Kornimate/medical-research-clean huggingface dataset:
effects of armodafinil on cognition for patients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. subjects will be randomized to take armodafinil (nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. changes in weight during the six week study will also be tracked.


Eligibility criteria:
inclusion criteria * men and women age 18-65 years * patients with dsm-iv defined schizophrenia or schizoaffective disorder * treated with any atypical antipsychotic for at least 2 months * patients with documented weight gain \> 7% with current antipsychotic medication * able to provide written consent exclusion criteria * women who are pregnant or nursing. female participants must have a negative urine pregnancy test at screening. * dsm-iv defined substance or alcohol dependence within the 2 months preceding the start of the trial * treatment with a monoamine oxidase inhibitor (e.g., tranylcypromine, phenelzine, isocarboxazid) within 2 weeks of starting the trial * patients considered at high risk for suicide or violence * patients with history of or symptoms on systems review consistent with clinically significant and currently relevant hematologic, renal, hepatic, gastrointestinal, endocrine, pulmonary, dermatologic, oncologic or neurologic (including seizures or epilepsy) disease * patients with a history of or symptoms on systems review consistent with significant cardiovascular disease, bypass surgery, or concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure, angina pectoris, or recent (within last 6 months) myocardial infarction * use of any investigational drug within 4 weeks before screening * history of hypersensitivity or other intolerable adverse effects to modafinil * patients who experience severe sleep disturbances from modafinil

Keywords: schizophrenia cognition
efficacy of intravenous dexketoprofen and tenoxicam on propofol associated injection pain

Conditions: Injection Pain

Summary: propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. anesthesia providers have attempted a large number of remedies to prevent this pain on injection. previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. no studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. the investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1 and 2 * 18 - 65 years * general anesthesia scheduled for elective surgery exclusion criteria: * age \ 65 years * pregnancy * patients requiring a rapid sequence induction * refusal to participate and patients already participating in another study * allergy to study drugs * communication difficulty * psychiatric and neurolojic disorders * use of analgesics or sedative drugs within 24 hours before surgery. * emergency surgery * history of drug or alcohol abuse * asa 3 and above
adjusting to chronic conditions using education, support, and skills

Conditions: Chronic Obstructive Pulmonary Disease; Heart Failure; Anxiety; Depression

Summary: the current study seeks to test the effectiveness of a talk-therapy intervention designed to better meet the needs of chronically ill veterans. this project looks to recruit 450 veterans with either chronic obstructive pulmonary disease (copd) or heart failure (hf) who also have symptoms of worry, stress, anxiety, or sadness. participants will be randomly put into either the talk-therapy intervention or enhanced usual care. the talk therapy intervention will be provided by va clinicians in the primary care setting and will consist of 6 core meetings (30-45 minutes in duration) and 2 follow-up telephone meetings. enhanced usual care participants will receive feedback regarding the assessment findings and educational materials on copd and/or hf, depression and anxiety.

diseases of the heart and circulatory system, namely, chronic obstructive pulmonary disease (copd) and heart failure (hf), are two of the most common and disabling chronic diseases. both copd and hf account for significant disability, mortality, and healthcare costs and are associated with lower health status and more functional and social limitations than other chronic illnesses, such as hypertension and diabetes. as our population ages and life span increases, the numbers of patients with these conditions and the subsequent healthcare costs will increase dramatically. the symptoms associated with copd and hf can significantly affect daily functioning. physical symptoms are often linked to increased levels of psychological distress, namely, anxiety and depression, which significantly affect quality of life and functioning above and beyond the impact of the medical disease. as depression and anxiety are modifiable clinical factors, there is a potential to significantly alter patient outcomes, as well as use of healthcare services. however, focused interventions are needed, given the high risk for poor mental health treatment and underuse of mental health services in persons with copd and hf. unfortunately, few intervention studies have been conducted in medically ill patients with these conditions. the current project will examine whether existing va clinicians in the primary care setting, with training and support, can effectively administer a structured cognitive behavioral therapy (cbt) intervention for depressed and anxious veterans with copd and hf.

Eligibility criteria:
inclusion criteria: * copd and/or hf diagnosis; confirmation based upon medical chart review. * clinically significant symptoms for anxiety and/or depression. exclusion criteria: * cognitive impairment * presence of bipolar, psychotic or substance abuse disorder.

Keywords: chronic obstructive pulmonary disease heart failure anxiety depression
the effect of music therapy and progressive muscle relaxation exercise on anxiety before the first clinical practice

Conditions: Anxiety; Stress

Summary: this study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.

this randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice. the students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups. the data of the study were collected with student information form and state-trait anxiety scale. the music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.

Eligibility criteria:
inclusion criteria: * being 18 years or older, * being enrolled in the nursing fundamentals theoretical course, * participating fully in the attempts being applied in the study, * volunteering to participate in the study. exclusion criteria: * be graduating from health vocational high school * not being in the field of application determined on the first clinical application day.
hsk7653 metformin add-on study in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the efficacy of hsk7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of hsk7653 in chinese patients with type 2 diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.

the treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). during the double-blind period, participants will receive 10 mg or 25 mg dose of hsk7653, or linagliptin, and with matching placebo respectively. during the open-label period, all participants will receive 25 mg dose of hsk7653. all participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years, male and female patients; * type 2 diabetes mellitus; * insufficient glycaemic control with diet/exercise therapy and metformin agent monotherapy; * did not receive regular long-term medication of oral hypoglycemic drugs (except metformin) or insulin within 1 year prior to informed consent; * hba1c in the range of ≥7.5 to ≤11.0% at screening; * fpg \< 15 mmol/l at screening; * bmi (body mass index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening. exclusion criteria: * diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent; * history of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent; * current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent; * serious gastrointestinal disease within 2 weeks prior to informed consent; * serious infection, trauma, and surgery within 3 months prior to informed consent; * history of treatment with dipeptidyl-peptidase 4 (dpp-4) inhibitor, glucose-dependent insulinotropic polypeptide (gip) or glucagon-like peptide-1 (glp-1) receptor agonist; * treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent; * hemoglobin (hgb) \< 10.0 g/dl(100 g/l); * alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent; * active infectious diseases; * participation in another trial with an investigational drug or instrument within 3 months prior to informed consent; * women who are nursing or pregnant, or subjects who have planned parenthood; * contraindication for empagliflozin or linagliptin; * other protocol-defined inclusion/exclusion criteria.
multidisciplinary research into the effects of resistance exercise and whey protein supplementation in healthy older men

Conditions: Sarcopenia; Muscle Atrophy

Summary: the aim of this randomised, double-blind, placebo-controlled, parallel groups trial is to investigate the effects of 12 weeks resistance exercise and whey protein supplementation on energy metabolism, markers of appetite, inflammation and hormonal response and body composition and strength and functional performance. generally healthy, retired men aged 60-80 years will be recruited (n = 52 in total, n = 13 per group). participants will be randomised to either: a) control group, b) whey protein supplement group, c) resistance exercise + control group or d) resistance exercise + whey protein supplementation group.

with demographics indicating that the world's population aged \>60 years will increase from 600 million reported in 2000, to \>2 billion by 2050, there is an increasing interest in health issues related to ageing. one area of particular interest is sarcopenia, defined as the progressive loss of muscle mass, strength and physical function as a consequence of ageing. sarcopenia has been associated with an increase in cardiovascular disease, poor metabolic and cognitive function, reduced quality of life and early mortality. studies have reported beneficial effects of both resistance exercise and increasing protein intake independently and in combination on markers of sarcopenia (mostly increases in muscle mass, strength and physical function). however, little is known about the effects of combined intervention on energy metabolism, appetite and cognitive and endocrine function. this randomised, double-blind, placebo-controlled, parallel groups trial will investigate these, alongside assessing the effects of combined intervention on total lean tissue mass, muscular strength and functional performance.

Eligibility criteria:
inclusion criteria: * retired men aged 60-80 years * body mass index 18.5-30 kg/m2 * not participated in resistance exercise within the last 6 months * free from musculoskeletal injury exclusion criteria: * retired men aged \ 80 years * current smokers, or ex-smokers ceasing \<6 months ago * body mass index \ 30 kg/m2 * currently participating in resistance exercise regularly (within last 6 months) * not weight stable and/or looking to start a weight loss programme * individuals participating in another research project (within the last 6 months) involving dietary and/or exercise intervention * existing or past medical history of vascular disease, cancer, diabetes, neurological, kidney, pulmonary, digestive (coeliac disease), thyroidal disease, osteoporosis or history of falls * currently taking protein/amino acid supplements regularly * currently prescribed non-steroidal anti-inflammatory medication, hormone replacement therapy (hrt), diabetic medication, beta-blockers, statins * uncontrolled blood pressure (blood pressure \>160/100 mmhg) * self-reported lactose intolerant or allergic to wheat or potatoes * individuals with a pacemaker * neuromuscular disorders or injuries

Keywords: sarcopenia resistance exercise protein
serum tnf-a in comparison to sequential organ failure assessment (sofa) score monitoring in critically ill patients

Conditions: Sepsis; Critically Ill

Summary: a total of ninety patients (52men and 38women) were included in the study. forty five patients developed septic complication during icu stay (sepsis group). forty five patients were critically ill without evidence of infectious organism (sirs group). at admission, patients data include clinical status; sofa score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured. routine cultures were obtained. the attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in icu. a serum level of tnf-a and sofa score was monitored.

the patients staying in icu for more than 24 hours were enrolled in the study. patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study. at admission, patient's age, sex, weight and height were recorded. patients data that include the clinical status; sequential organ failure assessment (sofa) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and crp) and arterial blood gas analysis were measured. routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. we attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmh2o. when needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in icu.

Eligibility criteria:
inclusion criteria: * the patients staying in icu for more than 24 hours were enrolled in the study. exclusion criteria: * the patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; * patients received massive blood transfusion; * patients with radiation therapy and patients with previous organ transplantation were excluded from the study.

Keywords: tnf alpha sofa score
long-term study of mp-214 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the long-term safety, tolerability, and efficacy of mp-214 in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the patient before the completion of study a002-a4 * patients who have completed the a002-a4 study exclusion criteria: * patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (aes), as judged by the investigator (or subinvestigator) the information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: schizophrenia antipsychotic agents mental disorder psychotropic drugs dopamine agents risperidone central nervous system agents
study of vegf-a targeting nir-ii fluorescence endoscopy in the gastrointestinal tract

Conditions: Gastrointestinal Carcinoma; Dysplasia; Gastrointestinal Polyp

Summary: in this study, the investigators are studying new ways to look for abnormal tissues of the gastrointestinal tract during an endoscopy. we are using a vegf-a targeting fluorescent probe and a nir-ii fluorescent endoscope to help detect abnormal tissues that are hard to see by the naked eye. the main purposes of this study include: 1. to translate the nir-ii approach into the endoscopy, and understand its advantages and limitations on detecting abnormal tissues in gastrointestinal. 2. to validate whether topical administration of a targeting probe can stick to abnormal tissues and be detected by the nir-ii endoscope. 3. to validate the safety and effectiveness of the topical administration of vegf-a targeting probes for clinical application.


Eligibility criteria:
inclusion criteria: * known or suspected gastrointestinal lesions. * scheduled for a clinically-indicated endoscopy. * mentally competent person, 18 years or older. * approved to sign the informed consent. * adequate potential for follow-up. exclusion criteria: * subjects with known allergy or negative reaction to icg or derivatives. * undesirable function of heart, lung, kidney, or any other organs. * enrolled in other trials in the past 3 months. * pregnant or trying to conceive. * unable to tolerate an endoscopy. * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * the researchers considered inappropriate to be included.
safety and efficacy of sublingual immunotherapy for allergic rhinitis due to artemisia annua

Conditions: Allergic Rhinitis

Summary: allergic rhinitis (ar) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. allergen specific immunotherapy (ait) is the only etiological treatment available for ar.traditionally, ait is divided into subcutaneous immunotherapy (scit) and sublingual immunotherapy (slit). artemisia annua is one of the most important allergen that is responsible for seasonal ar in china during july and october. the trial is a randomized, double-blind, placebo-controlled, multicentred, phase iii trial. 702 subjects with allergic rhinitis caused by artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.


Eligibility criteria:
inclusion criteria: * presence of seasonal rhinitis symptoms for over 2 years * artemisia-specific immunoglobulin e (ige) levels (immunocap) of class 3 or higher * patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol. * patients who are able to understand the information given and the consent and complete the daily record card. exclusion criteria: * patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy * patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks * patients whose humulus- or artemisiifolia-specific immunoglobulin e (ige) levels (immunocap) same as or higher than artemisia-specific immunoglobulin e (ige) level.
recombinant human granulocyte macrophage colony stimulating factor(rhgm-csf) treating oral mucositis

Conditions: Nasopharyngeal Cancers

Summary: this is a open,randomized phase ii trial comparing effectiveness and safety of local use of rhgm-csf and compound vitamin b12 to compound vitamin b12 solution alone treating oral mucositis in primary nasopharyngeal cancer. the main end point is the incidence of grade ii and less oral mucositis at the end of treatment.the hypothesis of the study is that the local use of rhgm-csf and compound vitamin b12 can decrease the incidence of grade iii and more oral mucositis at the end of treatment compared to local use of compound vitamin b12 alone.

inclusion criteria: 1. grade ii oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma. 2. receiving 68-72 gray of radiation dose. 3. age between 18 and 65 years. 4. kps≥70. 5. patient who has given his/her written consent before any specific procedure of the protocol. exclusion criteria: 1. severe uncontrolled infection. 2. pregnant or breast-feeding females. 3. allergy to this medicine. 4. diarrhea. outcome measures: 1. grade of oral mucositis:nci common terminology criteria for adverse events v3.0, nci ctcae v3.0 2. pain: who,numerical rating scale(nrs) 3. tumor response to chemoradiotherapy:response evaluation criteria in solid tumors,recist1.1

Eligibility criteria:
inclusion criteria: 1. grade ii oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma. 2. receiving 68-72 gray of radiation dose. 3. age between 18 and 65 years. 4. kps≥70. 5. patient who has given his/her written consent before any specific procedure of the protocol. exclusion criteria: 1. severe uncontrolled infection. 2. pregnant or breast-feeding females. 3. allergy to this medicine. 4. diarrhea.

Keywords: rhgm-csf oral mucositis primary nasopharyngeal cancers chemoradiotherapy