Kornimate/medical-research-clean huggingface dataset:
paclitaxel in treating patients with extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.

objectives: i. determine the complete and overall response rate to paclitaxel in patients with previously untreated extensive stage small cell lung cancer. ii. determine the overall and progression free survival of these patients in response to this treatment regimen. iii. determine the toxicity of this treatment regimen in this patient population. outline: this is a multicenter study. patients receive paclitaxel iv over 3 hours weekly for 6 consecutive weeks. treatment continues every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 2 months for 1 year, then every 3 months for 2 years, and then annually for 2 years.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed extensive stage small cell carcinoma of the bronchus extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy measurable disease one lesion that measures at least 20 mm in diameter using conventional techniques or at least 10 mm with spiral ct scan lesions not considered measurable include: bone lesions leptomeningeal disease ascites pleural/pericardial effusion cystic lesions tumor lesions situated in a previously irradiated area abdominal masses not confirmed and followed by imaging techniques no disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes patient characteristics: age: 18 and over performance status: ctc 0-2 life expectancy: not specified hematopoietic: granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: sgot less than 2 times upper limit of normal bilirubin less than 1.5 mg/dl renal: not specified other: not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: no concurrent hormonal therapy except steroids for renal failure or hormones administered for nondisease related conditions radiotherapy: at least two weeks since prior radiotherapy no concurrent palliative radiotherapy surgery: not specified

Keywords: extensive stage small cell lung cancer
dose response study of inhaled ciclesonide (glucocorticosteroid) to patients with persistent asthma

Conditions: Asthma

Summary: to investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler


Eligibility criteria:
inclusion criteria: * males or females 12 years or older; history of persistent bronchial asthma for at least 6 months; documented use of an inhaled steroid for at least 1 month before screening; at screening, fev1 40% or more of predicted normal and at randomization, fev1 between 40 and 80% predicted normal; reversibility of fev1 by at least 12% and 200 ml post-bronchodilator; be able to use oral inhalers; non-smokers exclusion criteria: * history of life-threatening asthma; other pulmonary diseases; uri within 4 weeks before screening; use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months; beta-adrenergic blocking agent use; more than 2 in-patient hospitalizations or er visits due to asthma exacerbations in the prior year before screening; pregnant or breast-feeding females; females of child-bearing potential not using adequate means of birth control; clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease; abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results; history of drug or alcohol abuse; treatment with any investigational product within 30 days prior to study entry

Keywords: glucocorticosteroid; dose response; bronchospasm
immediate effect of one-session mrt in hemiparetics

Conditions: Hemiparesis;Poststroke/CVA; Satisfaction, Patient

Summary: immediate effect of one-session matrix rhythm therapy on the functional status and treatment satisfaction of hemiparetic patients will be investigated.


Eligibility criteria:
inclusion criteria: * to have single-sided hemiparesis for the first time, * to have hemiparesis at least four weeks earlier, * to have modified rankin score of ≤3 exclusion criteria: * to use a cardiac pacemaker, * to have communication problems, * to have other neurological, psychiatric and/or orthopedic problems other than hemiparesis.
safety and efficacy of buprenorphine transdermal system in subjects with moderate to severe osteoarthritis of hip or knee

Conditions: Osteoarthritis

Summary: the objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (btds) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. the double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer. * an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment. exclusion criteria: * ingest opioid analgesics on a daily basis. * ingest \>2500 milligrams (mg) acetaminophen on a daily basis. * require \ 80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: chronic pain opioid transdermal osteoarthritis
remifentanil for smooth emergence in elderly patients

Conditions: Drug Usage

Summary: elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anaesthetic drugs than younger patients. the purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing cough during emergence in elderly patients under sevoflurane and remifentanil anesthesia.


Eligibility criteria:
inclusion criteria: * asa physical status i or ii undergoing endoscopic sinus surgery or septoplasty under balanced anesthesia with sevoflurane and remifentanil exclusion criteria: * predicted difficult airway, body mass index \> 30 kg/m2, history of obstructive sleep apnoea chronic respiratory disease or coughing, current smokers patients angiotensin converting enzyme-inhibitors

Keywords: tracheal extubation remifentanil
consolidation serplulimab following concurrent chemoradiotherapy for ls-sclc patients

Conditions: Limited Stage Small Cell Lung Cancer

Summary: this study is a multi-center, single-arm phase ii study to evaluate the clinical efficacy and safety of consolidation hlx10 (serplulimab) following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small cell lung cancer

all eligible patients after screening will receive up to four cycles chemotherapy. recommended regimens are etoposide 100 mg/m2 intravenously on day 1-3 in combination with cisplatin 75 mg/m2 intravenously on day 1 or carboplatin auc=5 every 3 weeks. a total of 45gy in 15 fractions over 3 weeks will be delivered. pci is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25gy in 10 fractions over 2 weeks to the brain will be prescribed. intensity modulated radiation therapy (imrt) or volumetric modulated arc therapy (vmat) technique are required. patients without disease progression will receive an intravenous infusion of serplulimab 300mg every 3 weeks. treatment of serplulimab should be continued until disease progression, intolerable toxicity, withdrawal of consent, or to a maximum of 1 year. continuation of immunotherapy after disease progression is acceptable per investigators' discretion. the investigator and irrc respectively assess the tumor images according to recist 1.1.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years; ecog score 0-1. 2. histologically or cytologically confirmed small cell lung cancer. 3. limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on pet-ct considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest ct is less than 1 cm; (stage i-iiib without intrapulmonary metastasis in the 7th edition of ajcc staging in 2009) . 4. no other previous anti-tumor history, at least 3 months of expected survival. 5. no serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. exclusion criteria: 1. histologically or cytologically confirmed mixed sclc. 2. subjects suitable for surgery. subjects who are suitable for surgery but refuse surgical treatment can be included. 3. patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy. 4. patients with other active malignancies within 5 years or at the same time. 5. subjects with known history of severe allergy to any monoclonal antibody. 6. subjects with known anaphylaxis to carboplatin/cisplatin or etoposide. 7. in the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
the development of quantitative ultrasound imaging software platform

Conditions: Chronic Liver Disease; Thyroid Disease; Benign Breast Disease; Malignant Breast Neoplasm; Acute Myocardial Infarction

Summary: the goal of this observational study is to compare the image differences between conventional ultrasound and artificial intelligence-based ultrasound software in conscious adults. the main question it aims to answer is to evaluate the effectiveness by determining that the new image analysis method is considered valid if it helps to identify more than 30% of histological characteristics. participants will undergo the examination using the two methods mentioned earlier after signing the consent form.


Eligibility criteria:
inclusion criteria: * people with heart disease, thyroid disease, breast disease, and liver disease. exclusion criteria: * someone who has received surgery on the target organ in question.
comparison of two formulations of azd5363 and the effect of food on pharmacokinetic exposure, safety and tolerability

Conditions: Advanced Solid Malignancy,; Safety and Tolerability,; Pharmacokinetics, Pharmacodynamics,; Tumour Response,

Summary: comparison of two formulations of azd5363 and the effect of food on pharmacokinetic exposure, safety and tolerability

this study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, azd5363, in patients with advanced cancer . this study will investigate how the body handles azd5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on azd5363 tablet formulation.

Eligibility criteria:
inclusion criteria: - * aged at least 18 years * the presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist * the presence of at least one lesion that can be accurately assessed at baseline by computerised tomography (ct), magnetic resonance imaging (mri) or plain x-ray and is suitable for repeated assessment * estimated life expectancy of more than 12 weeks exclusion criteria: - * clinically significant abnormalities of glucose metabolism * spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids) * evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and human immunodeficiency virus (hiv) * evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures * a bad reaction to azd5363 or any drugs similar to it in structure or class

Keywords: advanced solid malignancy, azd5363, food effect, formulation comparison
triage score vs quick-sofa score in septic patients in the emergency department

Conditions: Sepsis; Emergencies

Summary: sepsis represents by its frequency, its morbidity and mortality and its cost to society a major public health issue with a constantly increasing incidence. it affects millions of people around the world each year and is the 2nd leading cause of death in intensive care units. the incidence of sepsis has been estimated by the world health organization (who), based on us data, at 15 to 19 million cases of sepsis per year worldwide.

this is a descriptive, mono-center study aimed at comparing a local triage score with that of qsofa in patients presenting to the sahloul emergency department with sepsis. a local triage score was calculated for each patient consulting the emergency room; this score makes it possible to classify patients according to severity and to predict the time to treatment. a form is completed prospectively for each patient admitted to the observation unit whose diagnosis of sepsis is confirmed and validated by a senior during the morning staff. the validated data were included in the ressus register (sepsis register of the sahloul emergency department). this is an observational database on the management of sepsis admitted to the emergency department in sahloul. it ensures a high level of confidentiality and protection of medical data. subsequent follow-up of patients was done by telephone contact to verify mortality at one month and one year.

Eligibility criteria:
inclusion criteria: * age \>18 years old * each patient diagnosed as an acute sepsi consulting the emergencies of chu sahloul, sousse exclusion criteria: * no exclusion

Keywords: sepsis severity prognosis triage mortalty
impact on management of the heart risk score in chest pain patients

Conditions: Chest Pain

Summary: aim of this study is to quantify the impact of the use of the heart risk score on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to not using the score.

during 14 months, patients presenting with chest pain to the emergency department (ed) of participating hospitals will be included in the study. first, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the heart score. then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the heart score in all chest pain patients (intervention period); during this intervention period patients with a heart score 0-3 will not be admitted to the hospital (in accordance with the results of our validation studies), and patients with a heart score above 3 will be treated according to current guidelines.

Eligibility criteria:
inclusion criteria: * all patients presenting with chest pain to the (cardiac) ed of ten participating dutch hospitals, older than 18 years. exclusion criteria: * children (age \<18 years) are excluded from study participation. subjects who are (for whatever reason) not able to fill in questionnaires are excluded from study participation. legal incapacity of every patient will be assessed by the attending doctor, according to the guidelines of legal incapacity. in case of doubt, consultation of the cardiologist (primary local investigator) will be possible.

Keywords: heart score risk score impact chest pain
study of gemcitabine plus ag-013736 versus gemcitabine for advanced pancreatic cancer.

Conditions: Carcinoma, Pancreatic Ductal

Summary: the purpose of this study is to determine whether investigational study drug, ag-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

this study was prematurely discontinued for futility on 23 january 2009, based on a planned interim analysis by an independent data safety monitoring board (dsmb) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. enrollment on this study has been discontinued.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. * adequate renal, hepatic and bone marrow function. * performance status 0 or 1. exclusion criteria: * prior treatment with any systemic chemotherapy for metastatic disease. * prior treatment with gemcitabine, ag-013736, or other vascular endothelial growth factor inhibitors. * current or recent bleeding, thromboembolic event and or use of a thrombolytic agent. * inability to take oral medication.

Keywords: randomized study of gemcitabine plus ag-013736 versus gemcitabine plus placebo for advanced pancreatic cancer.
application of the icf core set in stroke patients

Conditions: Stroke; Paralysis

Summary: sixty patients with stroke were applied a-24-item icf core set for stroke, standardized mini-mental state examination(smmse), stroke impact scale version(sis), rivermead mobility index(rmi) and home safety checklist(hscl). spearman and pearson correlation analysis was used to show the relation between the items of the scales and the icf core set for stroke items.

fourty men and twenty women stroke patients were included in this study.the demographics and clinical information of the participants were recorded. a physiotherapist created an icf core set for stroke for the study. the icf core set for stroke was used to show the significant relationship with standardized mini-mental state examination, stroke impact scale version 3.0, and rivermead mobility index. the duration of the assessment varied between 1 hour and 1.5 hours depending on the participant.

Eligibility criteria:
inclusion criteria: * being between the ages of 25-80, * having a single stroke, * not having any other condition affecting the evaluation such as aphasia, consciousness disorders, or other neurological diseases. exclusion criteria: * . stroke patients who did not complete the evaluations.
group therapy for postpartum depression

Conditions: Depression, Postpartum

Summary: this study will compare standard individual treatment to group therapy for the treatment of postpartum depression.

ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (ppd). this condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted. patients are randomly assigned to either relational group treatment or to standard individual treatment. assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.

Eligibility criteria:
inclusion criteria: * major depression with an infant under 7 months of age exclusion criteria: * bipolar disorder * schizophrenia * organic brain syndrome * antisocial personality disorder * current psychosis or mania * lifetime history of mental retardation * current alcohol or substance abuse * cognitive disability * infants born more than 6 weeks premature or with major medical conditions or developmental disabilities
study to assess the effect of food on combination dapagliflozin/metformin tablet in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.


Eligibility criteria:
inclusion criteria: * healthy * bmi 18-30 kg/m2 exclusion criteria: * history of clinically significant illness. * history of alcohol or drug abuse

Keywords: healthy volunteers dapagliflozin diabetes type 2 food interaction
retrospective observational study to define hbsag loss with or without seroconversion to antihbs in patients with chronic hepatitis by b virus treated with nucleoside/nucleotide analogs

Conditions: Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

Summary: define the patients who lost hbsag, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that


Eligibility criteria:
inclusion criteria: * \>18 years old * chronic hepatitis b (hbeag+ or hbeag-) * hbsag loss * treated with nucleoside/nucleotide analogues * with or without previous interferon (ifn/peg-ifn) * patients with hbsag loss after 2006 * immunocompetent patients exclusion criteria: * spontaneous hbsag loss * hbsag loss while treatment in monotherapy or combinated with ifn or peg-ifn. * patients with hepatitis delta virus (hdv) coinfection. * patients with hepatitis c virus (hcv) coinfection. * patients with hiv coinfection. * patients with liver transplant. * patients with reactivated hepatitis b virus (hbv) by immuno-suppressive treatment.

Keywords: hepatitis b nucleoside/nucleotide hbsag loss