Kornimate/medical-research-clean huggingface dataset:
study of high-dose influenza vaccine efficacy by repeated dosing in gammopathy patients

Conditions: Influenza; Gammopathy

Summary: a pilot study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

in this study, we will administer fluzone® high-dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. all patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent document * age \>= 18 years at the time of signing the informed consent form * diagnosis of any monoclonal gammopathy; monoclonal gammopathy of undetermined significance (mgus), asymptomatic/ active multiple myeloma, asymptomatic / active waldenstrom macroglobulinemia (wm) exclusion criteria: * an serious egg allergy or prior serious adverse reaction to an influenza vaccine * use of any other influenza vaccine for the 2014 to 2015 flu season * women who are pregnant or plan to become pregnant in the study period
turkish version of f-2-ms

Conditions: Cultural Adaptation; Reliability; Validity; Multiple Sclerosis; Fatigue

Summary: the aims of this study were to perform cultural adaptation of the f-2-ms and provide information regarding the factor structure, reliability and validity of the instrument in turkish speaking patients with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * individuals aged between 20-65 years, with an edss score of 0-5, who have not had an attack in the last 2 months, who have no cognitive problems (a score of 6 or more according to the hodkinson mental test), who do not have additional neurological diseases other than ms, and who volunteer to participate in the study will be included. exclusion criteria: * individuals with an edss score greater than 5, who are in the attack period, who have vestibulosupressant or drug or alcohol use habits that cause neuropathy, and who have communication problems will be excluded from the study.
efficiency of gds method for lumbar stabilization for non-specific low back pain in primary care

Conditions: Low Back Pain

Summary: the purpose of this randomized controlled trial was to assess the effectiveness of gds treatment method for patients with subacute or chronic non-specific low back pain in primary care of spanish national health service.

low back pain is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%. it is responsible for a major portion of work absenteeism and is actually among those conditions which generate the greatest expense due to health and labor costs. the spanish national health service is a universal and free health care system. non-specific low back pain (lbp) is a prevalent disorder, generating large health and social costs. there is considerable variation in lbp related clinical practice and a considerable number of clinical guidelines have been developed for the management of subacute and chronic lbp patients. experience in primary care centers of madrid shows that physiotherapeutic intervention based on gds method for articular and muscular chains is an efficient technique in the treatment of patients with diagnosis of non-specific low back pain compared with conventional physiotherapy treatment in primary care based on electrotherapy (tens and microwave) currently, no randomized studies examining the effects of this method for patients with subacute or chronic non-specific low back pain have been published.

Eligibility criteria:
inclusion criteria: participants were required to: * be aged 18 years or older; * have been diagnosed with simple mechanical lbp by their doctor and prescribed physiotherapy; * have an impairment secondary to functional overload and/or poor postural habits (patients with certain occupations were excluded if these could act as confounding factors); * not be receiving any other form of treatment; * not be neurologically compromised; and * to be in a subacute or chronic stage of lbp exceeding 4 weeks. exclusion criteria: subjects were excluded if they: * showed clear symptoms of depression; * refused to participate; * did not sign the informed consent form; * had any cognitive impairment that would prevent them from following instructions; * were unable to understand spanish sufficiently to adequately follow instructions; * had the intention of moving from the area; * had any form of contraindication to the physiotherapeutic techniques to be applied to both groups; * had red flags, or warning signs, of serious illness such as cancer, infection, fracture or cauda equinal syndrome; * had yellow flags, or risk factors, for a psychological disorder or had lumbar pain whose main cause was not mechanical.

Keywords: low back pain physical therapy modalities exercise movement techniques primary health care
the impact of pre-emptive home delivery of ors + zinc on treatment for child diarrhea

Conditions: Diarrhea Toddler

Summary: the aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of oral rehydration salts (ors) and zinc at home increases the use of ors to treat diarrhea cases among children under the age of 5 in bauchi, nigeria. the primary research questions for the study are: * rq1a: does pre-emptive home delivery with free distribution of ors and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ors to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)? * rq1b: does the intervention result in greater use of ors to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo? * rq1.1: how much does the effect of the intervention on use of ors to treat child diarrhea (for children under the age of 5) change over time? all wards in bauchi state will be randomly assigned to one of two groups: * treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ors and zinc co-packs - with two ors sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment * delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups. a total of 1,732 enumeration areas (eas) will be sampled across all wards for the study period. within each ea, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). the primary outcomes for the study include the use of ors to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.


Eligibility criteria:
inclusion criteria: * at least 15 years old * has at least one child under 5 at baseline * proficiency in english or hausa exclusion criteria: * living in a temporary home (nomadic population) * does not speak english or hausa * unable to give informed consent

Keywords: oral rehydration salts child diarrhea zinc
treadmill cardiovascular safety study of erenumab (amg 334)

Conditions: Stable Angina

Summary: a phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with stable angina to evaluate the effect of erenumab (amg 334) compared to placebo on exercise time during an exercise treadmill test.


Eligibility criteria:
inclusion criteria * history of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month * ischemic heart disease documented by myocardial infarction, coronary angiography or a revascularization procedure * receiving stable doses of cardiac medication * completes 2 exercise treadmill tests during screening meeting protocol requirements exclusion criteria: * participating in another investigational study * current or prior malignancy within 5 years of randomization * known sensitivity to any components of the investigational product * not able to complete all protocol required study visits * having the following within 3 months prior to or during screening: unstable angina or acute coronary syndrome, transient ischemic attack (tia) or stroke, revascularization procedure, or instability in st-segment depression between screening exercise treadmill tests, as assessed by the core electrocardiograph (ecg) laboratory

Keywords: angina stable angina cardiovascular disease exercise-induced angina
intravenous iron versus oral iron for severe postpartum anemia

Conditions: Anemia; Puerperal Disorders

Summary: the aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.

postpartum anemia is commonly defined as hemoglobin levels less than 8.5 g/dl and it is usually treated with oral iron supplements. blood transfusion is reserved to women with hemoglobin levels \< 6 g/dl and/or clinical symptoms of anemia. without treatment, the restoration of blood parameters in postpartum anemia can take approximately one month (hemoglobin levels increase to 2.8 g/dl in 30 days). several reports have demonstrated the efficacy of intravenous iron in severe anemia in non-obstetric pathologies. however, the clinical effect of intravenous iron in patients with postpartum hemoglobin levels ranging from 6.0 to 8.0 g/dl has been not reported. there has not been evaluated its capacity to restore hemoglobin levels and to minimize clinical side-effects of anemia (sickness, weariness, depression, anxiety).

Eligibility criteria:
inclusion criteria: 1. 18 years and older, 2. diagnosis of postpartum anemia within the first 48 h postpartum with an haemoglobin level equal or higher than 6 g/dl and lower than 8.0 g/dl, 3. ability to read and understand the relevant purpose of the trial and consent obtained in accordance with specifications of the local research ethics committee. exclusion criteria: 1. clinical symptoms or suspicion of acute or chronic infection. 2. allergic history or iron intolerance. 3. indication of blood transfusion. 4. non iron deficit anemia. 5. hepatopathy. 6. parenteral iron hypersensitivity.

Keywords: postpartum anemia intravenous iron
prospective evaluation of the tool-in-lesion technology of the galaxy system in routine clinical practice

Conditions: Lung Cancer; Lung; Nodule

Summary: a prospective observational study evaluating the accuracy of the tool-in-lesion technology of the galaxy systemtm in normal clinical practice.

the goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the galaxy systemtm with integrated tool-in-lesion tomography (tilt+) in bronchoscopically biopsying small peripheral pulmonary nodules.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. patients with indeterminate lung nodule 3. peripheral pulmonary subsolid and solid nodules (ppns) sized up to 3 cm measured as the largest dimension based on the pre-procedural ct 4. pre-procedural ct is conducted within 90 days of the bronchoscopy procedure 5. informed consent properly obtained per local regulations exclusion criteria: 1. known pregnancy or breastfeeding 2. patients with pure ground-glass nodules on pre-procedural chest ct 3. uncontrolled coagulopathy or bleeding disorders 4. ongoing systemic infection 5. history of lobectomy or pneumonectomy 6. patients with pacemakers or defibrillators 7. unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist 8. patients with pleural effusion or diaphragmatic paralysis
palliative 3-dimensional conformal radiation therapy in reducing radiation side effects in patients with lung cancer. icorg 06-34

Conditions: Lung Cancer

Summary: rationale: 3-dimensional conformal radiation therapy may lessen side effects caused by palliative radiation therapy and improve the quality of life of patients with lung cancer. purpose: this clinical trial is studying how well 3-dimensional conformal radiation therapy works in reducing the side effects of palliative radiation in patients with lung cancer.

the primary purpose of this study is to demonstrate that using technically sophisticated 3-dimensional conformal radiation therapy for the palliative treatment of lung cancer patients will result in equivalent degrees of symptom relief and a reduction in the primary endpoint of oesophagitis. single arm therapeutic clinical study. rt treatment regimens: 17 gy/2 fractions or 20gy/5 fractions or 39gy/13 fractions primary endpoint: -the occurrence of grade 3 or higher oesophagitis in the interval between start and 1-month post completion of treatment as determined by ctcae version 4.02 patients will be assessed pre treatment, during treatment, 2 weeks post completion of treatment, one month post completion of treatment, three months post completion of treatment, and three monthly thereafter -all patients who complete treatment (and whose on-treatment toxicity is documented) will be evaluable. secondary endpoint: * quality of life assessment. all patients will be required to complete the eortc qlq-c15-pal (version 1) and the lung specific module (lc 13) * the occurrence of other aes safety endpoint: -radio-induced oesophagitis, acute and long term, using the ctcae version 4.02.

Eligibility criteria:
inclusion criteria: * age \> 18 years * karnofsky performance status of \> or equal to 40% * patients with locally advanced or metastatic small cell or non-small cell lung cancer * the presence of intra-thoracic symptoms requiring palliative treatment * wbi (if required) is permitted * the patient's condition must permit waiting for the 3-dimensional design process to be implemented. this will be at the discretion of the consultant physician * patients presenting with pleural effusions - provided the pleural effusion does not prevent the reasonably accurate delineation of the target volume * intra-thoracic disease requiring palliation must be clearly evident on a diagnostic ct scan * life expectancy of at least 3 months (assessed by clinician) * provision of written informed consent in line with ich-gcp guidelines exclusion criteria: -in the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Keywords: recurrent non-small cell lung cancer recurrent small cell lung cancer extensive stage small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
lung ultrasonography after major cardiac surgery

Conditions: Pneumonia; Cardio/Pulm: Respiratory Failure; Cardiopulmonary Bypass

Summary: diagnosis of pneumonia remains difficult in intensive care unit (icu), notably after cardiac surgery. lung ultrasonography (lus) has been successfully used for diagnosis of pneumonia, but its usefulness and reliability was never evaluated after cardiac surgery. this study investigates the clinical relevance of lus for pneumonia diagnoses in cardiac icu.


Eligibility criteria:
inclusion criteria: * cardiac surgery with sternotomy and cardio-pulmonary bypass (cpb) less than 3 days before * at least one component suggestive of arf: * if mechanical ventilation, a pao2 / fio2 ratio \<200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation, * if spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea\> 25/min, upper or intercostal swallowing, abdominal swing ...), spo2 \< 90% or pao2 \<60 mmhg despite oxygen therapy ≥ 3l/min. exclusion criteria: * minor patients * pregnancy * sleep apnea syndrome * participation refusal
predicting treatment response to exposure therapy using carbon dioxide

Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia

Summary: anxiety disorders affect over a quarter of the population, yet very little is known about the variables that predict treatment outcome. the planned study explores whether a patient's response to a physiological test involving inhalation of carbon dioxide predicts their response to exposure therapy.

anxiety sensitivity (as) refers to an individual's fear of experiencing anxiety-related symptoms (e.g., dyspnea or heart palpitations) and is a core construct underlying the initiation and maintenance of pathological anxiety. recent evidence suggests that reducing as may be critical for the prevention and treatment of anxiety across diagnostic categories. exposure therapy, an important component of cognitive behavioral therapy (cbt), is one of the most effective treatments for reducing as, and has been shown to improve symptoms across a number of different anxiety disorders. meta-analyses reveal an approximately 50% treatment response rate, with the remaining half of patients showing either no response or dropping out of treatment early. unfortunately, there is a paucity of research exploring which variables predict treatment outcome and there are currently no tests for predicting which patients would benefit the most from exposure therapy. in this study, participants will complete two sessions of a carbon dioxide (co2) habituation paradigm, a safe and noninvasive physiological test that entails repeated exposures to single vital capacity inhalations of 20% co2. both co2 testing sessions will be completed within a 72-hour time period. patients then complete a 10-week group-based exposure therapy to determine whether an individual's degree of habituation to co2 predicts treatment outcome.

Eligibility criteria:
inclusion criteria: 1. dsm-v diagnosis of an anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia) 2. anxiety sensitivity index (asi-3) total score \> 29 3. overall anxiety severity and impairment scale (oasis) score \> 8 4. between 18-55 years of age 5. subject must be "treatment-seeking" and willing to enroll in the 10-week group-based exposure therapy exclusion criteria: 1. comorbid bipolar disorder, schizophrenia, anorexia or bulimia nervosa, or obsessive-compulsive disorder 2. current substance use disorder \> moderate (within the past 6 months) 3. currently taking a psychotropic medication 4. currently receiving psychotherapy/counseling for anxiety 5. currently being treated as an inpatient 6. active suicidal ideation with intent or plan 7. history of neurological, cardiovascular or respiratory problems (e.g., asthma, severe brain injury)
antibiotics for prevention of ssi in obese women undergoing cs

Conditions: Surgical Site Infection

Summary: effect of cephalexin plus metronidazole on ssi better than cephalexin alone in obese women undergoing cs

comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing cs and follow up of any signs of wound infection

Eligibility criteria:
inclusion criteria: * obese women under elective cs exclusion criteria: * immunodeficient women
genetic architecture of neutrophil-mediated inflammatory skin diseases

Conditions: Neutrophil-mediated Inflammatory Dermatoses; Inflammatory Dermatoses

Summary: this study is to identify rare, disease-causing mutations of several rare neutrophil dermatoses. to identify associations between nmid and variants in the genome next generation sequencing, mainly whole exome sequencing, will be used. in a second approach the expression level of already known inflammatory proteins in skin samples will be investigated.

the origin of rare severe inflammatory skin diseases in dermatology is insufficiently known. they have in common the presence and activation of phagocytes, affect the quality of life through pain and inflammation and disfiguration, and can even be fatal. this study is intended to build on the findings that several of these neutrophil-mediated inflammatory dermatoses (nmid) have a genetic background and to identify rare, disease-causing mutations of several rare neutrophil dermatoses. this non-clinical case-control study is a research project with biological material and health-related data. to identify associations between nmid and variants in the genome next generation sequencing, mainly whole exome sequencing, will be used. in a second approach the expression level of already known inflammatory proteins in skin samples will be investigated. the data are obtained and verified using standardized methods as e.g. nanostring, rna sequencing and qrt-polymerase chain reaction (pcr), proteomics assays and immunohistochemistry as well as flow cytometry and imaging mass cytometry, elisa, and western blot.

Eligibility criteria:
inclusion criteria: * written consent of the participating person * diagnosis of a disease in the nmid form group or proband of the control group exclusion criteria for patients: * missing informed consent if samples collected after 2014 * no diagnosis of nmid exclusion criteria for healthy controls: * missing informed consent

Keywords: inflammasome inflammation-driving pathway gene variants next generation sequencing
pain, discomfort, and functional impairments during maxillary expansion

Conditions: Constriction

Summary: maxillary expansion is associated with varying degrees of pain and functional impairments. the current study aims to compare rapid maxillary expansion using a mcnamara-type (bonded) appliance and slow maxillary expansion using a removable palatal expansion appliance concerning patient-centered outcomes. those outcomes will include pain and discomfort, mastication difficulties, swallowing difficulties, and pressure on the soft tissues.

skeletal maxillary constriction is one of the common orthodontic problems of all ages, which could be unilateral or bilateral. if it is neglected and not treated, it may result in later orthodontic problems such as skeletal deviation of the lower jaw. the current study aims to use two types of expanders to treat skeletal maxillary constriction in adolescents aged between 12 and 16 years. the study sample will include 52 patients who will be equally divided into two groups: the slow and the rapid maxillary expansion groups. patients will be asked to answer a questionnaire within five assessment times during the expansion procedure. the questionnaire will contain four questions: 1) what is the degree of discomfort/pain? 2) what is the degree of mastication difficulties? 3) what is the degree of swallowing difficulties? 4) what is the degree of any sense of pressure in soft tissue?

Eligibility criteria:
inclusion criteria: 1. adolescents between 12 and 16 years. 2. early permanent dentition. 3. skeletal bilateral maxillary constriction. 4. there is no loss or absence of any permanent teeth except for the third molar. 5. dental and skeletal class i/ii malocclusion. 6. normal/mild vertical growth pattern. exclusion criteria: 1. previous orthodontic treatment. 2. a severe horizontal growth pattern. 3. any periodontal diseases. 4. any general diseases or syndromes.

Keywords: pain discomfort crossbite maxillary expansion