Kornimate/medical-research-clean huggingface dataset:
phase i study of vasoactive intestinal peptide in patients with acute respiratory distress syndrome and sepsis

Conditions: Sepsis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Adult

Summary: objectives: i. determine the maximum tolerated dose of vasoactive intestinal peptide in patients with acute respiratory distress syndrome. ii. evaluate the safety and pharmacodynamic activity of this peptide in these patients.

protocol outline: this is a dose escalation study. patients receive vasoactive intestinal peptide (vip) iv over either 6 or 12 hours. cohorts of 3 patients each receive escalating doses of vip over either 6 or 12 hours until the maximum tolerated dose is determined. patients are followed for 30 days.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of adult respiratory distress syndrome (ards) with sepsis ards characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance sepsis characterized by: two or more of the following: fever or hypothermia; tachycardia; tachypnea; wbc greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; hypotension; clinical suspicion of infection; inadequate organ perfusion or organ dysfunction as demonstrated by: acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) or unexplained metabolic acidosis or oliguria for greater than 2 hours or unexplained coagulopathy (elevated pt or ptt or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) or acute elevation of bilirubin to greater than 2.0 mg/dl and elevation of alkaline phosphatase, sgot, or sgpt no sepsis with unstable bp --prior/concurrent therapy-- at least 30 days since prior enrollment in investigational trial; no other concurrent enrollment in investigational trial --patient characteristics-- hematopoietic: see disease characteristics; no uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); no chemotherapy induced neutropenia (granulocyte count less than 1000/mm3) hepatic: no severe liver disease with portal hypertension renal: no anuria (urine output less than 50 ml/day) cardiovascular: no cardiogenic shock neurologic: no recent stroke, head trauma, or increased intracranial pressure; no other serious neurologic disorder other: not pregnant; no acquired immune deficiency syndrome; no immunosuppressed transplant patients; no severe burns; no irreversible underlying condition with rapidly fatal course; no marked obesity; no recent history of diarrhea

Keywords: cardiovascular and respiratory diseases immunologic disorders and infectious disorders neonatal disorders rare disease respiratory distress syndrome sepsis
modeling and predicting real world behavior using mobile sensor data on patients with major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.

this study is a smartphone-based, randomized, single-blind, controlled parallel- design study with two intervention arms and one control arm. the two intervention arms will receive in-app messages and phone-based support, which will be triggered by participant's self-reported surveys and passive behavioral data gathered through a smartphone app. the study will include a nationwide sample of adult (18 years or older) smartphone users, who are currently experiencing depressive symptoms. the primary outcome will be decrease in depression symptom severity, as measured by the 9-item patient health questionnaire, over 6 months.

Eligibility criteria:
inclusion criteria: * currently suffering from depression (as measured by a phq-9 score of 10 or more at the time of screening) * own an iphone or android smartphone with a mobile voice calling plan with a us carrier * fluency in english exclusion criteria: * participants with visual or hearing impairment * recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening) * recent loss of a loved one (within the past two months at the time of screening) * unable or unwilling to accept end user license agreement, or to provide information regarding their demographic characteristics and mental health history
using of extracorporeal shockwave therapy in treatment of achilles tendinopathy

Conditions: Achilles Tendinopathy

Summary: the purpose of this study was to determine the effect of extracorporeal shock wave therapy (eswt) on functional activity and pain in patients with achilles tendinopathy

fifty patients of both sexes with achilles tendinopathy aged 18-40 years, were assigned randomly into two equal groups. the study group received eswt in addition to a conservative physical therapy program for four weeks, while the control group received a conservative physical therapy program only. pain and functional mobility were assessed before and after treatment through a visual analog scale (vas) and victorian institute of sports assessment - achilles questionnaire (visa-a), respectively

Eligibility criteria:
inclusion criteria * clinical history of achilles tendon pain for at least six months * a minimum of three months conservative treatment administered without benefit for at least four weeks before eswt. exclusion criteria: * patients underwent physical therapy in the four weeks prior enrollment to study. * patients had taken non-steroidal anti-inflammatory medication during the previous week * patients had received peritendinous injections of a local anesthetic or corticosteroid within last 4 weeks * patients had bilateral achilles tendinopathy * patients with other conditions that could significantly contribute to posterior ankle pain (osteoarthritis, radiculopathy, systemic neurologic conditions) * patients having previous injury or surgical treatments of the ankle.
autologous stem cells in pediatric patients with dilated cardiomyopathy

Conditions: Cardiomyopathy, Dilated

Summary: the purpose of this study is to determine whether an autologous stem cell infusion through catheterism is safe and effective in the treatment of pediatric dilated cardiomyopathy. process: 1. primary evaluation * clinical history * echocardiogram to evaluate ejection fraction and other parameters 2. signing of informed consent and clearing doubts 3. bone marrow stimulation for 3 consecutive days with g-csf (granulocyte colony stimulating factor) applied subcutaneously 4. on the 4th day, in operation room and under sedation: bone marrow harvest performed by hematologists through posterior iliac crests(amount calculated at 8cc/kg, without exceeding 150ml). 5. recovery room with family members while the cells are being processed in the hematology laboratory. 6. approximately 3 hours after the 1st procedure, the patient re-enters the operation room, which is equipped for cardiac catheterization, so that cardiologists infuse the stem cells through the femoral artery into the coronary arteries which irrigate the heart´s muscle fibers. 7. patient goes back to the recovery area until the anesthesia effect is gone and can tolerate oral liquids. 8. clinical and echocardiographic follow-ups at 6 weeks and 6 months after the procedure.

* the patient will receive standard surgical care, accompanied by a nurse at all times. * premedication includes: omeprazole (gastric protector), ketorolac (anti-pain and swelling), ondansetron (antivomiting).

Eligibility criteria:
inclusion criteria: * ejection fraction less than 35 percent in echocardiogram * more than 3 months with complete medical treatment without significant improvement * complete medical treatment: digitalics, diuretics, vasodilators and beta blockers exclusion criteria: * not signing informed consent * active infection at enrolling time * inadequate g-csf application

Keywords: dilated cardiomyopathy idiopathic bone marrow stem cells cd34 + autologous
an observational study to assess optive mega-3 (om3) on dry eye symptoms and quality of life of adult participants with mild to moderate dry eye disease (ded)

Conditions: Dry Eye

Summary: dry eye disease (ded) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. this study will evaluate real-world experiences with optive mega-3 (om3) on relieving dry eye symptoms in adult participants with ded. om3 is an over the counter (otc) monograph drug indicated for the temporary relief of symptoms of eye dryness. participants will administer 1 drop of om3 on day 1 for the acute phase of the study, then participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through day 15. around 50 adult participants will be enrolled at one site in the united states. there is expected to be no additional burden for participants in this trial. study visits may be conducted on-site as per standard of care.


Eligibility criteria:
inclusion criteria: * during a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study. * participant has at least one of the following signs of dry eye: * three consecutive tear break-up time (tbut) tests \<= 10 seconds in at least one eye at screening visit or; * grade 1 to 4 (modified national eye institute \[nei\] grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at screening visit. exclusion criteria: * use of artificial tears in the last 24 hours. * use of more than 4 drops of artificial tears per day in each eye. * use of dry eye treatment other than artificial tears.

Keywords: dry eye om3 optive mega-3 agn-omega3
effect of exercise after heart transplantation

Conditions: Heart Transplantation

Summary: this is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. the intervention and follow up period is 1 year. the primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by vo2peak) than previously shown in heart transplant recipients.


Eligibility criteria:
inclusion criteria: * norwegian heart transplanted patients \> 18 years of age * 1-8 years after heart transplantation * optimal medical treatment * stable condition * written informed consent * must have access to a physical therapist or personal trainer in their hometown * motivation for exercise exclusion criteria: * unstable condition * in need of revascularization or other invention * infections, open wounds or skin diseases * physical disabilities which prevent participation * other diseases, illnesses or conditions which contradict exercise

Keywords: heart transplantation aerobic exercise exercise, physical exercise test treadmill test vo2 peak muscle strength quality of life reinnervation heart rate myocardial function
plasma rbp levels in patients with idiopathic hypogonadotrophic hypogonadism

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Summary: the aim of the present study was to demonstrate the rbp4 levels, association of rbp4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.


Eligibility criteria:
inclusion criteria: decreased serum testosterone concentration below the normal range (serum t \< 300ng/dl), fsh and lh levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on mri, presence of gonadotropin response to repetitive doses of gnrh, normal smell test and normal karyotypes exclusion criteria: previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. because of possible confounding effects, patients with other hormone deficiencies were excluded. -

Keywords: hypogonadism retinol binding globulin 4 testosterone treatment
managing aftercare for stroke (mas): mas-i - a cross sectional study of post-rehabilitation stroke burden and patients' needs

Conditions: Ischemic Stroke

Summary: in this first step of the study the investigators will assess the needs, disease burden and current treatments of long-term stroke patients (phase mas-i). the ultimate aim of the complete mas project (mas i, ii \& iii) is the development of a model of stroke aftercare delivery that can be evaluated to estimate effects in both our local and the wider stroke population.

after discharge from hospital the current healthcare system in germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. the investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. in this study the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.

Eligibility criteria:
inclusion criteria: * age ≥18 years * participation in one of the previously conducted stroke cohort studies: strawinski or predict * modified rankin score (mrs) recorded as = 1 - 5 (at last follow up during cohort study) * informed consent signed by patient or legal representative exclusion criteria: * unwilling to have pseudonymised data stored, analyzed \& anonymously published. * patients participating in the previous studies recruited in centres outside berlin

Keywords: stroke aftercare
a study of ro5093151 in patients with non-alcoholic fatty liver disease

Conditions: Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Summary: this multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of ro5093151 in patients with non-alcoholic fatty liver disease. patients will be randomized to receive either daily oral doses of ro5093151 or matching placebo. the anticipated time on study treatment is 12 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 35-65 years of age * hepatic steatosis assessed by magnetic resonance spectroscopy (mrs) with liver fat \>5.56% at screening * body mass index (bmi) \>27 kg/m2 at screening * insulin resistance assessed by homeostatic model assessment-insulin resistance (homa-ir) \> 2.5 at screening * agreement to maintain prior diet and exercise habits during the full course of study exclusion criteria: * history of diabetes mellitus based on world health organization (who) criteria * known polycystic ovary syndrome * other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis * known autoimmune disease or chronic inflammatory disease * myocardial infarction or stroke within 6 months prior to screening * patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening
personalized health planning in shared medical appointments for individuals with type ii diabetes pilot study

Conditions: Type II Diabetes

Summary: the primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (php), in the context of a a shared medical appointment (sma) for individuals with type ii diabetes in a primary care setting.

all data for the prospective portion of this study was done being collected in september 2016. the retrospective chart review will collect data up until march of 2017 (six months after the last subject completed the prospective phase by attending their last sma session).

Eligibility criteria:
inclusion criteria: * a diagnosis of type 2 diabetes within the last year * a current patient at duke family medicine. * an a1c score greater than 7 and less than 14. exclusion criteria: * a diagnosis of pre-diabetes * a diagnosis of type i diabetes * individuals with amputations as a result of their diabetes are excluded form this study. * individuals with renal dialysis will not be included in this study.

Keywords: type ii diabetes personalized health planning shared medical appointments
product testing of the faceview mask™: usability survey

Conditions: Hearing Disability

Summary: the study aims to gather participants' perceptions of the novel transparent surgical n95 respirator vs. a conventional surgical n95 respirator. following fitting of the masks, participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

the investigators will recruit adult participants to complete a usability survey on a transparent surgical n95 respirator (i.e., faceview mask) designed to improve communication. the study aims to gather participants' perceptions of the novel transparent surgical n95 respirator vs. a conventional surgical n95 respirator. following fitting of the masks (5 minutes wear time each), the participants will complete a questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to communication.

Eligibility criteria:
inclusion criteria: * at least 18 years old * have no health conditions that would prevent them from safely wearing an n95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease) * read in english and communicate in english or american sign language * be able to provide or arrange their own transportation to the study location exclusion criteria: * children are to be excluded from the proposed research project because the current faceview mask™ is designed for adults * adults who are non-english communicators * any adult with health conditions that would prevent them from safely wearing an n95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease)

Keywords: lip reading face mask
the utility of oxygen insufflation during flexible fiberoptic bronchoscope-guided intubation

Conditions: Lumbar Spinal Stenosis

Summary: this study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation. one group receives oxygen via suction channel of fiberoptic bronchoscope during intubation. the other group does not receive oxygen during fiberoptic bronchoscope-guided intubation. then, the velocity of deoxygenation difference of pao2(baseline

fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with anticipating difficult airway. this technique takes several minutes without oxygen supply, which results in hypoxia when it prolonged. if continuous supply of oxygen during procedure improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin during procedure.

Eligibility criteria:
inclusion criteria: * patients who have surgery under general oral endotracheal anesthesia with invasive arterial blood pressure monitoring exclusion criteria: * history of lung disease * abnormality in chest x-ray * anticipating difficult intubation * pregnant women * who is unable to understand and agree the consent form
a study of cp-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: to evaluate the efficacy, safety and tolerability of cp-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

trial enrollment was prematurely discontinued on december 3, 2007. the results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with cp-195543 and celecoxib was administered. the decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. previously enrolled study participants continued in the study and the trial completed on february 27, 2008.

Eligibility criteria:
inclusion criteria: * a diagnosis of ra based upon the american college of rheumatology 1987 revised criteria * active disease at screening * stable dose of methotrexate between 10-25 mg/week oral or parenteral exclusion criteria: * a diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the investigator, would interfere with disease activity assessments * a history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides
laparoscopic sleeve gastrectomy and gastroesophageal acid reflux

Conditions: Gastroesophageal Reflux; Obesity

Summary: symptomatic gastroesophageal reflux (ger) is considered by many a contraindication to laparoscopic sleeve gastrectomy (lsg). however, of the few studies that have investigated the relationship between lsg and ger the majority reported only changes in symptoms and manometric data, while assessment of ger using 24-hour ph monitoring is lacking. the aim of this study is to evaluate the effect of lsg on ger in morbidly obese patients.

consecutive morbidly obese patients selected for lsg are included in a prospective clinical study. gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h ph monitoring before and 24 months after lsg.

Eligibility criteria:
inclusion criteria: * history of obesity exceeding 5 years * documented previous weight loss attempts, * body mass index (bmi)) of 40-50 kg/m2 * age of 18-60 years. exclusion criteria: * contraindications to pneumoperitoneum * large esophageal hiatal hernia * pregnancy, * drug or alcohol abuse, * psychological disorders (e.g., bulimia, depression) * hormonal or genetic obesity-related disease, * previous gastric surgery

Keywords: obesity gastroesophageal reflux sleeve gastrectomy ph-monitoring manometry
multiple areas of pain (map)

Conditions: Chronic Pain

Summary: this study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.


Eligibility criteria:
key inclusion criteria: * chronic pain of the trunk and/or limbs lasting at least 6 months * overall pain intensity of at least 5 on a 0 to 10 scale * subject is able to independently complete all assessments in english * 18 years of age or older * subject signs an institutional review board-approved informed consent form provided in english key exclusion criteria: * currently implanted with an active implantable medical device to treat pain * currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs * subject has undergone an interventional pain procedure less than 1 month prior to the study