Kornimate/medical-research-clean huggingface dataset:
the effect of duloxetine on mood, quality of life and cognitive functioning in glioblastoma patients

Conditions: Depression

Summary: primary tumor glioblastoma is the most common malignant brain. standard treatment includes biopsy or excision of the tumor in order to obtain a pathological diagnosis, and tumor mass reduction. after the surgery patients are treated with radiation and temodal. the most common psychiatric symptom in this patient population is depression, valued at up to approximately 50% in patients with glioma . depression not only adversely affects the quality of life of patients but also impairs the ability and cognitive function due to the complex clinical course of patients with glioblastoma. there is a tendency to give diagnosis of depression in this patient population, due to a lack of awareness, knowledge and literature on the subject. this study was designed to prospectively randomized, controlled, double-blind study. this method of recruitment - patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research.

this study was designed to prospectively randomized, controlled, double-blind study.this method of recruitment patients who undergo resection or biopsy of glioblastoma (newly diagnosed glioblastoma), immediately after diagnosis, patients will receive an explanation about the study and sign a consent form will enter research. patients who underwent resection or biopsy of glioblastoma (newly diagnosed glioblastoma), will randomization ratio of 1: 1 by the pharmacist (by age, karnofsky score, the degree of tumor resection) two research groups: group # 1: consisting of 50 patients who will be treated immediately after diagnosis, 30 mg cymbalta morning for a week and then a dose exceeding 60 mg for 3 months. group # 2: will include 50 patients treated immediately after diagnosis placebo for 3 months.

Eligibility criteria:
inclusion criteria: * patients who signed an informed consent form * patients who underwent resection or biopsy for gbm * kps\> 70 exclusion criteria: * patients being treated with antidepressants * unable to answer the questionnaires because of an inability to communicate * patients being treated; monoamine oxidase inhibitors (maoi) cyp1a2 inhibitors or (cyp2d6 inhibitors (ssris such as fluoxetine, paroxetine, or anti-arrhythmia such as quinidine) patients with glaucoma, narrow angle * severe renal dysfunction. according to laboratory criteria specified earlier. * hepatic insufficiency - which laboratory criteria mentioned earlier. * pregnant women patients dementia * patients who previously suffered from depression in the past or within 5 years of diagnosis, and currently do not receive drug therapy * sensitivity to any of its ingredients

Keywords: depression glioblastoma
effects of ketamine on precipitated opioid withdrawal under general anaesthesia

Conditions: Opiate Dependence

Summary: the purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (rai).


Eligibility criteria:
inclusion criteria: * diagnosed opiate dependence according to icd 10 and/or dsm 4; * duration of substance abuse more than 1 year * no or minor co-morbidities; * grade i-ii according to physical status classification system of american society of anesthesiologists. exclusion criteria: * current history of long acting opiate or poly-substance abuse; * acute medical or surgical condition; * pregnancy; * breastfeeding.
a study of trifluridine/tipiracil (also known as s 95005 or tas-102) in patients with a pretreated colorectal cancer that has spread (metastatic).

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mcrc). eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or sponsor decision.


Eligibility criteria:
inclusion criteria: * male or female participant aged ≥18 years old. * has definitive histologically confirmed adenocarcinoma of the colon or rectum. * has metastatic lesion(s). * has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-vegf monoclonal antibody and at least one of the anti-egfr monoclonal antibodies for ras wild-type patients) for mcrc and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies. * has eastern cooperative oncology group (ecog) performance status of 0 or 1 during the screening period. * is able to take medications orally (i.e., no feeding tube). * has adequate organ function. * women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. women and female partners using hormonal contraceptive must also use a barrier method. exclusion criteria: * pregnancy, breastfeeding or possibility of becoming pregnant during the study. * eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil. * has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil. * has rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption. * has certain serious illness or medical condition(s) described in the protocol. * has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration. * has unresolved toxicity of greater than or equal to common terminology criteria for adverse events (ctcae) grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

Keywords: metastatic colorectal cancer trifluridine/tipiracil early access
ambulatory blood pressure reduction after rosiglitazone treatment in normotensive type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure-reducing effects.

the first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks' treatment. another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm hg decline in office blood pressure after 8 weeks of treatment.

Eligibility criteria:
inclusion criteria: * blood pressure of patients were in normotensive limits according to the jnc vii * diabetes mellitus treated with oral antidiabetics or diet exclusion criteria: * any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease * anti-hypertensive treatment

Keywords: blood pressure, rosiglitazone,diabetes mellitus, type 2,
evaluation of articaine 4% versus mepivacaine 2% for surgery of molars thirds: clinical trial.

Conditions: Pain; Teeth, Impacted

Summary: the extraction of third molars, a frequent treatment in clinical dental practice, can lead patients to painful symptoms during and after surgery. the dental surgeon must correctly indicate the need for extraction and also provide patients who need this treatment greater comfort and control of pain in the trans and postoperative period. thus, it is necessary to use an effective local anesthetic favoring the factors inherent to the postoperative and achieving good treatment results.

this study will compare the use of articaine at 4% to that of mepivacaine at 2% for lower third molar surgeries semi-included and / or included. i will select 16 patients who require surgical treatment for extraction of third molars, aged between 16 and 40 years at the são paulo state university. these will participate simultaneously in the two groups: group 1 mepivacaine (mep) and group 2 articaine (art), and the division will be performed by randomization, so that each patient will have each side (right or left) allocated in different groups. the primary evaluation variable will be to compare the pain index in the immediate postoperative period, using visual analog scale (vas), and will also analyze hemodynamic parameters, such as patient and operator satisfaction. the results will be submitted to qualitative and quantitative statistical analysis. the descriptive data will be compared using the statistical analysis of variance (anova) and tukey test with a significance level of 5%.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification -(asa i) patients; * patients with need for extraction of lower third molars included and / or semi-included; * teeth in opposing hemiarch with the same classifications as pell and gregory and winter; * age between 16 and 40 years; * patients who agree to voluntarily participate in the survey. exclusion criteria: * history of allergic reactions (hypersensitivity) to anesthetics; * patients presenting with local or systemic alterations that contraindicate the procedure; * current use of drugs that may interfere with the action of anesthetics; * need for sedatives or anxiolytic drugs during extraction; * pregnancy or breastfeeding; * third erupted lower third molars.

Keywords: pain third molar articaine mepivacaine
natalizumab in combination with glatiramer acetate (ga) in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine if natalizumab in combination with glatiramer acetate (ga) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting multiple sclerosis (ms).


Eligibility criteria:
inclusion criteria: * diagnosis of ms as defined by mcdonald et al., criteria # 1-4 * between the ages of 18 and 55, inclusive * baseline edss score between 0.0 and 5.0, inclusive * have been treated with ga for at least the 12 months prior to randomization exclusion criteria: * primary progressive, secondary progressive or progressive relapsing ms * ms relapse has occurred within the 50 days prior to randomization * a clinically significant infectious illness * history of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or ga for 20 weeks.

Keywords: multiple sclerosis ms
fear of activity and functional capacity in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: to identify whether coronary artery disease (cad) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in cad patients.

cardiac rehabilitation (cr) is a well-known way of secondary prevention in heart diseases. cr is shown to be effective in reducing cardiovascular morbidity and mortality. cr also enhances exercise capacity and quality of life, promotes healthy and active lifestyle and reduces psychosocial stress and depressive symptoms in coronary artery disease (cad). exercise is one of the most important component of cr. the positive prognostic effect of the exercise on cardiovascular disease is mediated by mechanisms such as reducing numerous risk factors, enhancing endothelial function, declining arterial inflammation and stiffness, improving diastolic function, remodeling of left ventricle, and stabilization of electrical activity. each 1 met increase in functional capacity is known to improve survival by 12 %. exercise capacity is a more powerful predictor of mortality among men than other established risk factors for cardiovascular disease. the prevalence of fear of activity in cad, heart failure and female patients have been studied by several researchers reporting variable results. it ranges from 70% in acute hospitalized cad patients to 20% in chronic patients in community. muscle endurance, steps per day measured by pedometer, ipaq were found to be lower in patients with high level of fear of activity.they did not measure exercise capacity objectively. research investigating the effect of fear of activity on exercise capacity in patients with cad is lacking. the aim of this study is to identify whether coronary artery disease (cad) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in cad patients. the hypothesis of this study were that cad patients would have lower exercise capacity than healthy subjects and cad patients with higher fear of activity would have lower exercise capacity.

Eligibility criteria:
inclusion criteria: * age \> 18 years * history of diagnosis of cad and/or cardiac event in the past 1-60 months * being medically stable * cognitive and physical ability to complete the required tests. exclusion criteria: * patients with recent cardiac event sooner than 1 month * musculoskeletal/neurologic problems imparing ambulation or current hospitalization
immune score based radiomics in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: in nasopharyngeal carcinoma (npc), tumor, node and metastasis (tnm) staging system is the main tool for determining treatment strategy and assessment of prognosis. however, the prognoses of patients with the same tnm stage after similar treatment vary widely. the aim of this study is to establish an immune score based radiomic staging system for npc.


Eligibility criteria:
inclusion criteria: patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma. ecog performance status: 0-1 with normal liver function test (alt, ast ≤2.5uln) renal: creatinine clearance ≥60ml/min without hematopathy,marrow: wbc \>4\*109/l, hgb\>90g/l, and plt\>100\*109/l. written informed consent exclusion criteria: contraindications for mri scan prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended rt treatment volume) patient is pregnant or lactating any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), or emotional disturbance.
intravitreal injections of melphalan for retinoblastoma

Conditions: Retinoblastoma

Summary: retinoblastoma treatment has become more and more focused in the last years. new treatments developed by dr. kaneko from japan in 1995 are now being tested in clinical trials. intra-arterial chemotherapy with melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. for these cases intravitreal injections of melphalan have been successful in japan. in this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

intravitreal injections of melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.

Eligibility criteria:
inclusion criteria: * retinoblastoma that has not responded to chemotherapy * retinoblastoma that has vitreal seeding exclusion criteria: * previous failure of ivit melphalan

Keywords: retinoblastoma
an efficacy and safety evaluation of tiotropium add-on therapy in patients with severe persistent asthma

Conditions: Asthma

Summary: the primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to gina step 4 classification


Eligibility criteria:
inclusion criteria: outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (gina step 4), smoking history \ = 1 year smoking cessation; patients must be symptomatic exclusion criteria: patients * with a recent history (i.e., six months or less) of myocardial infarction, * who have been hospitalized for heart failure (nyha class iii or iv) within the past year, * with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, * with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years, * who have undergone thoracotomy with pulmonary resection, * with moderate to severe renal impairment (creatinine clearance = 50 ml/min)
modified intubation-surfactant-extubation (insure) technique in preterm neonates with respiratory distress syndrome

Conditions: Respiratory Distress Syndrome of Newborn

Summary: this study evaluates the less invasive surfactant administration (lisa) combined with synchronized nasal intermittent positive pressure ventilation (snippv) technique in the treatment of respiratory distress syndrome (rds) of preterm neonates. the modified insure group will receive "lisa + snippv" technique, while the traditional insure group will receive the intubation, surfactant, extubation and cpap technique.


Eligibility criteria:
inclusion criteria: 1. premature infants with birth weight \< 2500g and gestational age \< 36+6 weeks; 2. high-risk premature infants with early symptoms of rds or infants who are diagnosed clinically rds. 3. the participating hospital obtained the consent of the ethics committee. 4. parental informed consents were obtained. exclusion criteria: 1. severe congenital malformations. 2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of fallot, etc.) which affects systemic hemodynamics. 3. congenital hereditary metabolic diseases. 4. parental informed consent was not obtained.

Keywords: insure lisa snippv
source profiling of biohazardous aerosols in hospitals

Conditions: Respiratory Tract Infections

Summary: to characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.


Eligibility criteria:
inclusion criteria: 1. adult patients (\>18 years old) that can give valid consent 2. urti: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. amongst these, cough should be a major complaint. 3. lrti (cap): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the cxr. (bts 1993). exclusion criteria: 1. pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections) 2. patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally. 3. patients with tocc associations with infections such avian flu or sars (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or npa revealed positivity of influenza a/b 4. patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of \>2l/min, any types of shock, etc. 5. underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)

Keywords: healthy subjects lower respiratory tract infections upper respiratory tract infections
multiple ascending dose study of spc5001 in treatment of healthy subjects and subjects with fh

Conditions: Hypercholesterolemia

Summary: the purpose is to study safety and tolerability.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects and subjects with heterozygous familial hypercholesterolemia * healthy male or female subjects, age 18 to 65 years, inclusive will be enrolled in cohorts 1 through 4. * in cohort 5, male or female subjects with heterozygous familial hypercholesterolemia, confirmed through genetic testing, without a history of cardiovascular disease (e.g. coronary artery, peripheral artery or cerebrovascular disease), hypertension or diabetes mellitus age 18-45 years, inclusive, will be enrolled. 2. bmi of 18-33 kg/m2 3. screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met: * ldl ≥.3.24 mmol/l (≥ 100 mg/dl) * triglycerides (fasted) \< 4.5 mmol/l (\< 398 mg/dl) * alt within normal limits for healthy subjects and alt \< 2 x uln for fh subjects exclusion criteria: 1. any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential - history or presence of malignancy within the past year is an exclusion criterion. subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. 2. active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection 3. use of prescription medication within 14 days prior to the planned first drug administration and throughout the study. for the fh subjects statin therapy (and other lipid lowering therapies) will be prohibited within 4 weeks prior to the first study drug administration. 4. use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. this includes all vitamins, herbal supplements, or remedies. an exception can be made for medication or supplements that in the opinion of both the investigator and the sponsor do not complicate or compromise the study or interfere with the study objectives. 5. positive results on the following screening laboratory tests: urine or serum pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis b surface antigen, hepatitis c antibody, and human immunodeficiency virus (hiv) antibody.

Keywords: hypercholesterolemia hyperlipidemia ldl hdl pcsk9 lna-oligonucleotide