Kornimate/medical-research-clean huggingface dataset:
accuracy of pulse oximeters with profound hypoxia at rest (niho19)

Conditions: Hypoxia

Summary: the aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. study will be used with patients at rest.

this study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by nihon kohden corporation sufficiently to support performance claims for an fda 510k submission or iso technical file. specifically, spo2 and pulse rate accuracy will be assessed for a nihon kohden olv-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria:
inclusion criteria: * both male and female subjects who can give written informed consent * healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below * meeting the demographic requirements exclusion criteria: * age below 18 or over 50 * pregnant women * significant arrhythmia * blood pressure above 150 systolic or 90 diastolic * carboxyhemoglobin levels over 3% * subjects whom the investigator consider ineligible for the study
chewing gum on postoperative ileus in children

Conditions: Bowel Ileus; Flatus

Summary: traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. this approach includes earlier mobilization of the patient, and introducing solid food sooner. additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier. the aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.

after intestinal surgery, many patients suffer from a "postoperative ileus" (poi). the cause is multifactorial and can be attributed to surgery itself, the lingering effect of the anesthetic, the use of narcotics and decreased mobility of the patient. an ileus can delay the time to full diet, thus lengthening the hospital stay of the patient - sometimes up to several weeks. there is evidence that early drinking/eating and increased mobility may accelerate the return of bowel function. "fast-tracking" is well documented in the adult literature; protocols have been put in place to enhance gi tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus. "fast-tracking" has been done in pediatric patients but not in a large rct for abdominal surgery.

Eligibility criteria:
inclusion criteria: * children more than or equal to 4 years of age * children who undergo abdominal surgery (both laparoscopic or open) * children who have an expected postoperative length of stay more than 24 hours exclusion criteria: * children who are less than 4 years of age * children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability) * children or their parents are not willing to sign consent * children or their parents are unable to follow directions regarding gum chewing, * children who have a gi dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)
study of the progression of bacterial conjunctivitis symptoms upon antibiotic treatment

Conditions: Bacterial Conjunctivitis

Summary: the primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.


Eligibility criteria:
inclusion criteria: 1. diagnosis in one or both eyes of bacterial conjunctivitis based on: * symptoms less than or equal to 24 hours prior to first visit * rating \> or equal to 1 for bulbar conjunctival injection * must have a rating \> 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at visit 1, and 2. must experience some matting in the affected eye(s). 3. 1 year of age or older, of any race and either sex 4. able to understand and sign an informed consent that has been approved by an institutional review board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation. 5. must agree to comply with study visit schedule, photographs and other study requirements. if subject is a minor, the parent or guardian must agree to ensure compliance. exclusion criteria: 1. cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for \> 24 hours. 2. any current lid disease on clinical examination. 3. known or suspected allergy or hypersensitivity to fluoroquinolones. 4. suspected fungal, viral (e.g. herpes simplex) or acanthamoeba infection, based on clinical observation. 5. any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency). 6. use of topical ocular medications during the study period. 7. antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study. 8. women of childbearing potential not using reliable means of birth control. 9. women who are pregnant or lactating. 10. enrollment of more than one person per household at the same time. 11. enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals. 12. participation in any investigational drug or device study within 30 days of entering this study.

Keywords: bacterial conjunctivitis
restore-b: a trial comparing prepectoral implant-based breast reconstruction with and without mesh

Conditions: Breast Cancer; Risk Reduction

Summary: the goal of this feasibility randomised controlled clinical trial (rct) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk. the main questions it aims to answer are: * to determine the feasibility of a definitive rct comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction. * to determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction. participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. participants will be blinded to their allocation until day 90 post operatively. participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.

trial design: restore-b is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery. patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted). planned trial period: the overall period of the trial is: 12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results. trial participants: women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery intervention: immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (adm or synthetic). comparator: immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (adm or synthetic) (standard of care).

Eligibility criteria:
inclusion criteria: * women \> 18 years * participant is able and willing to give informed consent for participation in the trial * eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery. * in the investigator's opinion, can comply with all trial requirements. exclusion criteria: the participant may not enter the trial if any of the following apply: * participant is pregnant, lactating or planning pregnancy during the trial * patient refusal * delayed breast reconstruction post simple mastectomy

Keywords: breast surgery breast reconstruction prepectoral implant mesh acellular dermal matrix
rescue emetic therapy for children having elective surgery

Conditions: Post Operative Nausea and Vomiting; Rescue Emetic Therapy

Summary: to compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a "rescue therapy" for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. we hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective "rescue therapy" in children having surgery in an ambulatory surgery center. 1. problem: despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (pov). goal: to determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation. 2. hypothesis: anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy." 3. hypothesis: metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as "rescue therapy."


Eligibility criteria:
inclusion criteria: 1. pediatric patients 3-17 years old 2. patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration, 3. patients receiving a general anesthetic (inhaled agent without nitrous oxide) with pov prophylaxis with two agents (ondansetron and dexamethasone) 4. post operative vomiting in pacu or second stage recovery requiring antiemetic rescue. exclusion criteria: 1. vomiting in the past 24 hours or antiemetics in previous 24 hours 2. allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine 3. patients with diabetes 4. patients with seizures 5. patients receiving a benzodiazepine premedication

Keywords: ponv post operative nausea and vomiting rescue emetic therapy
bayer/cognitive assessments with multiple sclerosis subjects

Conditions: Multiple Sclerosis, Relapsing-remitting; Multiple Sclerosis, Secondary Progressive

Summary: this study is designed to identify a brief screening evaluation for ms patients that is sensitive and specific to the ms population and which correlates with the findings of our standard-of-care neuropsychological assessments.

seventy five randomly identified patients will be evaluated. consenting patients will perform a symbol digit modalities test (sdmt) and have the ms center´s standard neuropsychological assessment performed. tests comprising the standard assessment will be the rbans (randolph, 1998), multiscore depression inventory, cross and clock drawings. the selfreported beck depression inventory (bdi-ii) will also be obtained. an expanded disability status scale (edss) will be recorded for each patient. the rbans consists of six scales labeled (1) immediate memory, (2) visuospatial/ constructional, (3) language, (4) attention, (5) delayed memory, and (6) total. depression will be assessed by the bdi and the multiscore depression inventory. the sdmt will be administered using standard instructions either orally or in writing. use of the established norms for the sdmt will be used to determine if the ms patient is demonstrating some cognitive dysfunction. scores less than 1.0 to 1.5 standard deviations below mean are suggestive of cerebral dysfunction. the results will be controlled for age, gender, and educational level. additionally, the results of the 75 patient assessments will be reviewed to see the concordance between the results of the sdmt and the neuropsychological battery. the association of cognitive dysfunction as identified by the sdmt will be correlated with each of the six rbans scales and other parameters of the cognitive aspects of the battery. statistical analysis will determine the sensitivity and specificity of the sdmt in determining abnormalities as well as an optimum cutpoint. this analysis will indicate possible cognitive problems and the need for further testing and, potentially, intervention.

Eligibility criteria:
inclusion criteria: * edss at last visit ≤ 7.0 * relapsing/remitting or secondary progressive ms exclusion criteria: * severe depressive illness: beck depression inventory score \> 55. * unable to read with/without glasses- visual acuity better than or equal to 20/60 in one eye. * unwilling to sign informed consent. * evidence on clinical examination of severe dementia at discretion of evaluating neurologist.
mindfulness - based stress reduction and the relationship on inflammation in autoimmune hepatitis

Conditions: Autoimmune Hepatitis

Summary: the study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction (mbsr) intervention on patients with autoimmune liver disease specifically autoimmune hepatitis type i. mbsr is a standardized intervention that has shown benefit in addiction disorders and other psychiatric disorders. there has been no study evaluating or showing the benefit of the use of mbsr in autoimmune liver disease. with published data showing the evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized that such an intervention such as mbsr may have therapeutic effect in patients with autoimmune liver disease.

with the understanding that autoimmune hepatitis has a relationship with psychological stress, the use of a strategy such as mindfulness stress based reduction (mbsr) may similarly have a substantial impact as seen in other disease conditions. the proposed hypothesis is that undergoing mbsr has potential to benefit patients with autoimmune hepatitis in relation to decreased relapse rate and ultimately improved quality of life. the focus of this study is surrounding the possibility of psychosocial stress for relapse in aih. the investigators, however, would like to also understand the role of serological testing at the time of these relapses and during states of psychosocial stress to demonstrate if the association can be found. during active disease activity or relapses of autoimmune hepatitis, there is an expected rise in alanine aminotransferase (alt) and immunoglobulin g (igg) levels. demonstrating the correlation of alt and igg with disease status and possible improvement with stress modifications is also key for this proposed study.

Eligibility criteria:
inclusion criteria: * between ages 18-80 years * diagnosis of autoimmune hepatitis type i exclusion criteria: medical * hospitalization in the last 30 days * new immunosuppression agent started \<6 weeks prior to study * patients with concurrent viral hepatitis and/or alcoholic liver disease * patients with decompensated cirrhosis (defined as ascites, encephalopathy, variceal hemorrhage) * patients with hepatocellular carcinoma * patients post-liver transplantation psychological * any psychotic disorder or current psychiatric symptoms attitudinal * inability to commit to program schedule and attendance of classes physical * inability to physically attend classes; disability or physical impairment not included as an exclusion criteria other * inadequate english proficiency * inability to read and/or write
application of high flow nasal cannula for prevention of post-extubation atelectasis in children undergoing surgery

Conditions: Atelectasis

Summary: postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation

after surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device

Eligibility criteria:
inclusion criteria: * general anesthesia exclusion criteria: * preterm * bronchopulmonary dysplasia * upper respiratory infection history * respiratory disease * cardiac surgery
effects of ground-based walking training in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: pulmonary hypertension (ph) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmhg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. ph characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. it is recommended that patients with ph should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. ground-based walking training is a safe and effective method for copd patients. in the literature, there are no studies evaluating the effects of ground-based walking training in ph patients.

the aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with ph.

Eligibility criteria:
inclusion criteria: * 18-80 years * diagnosed with ph * followed by the department of chest diseases at least six months * not participating in the rehabilitation program in last year exclusion criteria: * functional group four due to who functional classification * ph due to left heart diseases, ph due to lung diseases and/or hypoxia * treatment and medication change in the last three months * cooperation problems * patients with successful pulmonary endarterectomy operation * smoking * patients with uncontrolled cardiovascular diseases * patients with orthopeadic and/or neurologic disorders that could limit exercise tests * syncope history in recent

Keywords: pulmonary hypertension walking training exercise balance quality of life
study to assess darbepoetin alfa in subjects with chronic kidney disease

Conditions: Kidney Disease; Chronic Kidney Disease

Summary: the purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.


Eligibility criteria:
inclusion criteria: * currently diagnosed with chronic kidney disease, either receiving or not receiving dialysis * anemic * currently on erythropoietic therapy * controlled hypertension * clinically stable

Keywords: chronic kidney disease dialysis anemia nephrology
evaluation of gd-eob-dtpa mri for detection and characterization of liver nodules in cirrhotic patients undergoing liver transplantation and potential impact on transplant eligibility

Conditions: Hepatocellular Carcinoma

Summary: chronic liver disease including cirrhosis is one of the most important factors in the multi-step progression of hepatocarcinogenesis, from benign regenerative nodules to early hepatocellular carcinomas (hccs) and finally to overt hccs. early diagnosis of hcc, differentiation from benign hepatocellular nodules, and surgical resection of the tumor or transplantation of the liver provide the best chance for long-term survival. several studies have evaluated mri enhanced with superparamagnetic iron oxide, gadolinium-based contrast material, or both, for the detection and differential diagnosis of focal hepatic lesions. however, the differentiation of hcc from benign and or borderline hepatocellular nodules remains difficult, particularly in patients with cirrhosis, because of the architectural distortion of liver parenchyma and the development of cirrhotic nodules, ranging from benign regenerative nodules to overt hcc, with overlapping imaging features. recently, gadoxetic acid (gadoliniumethoxybezyl-diethylenetriamine pentaacetic acid; primovist®, bayer health care pharmaceuticals), a gadolinium-based paramagnetic contrast agent that produces both dynamic and liver-specific hepatobiliary mri studies has gained widespread use. some studies have showed that gadoxetic acid-enhanced mri allows the accurate detection and characterization of hcc. investigators plan to assess this in particular as it is a question of great relevance. execution of well conducted prospective studies will also clarify inclusion of gd-eob-dtpa enhanced mri as the technique of choice in evaluation of patients at risk for hcc.


Eligibility criteria:
inclusion criteria: * a. patients with liver cirrhosis enlisted for liver transplantation with high probability of undergoing transplantation within the ensuing 12 months b. patients who are diagnosed or suspected with hcc and listed for liver transplant surgery with priority meld (model for end-stage liver disease) points based on the cancer diagnosis, regardless of whether they have or have not received pre-transplant treatments (incl. rfa, tace, and xrt) c. subjects must be able to undergo mri exclusion criteria: * a. gfr \<30 ml/min/1.73 m2 b. elevated bilirubin (\>3mg/dl) c. pregnant and/or nursing women d. contraindications to mri such as pacemaker or ferromagnetic implants e. hypersensitivity to primovist or to any ingredient in the formulation or component of the container f. younger than 18 years of age

Keywords: cirrhosis hcc primovist