Kornimate/medical-research-clean huggingface dataset:
diabetes study with rosiglitazone monotherapy versus metformin or glyburide/glibenclamide

Conditions: Diabetes Mellitus, Type 2

Summary: the study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients (\< 3years) with type 2 diabetes. * fasting plasma glucose (fpg) range of 126-240 mg/dl at screening. * no previous treatment with oral or parenteral glucose-lowering therapy. exclusion criteria: * history of lactic acidosis. * anemia (\<11g for males, \<10 g for females). * unstable or severe ny heart association-class 3 or 4. * any ny heart association congestive heart failure. * patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

Keywords: type 2 diabetes monotherapy treatment naive
effectiveness and safety of bio-11006 inhalation solution to treat the overproduction of mucus and inflammation in copd

Conditions: COPD; Chronic Obstructive Pulmonary Disease

Summary: the symptoms associated with copd include overproduction of mucus and inflammation in the lungs. overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated copd exacerbations. therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit copd patients. the drug under evaluation in this study, bio-11006 inhalation solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.

copd encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. the most common form of copd is a combination of chronic bronchitis and emphysema. many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. a treatment that inhibits mucus hypersecretion or blocks inflammation could benefit copd patients with chronic bronchitis. the drug under evaluation in this study, bio 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. in this study, bio-11006 will be administered to copd patients with chronic bronchitis, and the effects lung function will be assessed.

Eligibility criteria:
inclusion criteria: * clinically stable male or female outpatients, 45 years of age or older * active copd with chronic bronchitis indicated by: (1) fev1 = 40% to 70%, (2) fev1/fvc ≤70%, (3)chronic productive cough for 3 months in each of 2 successive years, and (4) sputum (phlegm) production at least several days a week over the past 4 weeks * current or previous smoker with a 20-pack year history exclusion criteria: * treatment with oral prednisone during the 6 weeks before enrollment * changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment * treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment * current asthma as determined by the investigator * change in smoking status during the previous 6 months

Keywords: chronic obstructive pulmonary disease copd chronic bronchitis
effect of reconditioning exercise on older adults with urinary tract cancer following curative surgery

Conditions: Rehabilitation

Summary: as population ages, geriatric patients with urinary tract cancer suffer from more complications and functional decline that alter treatment plan despite advance in cancer surgery. it was found that these urinary tract cancer survivors required a longer time to recover to the state before the treatment, and some may be even unable to recover to the state before the treatment. exercise intervention has been found to be beneficial to improve functional capacity for cancer survivors, such as breast cancer. however, it is unclear whether exercise intervention could also improve functional recovery and mobility in patients with urinary tract cancer following curative surgery, especially in older adults. the purpose of this study is to investigate the effect of reconditioning exercise on morbidity, oncological outcomes, and functional recovery in older adults with urinary tract cancer following curative surgery. patients aged over 65 years old and after having undergone curative surgery for confirmed urinary tract cancer will be recruited. the participants will be assigned into two groups using blocked randomization design. one group will receive reconditioning exercise training for five consecutive days, and the other group will receive exercise education. structured questionnaire for comprehensive geriatric assessment and functional mobility, such as walking performance, will be used to assess the training effect. outcome measures are assessed including major complication after surgeries, changes in functional status, tumor progression, and length of survival. physical function measurement will include hand grip, muscle strength of lower extremities, and gait performance.


Eligibility criteria:
inclusion criteria: * after having undergone curative surgery for confirmed urinary tract cancer * able to independently walk for at least 8 meters before surgery * able to follow 3-step commands exclusion criteria: * having unstable medical conditions or metastasis * having neuromuscular diseases, such as stroke, parkinson's diseases * unable to attend training sessions * having other health issues which would interfere evaluation and exercise training
modified thoracoabdominal plane block and rectus block combination

Conditions: Visual Analogue Scale

Summary: the aim of our study was to investigate the effect of the combination of modified thoracoabdominal plane block (m-tapa) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.


Eligibility criteria:
inclusion criteria: * over 18 years old * asa1-2 * laparoscopic cholecystectomy cases exclusion criteria: * bleeding disorders * anticoagulant use * patients with previous nerve damage * lack of patient consent * patients with liver and kidney failure * patients allergic to local anesthetics used * patients with bmi \> 35
the comparison of oxidative stress between inhalation anesthetics

Conditions: Oxidative Stress; Cardiac Surgery

Summary: oxidative stress is an unavoidable event during cardiac surgery. isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.the aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(cpb) (3)to investigate the effect of different anesthetics on isoprostanes.

enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue. isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.the aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.

Eligibility criteria:
inclusion criteria: * patients receiving cardiac valve surgery in asa ii-iii physical status exclusion criteria: * trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery

Keywords: isoprostanes mass spectrometry
fusionless treatment of idiopathic scoliosis with the scoli-tether system during the growth period

Conditions: Adolescent Idiopathic Scoliosis; Juvenile Idiopathic Scoliosis

Summary: the goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (ais) with the scoli-tether (miscoli) system.


Eligibility criteria:
inclusion criteria: 1. diagnosis of juvenile or adolescent idiopathic scoliosis 2. male and female subjects greater than 8 years of age with significant growth remaining 3. risser stage 0 or 1 4. subjects should have at least three years of estimated growth remaining based on risser staging 5. major thoracic scoliosis with cobb angle \> 40° and \< 70° and lenke i, ii or v curve pattern. cobb measurements refer to measures taken without a brace. patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure 6. thoracic kyphosis (t5-t12) \< 50° 7. instrumentation to be applied no more cephalad than t4 and no more caudal than l2 (inclusive) 8. menses \< 4 months 9. subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations 10. subject assent and parent/legal guardian consent obtained and documented. exclusion criteria: 1. scoliosis curve is less than 30° or more than 70° 2. thoracic kyphosis is greater than or equal to 50° (t5-t12) 3. the vertebrae to be instrumented is less than 12mm in height (based on the staple size) 4. one of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length) 5. one of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length) 6. non-idiopathic scoliosis 7. non-ambulatory 8. subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, paget's disease and metabolic bone disease 9. prior thoracic surgery 10. abnormal neurological status at baseline 11. any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest
postpartum glucose tolerance with levonorgesterel iud use in women with recent gestational diabetes

Conditions: Gestational Diabetes; Glucose Intolerance; Type 2 Diabetes; Intrauterine Contraception

Summary: the study is being done in order to gain information on the most suitable types of birth control in women who recently had gestational diabetes, or diabetes diagnosed during pregnancy. the intrauterine device (iud) is a highly effective form of birth control. it is inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the type of iud (hormone-releasing or copper). the hormone-releasing iud works for 5 years and releases a hormone called a progestin into the uterus. the copper iud contains no hormones and works for 10 years. the iud is an excellent form of birth control postpartum, but it is unknown if the hormone-releasing iud will affect blood sugars and increase a woman's risk of becoming diabetic when she's not pregnant. the hypothesis is that the hormone-containing iud will not increase blood sugars, so women who use the hormone-containing iud will have similar blood sugars to those who use the copper iud or have had their tubes tied (no hormones).


Eligibility criteria:
inclusion criteria: 1. age 18-45 years at the time of enrollment 2. single gestation in the current pregnancy 3. gdm in the current pregnancy, diagnosed by 2- or 3-hour oral glucose tolerance test (ogtt) performed at 24-32 weeks gestation 4. desires intrauterine contraception or tubal ligation postpartum 5. willing and able to read and sign an informed consent form in english 6. willing to comply with the study protocol exclusion criteria: 1. history of pre-gestational dm, type 1 or 2 2. pregnancy conceived with assisted reproductive technologies 3. positive for human immunodeficiency virus (hiv) infection 4. desires repeat pregnancy within the first 12 months following delivery

Keywords: intrauterine device gestational diabetes postpartum contraception postpartum birth control
multi-center validation of a deep learning based bowel preparation evaluation system

Conditions: Adenoma; Bowel Preparation

Summary: a deep learning based system to calculate the proportion of boston bowel prep scale (bbps) score of 0-1 during withdrawal phase has been constructed previously. this multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.

inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. however, bowel preparation assessment involved subjectivity and uncertainty. we constructed a deep learning based system to calculate the proportion of boston bowel prep scale (bbps) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.the multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or above; * ability to read, understand and sign informed consent forms; * the researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures. exclusion criteria: * patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.); * patients with galactosemia; * pregnant or lactating women; * patients used lactulose, a stimulant, or laxative within 7 days; * patients refused to sign informed consent forms.
octreotide acetate in microspheres in patients with diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.


Eligibility criteria:
inclusion criteria: * males and females with type 1 and type 2 diabetes mellitus * moderately severe or severe npdr or mild pdr in at least one eye: * with an early treatment diabetic retinopathy study (etdrs) visual score of \> 35 letters; and * not previously treated with scatter photocoagulation. * hba1c \< 13% at study entry exclusion criteria: * condition which could interfere with the assessment of retinopathy progression * history of symptomatic gallstones without cholecystectomy * brittle diabetes or history of severe hypoglycemia unawareness * previous treatment with a somatostatin analogue

Keywords: diabetic retinopathy, octreotide acetate in microspheres
the cervical length and thickness of cesarean section scar with preterm labor

Conditions: Preterm Labor

Summary: although the cesarean section is one of the most common obstetric operations around the world, the world health organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity. preterm is defined as babies born alive before completing 37 weeks of pregnancy. preventing preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.


Eligibility criteria:
inclusion criteria: 1. singleton pregnant 2. gestational age at 18 weeks 3. previous vaginal or cesarean section exclusion criteria: 1. twins pregnancy in their second birth 2. previous preterm labor 3. diabetic during the second pregnancy 4. hypertensive during the second pregnancy 5. cigarette use during the second pregnancy 6. congenital anomalies
efficacy, safety and underlying mechanisms of sphenopalatine ganglion acupuncture for seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: in recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (ar). indeed, the latest american clinical guidelines recommended acupuncture treatment for ar patients who are interested in non-pharmacological treatment. in conventional acupuncture treatment for ar, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (spg) to improve nasal symptoms and quality of life in nasal inflammatory diseases. the investigators hypothesize that, compared with sham acupuncture and rescue medication (rm), active spg acupuncture combined with rm would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. to test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of spg acupuncture in pollen-induced seasonal ar patients and to explore the potential underlying mechanisms.


Eligibility criteria:
inclusion criteria: 1. history of physician-diagnosed sar with at least 2 years of typical symptoms, and tnss\>=6 at v0. 2. positive skin prick test (spt) and/or positive serum antigen specific ige to local seasonal pollens (giant ragweed, mugwort, goosefoot, etc) exclusion criteria: 1. oral steroids within 4 weeks prior to recruitment 2. nasal steroids and/or antihistamine 2 weeks prior to recruitment 3. perennial ar 4. any respiratory infection within the previous 4 weeks prior to recruitment 5. history of nasal polyps, asthma or autoimmune disorders 6. previously received acupuncture therapy for ar within 1 month prior to recruitment

Keywords: acupuncture sphenopalatine ganglion seasonal allergic rhinitis neuropeptides inflammatory cytokines neuro-immune interactions
a single dose study investigating the elimination of pd-0332334 in patients receiving regular hemodialysis

Conditions: Renal Dialysis; Pharmacokinetics

Summary: 1. quantify how much pd-0332334 is removed from the blood with hemodialysis 2. investigate the pharmacokinetics of a single dose of pd-0332334 in subjects receiving regular hemodialysis treatments. 3. investigate the safety and tolerability of a single dose of pd-0332334 in subjects receiving hemodialysis.

assess the elimination of pd-0332334 from the blood with hemodialysis

Eligibility criteria:
inclusion criteria: * patients receiving regular hemodialysis * male or female patients 18 to 65 years exclusion criteria: * severe heart failure * renal transplant or renal allograft * illicit drug use (with the exception of prescribed sedatives)

Keywords: pharmacokinetics, pd-0332334, hemodialysis, renal dialysis
patient reported outcomes study using electronic monitoring system for advanced or metastatic solid cancer

Conditions: Breast Cancer; Lung Cancer; Colorectal Cancer; Liver Cancer; Stomach Cancer; Endometrial Cancer; Ovarian Cancer; Squamous Cell Carcinoma of the Head and Neck

Summary: this is a multicenter, open-label, randomized, controlled study to test the hypothesis that epro monitoring added to usual care helps prolong os or maintain and improve hrqol in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.


Eligibility criteria:
inclusion criteria: 1. unresectable, advanced, metastasized, or relapsed solid tumors (breast cancer, lung cancer, colorectal cancer, liver cancer, stomach cancer, endometrial cancer, ovarian cancer, or squamous cell carcinoma of the head and neck) 2. expected to be able to undergo treatment or observation for at least 6 months at the study site 3. eastern cooperative oncology group (ecog) performance status (ps) of 0, 1, or 2 4. receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (in principle, patients should be receiving pharmacotherapy on an out-patient basis.) 5. capable of using electronic device (includes cases needing some assistance) 6. aged 18 years or older at informed consent 7. written consent for the study personally obtained from the subject exclusion criteria: 1. has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors\*notes 1, 2 2. currently participating in a study where pro is tracked and the results are passed on to a physician 3. the following are exclusion criteria for individual types of cancer 1) breast cancer * scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer * scheduled to receive or currently receiving first regimen of anti-her2 therapy for her2-positive disease 2) liver cancer * hepatic function of child-pugh b/c 4. undergoing or scheduled to undergo radiation therapy for curative purposes 5. deemed otherwise unsuitable for the study by the investigator or sub-investigator * notes: 1. if the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy. 2. does not include endocrine therapy for breast cancer.