Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety and efficacy of ym178 in patients with overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: the purpose of the study is to evaluate the effect of ym178 in patients with overactive bladder for 12-week administration.

this study examines the superiority of ym178 over the placebo and evaluates the safety and pharmacokinetics of ym178 in patients with overactive bladder, and to compare the efficacy and safety of ym178 over those of tolterodine, the control drug, without a non-inferiority test. the drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Eligibility criteria:
inclusion criteria: * patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period * patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself * patient with an average frequency of micturition of 8 or more times per 24-hour period * written informed consent has been obtained exclusion criteria: * patients without experience of urge incontinence before informed consent * patients given a clear diagnosis of stress incontinence * patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc) * patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis * patients with a previous history of recurrent urinary tract infection * patients complicated with or with a history of bladder tumor or prostatic tumor * patients confirmed to have a post-void residual volume of ≥ 100 ml or with a clinically significant lower urinary tract obstructive disease * patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period * patients with an indwelling catheter or practicing intermittent self-catheterization * patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia * patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period * patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or \< 50 bpm * patients with polyuria exceeding 3000 ml in mean daily urine volume * patients meeting any of the following in the examinations * patients with abnormal electrocardiogram judged inappropriate as subjects by the ecg evaluation committee * patients with ast (got) or alt (gpt) 2.5 times higher than the upper limit of the normal range (or 100 iu/l) * patients with a blood creatinine level ≥ 2.0 mg/dl

Keywords: urge incontinence ym178 overactive bladder urgency urinary incontinence mirabegron micturition
radiation therapy and cetuximab in treating patients with recurrent head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. some block the ability of tumor cells to grow and spread. others find tumor cells and help kill them or carry tumor-killing substances to them. giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells. purpose: this clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

objectives: primary * to assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck. secondary * to assess the feasibility of delivering this regimen in these patients. * to assess the impact of this regimen on local control, distant control, and overall survival of these patients. outline: patients receive cetuximab iv over 60-120 minutes once weekly in weeks 1-5. patients undergo 1 fraction of stereotactic-body radiotherapy (rt) in week 2. at 4 weeks after rt completion, patients may receive additional cetuximab iv combined with a 28-day chemotherapy regimen, per investigator discretion. after completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx * medically or surgically inoperable disease or patient refuses surgery * recurrent disease * previously irradiated disease meeting the following criteria: * prior radiotherapy completed \> 6 months from re-irradiation * prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields * majority of the recurrent tumor volume (\> 50%) received prior radiotherapy dose of 30-75 gy * no distant metastatic disease patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 3 months * negative pregnancy test * fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment * no prior allergic reaction to study drugs prior concurrent therapy: * see disease characteristics * no prior surgical resection of the recurrent primary tumor and/or regional lymphatics

Keywords: recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
ixabepilone in combination with carboplatin in patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase ii dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * age ≥20 years * histologic or cytologic diagnosis of advanced non-small cell lung cancer (nsclc) * advanced nsclc, defined as stage iiib (without indications for radiotherapy), stage iv, or recurrent * no prior chemotherapy-containing regimens for the treatment of nsclc * eastern cooperative oncology group performance status of 0-1 * life expectancy of at least 12 weeks * accessible for treatment and follow up; patients who could be hospitalized for first 15 days of cycle 1 * adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy) exclusion criteria: * women of childbearing potential (wocbp) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug * women pregnant or breast feeding * women with a positive pregnancy test result on enrollment or prior to study drug administration * sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are wocbp * patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases * prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine) * common terminology criteria (ctc) grade 2 or greater neuropathy * psychiatric or other disorders rendering the patient incapable of complying with protocol requirements * any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (patients with a history of malignancy but without evidence of disease for 5 years are eligible) * serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy. * myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months * known history of infection with human immunodeficiency virus * inadequate bone marrow function * inadequate hepatic function * inadequate renal function * known prior severe hypersensitivity reaction (ctc grade 2 or greater) to agents containing cremophor®el * known severe hypersensitivity reaction to agents containing carboplatin and other platinum * prior treatment with an epothilone and/or with platinum * history of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years * on treatment with strong cytochrome p450 3a4 inhibitor * current imprisonment * compulsorily detention for treatment of psychiatric or physical illness
effect of prophylactic and therapeutic anticoagulants in egyptian patients with covid-19

Conditions: Covid19; Corona Virus Infection; Hypercoagulability

Summary: since the end of 2019, egypt and the whole world have been suffering from the coronavirus disease 2019 (covid-19) pandemic, which is caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2). according to the world health organization (who), since the emergence of this new pandemic, there have been more than 97 million confirmed cases of covid-19 patients and two million death globally; around 160 thousand of these cases are in egypt. recent clinical investigations found a high incidence of thrombotic complications in these patients, even with the standard anticoagulant thromboprophylaxis.coronavirus disease 2019 (covid-19) causes a hypercoagulable state. among the pathological sequel of covid-19 infection, is the presence of a micro-thrombi in the pulmonary circulation which was shown in several autopsy studies. this thrombosis is believed to contribute to gas exchange impairment among patients with covid-19 infection. some observational studies have shown anticoagulation benefits with reduced mortality, mainly in patients requiring mechanical ventilation. however, these findings remain uncertain and need to be validated in further studies. this study is performed to evaluate whether therapeutic anticoagulation could improve covid-19 patients' clinical outcomes compared to prophylactic anticoagulation in terms of improving gas exchange, reducing the need to maintain mechanical ventilation, shortening hospital admission period and mortality rate as well as recovering d-dimmer levels to its normal values.


Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years.. 2. covid-19 hospitalized patients with pneumonia proved by chest x-ray or ct scan. 3. confirmed infection with covid-19 virus using rt-pcr or strongly suspected to be infected with pending confirmation studies. 4. prothrombin time/international normalized ratio (inr)\<1.5; activated partial thromboplastin time (aptt)/ratio\<1.5, and platelet count greater than 100,000/mm3. exclusion criteria: 1. age greater than 85 years-old 2. creatinine clearance (crcl)\<10ml/min. 3. severe circulatory shock with a dose of norepinephrine higher than 1.0 μg/kg/min. 4. pregnant women. 5. recent major surgery or severe trauma in the last 3 weeks or recent hemorrhagic stroke in the last 3 months. 6. active bleeding, blood dyscrasia such as hemophilia and von willebrand factor deficiency.

Keywords: covid-19 hypercoagulability anticoagulants
dynamics of muscle mitochondria in type 2 diabetes (dynammo t2d)

Conditions: Insulin Resistance

Summary: insulin promotes the clearance of sugars from the blood into skeletal muscle and fat cells for use as energy; it also promotes storage of excess nutrients as fat. type 2 diabetes occurs when the cells of the body become resistant to the effects of insulin, and this causes high blood sugar and contributes to a build-up of fat in muscle, pancreas, liver, and the heart. understanding how insulin resistance occurs will pave the way for new therapies aimed at preventing and treating type 2 diabetes. mitochondria are cellular structures that are responsible for turning nutrients from food, into the energy that our cells run on. as a result, mitochondria are known as "the powerhouse of the cell." mitochondria are dynamic organelles that can move within a cell to the areas where they are needed, and can fuse together to form large, string-like, tubular networks or divide into small spherical structures. the name of this process is "mitochondrial dynamics" and the process keeps the cells healthy. however, when more food is consumed compared to the amount of energy burned, mitochondria may become overloaded and dysfunctional resulting in a leak of partially metabolized nutrients that can interfere with the ability of insulin to communicate within the cell. this may be a way for the cells to prevent further uptake of nutrients until the current supply has been exhausted. however, long term overload of the mitochondria may cause blood sugar levels to rise and lead to the development of type 2 diabetes. this study will provide information about the relationship between mitochondrial dynamics, insulin resistance and type 2 diabetes.

the traditional view of mitochondria as isolated, spherical, energy producing organelles is undergoing a revolutionary transformation. emerging data show that mitochondria form a dynamic networked reticulum that is regulated by cycles of fission and fusion. the discovery of a number of proteins that regulate these activities has led to important advances in understanding human disease. data show that activation of dynamin related protein 1 (drp1), a protein that controls mitochondrial fission, is reduced following exercise in prediabetes, and the decrease is linked to increased insulin sensitivity and fat oxidation. the proposed research will test the hypothesis that mitochondrial dynamics is a key mechanism of insulin resistance in type 2 diabetes. translational first-in-man studies will use an acute lipid challenge to investigate the physiological significance of altered skeletal muscle mitochondrial dynamics on insulin sensitivity in humans. the experimental approach harnesses innovative molecular and cellular tools, interfaced with physiologically significant human studies to obtain meaningful data on insulin resistance, and has the potential to generate insights that will lead to new diabetes therapies for future generations.

Eligibility criteria:
inclusion criteria: * healthy * sedentary * normal glucose tolerance * bmi \<25 kg/m2

Keywords: mitochondrial dynamics insulin resistance
safety and efficacy of libigel® for treatment of hypoactive sexual desire disorder in surgically menopausal women

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of libigel 300mcg in the treatment of hsdd in surgically menopausal women.


Eligibility criteria:
inclusion criteria: * must be between the ages of 30 to 65 years * must have undergone hysterectomy and bilateral salpingo-oophorectomy exclusion criteria: * a history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation * any systemic skin diseases or local skin abnormalities in the area of application * diagnosed with another primary female sexual dysfunction (e.g., sexual aversion disorder, female sexual arousal disorder). * a medical condition that could affect or interfere with sexual function * using a systemic transdermal gel or cream estrogen therapy.

Keywords: testosterone hypoactive sexual desire disorder menopause
evaluation of electrocardiographic measurements by high density electrode ecg

Conditions: Ventricular Arrhythmias

Summary: cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ecg 12). a limitation of the current ecg technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. more extensive sampling of the body surface may contribute to additional clinical information. the present study investigates the additional sensitivity of ecg using 128 body surface leads (high density (hd) ecg) in measuring global or regional cardiac activity.


Eligibility criteria:
inclusion criteria: * patient managed at the bordeaux university hospital for assessment of documented severe ventricular arrhythmia (vf, sudden resuscitated death) or suspected (syncope, family history of sudden death, ecg or holter abnormality) or impaired ventricular conduction, or * patients managed for prophylactic ventricular defibrillator implantation, according to international recommendations: heart disease with ejection fraction \< 35%, heart disease with sustained ventricular tachycardia, cardiomyopathies with high rhythmic risk, * women of childbearing age with effective contraception. exclusion criteria: * patients under 14 years old, * pregnant or nursing woman.

Keywords: signal averaging ecg cardiac electrophysiology
dead space and inhaled nitric oxide in pediatric acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: the goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[avdsf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (avdsf) is an important marker of heterogeneity in the inhaled nitric oxide (ino) treatment effect for children with acute respiratory distress syndrome (ards). the study aims are: 1. to validate avdsf for risk stratification of mortality in pediatric ards 2. to determine if there is heterogeneity in treatment effect for ino defined by avdsf 3. to detect the association between avdsf and microvascular dysfunction trajectory and whether ino therapy modifies this association this is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ards. in a subgroup of 450 children with severe ards, longitudinal blood samples will be obtained to measure plasma protein markers.


Eligibility criteria:
inclusion criteria: * age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent. * within 72 hours of the start of invasive mechanical ventilation and meet the criteria for pediatric ards (new infiltrate on chest imaging and a known ards risk factor within 7 days of the onset of hypoxemia) and either meet criteria for moderate or severe pediatric ards between 4-72 hours of imv (oi ≥ 8 or osi ≥ 7.5) or have an oi ≥ 20 or an osi ≥ 14 x 15 minutes between 0-4 hours of imv. * subgroup of children eligible for longituduinal blood collection: children with severe pards (oi ≥ 16 or an osi ≥ 12 between 4-72 hours of imv) or those with an oi ≥ 20 or an osi ≥ 14 for 15 minutes between 0-4 hours of imv will be eligible for collection of longitudinal plasma samples. exclusion criteria: * non-conventional invasive mechanical ventilation (i.e. high frequency oscillatory ventilation, airway pressure release ventilation) at the time of icu admission * ecmo or ino (or other inhaled pulmonary vasodilator therapy) at the time of icu admission * significant lower airways obstruction (examination of ventilator and capnography waveforms by site study or medical team) * air leak \>20% (endotracheal tube, tracheostomy tube, or thoracostomy tube) * home invasive mechanical ventilation * cyanotic congenital heart disease * previous enrollment in the dino study * do not resuscitate order at the time of pediatric ards diagnosis. * blood gas not obtained prior to initiation of ecmo, ino, or non-conventional ventilation.

Keywords: pediatrics mechanical ventilation inhaled nitric oxide
low friction bed sheet

Conditions: Spinal Cord Injury; Pressure Ulcer

Summary: introduction: it is known that people with spinal cord injury (sci) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. it was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with sci. method: prospective, randomised crossover study. patients with a subacute spinal cord injury will be recruited. each patient spends five consecutive nights on the new, respectively, conventional bed sheet. after the five nights, patients are asked to complete a linear questionnaire (vas) concerning well-being, odour, perspiration and wrinkling. in addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.


Eligibility criteria:
inclusion criteria: * sci patients without a presser ulcer for the last 2 months * paraplegic and tetraplegic patients * complete and incomplete lesion (ais a, ais b, ais c, ais d) * caused by illness or traumatic event * smoker and non-smoker exclusion criteria: * progressive disease * severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
colectomy reconstruction for ulcerative colitis, ileorectal anastomosis vs ileal pouch-anal anastomosis in ulcerative colitis.

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Ileostomy - Stoma

Summary: background there are no prospective trials comparing the two main reconstructive options after colectomy for ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. an attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves. methods adult ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. patients not declining reconstruction or not considered eligible for both methods will be followed as controls. the cruise study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, qol, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis. discussion reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, quality of life and patient satisfaction. the aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis (uc) aged between 18 and 60 * scheduled for or have previously undergone subtotal colectomy and ileostomy. * patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical mezalasin only. exclusion criteria * rectal inflammation of mayo score \>1 * poor sphincter function, perianal disease * uncertainty regarding uc diagnosis p * previous colorectal cancer or severe dysplasia * primary sclerosing colitis diagnosis * \>2 year since subtotal colectomy

Keywords: ulcerative colitis, colectomy reconstruction