Kornimate/medical-research-clean huggingface dataset:
open label study to analyze the effect of telotristat ethyl on weight regulation/gain

Conditions: Pancreatic Cancer; Neuroendocrine Tumors; Cachexia; Cancer

Summary: this single arm study will evaluate whether xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (net) patients with a history of carcinoid syndrome.

the purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (xermelo) among patients with a neuroendocrine tumor (net) with history of carcinoid syndrome. we want to know if taking xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. a better understanding of the mechanisms of weight gain from xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histopathologically confirmed diagnosis of a metastatic net. * documented history of carcinoid syndrome. * currently receiving treatment with long-acting ssas with a plan to initiate therapy with telotristat-ethyl as per standard of care. * ecog performance status 0-1 and/or karnofsky \>60%. * greater than or equal to 3 month life expectancy. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * patients experiencing more than 12 watery bms per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection. * history of short bowel syndrome. * clinically important baseline elevation in liver function tests. * patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * malignant ascites requiring paracenteses. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * bowel obstruction, partial, or total. * pregnancy * patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
primary care in aura for covid-19

Conditions: Primary Care : Suspected and Confirmed Cases of COVID-19; Primary Health Care; COVID-19 Pandemic

Summary: as few data are available on the epidemiology of the covid-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the french region auvergne-rhône-alpes (aura), able to monitor the evolution of the current epidemic.


Eligibility criteria:
inclusion criteria: * suspect or confirmed covid-19 case consulting in primary care in the aura region exclusion criteria: * patient with a covid-19 diagnosis excluded after clinical examination or investigation. * patient refusing to participate to the study

Keywords: covid-19 primary care clinical epidemiology practice assessment
eus-guided rfa for pancreatic neoplasms

Conditions: Pancreatic Neoplasms

Summary: radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. recently, eus-guided rfa has become available and the device allows eus-guided treatment of pancreatic neoplasms. the procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. the aim of the current study is to perform a multi-center prospective study on eus-guided radiofrequency ablation (rfa) of solid pancreatic neoplasms. the hypothesis is that eus-guided rfa is safe, feasible and effective for treating solid pancreatic neoplasms.

rfa causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°c and leading to coagulative necrosis. the technique has been widely used in many solid organ tumors and has been shown to result in 5-year survival rates comparable to surgery. the technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery. this study is a multi-center prospective study involving four high volume international institutions. consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. eus-guided rfa would be performed using a 19-gauge rfa electrode and a generator. the primary outcome would be the overall adverse events rate. secondary outcomes include mortality, technical success rate, completion ablation rate, 1 \& 3 year overall and disease-free survival.

Eligibility criteria:
inclusion criteria: * age 18 years-old or above * suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (\<5cm in largest diameter) that was confirmed by fine needle aspiration cytology * unsuitable for surgery, due to one (or more) of the following items: * asa score \> ii\* * an alternative advanced malignancy * unsuitable for surgery upon expert's opinion for any other reason * healthy individuals who are not keen for surgical resection * eligible for endoscopic intervention * written informed consent exclusion criteria: * coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/ul * pregnancy * patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study * patients unwilling to undergo follow-up assessments * patients with liver cirrhosis, portal hypertension and/or gastric varices.

Keywords: eus-guided rfa pancreatic ca interventional eus
factors affecting outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations as regard parameters of laser device, nature of lesion and patient factors

Conditions: Benign Laryngeal Lesion

Summary: studying the different factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations


Eligibility criteria:
inclusion criteria: - all patients with benign laryngeal lesions exclusion criteria: * patients presenting with or have history of malignant laryngeal lesion

Keywords: diode benign laryngeal laser
multiple dose pharmacokinetics of canagliflozin/metformin 150/1,000 mg fixed dose combination

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the multiple dose pharmacokinetics of 2 canagliflozin/extended release metformin (cana/met xr) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

this is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (fdc) of 150 mg/1,000 mg canagliflozin/extended release metformin (cana/met xr) tablets. the study will consist of 3 phases: a screening phase of approximately 3 weeks, an open-label treatment phase, (when the participants will be confined to the study center for 11 days), and a follow-up phase of about 10 days. the total duration of the study will be about 42 days for each participant. during the open-label treatment phase, approximately 12 healthy adult participants will receive a single oral dose of 2 cana/met xr tablets once daily for 7 days after a provided dinner. participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on days 1 and 7 only.

Eligibility criteria:
inclusion criteria: * must sign an informed consent document indicating they understand the purpose of the study and procedures * must have a body mass index (bmi) of between 18 and 30 kg/m², inclusive * must have a body weight of not less than 50 kg * must have a blood pressure between 90 and 140 mmhg inclusive, systolic, and no higher than 90 mmhg diastolic at screening * must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests) exclusion criteria: * history of or current clinically significant medical illness * use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements) * known allergy to canagliflozin or metformin or any of the excipients of the formulation * known allergy to heparin or history of heparin induced thrombocytopenia * history of smoking or use of nicotine-containing substances within the previous 2 months

Keywords: healthy volunteers canagliflozin metformin invokana® type 2 diabetes mellitus
evaluation of new semen collection & transportation kit

Conditions: Sperm Parameters in Fertile and Infertile Men

Summary: examine the effect of overnight transport conditions on sperm parameters on semen samples collected and mailed to cleveland clinic andrology center.


Eligibility criteria:
inclusion criteria: * normal healthy men with normozoospermic semen parameters * infertile men referred by the infertility specialist (urologist) exclusion criteria: * controls with abnormal semen parameters * infertile men from other referrals (gynecologists) * severe oligozoospermic (\<1 x 106 sperm/ml) infertile men
a study of asp1941 in japanese patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of asp1941 in patients with type 2 diabetes mellitus. safety, tolerability and pharmacokinetics are also evaluated.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients for at least 12 weeks * hba1c value between 7.0 and 10.0% at screening * fasting plasma glucose ≥ 126mg/dl and \< 240mg/dl at screening * body mass index (bmi) 20.0 - 45.0 kg/m2. exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria（albumin/creatinine ratio \> 300mg/g） * dysuria and/or urinary tract infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: asp1941 diabetes mellitus blood glucose
the influence of emg-triggered robotic movement on function and mobility of stroke patients

Conditions: Ischemic Stroke

Summary: rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the luna emg neurorehabilitation robot. a total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. each patient was randomly assigned to an intervention (robot) or control group (rg or cg). all patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. people with rg had 30 minutes of training sessions on the luna emg robot, while cg received exercises on the lower limb rotor. patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the ashworth scale, rivermead mobility index (rmi), repty functional index, time up and go test (tug) and muscle circumference on the thigh.


Eligibility criteria:
inclusion criteria: * ischemic stroke, * not later than 6 months ago, * muscle strength of extensors and knee flexors on the lovetta scale below 3, * functional disorders of the lower limb, * patient's condition allowing full understanding of commands * continued/uninterrupted rehabilitation process for 28 days exclusion criteria: * cognitive impairment-lack of or poor cooperation between the patient and the therapist, * stroke (more than 6 months after the incident), * unstable clinical condition, * muscle strength of knee extensors and flexors on the lovett scale greater than or equal to 3, * rigid fixed contractures within the lower limb, * significant spasticity (ashworth scale of 3 and above)

Keywords: stroke, rehabilitation, emg-triggered rehabilitation, robotic-assisted movement, gait
single cell genomics of psoriatic skin

Conditions: Psoriasis

Summary: the purpose of this study is to understand how genetics play a role in psoriasis. specifically, a genetic allele hla-cw6 is known to be associated with psoriasis, and this study aims to find out how it affects genetic and protein expression in patients with psoriasis, compared to healthy people, at a single-cell level using a novel flow cytometry and rna-sequencing protocol.


Eligibility criteria:
inclusion criteria: for subjects in the psoriasis group: 1. ability to provide written consent and comply with the protocol 2. at least 18 years of age 3. diagnosis of plaque psoriasis for at least 6 months prior to enrollment 4. bsa \> 5% and at least one target plaque on trunk or extremities greater than 10cm2 for control subjects: 1. ability to provide written consent and comply with the protocol 2. at least 18 years of age 3. no previous diagnosis of psoriasis or other inflammatory skin conditions exclusion criteria: for subjects in the psoriasis group: 1. subject has non-plaque form of psoriasis. 2. subject has drug-induced psoriasis. 3. pregnancy at any point during the study period. 4. known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents. 5. known hiv positive status. 6. evidence of abnormality of any immune cell population from a drug-induced or genetic cause. 7. known coagulopathy. for control subjects: 1. any physical examination findings by the investigators consistent with psoriasis or other inflammatory skin conditions. 2. pregnancy at any point during the study period. 3. known allergy to lidocaine, other local anesthetics, or any component of local anesthetic agents. 4. known hiv positive status. 5. evidence of abnormality of any immune cell population from a drug-induced or genetic cause. 6. known coagulopathy. 7. use of any immunosuppressant or immunomodulating therapies within 6 months.

Keywords: immunology, genetics
home to stay: a randomized trial evaluating a post-discharge mobile app for elective colorectal surgery

Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Utilization, Health Care; Surgery; Post Discharge Monitoring

Summary: a single center randomized controlled trial to evaluate the effect of a post-discharge mobile health application on 30-day re-admission and patient reported outcomes following elective colorectal surgery

background: following elective colorectal surgery, rates of re-admission are high and result in significant healthcare resource use. however, up to 20% of these re-admissions may be preventable. this represents an opportunity to improve patient outcomes, reduce health care utilization and costs through targeted interventions. home to stay is an integrated discharge monitoring program using a mobile app platform that was developed to support the needs of patients following discharge after colorectal surgery. in the initial pilot testing, the 30-day re-admission rate for patients using home to stay was reduced from 18% to 6% and patient anxiety was reduced in over 75% of the participants. methods: this study is a two arm, single center, randomized control trial that will be conducted in the colorectal unit of an academic tertiary care center. patients will be randomized1:1 using a single randomized consent design to either usual follow up in the control group or post discharge monitoring with home to stay in the intervention group. objective: the objective of this study is to evaluate the home to stay app and its effect on healthcare utilization and patient reported outcomes.

Eligibility criteria:
inclusion criteria: * patients undergoing elective, inpatient colorectal surgery * able to speak and read in english * able to provide informed consent * have access to a smartphone/tablet or desktop computer with internet access exclusion criteria: * patients undergoing semi-elective/emergent procedure * patients undergoing elective day surgery * expected post operative admission of less than 3 days * discharge to another institution (rehabilitation facility/nursing home/long term care).
anesthesia depth increases the degree of postoperative dementia, delirium, and cognitive dysfunction

Conditions: Anesthesia; Delirium; Dementia; Bispectral Index Monitor

Summary: anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. in animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. the amount of those markers seems to correlate well with the degree of dementia \[1\]. in contradiction, a single study indicates that the incidence of postoperative cognitive deficit (pocd) decreases if hypnotic depth is deep \[2\]. unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to pocd and dementia. another possibility is that stress and noxious stimulation induced by light anesthesia results in pocd, whereas deep anesthesia protects from it or inhibits implicit memory. the investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period. the investigators' hypothesis is that the incidence of pocd and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the bis- guided anesthesia group with the superficial but sufficient anesthesia level.


Eligibility criteria:
inclusion criteria: * adults older than 70 years * major surgery ( spine, orthopedic, urologic, gynecology, abdominal) exclusion criteria: * adults younger than 71 years * major blood loss surgery * allergy to soja oil, nuts, other ingredients of propofol * patient wants to have spinal or regional anesthesia only
comparative effects on diaphragmatic electrical activity and respiratory pattern of various levels of assistance

Conditions: Respiratory Failure

Summary: exploration of the effects on diaphragmatic electrical activity (emg) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (ps) and in neurally adjusted ventilatory assist (nava) by step by step increasing of the level of assistance. flow, airway pressure, transesophageal emg signal and transcutaneous emg signal will be recorded.

exploration of the effects on diaphragmatic electrical activity (emg) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (ps) and in neurally adjusted ventilatory assist (nava) by step by step increasing of the level of assistance. flow, airway pressure, transesophageal emg signal and transcutaneous emg signal will be recorded. aims of the study: 1. to study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in ps and in nava in intubated spontaneously breathing patients 2. to compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique

Eligibility criteria:
inclusion criteria: - patients admitted to the icu, intubated for acute respiratory failure, and ventilated in ps mode will be eligible for inclusion in the study. exclusion criteria: * severe hypoxemia requiring an fio2 \> 0.5 * hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-) * oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery; * active upper gastro-intestinal bleeding; * known coagulation disorder; * any other contraindication to the insertion of a naso-gastric tube; * poor short term prognosis (death expected within the next seven days) * age \< 18 years old.

Keywords: mechanical ventilation electrical diaphragmatic activity
associations of vitamin d deficiency and vitamin d receptor polymorphisms with the risk of primary open-angle glaucoma

Conditions: Vitamin D Deficiency; Primary Open- Angle Glaucoma

Summary: this study investigated whether vitamin d receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele and vitamin d deficiency is an important factor in the development of glaucoma. primary open-angle glaucoma patients and age-matched people in the han population were enrolled. serum levels of 1a, 25-dihydroxyvitamin d3 were measured by enzyme-linked immunoabsorbent assay. vitamin d receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.


Eligibility criteria:
inclusion criteria: * intraocular pressure greater than 22 mmhg with two or more medications * wide anterior chamber angle * glaucomatous optic neuropathy (glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect) * visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry exclusion criteria: * the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma * high myopia * macular degeneration * other ocular diseases * a known history of systemic diseases and administration of vitamin d3 or other analog

Keywords: vitamin d primary open- angle glaucoma