Kornimate/medical-research-clean huggingface dataset:
comparative study of cardiopulmonary exercise test land versus water

Conditions: Congestive Heart Failure

Summary: at the neck level immersion, the water pressure causes significant displacement of blood from the lower limbs to the intrathoracic circulation, triggering adaptive physiological responses due to the increase in central blood volume and consequent cardiovascular burdens. immersion in warm water breaks the homeostasis, stimulates regulation mechanisms and responses of organs and systems beneficial to healthy and heart failure individuals. in literature there are a growing number of studies demonstrating the efficacy of exercises performed in the water.

this study is about to compare the responses of one effort in two different environment. a group of 90 men, age between 55 to 75 years old recruited after a medical consultation, with the diagnostic of congestive heart failure (chf), under treatment at the institute of medicine and rehabilitation and institute dante pazzanesi, considered clinically stable (no cardiac symptoms or changes in medication for at least 30 days) and funcional class i, ii, iii according to nyha. experimental design: patients will perform an test, first on land, and in a week time in a underwater treadmill. the data will be collected in four distinct moments: 1- anaerobic threshold (at), 2- respiratory compensation point (rcp), 3- maximal effort (me) and recovery (r). we will compare the following variables: test total time; perceived exertion scale (borg); heart rate (hr); oxygen consumption (vo2); carbon dioxide production (vco2); oxygen pulse (vo2/fc); the ventilatory efficiency (ve/vo2) and (ve/vco2); respiratory quotient (vco2/vo2); systolic and diastolic blood pressure; electrocardiographic changes, compatible with ischemia or arrhythmia.

Eligibility criteria:
inclusion criteria: patientes, 55 - 75 year, with congestive heart failure (chf)functional class i - ii and iii according to the new york heart association (nyha) and injection fracion 32% to 38% exclusion criteria: any peripheral artery disease, diabetes, pulmonary disease, hypertension (blood pressure \>160/90) or significant cardiovascular morbidity.

Keywords: ergospirometry cardiopulmonary exercise test exercises immersion
the safety and efficacy of spd465 in adults with attention deficit hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: this is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of spd465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with adhd. the controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.


Eligibility criteria:
inclusion criteria: * adult men and non-pregnant women between the ages of 18 and 55 * confirmed diagnosis of adhd as defined by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) * baseline adhd score of at least 24 exclusion criteria: * weight less than 100 pounds or greater than 250 pounds * psychiatric diagnosis such as a severe comorbid axis ii or axis i disorder * pregnancy or breastfeeding * history of seizures * positive urine drug screen
pharmacosurveillance data repository of patients with and without history of anaphylactic reactions subsequent to xolair dosing

Conditions: Allergic Asthma

Summary: this study will establish a clinical data and serum repository of anaphylaxis cases associated with xolair administration and control patients who have received xolair without associated anaphylaxis. this is an observational repository and not an investigational clinical trial. associated with the repository is an optional skin testing substudy.


Eligibility criteria:
inclusion criteria for cases: * confirmed anaphylaxis based on sampson criteria subsequent to xolair inclusion criteria for controls: * at least 1 patient control among 4 controls who discontinued xolair for at least 16 weeks but not more than 18 months at enrollment * at least one dose of xolair in the 18 months before the date of the case event (index date) * no prior anaphylaxis or other hypersensitivity reaction subsequent to xolair dosing, including any reactions to its components

Keywords: asthma anaphylaxis
malnutrition clinical characteristics validation and staffing optimization study (mcc study)

Conditions: Malnutrition

Summary: the purpose of this study is to establish the validity of the adult and pediatric malnutrition clinical characteristics (mcc). in addition, this project will: examine the relationship between the mcc and an objective measure of body composition; and establish the relationship between in-patient registered dietitian nutritionist (rdn) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. the total number of participants enrolled across the 120 facilities will be between 2400-9600. the aims of the study include: 1. assess the interrater reliability of the mcc. 2. determine the predictive validity of the adult and pediatric mcc relative to a portfolio of patient medical outcomes. 3. determine the relationship between the adult and pediatric mcc and body composition measurements conducted via bioelectrical impedance analysis (bia) in a subset of patients. 4. identify the utility of bia for body composition analysis in clinical settings. 5. estimate the level of rdn care necessary to improve patient outcomes within the portfolio of outcomes. specifically: quantify the dose (minutes of care and frequency of encounters) of rdn care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders. 6. identify the additional level of rdn care necessary to improve the medical outcomes in patients who have been identified as malnourished using the mcc.


Eligibility criteria:
inclusion criteria: * adult and pediatric acute care patients at participating facility * newly identified as needing in-patient nutrition care through current facility policy * receive initial nutrition care one day before study enrollment day * patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated * patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent * patient and/or parent, legal guardian or legally authorized representative are fluent in english or spanish exclusion criteria: * received nutrition care previously during current admission * pregnant women * prisoners * infants currently in the neonatal intensive care unit (nicu) with a diagnosis of prematurity * neonates of uncertain viability or non-viable neonates * patients receiving palliative/hospice care * patient admitted for long-term acute care (ltac)
role of ultrasound in diagnosis of acute abdomen in pediatric group

Conditions: Ultra Sound in Diagnosis of Acute Abdomen in Pediatric Group

Summary: acute abdomen can be defined as "a syndrome induced by wide variety of pathological conditions that require emergent medical or more often surgical management" \[1\].there are a plethora of causes that can lead to acute abdomen in children, they vary depending on the ages of the children and can be divided into diseases that can be treated with medical care and those in which emergency surgical intervention must be considered \[2\]. ultrasonography is the initial choice in the diagnosis of the different causes of acute abdomen in children \[3, 4\]. it is very useful as it is non-invasive, cost- effective, repetitive, with no radiation exposure, as good as laparoscopy, can be done even in patients with scarred abdomen \[5\].

-patient preparation: * no specific preparation is needed. * demographic data including age, sex, detailed history, clinical presentation, laboratory tests, and data of any other investigations or operation will be obtained. * clinical examination will be done in emergency pediatric unit for provisional diagnosis. -study instruments:• patients will examined by grey-scale ultrasonography (u/s) combined with color doppler ultrasonography (cdus). 3-technique of examination * will be in supine position. * patient first examination of whole abdomen will be done by grey -scale u/s using both 3.5 mhz and 7.5 mhz transducers .it will be done in both longitudinal ( parallel to long axis of the patient ) and transverse ( perpendicular to long axis of the patient ) orientation . * then finally examination by color doppler us will be done for assessment of organ perfusion and diagnosing inflammation.

Eligibility criteria:
inclusion criteria: * -in this study, 100 patients referred from the emergency pediatric unit for the assessment of the cause of acute abdomen. exclusion criteria: * - patients of age group above 18 years * patients with trauma.
foot and ankle range of motion (stretching) apparatus

Conditions: Plantar Fasciitis; Flatfoot; Calcaneus Fractures

Summary: range of motion at ankle joint and subtalar joint will be assessed before and after utilization of arm device. the changes in range of motion will be recorded and compared to literature.

the purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization. project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization exclusion criteria: * not physically able to use device * patients with pain disorders * patients lacking necessary hand-eye coordination * patients using lower extremity external fixator * patients with history of non-compliance

Keywords: range of motion ankle fractures elderly patients
randomized placebo-controlled study of l. reuteri ncimb 30351 in gi functional disorders and food allergy in newborns

Conditions: Infantile Colic; Constipation; Infantile Diarrhea; Gastro Esophageal Reflux

Summary: this study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug lactobacillus reuteri ncimb 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive. the aim of the study is to assess clinical effects of probiotics lactobacillus reuteri ncimb 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed. a prospective study comparing two treatment groups: group 1 (treatment group) - 60 infants. group 2 (control group) - 30 infants, placebo. the study drug will be taken in 1 time per day within 25 days. allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.


Eligibility criteria:
inclusion criteria: 1. parents / guardians speak russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (icf). 2. vaginal delivery. 3. full-term newborn. 4. age at the time of the signing of informed consent form 1-4 months 28 days. 5. breast- and formula-fed infants. 6. colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms). 7. infant does not have other deviations in health, which would require the appointment of a specialized diet 8. parents / guardians can and ready to regularly fill out the proposed diary form. exclusion criteria: 1. born by cesarean section. 2. premature newborn. 3. congenital abnormalities or other clinical manifestations that may interfere with the study. 4. lactase food supplements. 5. other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
cognitive remediation for schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.

schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. the personal, social and economic costs of this illness are enormous. neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (bellack, gold \& buchanan; 1999; green, 1996). while standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (keefe et al., 1999). hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation. the purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: computer assisted cognitive remediation (cacr). fifty individuals with schizophrenia and related disorders will be recruited and randomly assigned to one of two conditions: a) 36 sessions of cacr; or b) 36 sessions of a manualized computer control condition (rc). the efficacy of cacr will be assessed on behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. we hypothesize that cacr will be more effective than the control treatment in each domain.

Eligibility criteria:
inclusion criteria: 1. diagnosis of either schizophrenia or schizoaffective disorder according to dsm-iv criteria 2. age 18 through 50 3. subjects will be clinically stable as judged by current outpatient or inpatient treatment staff 4. primary psychiatric medication is a new generation antipsychotic other than clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment. exclusion criteria: 1. documented history of organic brain disease 2. documented history of mental retardation 3. physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises 4. diagnosis of current substance dependence according to dsm-iv criteria 5. participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).

Keywords: treatment cognition schizophrenia
the effectiveness of manipulation treatment in cervical region

Conditions: Neck Pain

Summary: neck pain is the second most common musculoskeletal pain after lumbar pain. prevalence is 27.2% female and 17.4% in male population (1, 2). approximately 1/3 of acute onset neck aches become chronic. it causes increasing the cost of treatment and also the loss of labor (3, 4).

acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. a-v malformation and syringomyelia are the causes of chronic cervical pain (5). mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10). the pain in the head and neck region affects the quality of life, cognitive and functional status of the person. the most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). in most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).

Eligibility criteria:
inclusion criteria: * clinical diagnosis nonspecific neck pain (nsnp) * symptoms should last longer than 2 weeks exclusion criteria: * any known cause such as radiculopathy or neurological diseases, * history of neck surgery, * history of vertebral fracture, * osteoporosis, * tumor or a mass in the vertebral column, * any spinal thrust manipulation contraindication, * medication usage such as antiinflammatory or analgesic which might effect outcome assessments, * history of spinal manipulation

Keywords: tape pain rehabilitation
the effect of im testosterone undecanoate on biochemical and anthropometric characteristics of metabolic syndrome in hypogonadal men

Conditions: Metabolic Syndrome; Hypogonadism

Summary: the objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.


Eligibility criteria:
inclusion criteria: * a signed informed consent to participate in the study * men aged 35 to 70 with testosterone levels below 12 nmol/l or free testosterone below 225 pmol/l * presence of the metabolic syndrome according to the idf definition exclusion criteria: * patients under 35 or above 70 years. * participation in any clinical study within 30 days before the first injection of the drug * simultaneous participation in another clinical study * incapable subjects as well as prisoners * suspicion of a serious organic or mental disease according to medical history and/or clinical examination * prostate cancer, breast cancer or suspicion thereof * presence or history of hepatic tumors * acute or chronic hepatic disease * presence of renal diseases with renal failure * changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion * suspected lack of the patient's compliance * hypersensitivity to the active substance

Keywords: metabolic syndrome hypogonadism testosterone undecanoate
substrate and trigger ablation for reduction of atrial fibrillation trial - star af ii study

Conditions: Atrial Fibrillation

Summary: this investigation is designed with the hypothesis that combined pv antral isolation and ablation of complex fractionated electrograms (pvi+cfe) approach will offer a higher success rate compared to the wide circumferential pulmonary vein antrum isolation (pvi) approach and to the combined pv antral isolation and empiric linear ablation (pvi+lines) approach.


Eligibility criteria:
inclusion criteria: * patients age is18 years or greater; * patients undergoing a first-time ablation procedure for af; * patients with persistent af; * persistent af will be defined as a sustained episode lasting \> 7 days and less than 3 years. * patients with symptomatic af that is refractory to at least one antiarrhythmic medication; * at least one episode of persistent af must have been documented by ecg, holter, loop recorder, telemetry, trans telephonic monitoring (ttm), or implantable device within last 2 years of enrollment in this investigation; * patients must be able and willing to provide written informed consent to participate in this investigation; and * patients must be willing and able to comply with all peri-ablation and follow-up requirements. exclusion criteria: * patients with paroxysmal af; * patients with long-standing persistent af; * patients for whom cardioversion or sinus rhythm will never be attempted/pursued; * patients with af felt to be secondary to an obvious reversible cause; * patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor; * patients with left atrial size ≥ 60 mm (2d echocardiography, parasternal long axis view); and * patients who are pregnant.
investigating the localization of consciousness through patients with disorders of consciousness: anterior vs. posterior cortex debate

Conditions: Disorders of Consciousness

Summary: patients enrolled in the study underwent five assessments using the crs-r(coma recovery scale-revised) within 10 days, along with an 18f-fdg-pet scan.

patients enrolled in the study underwent five assessments using the crs-r (coma recovery scale-revised) within 10 days, along with an 18f-fdg-pet (18f-fluorodeoxyglucose-positron emission tomography) scan. the crs-r evaluations were conducted by professionally trained and highly experienced personnel. during the crs-r assessments, patients' behavioral responses were recorded in the domains of visual, auditory, motor, oromotor/verbal, communication, and arousal. based on the optimal crs-r results obtained within the 10-day period, patients were categorized into mcs (minimally consciousness state, criteria: consistent command-following, reproducible responses to commands, object recognition, intelligible verbalization, partially accurate communication, object localization, visual pursuit and visual object localization, spontaneous motor responses, object manipulation, and/or localization to noxious stimulation) or uws (unresponsive wakefulness syndrome, criteria: preserved wakefulness accompanied by behavioral responses such as localization to sound, auditory startle, visual startle, withdrawal/flexion movements, abnormal posturing, vocalizations/oromotor movements, and reflexive oromotor responses). all patients exhibited stable vital signs. for data analysis, a healthy control group from belgium was included to compare brain metabolism between patients with disorders of consciousness and healthy individuals.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of disorders of consciousness after 5 crs-r assessments; * age \>18 years; * stable vital signs; * no use of sedatives or neuromuscular blockers within 24 hours prior to enrollment. exclusion criteria: * acute-phase patients (injury duration \<28 days); * fewer than 5 crs-r assessments completed within 10 days; * patients diagnosed with emcs (emerging minimally conscious state); * patients with unclear diagnoses (cases where experienced evaluators could not reach a consensus diagnosis); * patients with persistent seizures.

Keywords: disorders of consciousness mcs pet uws