Kornimate/medical-research-clean huggingface dataset:
trial of linaclotide in patients with chronic idiopathic constipation

Conditions: Chronic Idiopathic Constipation

Summary: the objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (cic). the primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (csbm) overall responder.

the trial also included a 145 ug linaclotide treatment arm (an fda-approved dose for cic) as an established positive control to validate the study design.

Eligibility criteria:
inclusion criteria: * patient has completed a colonoscopy if one is needed according to the american gastroenterological association (aga) criteria, with no clinically significant findings * patient has no clinically significant findings on a physical examination and clinical laboratory tests * patient meets protocol criteria for cic: reports \< 3 bowel movements (bms) per week and reports one or more of the following during ≥ 25% of bms: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis * patient is compliant with daily interactive voice response system (ivrs) calls * patient reports an average of \< 3 complete spontaneous bms (csbms) and ≤ 6 sbms per week by the ivrs over the 14 calendar days before the randomization visit and the calendar day of randomization. exclusion criteria: * patient has history of loose or watery stools * patient has symptoms of or been diagnosed with irritable bowel syndrome (ibs) * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments * patient has bristol stool form scale score of 7 during pretreatment period.
a pilot study to explore the role of gut flora in psoriasis

Conditions: Psoriasis; Psoriasis Vulgaris; Psoriasis Universalis; Psoriasis Face; Psoriasis Nail; Psoriatic Plaque; Psoriasis Diffusa; Psoriasis Punctata; Psoriasis Palmaris; Psoriasis Circinata; Psoriasis Annularis; Psoriasis Genital; Psoriasis of Scalp; Psoriasis Geographica

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding psoriasis.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding psoriasis

Eligibility criteria:
inclusion criteria: 1. signed informed consent by patient 2. male or female patients age 18 and older. 3. diagnosis of psoriasis based on psai of greater than or equal to 12 at screening exclusion criteria: 1. refusal by patient to sign informed consent form 2. treatment with antibiotics within 2 weeks prior to screening 3. treatment with probiotics within 6 weeks prior to screening 4. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 5. postoperative stoma, ostomy, or ileoanal pouch 6. participation in any experimental drug protocol within the past 12 weeks 7. treatment with total parenteral nutrition 8. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 9. inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
assessment of liver glucose metabolism in diabetic subjects

Conditions: Newly Diagnosed Type 2 Diabetes (During the Last 12 Months)

Summary: type 2 diabetes is associated with hepatic insulin resistance. one consequence of insulin resistance of the liver is an altered hepatic glucose metabolism. this study investigates whether the whole body (m-value) and hepatic insulin sensitivity obtained by hyperinsulinemic euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (botnia clamp) in subjects with type 2 diabetes.

the hyperinsulinemic euglycemic clamp represents the gold standard for measuring peripheral insulin sensitivity. the insulin sensitivity is described by the m-value,which is calculated from glucose infusion rates during the last 30min of the clamp. glucose is metabolised in the periphery: 50% by neural tissues, 20% by splanchnic bed and liver, 15% by skeletal muscle, 5% by adipose tissue and 10% by blood cells and other tissues. under hyperinsulinemic conditions there is a strong shift in glucose utilization: 85% skeletal muscle and 15% by neural tissues, splanchnic bed and liver, adipose tissue, blood cells and other tissues. the contribution of skeletal muscle varies with different insulin sensitivity. we now want to investigate whether there is a difference in tissue-specific insulin sensitivity measured from a botnia clamp (intravenous glucose tolerance test (ivgtt) and following clamp) and a single hyperinsulinemic euglycemic clamp? after a 60min ivgtt blood glucose levels in type 2 diabetic subjects are still elevated compared to baseline. high blood glucose levels can influence several parameters and may also affect insulin sensitivity. until now, it is not proven, that the clamp preceding ivgtt does not have a significant influence on the m-value.

Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes (during the last 12 months)or non-diabetic subjects exclusion criteria: * severe chronic diseases * hepatitis b, c oder hiv infection * malignancies * immune suppressive therapy * psychiatric illnesses * drug or alcohol abuse * anemia * renal dysfunction

Keywords: type 2 diabetes insulin sensitivity hyperinsulinemic euglycemic clamp
ehr embedded comparative effectiveness studies--wwc

Conditions: Obesity

Summary: randomize everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in ehr systems to do comparative effectiveness research. two demonstration projects are being conducted in the dartmouth hitchcock medical center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

ehr embedded comparative effectiveness studies-wwc will be held in the weight and wellness clinics at dartmouth-hitchcock medical center. this study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Eligibility criteria:
inclusion criteria: adults (\>18) able to consent, with sufficient fluency in english; initial rd and hc visits are part of routine care as recommended by the provider; willing to be randomized exclusion criteria: pregnant women; prisoners; children (\<18) -
efficacy and safety study of a test naproxen sodium 220mg tablet in postoperative dental pain

Conditions: Post-operative Dental Pain

Summary: to evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two test naproxen sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

this is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two test npx 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. subjects will undergo dental extraction of three or four third molars.

Eligibility criteria:
inclusion criteria: 1. 17 - 50 years old 2. weigh 100 pounds or greater and have a body mass index (bmi) of 17.5 to 30.4 (inclusive) at screening 3. dental extraction of three or four third molars 4. meets post-surgical pain 5. females of childbearing potential and males agree to contraceptive requirements of study 6. have a negative urine drug screen at screening, and on day of surgical procedure exclusion criteria: 1. pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant 2. have a known allergy or hypersensitivity to naproxen or other nsaids, including aspirin, or to acetaminophen, hydrocodone or other opioids 3. not able to swallow large tablets or capsules 4. history of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study 5. use analgesics 5 or more times per week 6. history of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years 7. use of immunosuppressive drugs within 2 weeks of screening 8. history of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
abrupt versus tapered interruption of chronic clopidogrel therapy after des implantation

Conditions: Coronary Artery Disease

Summary: the hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).

a possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. however, a systematic evaluation of the role of rapid thienopyridine withdrawal on ischemic complications in patients with treated coronary artery disease has not been addressed by specifically designed studies. the objective of this study is to evaluate the safety and efficacy of abrupt or tapered interruption of chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.

Eligibility criteria:
inclusion criteria: * patients with planned interruption of chronic clopidogrel therapy after des implantation * informed, written consent by the patient exclusion criteria: * planned surgery within the next month * active bleeding as reason for clopidogrel discontinuation * concomitant coumadin therapy * pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory) * malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance. * patient's inability to fully comply with the study protocol.

Keywords: clopidogrel drug-eluting stent
study of daraxonrasib (rmc-6236) in previously treated patients with ras mutated nsclc (rasolve 301)

Conditions: NSCLC (Non-small Cell Lung Cancer); Non-Small Cell Lung Cancer; NSCLC; NSCLC (Non-small Cell Lung Carcinoma); NSCLC (Advanced Non-small Cell Lung Cancer)

Summary: the purpose of this study is to evaluate the safety and efficacy of a novel ras(on) inhibitor compared to docetaxel.

this is a global, randomized, open-label, phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (pfs) or overall survival (os) compared to docetaxel chemotherapy in patients with nsclc who were previously treated. patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.

Eligibility criteria:
inclusion criteria: * at least 18 years old and has provided informed consent. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * histologically confirmed nsclc, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy. * measurable disease per recist v1.1. * adequate organ function (bone marrow, liver, kidney, coagulation). * one to two prior lines of therapy including an anti-pd-1/anti-pd(l)-1 agent and platinum-based chemotherapy. * documented ras mutation status, defined as nonsynonymous mutations in kras, nras, or hras at codons 12, 13, or 61 (g12, g13, or q61). * able to take oral medications. exclusion criteria: * prior therapy with direct ras-targeted therapy or docetaxel. * untreated central nervous system (cns) metastases. * medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired gi function). * ongoing anticancer therapy. * pregnancy and/or breastfeeding.

Keywords: nsclc non-small cell lung cancer lung cancer ras kras hras nras ras wild-type ras q61 mutation ras g12 mutation ras g13 mutation
the effects of probiotics on stress among healthy adults from umm al-qura university at makkah

Conditions: Stress; Constipation; Anthropometry; Bowel Disease

Summary: the goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy saudi adults for both males and females. the main questions it aims to answer are: does probiotic supplementation decrease stress levels? does probiotic supplementation improve bowel habits? researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.

participants were required to 1. attend a visit to the nutrition clinic at umm al-qura university to assess for eligibility. 2. eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected 3. participants were randomized based on lottery based method to an interventional or control group 4. intervention group received 30 capsules of probiotics (lactobacillus rhamnosus gg, 6x10\^9 cpu) to be taken once daily 5. after 30 days, all participants had to attend a second visit at the nutrition clinic at umm al-qura university to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).

Eligibility criteria:
inclusion criteria: * students at umm al-qura university * age ≥ 18 years * healthy individuals * both genders * saudi nationality exclusion criteria: * diagnosed with chronic illness or/and psychiatric condition * consumption of medications or supplements in the previous 3 months * pregnant and breastfeeding * smoker

Keywords: probiotics saudi arabia stress gut-brain axis gastrointestinal tract
svt-15652 otic solution for the treatment of otomycosis

Conditions: Otomycosis

Summary: multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from otomycosis. this study will compare the efficacy and safety of svt-15652 otic solution to that of placebo, when administering one vial twice daily during 14 days.


Eligibility criteria:
main inclusion criteria: * at least 18 years of age * clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. * signs/symptoms of pruritus, otalgia and ear fullness. * debris or drainage clinically consistent with fungal infection. main exclusion criteria: * known bacterial otitis externa or malignant otitis externa. * tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. * structural ear anomalies which may difficult the evaluation of the therapeutic response. * uncontrolled diabetes mellitus. * any infection requiring systemic antimicrobial or systemic antifungal therapy. * concomitant medicines that may interfere with the study evaluations.
changes in spontaneous ventilation in response to changes in extracorporeal carbon dioxide removal

Conditions: Respiratory Insufficiency

Summary: in physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and ph) levels. in healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (kolobow et al., 1977). during acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (crotti et al., 2012). however, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans. aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.


Eligibility criteria:
inclusion criteria: * acute respiratory insufficiency * extracorporeal gas exchange support * the patient is spontaneously breathing (including assisted ventilation) exclusion criteria: - age below 18 yrs
feasibility study of transcranial ultrasound stimulation (tus) on stroke patients

Conditions: Intracerebral Hemorrhage; Hemiplegia

Summary: currently, the main treatment method for intracerebral hemorrhage (ich) is medication or surgery. however, the effectiveness of medicines is moderate and there are several side effects. in this clinical trial, we would like to enhance the protein levels of brain derived neurotrophic factor in the brain by the transcranial ultrasound stimulation (tus). by this technology, the symptoms of ich could be alleviated and the side effects of medicines might be avoided. preclinical trials have also shown that low-intensity pulsed ultrasound can alleviate the degree of neuroinflammation, neurodegeneration and significantly improve motor and cognitive deficits after brain injury. the purpose of this clinical trial is to evaluate the safety and feasibility of tus for the treatment of patients with hypertensive intracerebral hemorrhage. the primary safety assessment indexes are brain magnetic resonance imaging (mri) and brain magnetic resonance angiography (mra). the secondary safety assessment indexes include weight, vital signs, electrocardiogram, general blood biochemical tests, adverse reaction events, and concurrent drug tracking. the feasibility assessment includes blood specific biomarker expression and neurological function \& quality of life scales.


Eligibility criteria:
inclusion criteria: * age between 20 and 65 years old * hemiplegia or hemiparesis * has a history of hypertension * a victim of first episode of hypertensive intracerebral hemorrhage at basal ganglion * 3 to 12 months after the episode of hypertensive intracerebral hemorrhage * medically stable * the blood flow of middle cerebral artery (m1) could be detected by transcranial doppler exclusion criteria: * severe heart failure (new york heart association class 4) * severe angina pectoris (canadian cardiovascular society class 4) * chronic kidney disease stage 5 * hepatic encephalopathy stage 2 or more advanced * uncontrolled diabetes mellitus in recent 6 months (hba1c \> 8.5) * combined with intraventricular hemorrhage causing hydrocephalus and underwent ventriculoperitoneal shunt placement surgery * high-dose radiation exposure in recent 1 year * blood flow of middle cerebral artery (m1) could be not be detected by transcranial doppler at either side * major psychological disease in recent 6 months (for example, uncontrolled depression, schizophrenia, and bipolar disease) * has evidence of any autoimmune disease, neurodegenerative disease (such as parkinsonism, alzheimer's disease), or epilepsy * has clinically significant systemic disease or severe infection (pneumonia, sepsis) * pregnant or lactating women * allergy to mri contrast * uncontrolled hypertension (systolic blood pressure higher than 160 mmhg or diastolic blood pressure higher than 100 mmhg) transcranial doppler * aneurysm, brain tumor, or arteriovenous malformation identified by mra * has coagulation disorders or other coagulation problems identified by blood test (abnormal complete blood count, prothrombin time, or partial thromboplastin time)
application of hybridapc in the treatment of barrett

Conditions: Barrett's Esophagus

Summary: the purpose of this study is to evaluate the efficacy and safety of the new technique of hybridapc in the treatment of barrett.

after thermal ablation of barrett's esophagus, stricture formation is reported in 5 to over 10% of patients. submucosal fluid injection prior to ablation may lower the risk of stricture formation. the new technique of hybridapc which combines submucosal injection with apc is considered to reduce the complication.

Eligibility criteria:
inclusion criteria: 1. patients age is from 18 to 70. 2. patients who were diagnosed with barrett's esophagus. 3. informed consent. exclusion criteria: 1. patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy. 2. severe bleeding tendency. 3. poor compliance. 4. patient is very ill and life expectancy is less than 2 years. 5. esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding. 6. severe esophageal stenosis. 7. pregnancy. 8. lesion is located in esophageal diverticulum or spread their diverticulum.

Keywords: argon plasma coagulation submucosal injection barrett esophagus
intraocular fluid detection in endophthalmitis

Conditions: Intraocular Inflammation

Summary: endophthalmitis is also called vitreous inflammation. broadly speaking, it refers to all kinds of serious intraocular inflammation, such as vitreitis, anterior chamber empyema and eye pain caused by intraocular infection, intraocular foreign body, tumor necrosis, severe non infectious uveitis, lens cortex allergy, etc. clinically, it generally refers to infectious endophthalmitis caused by bacteria, fungi or parasites. according to the different ways of infection, it can be divided into exogenous endophthalmitis and endogenous endophthalmitis. exogenous endophthalmitis is more common. when inflammation involves sclera or extraocular orbital tissue, it is called "panophthalmia". endophthalmitis is a kind of serious intraocular inflammation which can lead to the loss of visual function. early diagnosis and treatment is the key. studies have found that the changes of cytokines in aqueous humor are helpful for the diagnosis of endophthalmitis. okhrvai et al. also pointed out that the application of pcr can reduce the diagnosis time of endophthalmitis. this study mainly verified the use of molecular biology technology to detect the changes of vcam, icam-1 and other cytokines, bacteria, viruses, fungi, toxoplasma gondii igg in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * ① clinical manifestations: eye pain, photophobia and tears, decreased vision, conjunctival congestion and edema, etc. ② special examination: anterior examination showed conjunctival congestion and edema, postkeratosis, anterior chamber empyema and other inflammatory manifestations. fundus examination showed vitreous opacity, fundus hemorrhage and white lesions. ③ laboratory examination: bacteria, viruses, fungi and toxoplasma gondii were detected in the aqueous humor and vitreous humor of the patients. exclusion criteria: * 1. with tumor, rheumatoid and other autoimmune diseases. 2. accompanied by diabetes and other systemic chronic diseases. 3. patients with retinal and choroidal vascular diseases and history of eye surgery were excluded.