Kornimate/medical-research-clean huggingface dataset:
central venous pressure change with volume challenge in patients with hemodynamic instability

Conditions: Acute Circulatory Failure

Summary: we conducted this study to assess the value of early change in central venous pressure (cvp) in predicting fluid responsiveness in mechanically ventilated patients.

in patients with shock a primary goal of treatment is to restore and maintain organ perfusion, for which an adequate cardiac preload is required. apart from the situations in which hypovolemia is evident and a favourable response to fluid administration will be seen, clinical and biological parameters often fail to predict hypovolemia. inappropriate use of volume expansion carries out the risk of generating volume overload and pulmonary oedema. consequently, reliable predictors of fluid responsiveness are needed especially in the early phase of cardiocirculatory deterioration. in the clinical setting, different static and dynamic indices have been shown to be useful indicators of cardiac preload. central venous pressure (cvp) is widely used to measure right ventricular preload in patients requiring invasive hemodynamic monitoring. however, the use of the cvp is much criticized because cvp poorly predicts cardiac preload and volume status. however several decades ago, weil and henning proposed the fluid challenge technique, based on the 2-5 rule using cvp. there is a method for guiding volume repletion based on measurements of the patient's response to fluid load. this method has not been validated in the prediction of fluid responsiveness. we therefore conducted a prospective study that in all patients we measured cvp change and stroke volume variation (svv) after administration of fluids. patients were classified as fluid responders when their svv is \>10% after volume expansion and non-responders if svv is ≤10%.

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients * acute circulatory failure defined by the need of vasopressive drugs (dopamine \>5µg/kg/per minute or norepinephrine) with signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output below 0.5 ml per kilogram of body weight per hour during at least 2 h). * admission serum lactate level more than 2.5mmol/l exclusion criteria: * severe hypoxemia defined as a ratio of arterial oxygen pressure to fraction of inspired oxygen \[pao2/fio2\] \< 100 mmhg

Keywords: acute circulatory failure hemodynamic stability hypovolemia
efficacy of topical liposomal form of drugs in cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: leishmaniasis with diverse clinical manifestations is caused by different species of leishmania and is endemic in many countries. although cutaneous leishmaniasis (cl) is a self-healing disease, but it takes a long time to heal. pentavalent antimonials are still the first-line treatment of cl which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. paromomycin sulfate (pm) reported to show anti-leishmania activity against both cl and visceral leishmaniasis (vl) since 1960s. therapeutic strategy with high efficacy is urgently needed especially for anthroponotic cutaneous leishmaniasis (acl). liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. several lipid-based formulations have been developed to treat experimental leishmaniasis. recently different doses of liposomal formulation of pm and liposomal formulation of glucantime were prepared and showed high efficacy in vivo against l. major infection in balb/c mice. in this study the efficacy of liposomal formulation of pm or liposomal formulation of glucantime in combination with systemic glucantime in the treatment of acl parasitologically proven patients will be evaluated. the clinical trial will be carried out according to the international approved gcp (good clinical practice) guide lines.


Eligibility criteria:
inclusion criteria: * male or female aged between 12 to 60 years. * parasitologically proven cl due to l. tropica. * history of failure to at least one full course of systemic glucantime. * in general good health based on history and physical examination. * number of lesion at most 4. * lesion size less than 3 cm. * signed informed consent voluntarily and knowingly. * guardian's signature for volunteer less than 18 years old. exclusion criteria: * pregnant or lactating women and those who are planning to be pregnant in next 60 days. * use of other types of treatment for cl. * involvement in any other drug or vaccine trial during the study period. * known heart, kidney, liver diseases based on history and physical exam. abnormal ecg.

Keywords: cutaneous leishmaniasis caused by l. tropica
internet-based emotion regulation intervention for sexual health

Conditions: Sexual Dysfunction; Sexual Dysfunctions, Psychological

Summary: introduction: emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. only recently have the effects of these interventions on sexual health started to be investigated. internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. the aims of the sher 2 study are: a) determine the efficacy of an internet-based emotion regulation intervention for sexual health and sexual satisfaction, and; b) explore the effects of the intervention on (1) emotion regulation skills; (2) mental health; (3) sexual self-perception.


Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age, * fluent in brazilian portuguese, * self-reported sexual problems, assessed in men by a score of \< 21 on the international index erectile function (iief) and in women by a score of \< 26 on the female sexual function index (fsfi), * in a stable relationship for at least the preceding 3 months. exclusion criteria: * medical conditions that can interfere with the outcomes of the intervention, e.g., diabetes, cancer, cardiovascular problems, * ongoing psychotherapy. * no sexual activity in the previous 4 weeks.

Keywords: internet intervention emotion regulation sexual health
rheum@home: ra remote patient monitoring

Conditions: Rheumatoid Arthritis

Summary: the goal of this pragmatic multicentre clinical trial is to investigate whether telemonitoring with rheum@home leads to less outpatient visits, while maintaining tight disease control and high patient-experienced quality of care in patients with rheumatoid arthritis. participants will be asked to * complete questionaires every 4 weeks * perform a walking test every 4 weeks * routine lab * routine disease activity measurement by a qualified assessor researchers will compare care via the telemedicine system (intervention) or standard care (control) to see if there are differences in the number of rheumatology outpatient visits and patient reported quality of care after 12 months follow up.


Eligibility criteria:
inclusion criteria: * all consecutive patients; * signed, written informed consent; * 18 -75 years of age; * clinical diagnosis of ra; * ≥ 6 months stable low disease activity or remission, according to the treating rheumatologist; * able to read and understand simple dutch language instructions; * ownership or access to a smartphone, tablet or computer and having internet access; * able to conduct a teleconsultation on a smartphone, tablet or computer. exclusion criteria: * severe comorbidity or other factors necessitating continuation of regular outpatient visits, according to the treating rheumatologist
efficacy of serum bovine immunoglobulin in improving nutritional status in advanced copd

Conditions: Advanced COPD (GOLD Stage 3 or 4) With Cachexia

Summary: this study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (sbi), in helping patients with advanced copd with cachexia (a wasting syndrome) improve their nutritional status and gain weight. the medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. the primary hypothesis is that sbi protein isolate (sbi) will improve the nutritional status of cachexic patients with advanced stages of copd.


Eligibility criteria:
inclusion criteria: * age between age 30 and 80 at baseline visit * diagnosed with 2012 spirometric copd gold stage 3 (fev1/fvc ratio \<0.70, fev1 30-49% of normal) or gold stage 4 (fev1/fvc \<0.70, fev1 \<30% of normal or fev1\<50% of normal with chronic respiratory failure present) * able to tolerate and willing to undergo study procedures * body mass index below 21 * signed informed consent exclusion criteria: * history of comorbid condition severe enough to significantly impact 6 months outcomes * current substance abuse, including tobacco, alcohol and illicit drugs * diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia * dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures * active pulmonary infection with tuberculosis * non-copd obstructive lung disease (various bronchiolitides, sarcoidosis, lam, histiocytosis x) or parenchymal lung disease, pulmonary vascular disease, pleural disease, severe kyphoscoliosis, neuromuscular weakness, or other cardiovascular and pulmonary disease, that limit the interpretability of the pulmonary function measures * prior significant difficulties with pulmonary function testing * hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers, or to beef * history of lung or other organ transplant * currently taking \>20mg of prednisone or equivalent systemic corticosteroid * currently taking any immunosuppressive agent * history of lung cancer or any cancer that spread to multiple locations in the body * known hiv/aids infection * history of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures. * current or planned pregnancy within the study course. * currently institutionalized (e.g., prisons, long-term care facilities)

Keywords: gold, copd, cachexia, bmi
vitamin c & thiamine to treat sepsis and septic shock

Conditions: Sepsis; Septic Shock

Summary: investigators propose to investigate the use of iv vitamins b1 and c in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

investigators propose to investigate the use of iv vitamins b1 and c in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.

Eligibility criteria:
patients must meet all inclusion criteria: 1. between the ages of 18 and 90 years old 2. have severe sepsis or septic shock. severe sepsis and septic shock will be defined by the surviving sepsis 2012 guidelines. 3. weight more than 30 kg 4. full code exclusion criteria: 1. not diagnosed with severe sepsis or septic shock 2. younger than 18 or older than 90 years old 3. with a history of nephrolithiasis 4. who are pregnant 5. weigh less than 30 kg 6. not located in the icu 7. do not resuscitate (dnr) or do not intubate (dni), no escalation of care, or comfort measures only (cmo) 8. currently on dialysis

Keywords: sepsis septic shock vitamin c thiamine
computational modeling for prediction of acoustic changes in vowel production due to orthognathic surgery

Conditions: Jaw Deformity; Facial Asymmetry

Summary: a computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3d-images of the speaker's anatomy and the simultaneous recording of speech. since the computational model has separate models for the vocal folds and the vocal tract, patients undergoing an orthognathic surgery is an optimal test object for the model development. vocal folds remain unchanged while substantial changes take place in the vocal tract. moreover, since the aim of the research is to predict acoustic changes in speech due to operations in head neck area, the orthognathic patient group is par excellence an example of such a prediction problem. if the model can be shown to give valuable information pre-operationally, many other patient groups could benefit from the results.

orthognathic surgery deals with the correction of abnormalities of the facial tissues. the underlying cause for abnormality may be present at birth or acquired during the life as the result of distorted growth or trauma. orthodontic treatment alone is not adequate in many cases due to severity of the deformities. in a typical operation, the position of either one jaw (mandible or maxilla) or both jaws is surgically changed in relation to the skull base. the movement of the jaw position varies usually between 5-15 mm either to anterior or posterior direction. such a considerable movement has a very profound effect on the shape and volume of vocal tract resulting detectable changes in acoustics. although the surgery involves mandibular and maxillary bone, changes occur also in the position and shape of respective soft tissues and hyoid bone, as well. for this project, 20 adult patients (10 women and 10 men) undergoing orthognathic surgery will be enrolled. exclusion criteria include diseases and conditions in which mri examination is contraindicated (.e.g. pace maker), severe speech or hearing impairment, and other situations where the patient has difficulties with completing the tasks defined in the research protocol. furthermore, patients to whom segmental surgery of the jaws will be performed in connection of orthognathic surgery are excluded. a specific pre-selection criterion for patients is the presence of numerous dental amalgam fillings that may cause artifacts in mr images.

Eligibility criteria:
inclusion criteria: - healthy patients undergoing orthognathic surgery exclusion criteria: * patients with conditions in which mri examination is contraindicated (e.g. pace maker) * patients who require several operations or segmented jaw surgery * patients with cognitive impairment * patients with numerous dental amalgam fillings that may cause artifacts in mr images

Keywords: orthognathic surgery speech production mri
safety and efficacy study of recombinant human insulin-like growth factor-i/recombinant human insulin-like growth factor binding protein-3 (rhigf-i/rhigfbp-3) in myotonic dystrophy type 1

Conditions: Myotonic Dystrophy Type 1

Summary: to investigate the effects of rhigf-i/rhigfbp-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in dm1 patients

efficacy measures: endurance, ambulation, cognitive function, insulin resistance, cholesterol and triglycerides, muscle function and strength, pain, gastrointestinal function, quality of life minimum inclusion criteria 1. a diagnosis of dm1, confirmed by dm1 genetic mutation 2. age 21 to 65 years (inclusive) 3. ability to walk 30 feet - assistance with cane and/or leg bracing permitted 4. able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Eligibility criteria:
inclusion criteria (list is not inclusive): * a diagnosis of dm1, confirmed by dm1 genetic mutation * ability to walk 30 feet - assistance with cane and/or leg bracing permitted * able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication exclusion criteria (list is not inclusive): * congenital dm1 * weight greater than 100 kg or body mass index greater than 30 kg/m2 * prior treatment with glucocorticoids, anabolic steroids, testosterone, growth hormone, investigational agent within 60 days of screening * current diagnosis or history of malignancy expect for surgically cured skin cancer or pilomatricoma * changes in lipid lowering medications during the 3 months prior to screening * diaphragmatic weakness such that patients are unable to tolerate the supine position, or swallowing impairment such that patients are unable to maintain nutrition without use of gastrostomy. * major psychiatric illness (major depression, bipolar disorder or schizophrenia) within twelve months of screening * history of non-compliance with other therapies
a study of ly3819469 in participants with impaired and normal renal function

Conditions: Renal Insufficiency; Healthy

Summary: the main purpose of this study is to assess the amount of study drug (ly3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. the safety and tolerability of ly3819469 will also be evaluated in these participants. the study will last up to 17 weeks including screening period.


Eligibility criteria:
inclusion criteria: * have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²) * men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (wnocbp) may participate in this trial participants with normal renal function: * have estimated glomerular filtration rate (egfr) determined by chronic kidney disease epidemiology collaboration (ckd-epi) greater than or equal to 90 milliliter per minute (ml/min) participants with renal impairment: * severe renal impairment: have egfr determined by ckd-epi of less than 30 ml/min and not requiring dialysis * esrd: participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing exclusion criteria: * have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition * have any abnormality in the 12-lead electrocardiogram (ecg) * hemoglobin less than 8 grams per deciliter (g/dl) and clinically significant anemia symptoms * have known allergies to ly3819469, related compounds or any components of the formulation, or a history of significant atopy * have participated in any lp(a) sirna therapeutic clinical trial within the last 1 year
using a dissolved oxygen enriched dressing in nipple-sparing mastectomy

Conditions: Breast Cancer; Reconstructive Breast Surgery

Summary: this study will evaluate the effect of oxygenesys dissolved oxygen dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.

this study will recruit women who are undergoing a bilateral mastectomy for either cancer or a positive brca gene. women will be randomized to a different treatment per breast. one breast will receive the oxygenesys dressing and the other will receive the standard gauze dressing. the study will evaluate wound complication rates and compare the two treatments.

Eligibility criteria:
inclusion criteria: * subject is able to give written consent * females \>21 years of age * at least one breast diagnosed with cancer or mastectomy due to a positive brca gene mutation test. * subject is indicated for bilateral nipple-sparing mastectomy surgery with immediate breast reconstruction * subject is able to comply with the study protocol exclusion criteria: * primary tumor(s) located within 2cm of the areola margins * inability to perform follow up assessments * radiation treatment within 30 days of surgery * dermabond or other forms of surgical glue is used in the peri-areola region * subjects who are known to be allergic to any of the test product(s) or any component of the test product(s) * women who are pregnant * subjects who have been treated with an investigational drug or device within the past 30 days prior to enrollment

Keywords: nipple-sparing mastectomy nsm nipple sparing mastectomy
chest and abdominal wall strapping in infant with bronchiolitis

Conditions: Bronchiolitis

Summary: bronchiolitis is the most common cause of admission to the paediatric intensive care unit (picu) for respiratory distress. the care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). the lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction. infant \< 6 month with severe bronchiolitis admitted to the picu will be recorded in 4 conditions with or without chest wall strapping and with a continuous positive airway pressure (cpap) at 7 cmh2o or without cpap. physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.


Eligibility criteria:
inclusion criteria: * infant \< 6 months * admitted to the picu for less than 48 hours * with a diagnosis of bronchiolitis * with a respiratory distress sign (mwcas ≥ 3) and non-invasive ventilatory support * with a naso or oro gastric tube for feeding * with written informed consent from parents or legal guardians exclusion criteria: * infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease * contraindication to the use of a gastric tube * recent abdominal or thoracic surgery * investigator able to perform physiological recording not available * patient who is not affiliated (or does not benefit from) to a national social security system

Keywords: bronchiolitis work of breathing non-invasive ventilation infant