Kornimate/medical-research-clean huggingface dataset:
evaluation of the effect of novel recruitment maneuver therapy for postoperative pulmonary atelectasis

Conditions: Postoperative Pulmonary Atelectasis; Negative Pressure Therapy

Summary: 1. oxygenation index and bedside ultrasound would be used to evaluate the therapeutic effect of novel recruitment maneuver therapy in the patients with pulmonary atelectasis after cardiac surgery. 2. to establish a new therapy strategy for pulmonary atelectasis after cardiac surgery and to evaluate its effectiveness and safety for the cardiac patients complicated with postoperative pulmonary atelectasis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * underwent cardiac surgery with cpb * patients with lung ultrasound evidence of atelectasis after surgery * agree to participate in this study by themselves or their family member. exclusion criteria: * vasoactive-inotropic score (vis)\>20 * patients who were not suitable for using abdominal cpr compression-decompression instrument: bleeding from abdominal organs, abdominal aortic aneurysm, large abdominal tumor, intra-abdominal hypertension, etc * hemothorax or large pleural effusion confirmed by ultrasonography/x-ray * pneumothorax or air leak confirmed by ultrasonography/x-ray * considered by other researchers to be unsuitable for participation in this study

Keywords: negative extra-abdominal pressure (nexap) lung recruitment maneuver postoperative atelectasis cardiac surgery
the impact of distress on the ivf outcome

Conditions: Infertility

Summary: stress is a primary reason why in vitro fertilization (ivf) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (art) patients. the objective of this study is to determine if women who are randomized to a mind/body (mb) program prior to starting their first ivf cycle will have higher pregnancy rates than controls (c). this is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first ivf cycle. subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two ivf cycles. the primary outcome measure is clinical pregnancy rate.


Eligibility criteria:
inclusion criteria: * female boston ivf infertility patient * age 21-40 years * day 3 fsh level 12 miu/ml or below * day 3 e2 level 80 pg/ml or below * using own eggs (not an egg donor) * daily access to the internet * able to read, understand, and sign the informed consent in english exclusion criteria: * prescription antipsychotic medication * diagnosis of borderline or narcissistic personality disorder * previous participation in a mb group

Keywords: ivf, mind/body
study of ezetimibe and fenofibrate in patients with mixed hyperlipidemia (0653-036)(completed)

Conditions: Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

the duration of treatment is 48 weeks.

Eligibility criteria:
inclusion criteria: * high cholesterol and high triglycerides exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Keywords: mixed hyperlipidemia (high cholesterol and high triglycerides)
risk of acute liver injury in users of antimicrobials

Conditions: Drug-Induced Liver Injury

Summary: moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory disease. in the clinical development program, moxifloxacin was associated with some hepatic adverse drug reactions. to evaluate further the hepatic safety profile of moxifloxacin, a retrospective cohort study with nested case-control analysis will be conducted to assess the rate of noninfectious acute liver injury among new users of moxifloxacin and of other antimicrobials prescribed for similar indications, including amoxicillin, amoxicillin plus clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, and telithromycin. the study will be implemented in the population included in the healthcore integrated research database (hird). eligible patients are adults aged 18 years and older with continuous enrollment in the hird for at least 6 months before their first claim for a prescription for a study antimicrobial. follow-up will start at the date of the first prescription until the date of the earliest of the following events: noninfectious acute liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from database, or death. patients with chronic alcoholism or cirrhosis, infectious hepatitis, hiv/aids, or pregnant women will not be included.

study design is called 'cohort study with nested case-control analysis"

Eligibility criteria:
inclusion criteria: * all persons meeting the following criteria during the study period (july 1, 2001, through march 31, 2009) are eligible for study inclusion: * first insurance claim for a dispensing of one of the study antimicrobials during the study period ("new users") * aged 18 years old or older * continuous enrollment in the study database for at least 6 months prior to start of follow-up (which is the date of the first claim for any of the study antimicrobials) * patient data defined as acceptable for research purposes according to the quality criteria of the hird exclusion criteria: * pregnant women * patients with chronic alcoholism or cirrhosis * patients with history of acute and/or chronic infectious hepatitis or hiv/aids

Keywords: liver diseases anti-bacterial agents fluoroquinolones amoxicillin amoxicillin-potassium clavulanate combination clarithromycin doxycycline cefuroxime case-control studies retrospective studies cohort studies epidemiologic research design epidemiologic studies healthcore integrated research database (non-mesh) united states human insurance claim review
internet-based cbt vs. tau for stress-related disorders

Conditions: Adjustment Disorders; Exhaustion Disorder

Summary: stress-related mental illness is common and one of the main causes of sick leave in sweden. cognitive behavior therapy (cbt) is a promising treatment, but access to treatment is low. in a previously conducted study, we found that internet-based cbt in comparison to a waitlist control group was effective in reducing symptoms of stress. the aim of the present study is to take the next step and compare internet-based cbt for stress-related disorders to an active control condition.

non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. cognitive behavior therapy (cbt) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. the overall evidence-base for cbt for these disorders is however fairly week and access to treatment is low. in a previously published randomized controlled trial we found that internet-based cbt can yield large effects on core symptoms of stress for these disorders. delivering cbt via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. in the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. it is now therefore important to take the next step and investigate the effects of internet-based cbt in comparison to an active control condition. the primary aim of this study was to compare two internet-based treatments, cbt vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

Eligibility criteria:
inclusion criteria: * primary adjustment disorder or exhaustion disorder * regular access to a computer and to the internet * ability to read and write in swedish exclusion criteria: * substance abuse in the past 6 months * lifetime psychosis or bipolar disorder * suicide risk * initiated or changed psychopharmacological treatment for depression or anxiety in the past month * concurrent psychological treatment * cognitive behavior therapy for stress-related symptoms in the past year.

Keywords: internet-based treatment randomized controlled trial
immunonutrition for improving the efficacy of immunotherapy in patients with metastatic non-small cell lung cancer

Conditions: Lung Cancer, Nonsmall Cell

Summary: the present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling


Eligibility criteria:
inclusion criteria: * confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology); * first-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines; * will to participate by providing written informed consent; * availability to administer oral supplements and immunotherapy with or without chemotherapy; * eastern cooperative oncology group performance status ≤ 2; * life expectancy ≥ 6 months. exclusion criteria: * age \< 18 years; * inability to sign an informed consent; * indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
clinical assessment of two inlay -retained bridge designs

Conditions: Tooth Fractures

Summary: in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.

it has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage fdps with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. in comparison with the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

Eligibility criteria:
inclusion criteria: * absence of periapical or periodontal or diseases * sound abutment teeth or with small caries or filling on occlusal or proximal surfaces * maintenance of good oral hygiene * no tooth mobility or grade 1 can be accepted * sufficient occluso-gingival tooth height (5mm) * good alignment of abutment teeth * mesiodistal edentulous space preferred not exceed 12mm exclusion criteria: * patients under the age of 18 or being incapable of taking out a contract * patients with any medical condition that impaired correct oral hygiene * endodontic ally treated abutment teeth * a conspicuous medical or psychological history * bruxism, or known allergic reaction to the materials used * limited vertical space for the required connector height of 4mm * pregnant female patients

Keywords: proximal box design preparation
an open-label extension study of an investigational drug, fitusiran, in patients with moderate or severe hemophilia a or b

Conditions: Hemophilia A; Hemophilia B

Summary: primary objective: to evaluate the long-term safety and tolerability of fitusiran in male patients with moderate or severe hemophilia a or b secondary objectives: * to investigate the long-term efficacy of fitusiran * to characterize the safety and efficacy of concomitantly administered factor viii (fviii), factor ix (fix) or bypassing agents (bpa) and fitusiran for treatment of bleeding episodes * to assess changes in health-related quality of life (qol) over time * to characterize antithrombin (at) reduction and thrombin generation (tg) increase * to characterize the pharmacokinetics (pk) of fitusiran

it is anticipated that patients in this study will receive treatment with open label fitusiran for approximately 7 years or until fitusiran becomes commercially available, whichever occurs first.

Eligibility criteria:
inclusion criteria: * completed and tolerated study drug dosing in study tdr14767 (aln-at3sc-001) * male aged ≥18 years * moderate or severe, clinically stable hemophilia a or b as evidenced by a laboratory fviii or fix level ≤5% at screening. patients with a fviii or fix level \>5% at screening will be eligible on provision of a historic laboratory report indicating a trough level ≤5% * willing and able to comply with the study requirements and provide written informed consent exclusion criteria: * clinically significant liver disease * patients known to be human immunodeficiency virus seropositive and have a cd4 count \<200 cells/μl * history of venous thromboembolism * current serious mental illness that, in the judgment of the investigator, may compromise patient safety, ability to participate in all study assessments, or study integrity * clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, neurological, inflammatory, or other diseases that, in the judgment of the investigator, precludes study participation

Keywords: hemophilia rnai therapeutic
trial of quetiapine in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: this research study is being held at ucsd to determine whether the medication quetiapine helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. this study will see if the medication quetiapine helps symptoms of anxiety, depression, and obsessionality, in addition to increasing bmi. men and women between the ages of 18-65 and are currently suffering from anorexia nervosa are needed.


Eligibility criteria:
inclusion criteria: * meet criteria for dsm-iv anorexia nervosa (restricting or binge-eating/purging types) * at least 15% below ideal body weight * judged to be reliable to keep clinic visits and able to take all tests and examinations required by the protocol and be able to understand and decide whether or not to sign the informed consent. exclusion criteria: subjects will not be included in the study who present with any of the following: * schizophrenia or schizoaffective disorder (dsm-iv) * any ecg abnormality considered clinically significant by the investigator * subjects with liver enzymes elevated two times or more above normal * other laboratory abnormalities considered clinically significant by the investigator including laboratory deviations requiring acute medical intervention * pregnant women, women of childbearing potential not using medically accepted means of contraception (abstinence, iud, birth control pills, barrier devices or implanted progesterone rods stabilized for at least three months), and lactating women * serious suicide risk * any medical condition that would preclude the outpatient treatment of anorexia nervosa or the use of quetiapine * organic brain disease * history of severe allergies * multiple adverse drug reactions or known allergy to quetiapine * use of neuroleptic medications (except benzodiazepines) within 7 days preceding randomization * history of alcohol or substance abuse disorder as defined in the dsm-iv within the past 3 months.
a study of the effect of ro4607381 on atherosclerotic plaque in patients with coronary heart disease

Conditions: Coronary Heart Disease

Summary: this study will assess the effect of ro4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (chd) including patients with other chd risk factors. after a pre-randomisation period during which positron emission tomography computed tomography (pet/ct) and mri will be conducted, patients will be randomized to receive either ro4607381 600mg po daily, or placebo po daily. pet/ct and mri scans will be taken at intervals during the study. the anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * chd, including patients with other chd risk factors; * treated appropriately for dyslipidemia; * clinically stable. exclusion criteria: * previous exposure to any cholesteryl ester transfer protein (cetp) inhibitor or vaccine; * recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident; * severe anemia; * uncontrolled hypertension; * poorly controlled diabetes.
quality of life and survival in cardiac arrest patients

Conditions: Cardiac Arrest; Post-Anoxic Coma; Central Nervous System Diseases

Summary: quo vadis is a national observational study with the aim to describe clinical intervention and utilization of neuroprognostication tools in the management of patients admitted to icu following cardiac arrest

despite recent improvements in post-resuscitation care, about 50% of patients resuscitated from cardiac arrest die or have poor neurological prognosis. post-anoxic brain injury is common after cardiac arrest and is a major cause of post-resuscitation mortality. since there has been a significant investment in improving the emergency response to both in-hospital ad out-of-hospital cardiac arrest (ihca and ohca, respectevly) patients and reported improvements in short-term survival outcomes, the long-term neurological state and quality of life of survivors and their caregiver is of growing significance. quo vadis is a national observational study created to describe clinical interventions and utilization of neuroprognostication tools in the management of patients admitted to icu following cardiac arrest. the aims of the study are: * to create an italian registry that describes clinical interventions and neuroprognostication tools used in the management of patients admitted to icu following cardiac arrest * to evaluate, after one year from the cardiac arrest, the neurological outcome and the quality of life of the patients; * to evaluate, after one year from the cardiac arrest, the quality of life of caregivers; * to identify the most effective clinical intervention in the management of post-cardiac arrest patients admitted to icu; * to create a prognostic model for patients admitted to icu after cardiac arrest.

Eligibility criteria:
inclusion criteria: * age ≥ 14 years; * cardiac arrest within 24 hours icu admission exclusion criteria: * absence of informed consent; * age \< 14 years

Keywords: comparative effectiveness research
quantitation of mcardle's sign and evaluation of specificity for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study is designed to quantitate mcardle's sign, an increase in measurable weakness with neck flexion described in patients with multiple sclerosis, and to determine whether it is or is not specific for multiple sclerosis.

finger strength will be measure using a torque-measuring device designed to quantitate finger extension strength. the device was designed for point of treatment use, patient safety and portability. strength will be measured in 5 paired trials, first with neck extended and then with neck flexed. two protocols will be evaluated, one testing isometric strength against a fixed resistance and the second testing strength against dynamic resistance. mcardle's sign is the difference between strength with neck extension and strength with neck flexion. the data will be digitally registered and dynamic neck position will be recorded electronically in real time. graphs of dynamic changes in torque versus neck position will be generated and superimposed. strength will be quantitated using matlab software. consecutive patients with myelopathy of any cause with detectable finger extensor weakness will be studied, either due to ms or due to other cause of myelopathy (other inflammatory, vascular, compressive, neoplastic and other). additionally, normal controls will be studied as will patients with finger extension weakness due to peripheral nerve lesions.

Eligibility criteria:
inclusion criteria: * myelopathy of any cause with finger extension weakness * patients with peripheral neuropathy with finger extension weakness * healthy controls exclusion criteria: * pregnant subjects.
isotonic versus hypotonic fluid for maintenance iv therapy

Conditions: Gastroenteritis; Bronchiolitis; Sepsis; Urinary Tract Infection

Summary: hyponatremia associated with administration of hypotonic intravenous (iv) fluids may have serious complications. it has recently been suggested that isotonic saline may be a more appropriate choice of maintenance iv fluid. this pilot and feasibility study aims to compare isotonic saline to 0.45% saline in hospitalized children requiring parenteral fluid support in order to: aim 1: to determine the feasibility of conducting a double-blind, randomized controlled trial comparing these solutions. aim 2a: to compare the rate of change in serum na (mmol/l/hr) and the incidence of hyponatremia (na \<136 mmol/l) between patients receiving isotonic and hypotonic intravenous fluids at at least 50% of the traditional maintenance rate for an interval of at least 8 hours. aim 2b: to compare the incidence of adverse events between the two iv fluid treatment groups.


Eligibility criteria:
inclusion criteria: * 1 month to 18 years of age * require iv fluids for at least 8 hr. * baseline serum sodium \>=136 mmol/l \& \<=145 mmol/l exclusion criteria: * baseline serum sodium concentration less than 136 mmol/l or greater than 145 mmol/l * renal disease, a history of cardiac dysfunction or evidence of cardiac dysfunction, pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction * acute neurological illness such as meningitis or encephalitis * severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay)

Keywords: surgery