr) \> 30 breaths/min; 2) oxygen saturation (spo2) ≤ 93% at rest and in room air; 3) partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) ≤ 200 mmhg, 4) radiological picture and/or chest ct scan showing signs of interstitial disease and/or rapid progression of lung involvement. primary outcome: overall mortality at 28 days after hospitalization secondary outcome: adverse reaction to plasma transfusion.

Eligibility criteria:
inclusion criteria: * adult patients admitted for severe covid-19 exclusion criteria: * \< 18 years * participation in any other clinical trial of an experimental treatment for covid-19
brief behavioral treatment for insomnia in cancer survivors

Conditions: Chronic Insomnia

Summary: the purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

a randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of brief behavioral treatment for insomnia (bbti).

Eligibility criteria:
inclusion criteria: * \> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage i, ii, or iii: breast, colorectal, prostate, lung cancer * chronic insomnia exclusion criteria: * other preexisting sleep disorders except those with osa stable on cpap * unstable medical illnesses

Keywords: cancer survivors brief behavioral treatment older adults attention control intervention