Kornimate/medical-research-clean huggingface dataset:
cryotherapy for barrett's esophagus and early esophageal cancers

Conditions: Barretts Esophagus; Esophageal Cancer

Summary: this is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (egd) to ablate barrett's esophagus with changes of high-grade dysplasia (hgd) or intramucosal cancer (imca) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

the cryo-ablator system is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold. patients will prepare for esophagogastroduodenoscopy (egd) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. the egd will be performed using a therapeutic olympus endoscope. the cryocatheter is passed into the therapeutic channel of the endoscope. liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. this process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. patients will be contacted the following day to assess for any immediate complications. patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the barrett's mucosa has been achieved. follow up period of five years to monitor healing and progression.

Eligibility criteria:
inclusion criteria: group 1: * co-morbid conditions such as severe heart, lung, kidney or liver disease. * refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy. group 2: * patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell ca) with lesions extending beyond the mucosa but limited to the esophageal wall exclusion criteria: * age less than 18 years * co-morbid illness expected to cause death within 6 months * pregnancy * refusal or inability to give consent

Keywords: barrett's esophagus cryospray ablation high grade dysplasia early esophageal cancers esophageal neoplasms esophageal intramucosal cancer (imca) esophageal cancer limited to esophageal wall barretts esophagus high grade dysplasia (hgd)
molecular basis of pcos in oocytes and surrounding cells

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common disorder in women of reproductive age that is characterized by elevated androgen levels, ovulatory dysfunction and polycystic ovarian morphology (pcom). moreover, has been associated to insulin resistance, obesity, type 2 diabetes and infertility. women with pcos are a heterogeneous group, and specific pcos phenotype could have a substantial impact on oocyte quality and molecular profile. regarding the rotterdam criteria for pcos, four different phenotypes of the syndrome are defined (a, b, c, d). phenotypic group a is the most frequent and severe subtype of pcos. it is described that patients with so-called phenotype a exhibit a significantly increased risk of pregnancy complications compared to women with more favorable pcos phenotypes. specifically, this clinical-laboratory study will focus on the molecular characterization of pcos phenotype a. epigenetic are external modifications to dna that affect how cells "read" genes. these external modifications have garnered attention in the pathogenesis of pcos since epigenetics changes have been reported in various organs in women with the condition. however, remains unknown whether these alterations are also found in the egg and in its surrounding cells. further research is needed to understand the pcos disorder and to design treatments that can ameliorate the symptoms of the disease. in particular, this project aims to generate the molecular profiles of pcos phenotype a eggs and surrounding cells and compare them with the ones obtained from and healthy controls. this approach involves the aspiration of immature eggs without hormonal stimulation or with stimulation of only a few days.


Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 37 * biochemical hyperandrogenism * ovulatory dysfunction * polycystic ovaries) * bmi \> 25. * normal andro-gen levels * normal ovarian function * normal ovarian morphology * bmi \< 29. exclusion criteria: * congenital adrenal hyperplasia * cushing's syndrome * androgenic-secreting tumor * high (\>grade 2) grade endometriosis * major uterine or ovarian abnormalities * pregnant women * volunteers with metabolic syndrome
evaluation of ave5026 as compared to enoxaparin for the prevention of venous thromboembolism in patients undergoing major abdominal surgery

Conditions: Venous Thromboembolism

Summary: the primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of semuloparin sodium (ave5026) with q.d. s.c. injections of enoxaparin for the prevention of venous thromboembolic events (vte) in patients undergoing major abdominal surgery. the secondary objectives are to evaluate the safety of semuloparin sodium (ave5026) and to document semuloparin sodium (ave5026) exposure in this population.

randomization has to take place prior to the surgery. the total duration of observation per participant is 35-42 days from surgery broken down as follows: * 7 to 10-day double-blind treatment period; * 28 to 35-day follow-up period. mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.

Eligibility criteria:
inclusion criteria: * patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis). * patient \<60 years of age had to have one of the following additional risk factors for vte: * history of vte, * obesity, * chronic heart failure, * chronic respiratory failure, * inflammatory bowel disease, * cancer surgery. exclusion criteria: * any major orthopedic or general surgery in the 3 months prior to study start; * clinical signs or symptoms of dvt or pe within the last 12 months or known post phlebitic syndrome; * any contra-indications to the performance of venography; * high risk of bleeding; * known hypersensitivity to heparin or enoxaparin sodium; * end stage renal disease or patient on dialysis. the above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: digestive system surgical procedure urologic surgical procedure prevention of venous thromboembolism abdominal surgery
effectiveness of low-dose theophylline for the management of biomass-associated copd

Conditions: COPD; COPD Exacerbation; COPD Exacerbation Acute; Pollution Related Respiratory Disorder; Pollution; Exposure

Summary: chronic obstructive pulmonary disease (copd) is the fourth leading cause of death worldwide, and over 90% of copd-related deaths occurring in low- and middle-income countries (lmics). household air pollution (hap) - from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy - is the primary risk factor for copd in these settings. biomass-related copd has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated copd. despite the high global burden of biomass-related disease, little is known about the effectiveness of pharmacotherapies for biomass-related copd; to date, no clinical trials have focused specifically on treatment of biomass-related copd. this study proposes to assess the health impact of biomass-related copd and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related copd in uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of hap on lung function. the study additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost-effectiveness ratio and a range of willingness to pay thresholds.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years 2. full-time resident of study area 3. post-bronchodilator fev1/fvc \< the lower limit of normal of the global lung initiative mixed ethnic reference population 4. grade b-d copd 5. daily biomass exposure exclusion criteria: 1. plans to move within one year 2. uncontrolled hypertension 3. pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history) 4. current use of chronic respiratory medications (long acting beta 2 antagonists (laba), long-acting muscarinic antagonist (lama), inhaled corticosteroid (ics)) 5. history of post-treatment pulmonary tuberculosis 6. ≥10 pack year tobacco smoking history 7. known intolerance or contraindication to theophylline.

Keywords: biomass associated copd low-dose theophylline
niv mask assessment of usability and performance

Conditions: Respiratory Failure

Summary: assessment of usability, perceived comfort and performance of a niv mask in the hospital environment.

50 participants admitted for niv therapy will have the investigation mask fitted. the doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. some therapy settings and demographics will be recorded.

Eligibility criteria:
inclusion criteria: * admitted and indicated for non invasive ventilation therapy * assessed for capacity to consent and consent process documented * fits the investigation mask * aged 18 year or older exclusion criteria: - contraindicated for non invasive ventilation
pilot pharmacokinetic study of oral testosterone ester formulations in hypogonadal men

Conditions: Hypogonadism

Summary: determine the serum pharmacokinetic profile for two oral formulations of t-esters (one te and one tu) administered once -(qd) and twice-daily (bid) to hypogonadal men.

five period cross-over study in which subjects received a single day of dosing in each period. dosing was either qd or bid with one of two t esters (t-enanthate (te) or t-undecanoate (tu)). dosing was within 5 minutes of meals (breakfast and for bid dosing dinner). there was a minimum of a 5-day washout between periods. subjects were hypogonadal men.

Eligibility criteria:
inclusion criteria: male, ages 18 to 65 serum total testosterone less than or equal to 250 ng/dl naive to androgen replacement therapy subject must be on stable doses of thyroid or adrenal replacement hormones for at least 14 days prior to enrollment exclusion criteria: significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. patients with treated hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering mediation for at least three months. for non-insulin dependent diabetic subjects, hba1c\>9%. abnormal prostate digital rectal examination, elevated psa (serum psa \>4ng/ml), aua sympton score greater than or equal to 15 points, and a history or prostate cancer. serum transaminases \>2x upper limit of normal (uln) or serum bilirubin \>2.0 mg/dl. history of severe or multiple allergies, severe adverse drug reaction or leucopenia. known hypersensitivity to lidocaine or all surgical dressings. history of abnormal bleeding tendencies. oral, topical, or buccal t therapy within the previous week, or intramuscular t injection within the previous 4 week. use of dietary supplements that may increase serum t, such as androstenedione or dhea, within the previous 4 weeks. know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol. smokers who are unable to refrain from smoking during confinement periods. history of, or current evidence of, abuse of alcohol or any drug substance. poor compliers or those unlikely to attend. receipt of any drug as part of a research study within 30 days of inital dose administration in this study. blood donation (usually 550 ml) within the 12-week period before the initial study dose. hematocrit less than 35%. known clinical polycythemia or hematocrit greater than 50%. current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers, or barbiturates. history of sleep apnea.

Keywords: testosterone male hypogonadism low testosterone
evaluation of the cell detachment ratio on ph-responsive chitosan as a prognostic factor in lung cancer

Conditions: Clinical Decision-Making; Early Detection of Cancer

Summary: biomaterial-based cell culture models have been gaining increasing attention as potential therapeutic strategies. the purpose of this project is to evaluate whether the cell detachment ratio on ph-responsive chitosan could be correlated with the overall survival in lung cancer patients. through controllable cell-material interaction, this project has the intention to develop an alternative tool for both early diagnosis and accurate prognosis in cancer therapeutics.


Eligibility criteria:
inclusion criteria: * lung cancer patient between 20-70 years old who need surgery for the resection of lung lesions. * willing to sign the consent form under the informed consent. exclusion criteria: * vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Keywords: ph-responsive chitosan cancer stem-like cell cell detachment ratio prognostic factor
early changes in pulmonary function and vascular endothelial function and the correlation between them in t2dm patients

Conditions: Diabetes Mellitus, Type 2

Summary: current knowledge: to the best of our knowledge, no studies have reported the correlation between pulmonary function and the vascular endothelial function in diabetic patients during the preclinical period. indeed, diabetic nephropathy and retinopathy are the leading causes of end-stage renal failure and acquired blindness, respectively. however, when investigators treat patients with type 2 diabetes, investigators seldom consider the pulmonary vascular injury induced by glycemia. experimental studies have shown that pulmonary function and vascular endothelial function change during the preclinical stages of diabetic retinopathy. researchers have already established that compared to healthy subjects, patients with type 2 diabetes have a reduced alveolar gas exchange capacity. the no and et-1 can be used to assess the vascular endothelial function. what this paper contributes to our knowledge: regulating glycemia can improve vascular endothelial function . this study suggests that detecting the no and et-1 would allow for the prediction of changes in pulmonary function during the preclinical stages of diabetic retinopathy and the degree of retinopathy in the future.


Eligibility criteria:
inclusion criteria:1) symptoms of diabetes (thirst, polydipsia, diuresis, and unexplainable weight loss); 2) random blood sugar ≥11.1 mol/l, fasting plasma glucose ≥7.0 mol/l or an oral glucose tolerance test outcome (2-hour postprandial blood glucose) ≥11.1 mol/l; or 3) no symptoms of diabetes but either random blood sugar ≥11.1 mol/l or fasting plasma glucose ≥7.0 mol/l. - exclusion criteria:1) diagnosis of type 2 diabetes according to the guidelines of the american diabetes association;11 2) no history of smoking (never smoked), pulmonary disease or pulmonary infection (during the treatment or recovery period); 3) no hepatopathy, nephropathy, or gastrointestinal disease; and 4) a high likelihood of good compliance and the ability to visit our hospital for periodic assessments. the exclusion criteria were as follows: 1) diagnosis of type 1 diabetes; 2) pregnancy and/or active lactation; 3) intensive care with insulin treatment; 4) renal inadequacy, hypohepatia, or heart disease; 5) pneumonia, influenza (during the treatment or recovery period), phthisis or other pulmonary infection; 6) presence of multiple pulmonary cysts, bullae of the lung, or diffuse pulmonary calcifications confirmed via ct; 7) combined diabetic retinopathy and hypertension (for which antihypertensive drugs are used); 8) aneurysm, dissection of aorta; 9) inadequate control of serum lipid parameters by cholesterol-lowering drugs; 10) body mass index ≥32; and 11) the use of systemically injected glucocorticoids within 3 months prior to our study. -

Keywords: type 2 diabetes pulmonary function vascular endothelial function ultrasound
combined medication for improved analgesia in superficial pain

Conditions: Pain

Summary: this research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain). the investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers. the combination of medications under investigation is diclofenac and atropine. diclofenac has been approved by the u.s. food and drug administration (fda) to treat pain. atropine has been approved by the fda to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain. however, atropine has been used for many years in different european countries to treat painful conditions such as stomach cramps.this research study will compare diclofenac and atropine to placebo.


Eligibility criteria:
inclusion criteria: * male and female healthy volunteers. * 18-40 years of age. * ability to read and understand english; english can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures. exclusion criteria: * chronic pain condition or chronic or current treatment with any pain medication. * presence of any illness or medication use that is judged to interfere with the trial. for example: psychiatric disorder, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids. * unwillingness to receive brief pain stimulation administered by a heat probe on the hand. * allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication and atropine (treatment with antidepressants, neuroleptics, antihistaminic, levodopa, anti-acids. pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis, gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement, glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia, arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney failure)
safety of single doses of sar113945 and efficacy and safety of a new formulation given into the knee in osteoarthritis patients / part i

Conditions: Knee Osteoarthritis

Summary: study objectives: * part 1 tdu11685 to assess in patients with knee osteoarthritis (oa), the safety, tolerability and pharmacokinetics (pk) of single intra-articular doses of sar113945. * part 2 act12505 to assess in patients with knee oa, the efficacy, safety and tolerability of a single intra-articular dose of sar113945.

- screening will be performed within 28 days of dosing. following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility criteria:
inclusion criteria: - diagnosis of primary knee osteoarthritis, based upon the following: * x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation * patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72. * patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis. exclusion criteria: * patients younger than 40 years * women of child bearing potential. * women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level \>30 iu/l. * secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy. * presence of local skin abnormality at the affected knee joint. * intra-articular injection within 3 months. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
efficiency of radiofrequency ablation for surgical treatment of chronic atrial fibrillation with rheumatic valve disease

Conditions: Rheumatic Valve Disease; Atrial Fibrillation

Summary: the purpose of this study is to determine whether concomitant radiofrequency maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 rheumatic valve patients with chronic atrial fibrillation (af) having concomitant valve surgery were randomized to three groups: left atrial ablation group, bi-atrial ablation group, and amiodarone group. all patients were scheduled followed up before discharge and at 3rd, 6th and 12th postoperative months. standard 12-lead electrocardiography (ecg), 24-hour holter and transthoracic echocardiography were used to determine the rhythm and cardiac hemodynamic status.

the purpose of this study is to determine whether concomitant radiofrequency maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control,improved cardiac hemodynamic status and decreased thromboembolism events and to compare if biatrial is better than left atrial procedure? 150 patients with chronic af having concomitant cardiac surgery will be enrolled. patients will underwent bi-atrial radiofrequency,left atrial radiofrequency or no radiofrequency procedure randomly. all the patients will receipt amiodarone 200 mg/day for 12 months postoperatively. all patients were scheduled followed before discharge and at 3rd, 6th and 12th postoperative months.the following diagnostic procedures were performed 1. standard 12-lead electrocardiography 2. holter-ecg 3. transthoracic echocardiography

Eligibility criteria:
inclusion criteria: 1. patients with atrial fibrillation secondary to definite rheumatic valve disease 2. at least six months and no longer than 5 years of chronic atrial fibrillation 3. age \>=18 years and \<=70 patients who can give informed consent themselves in writing 4. no contraindication for amiodarone 5. negative pregnancy test (in women with childbearing potential) exclusion criteria: any one of the following exclusion criteria is sufficient to disqualify a patient from the study 1. left atrial diameter(lad)\>=70mm 2. left ventricular eject fraction(lvef)\<=30% 3. atrial thrombus 4. contraindication for anticoagulation therapy 5. less than 6 months since last episode of cerebral infarction 6. emergency operation 7. patients with a malignant tumor 8. pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period. 9. any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.

Keywords: radiofrequency ablation maze atrial fibrillation