Kornimate/medical-research-clean huggingface dataset:
antero-posterior versus antero-lateral electrode position for electrical cardioversion of typical atrial flutter

Conditions: Atrial Flutter

Summary: the aim of this study is to identify the one electrode position out of two most commonly used for external electrical cardioversion of typical atrial flutter, which needs less delivered energy and less needed number of shocks for successful cardioversion.

typical atrial flutter is the second-most prevalent atrial tachyarrhythmia. no guidelines for treatment exist and few studies investigate treatment of atrial flutter. mostly, guidelines for atrial fibrillation are followed for treatment of atrial flutter. atrial flutter has a different pathomechanism as atrial fibrillation, therefore special guidelines for treatment are needed. among drug treatment and ablation procedures, external electrical cardioversion is commonly used, especially for treatment of acute symptomatic patients. this study may help to further define safe and successful procedures for electrical cardioversion of atrial flutter.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of typical atrial flutter * signed written informed consent * eligibility for sedation and external electrical cardioversion exclusion criteria: * clinical diagnosis of arrhythmia other than typical atrial flutter * implanted icd or pacemaker * proof of atrial thrombi

Keywords: external electrical cardioversion typical atrial flutter electrode position antero-lateral antero-posterior biphasic cardioversion step-up protocol
effectiveness of indo-surft in reducing addictive substance use in women with substance use disorders

Conditions: Substance Use Disorders

Summary: relapse in women was associated with depression, interpersonal stress, and relationship conflict with others when compared with men. the differences in gender profiles with substance use disorders (sud) leads to the need for management strategies that are sensitive to each gender. this is a challenge to build a new module that can be applied continuously by collaborating cbt and several other psychosocial interventions, such as motivational enhancement therapy. the investigators compiled indonesia substance use reduction for female therapy (indo-surft). by implementing this module, it is hoped that it can provide short and long term effects and reduce the relapse rate in women with sud.


Eligibility criteria:
inclusion criteria: * women aged 18-59 years old * diagnosed with substance use disorders based on dsm-v or icd-10 exclusion criteria: * subjects with severe mental disorder or intellectual disability
rumination focus cognitive behavior therapy

Conditions: Depression; Dysthymic Disorder; Panic Disorder; Social Phobia; Generalized Anxiety Disorder

Summary: 1. to investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (wlcg). 2. to investigate the hypothesized mechanism of change: repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.

the effectiveness of a rumination focused cognitive-behavioral treatment (rf-cbt) will be compared with a wait list control group using a randomized control trial (rct) design in a culture where this has not been tested before. the treatment approach was design to specifically target repetitive negative thinking (e.g., rumination and worries). specifically, the treatment involves first a functional analysis design to help participants identify when rumination starts, distinguish between helpful versus unhelpful repetitive thinking, and learn more functional responses, and experiential and imagery exercises design to help them shift their thought processing towards concreteness, absorption and compassion. the main goal of the study is to test the effectiveness of this transdiagnostic approach in reducing symptom of depression and anxiety.

Eligibility criteria:
inclusion criteria: 1. be fluent in romanian, 2. be at least 18 years of age, 3. display elevated levels of worry and/or rumination (e.g., at least one self-report score above the following cut-offs: penn state worry questionnaire total score \> 50 and/or rumination response scale - brooding sub-scale ≥ 10) 4. have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, and/or panic disorder, or any combination of these conditions on structured clinical interview for the diagnostic and statistical manual for mental disorders (scid-i) exclusion criteria: 1. suicidal plans, 2. changes in the dosage if psychotropic medication during the last month (if present), 3. have bipolar disorder or psychosis (according to medication status) 4. have an alcohol/substance abuse and/or dependence disorder 5. currently take part in other psychological treatment, 6. obvious obstacle to participation (i.e., no current internet access, long travel plans during the treatment period etc.); 7. have a primary diagnostic of post-traumatic stress disorder and/or obsessive compulsive disorder

Keywords: rumination cognitive behavioural therapy (cbt) depression anxiety
cala one device for essential tremor

Conditions: Essential Tremor

Summary: this study evaluates the safety and effectiveness of the cala one device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. this study is a prospective, randomized, double-blinded, sham-controlled study.


Eligibility criteria:
inclusion criteria: 1. 22 years or older 2. a diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist 3. signed informed consent 4. at least one hand exhibiting kinetic tremor ≥ 2 as assessed by the tetras archimedes spiral task completed during the baseline evaluation, as assessed by the investigator in-person. 5. score of 3 or above in any one of the items of the bain \& findley adl scale exclusion criteria: 1. implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator 2. previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound, for the treatment of tremor 3. suspected or diagnosed epilepsy or other seizure disorder 4. pregnant 5. swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site 6. peripheral neuropathy affecting the tested upper extremity 7. alcoholism (score of 4 or higher on dsm-5) 8. other possible causes of tremor, including parkinson's disease, drug-induced, enhanced physiological tremor, dystonia 9. other neurodegenerative disease like parkinson-plus syndromes suspected on neurological examination. these include: multisystem atrophy, progressive supranuclear palsy, dementia with lewy bodies, and cortical basal ganglionic degeneration 10. changes in medication for tremor within 1 month prior to study enrollment 11. change in antidepressant medication within 3 months prior to study enrollment 12. botulinum toxin injection for hand tremor within 6 months prior to study enrollment 13. current participation in any other interventional research study 14. previous participation in any other cala health interventional research study 15. alcohol or caffeine consumption within 12 hours of study enrollment subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.
safety and effectiveness of ciclesonide nasal spray in children (6 to 11 years) with perennial allergic rhinitis (by9010/m1-403)

Conditions: Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever

Summary: the purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.


Eligibility criteria:
main inclusion criteria: * general good health, other than perennial allergic rhinitis * history and diagnosis of perennial allergic rhinitis by skin prick test * parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.) main exclusion criteria: * participation in any investigational drug trial within the 30 days preceding the screening visit or at any time during the trial * use of any prohibited concomitant medications as defined by the study protocol * non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the screening visit

Keywords: allergy perennial allergic rhinitis allergic rhinitis hay fever
phase ii study of irinotecan/capecitabine in patients with antracycline/taxane pretreated mbc

Conditions: Breast Cancer Metastatic

Summary: to evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer

this is a nonrandomized, open-label, phase ii study of irinotecan plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and taxanes. up to 44 qualified patients will be enrolled according to the exact single stage design. irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (days 1 and 8) followed by 1-week rest period. capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period). for practical reasons, capecitabine doses are rounded to the nearest dose that could be administered with a combination of 500-mg and 150-mg tablets of drug. capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of breast cancer stage iv or recurrent. * previous chemotherapy with anthracyclines and taxane in adjuvant setting * previous hormonal therapy in adjuvant and metastatic setting is allowed * prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. * no other forms of cancer therapy, such as radiation, immunotherapy for at least 3 weeks before the enrollment in study. * performance status of 0, 1, 2 on the ecog criteria. * clinically measurable disease, defined as uni-dimensionally measurable lesions with clearly defined margins on x-ray, ct scan, mri or physical examination. lesions serving as measurable disease must be at least 1 cm, as defined by x-ray, ct scan, mri, or physical examination. * estimated life expectancy of at least 12 weeks. * patient compliance that allow adequate follow-up. * adequate hematologic (wbc count ³ 3,000/mm3, platelet count ³ 100,000/mm3), hepatic (bilirubin level £ 1.5 mg/dl), and renal (creatinine concentration £ 1.5 mg/dl) function. * informed consent from patient or patient's relative. * males or females at least 18 years of age. * if female: childbearing women should use non-hormonal contraceptive method exclusion criteria: * mi within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia. * serious concomitant infection. * second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
childhood early oral aging syndrome: prevalence, etiological factors, and consequences on occlusion

Conditions: Aging

Summary: the early oral aging syndrome (eoas) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. in this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the early childhood oral aging syndrome (eoas) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the university nove de julho, will be selected. children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. a questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. subsequently, a clinical examination will be conducted using the new early childhood oral aging syndrome (eoas) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores i to iii that should be used concomitantly in cases of enamel defects presence, in addition to measuring the vertical dimension of occlusion (vdo). eoas scores will be computed and statistically analyzed for deciduous dentition with a significance level of p\<0.05.


Eligibility criteria:
inclusion criteria: * children from three to six years of age with complete deciduous teeth; * children regularly enrolled for dental care at the uninove pediatric dentistry clinic exclusion criteria: * children with amelogenesis or dentinogenesis imperfecta * children undergoing orthodontic treatment * children with a genetic syndrome
staphylococcus aureus skin and soft tissue infections

Conditions: Staphylococcus Aureus

Summary: the purpose of this study is to evaluate strategies to prevent staphylococcus aureus skin and soft tissue infections in soldiers during infantry training. this study will be conducted on three different bases among groups of male recruits to idf training base. they will provide nasal swabs to detect staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. after 14-30 days. all soldiers will be under surveillance for skin infection until the end of the training program.


Eligibility criteria:
inclusion criteria: * new recruit for a combat training unit
the safety and efficacy study of isu302 in patient with type i gaucher disease

Conditions: Gaucher Disease

Summary: the purpose of this study is to compare and evaluate the efficacy and safety of isu302, an investigational product, and cerezyme®, comparator, for type 1 gaucher disease patients


Eligibility criteria:
inclusion criteria: * the subjects have a diagnosis of type i gaucher disease * subjects between 2 years old and 75 years old * subjects documented with glucocerebrosidase deficiency * subjects with splenomegaly (as indicated by ct volumetric analysis as 5 times over than the standard size (0.2% of total body weight in kilograms)) * a hemoglobin concentration level:male \> 12 years of age \ 12 years of age\ 2 years of age and \<12 years of age \<10.5 g/dl * platelet count of \< 120,000 / ㎣ * treatment-naive to enzyme replacement therapy (ert) or treatment- experienced subjects who have not received ert in the 12 months before screening and antibody test result is negative * treatment naive to substrate reduction therapy (srt) or treatment- experienced subjects who have not received srt in the 12 months before screening * subjects or their spouses who provide consent to use one of following contraception methods, or women in menopause. (in this case, menopause is defined as a period after 12 months from the last menstruation) * condoms, sponge, foams, jellies, diaphragm, or intrauterine device (spouse or patient who had vasectomy or tubal ligation/ hysterectomy) * total abstinence from sexual intercourse: female patient using oral contraceptives must use other contraception method (barrier method) also during the trial period and after the completion of trial as well as up to 90 days from the conclusion of trial. * the subject or their legal representative has signed the informed consent. exclusion criteria: * treatment with any investigational product in 90 days before study entry * partial or total splenectomy * subjects who have a serious concurrent disease like infection or who abuse addictive drug and substances. * pregnant and/or breast-feeding women * presence of hepatitis b surface antigen or hepatitis c or the patients show positive reaction to human immunodeficiency virus (hiv) type1 * subjects with a history of allergic reaction to imiglucerase * subjects with a history of severe pulmonary hypertension caused by gaucher disease * any subject whom the investigator or the sub investigator considers as inad equate for this trial

Keywords: type i gaucher
effects of inhaled bicarbonate on airway ph in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

this study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Eligibility criteria:
inclusion criteria: 1. fev1 greater than 50% predicted. 2. ability to spontaneously expectorate sputum (with or without chest physiotherapy). 3. stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment. exclusion criteria: 1. reactive airway disease 2. use of inhaled hypertonic saline in the past 28 days 3. use of iv antibiotics in the past 4 weeks 4. changes in cf-related medications in the four weeks prior to study screening 5. spo2 \< 94% on room air or use of supplemental oxygen. 6. presence of untreated gastroesophageal reflux disease (gerd) or residual acid reflux symptoms in cases of treated gerd more than three times per week. 7. pregnant or nursing females.

Keywords: thick mucus obstructive lung disease
decisional process in male fertility preservation

Conditions: Infertility; Quality of Life; Cancer

Summary: the survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on 1. patient and parent feelings about fertility preservation counselling 2. influence of the emotional state of patients and parents on fertility preservation acceptance 3. support of medical staff and family the study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations

questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the cliniques universitaires saint luc) between january 2005 and may 2013. three different questionnaires, for children (\<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.

Eligibility criteria:
inclusion criteria: * prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013 exclusion criteria: * none
daily protein intake distribution and mps (arciii)

Conditions: Overweight

Summary: to determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis


Eligibility criteria:
inclusion criteria: * overweight/obese (bmi 27-40 kg/m2) * non-smokers * non-diabetic * no history of hyperlipidemia * not taking medications thought to interfere with study * considered generally healthy exclusion criteria: * efforts to lose weight in previous 16 weeks * hyperlipidemia * blood pressure ≥ 140/90 mmhg * smoking * heart and other organ disease * type 2 diabetes * gastrointestinal disease * orthopedic injury interfering with exercise * use of certain medications (hrt, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. simvastatin and zocor)
dynamic critical congenital heart screening with addition of perfusion measurements

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to implement and externally validate an inpatient ml algorithm that combines pulse oximetry features for critical congenital heart disease (cchd) screening.

the study will externally validate an algorithm that combines non-invasive oxygenation and perfusion measurements as a screening tool for cchd. in a previous study, the investigators created an algorithm that combines non-invasive measurements of oxygenation and perfusion over at least two measurements using machine learning (ml) techniques. the prior model was created and tested using internal validation (k-fold validation). thus, the investigators will test the model on an external sample of patients to test generalizability of the model. additionally, the team will trial a repeated measurement for any "failure" of the screen to assess impact on the false positive rate. study team will also use repeated pulse oximetry measurements (up to 4 total and including measurements after 48 hours of age, which may be done outpatient) to create a new algorithm that incorporates new data over time. the central hypothesis is that the addition of non-invasive perfusion measurements will be superior to spo2-alone screening for cchd detection and a model that incorporates repeated measurements will enhance detection of cchd while preserving the specificity.

Eligibility criteria:
inclusion criteria: * age \< 22 days * fetuses suspected to have congenital heart disease * newborns with suspected/confirmed critical congenital heart disease * asymptomatic newborn undergoing spo2 screening for cchd exclusion criteria: * echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing spo2 screening for cchd" * for newborns with confirmed/suspected congenital heart disease (chd): a) patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) corrective cardiac surgical or catheter intervention performed before enrollment or c) current infusions of vasoactive medications other than prostaglandin therapy.

Keywords: machine learning algorithm pulse oximetry