Kornimate/medical-research-clean huggingface dataset:
travoprost/timolol vs latanoprost/timolol fixed combination therapy

Conditions: Glaucoma

Summary: the primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (iop) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. this study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. it is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.


Eligibility criteria:
inclusion criteria: * primary open-angle glaucoma or exfoliative glaucoma * patients who require additional iop lowering on latanoprost monotherapy * morning iop greater than 20 mm hg on latanoprost monotherapy * untreated morning iop greater than 26 mm hg * patients older than 29 years * patients with early to moderate glaucoma (less than 14 decibel (db) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio) * on therapy with latanoprost monotherapy for at least 3 months * patients with a reliable visual field * best corrected distance snellen visual acuity \>1/10 * corneal pachymetry within the 550 ± 50 μm range * patients should understand the study instructions * patients willing to attend all follow-up appointments and willing to comply with study medication usage * patients who have open, normal appearing angles exclusion criteria: * history of combined topical therapy * contraindication to prostaglandins or timolol * history of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses * sign of ocular infection except for mild blepharitis * any corneal abnormality that could have affected the measurement of iop * chronic use of topical corticosteroids in the last 3 months before entering the study * current, or previous use of systemic corticosteroid treatment * uncontrolled systemic disease * change of a systemic medication during the study period * women of childbearing potential or lactating mothers * inability to understand the instructions and adhere to medications

Keywords: glaucoma fixed combinations 24-hour monitoring
effect of empagliflozin on nt-pro brain natriuretic peptide in heart failure patients with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: this study aims to evaluate the relationship between nt-probnp and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (hfmref 41-49%) and reduced ejection fraction (hfref ≤40%) whether diabetic or non-diabetic patients.

1. ethical committee approval has been obtained from ethics committee of faculty of medicine, alexandria university. 2. assigning an informed consent for agreement of participation should be taken by all participants in this clinical study. 3. heart failure patients with reduced and mildly reduced ejection fraction will be recruited from alexandria main university hospital (amuh), private hospitals and clinics. 4. a blood sample will be collected from 60 patients as baseline to test for n-terminal pro-b-type natriuretic peptide. 5. the same 60 patients will take empagliflozin for 6 months. 6. another blood sample will be taken from the same 60 patients to test the effect on n-terminal pro-b-type natriuretic peptide after empagliflozin administration. 7. the appropriate statistical test will be hold according to study design and parameters to evaluate the significant results. 8. results conclusion discussion and recommendations will be given.

Eligibility criteria:
inclusion criteria: * chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%) * 18-70 years * not receiving empagliflozin or any sglt2 inhibitor * elevated plasma nt-probnp (≥125 pg/ml) * egfr ≥ 20 ml/min/1.73m2 exclusion criteria: * acute coronary syndrome (acs) * pulmonary embolism * myocarditis * valvular heart disease * hypertrophic or restrictive cardiomyopathy * congenital heart disease * pulmonary hypertension * surgical procedures involving the heart * heart contusion * cardioversion, implantable cardioverter defibrillator (icd) shock * patients receiving digoxin * advanced age (\>70years) * ischemic stroke * chronic obstructive pulmonary disease * subarachnoid haemorrhage * severe infection (including pneumonia and sepsis) * anemia * renal dysfunction (egfr \<20ml/min/1.73m2) * liver dysfunction (mainly liver cirrhosis with ascites- child pugh b \& c) * severe burns * paraneoplastic syndrome * severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)

Keywords: empagliflozin heart failure with reduced ejection fraction nt-probnp
eras for patients received neoadjuvant chemotherapy

Conditions: Gastric Cancer

Summary: patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (eras) programs or the standard cares (sc) programs.

before, most trials about the eras for radical gastrectomy demonstrated eras programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. however, in most trials, patients who received neoadjuvant chemotherapy were excluded. the investigators designed this trial for patients received neoadjuvant chemotherapy. in this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the eras programs or the sc programs. finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the eras programs for locally advanced gastric cancer.

Eligibility criteria:
inclusion criteria: 1. patients received neoadjuvant chemotherapy with locally advanced gastric cancer. 2. age older than 18 and younger than 75 years. 3. american society of anesthesiologists (asa) class: i-iii. 4. participants can describe the symptom objectively and cooperate actively. 5. written informed consent. exclusion criteria: 1. patients allergic to oxaliplatin, tegafur gimerac etc. 2. patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> ii (nyha) 3. patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. 4. patients with severe liver and renal dysfunction (child - pugh ≥ 10; cr \< 25 ml/min). 5. patients who require simultaneous surgery for other diseases. 6. patients who received upper abdominal surgery previously. 7. pregnant or breast-feeding women.
loose-dose combination of acarbose and metformin for t2dm in metformin-failure patients

Conditions: Diabetes Mellitus, Type 2

Summary: to demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with t2dm that is inadequately controlled by metformin alone


Eligibility criteria:
inclusion criteria: * males and females, aged 18 to less than 80 years * diabetes mellitus type 2, that is insufficently controlled with metformin defined by hba1c between 7.0 % and 10.0%, inclusive * body mass index between 22 and 45 kg/m\^2, inclusive * women and men of reproductive potential must agree to use adequate contraception when sexually active exclusion criteria: * fasting plasma glucose \> 14.0 mmol/l * severe metabolic diabetic complications
personalized immunotherapeutic for antibiotic-resistant infection

Conditions: Infection; Immune Deficiency; Hypogammaglobulinemia; Septic Arthritis; Mycoplasma Hominis

Summary: m. a. suffers from hypogammaglobulinemia that has been complicated by refractory mycoplasma hominis septic arthritis. he has been receiving the antibiotic valnemulin under emergency investigational new drug (eind) 114686 following many prior treatments with standard antibiotics. m.a. has also been receiving intravenous immunoglobulin (ivig) replacement. the antibiotic and ivig have been helpful, but not sufficient for cure. antibodies have been shown to be critical for defense against mycoplasma. hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. the investigators propose to use m. hominis isolated from m. a. to vaccinate one transgenic cow (developed by sab biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human igg to m. a. after fda compassionate use ind application and local institutional review board (irb) approval.

m. a. suffers from hypogammaglobulinemia that has been complicated by refractory mycoplasma hominis septic arthritis. he has been receiving the antibiotic valnemulin under emergency investigational new drug (eind) 114686 following many prior treatments with standard antibiotics. m.a. has also been receiving intravenous immunoglobulin (ivig) replacement. the antibiotic and ivig have been helpful, but not sufficient for cure. antibodies have been shown to be critical for defense against mycoplasma. hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. sab biotherapeutics, inc. (formerly sanford applied biosciences, llc) located in sioux falls, sd, have developed transchromosomic (tc) cows containing human immunoglobulin (ig) heavy (igh) and light (igl) chain loci in the setting of inactivated bovine igh and ig lambda loci. to date, sab biotherapeutics (sab) has several products in development that have been tested in animal models, but to date no human trials. investigators propose to use m. hominis isolated from m. a. to vaccinate one transgenic cow, purify antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human igg to m. a. after fda compassionate use ind application and local institutional review board (irb) approval. m. a. is a highly educated person with full decision making capacity and is well aware of the uncertainties and risks associated with this treatment. this proposal is designed to offer this patient an alternative and perhaps curative approach to his disease.

Eligibility criteria:
inclusion criteria: * adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments. exclusion criteria: * none
greater houston area pediatric bipolar registry

Conditions: Pediatric Bipolar Disorder

Summary: the purpose of this study is to perform a comprehensive research assessment of children and adolescents who meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) criteria for bipolar disorder (bd) , offspring of a parent with bd, and healthy controls (hc), to obtain blood samples and saliva samples from each subject to allow the evaluation for bd biomarkers and genetic information, to notify participants about future research studies they may qualify for , to recommend follow-up with an outpatient provider if needed and to use magnetic resonance imaging (mri) (structural mri and diffusion tensor imaging) to investigate brain structures and relevant pathways associated with mood and behavioral regulation, conversion from softer forms of the bd spectrum (bd-nos) to harder forms (bd-i and bd-ii) and possible early identification.


Eligibility criteria:
inclusion criteria for bipolar patients or offspring of bipolar parents: * any current mood state (in the case of bipolar subjects) * for bipolar patients: dsm-v criteria for bd type i, bd type ii, or bd nos, as per the administration of the mini international neuropsychiatric interview for children and adolescents (mini-kid) * for the offspring of bipolar parents: at least one parent meeting dsm-v criteria for bd type i or bd type ii, or bd nos as per the administration of the mini adult exclusion criteria for bipolar patients or offspring of bipolar parents: * autism spectrum disorder (asd) * developmental intellectual disorder * severe neurological disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis) * schizophrenia * uncontrolled or severe medical problem per investigator judgment * for the offspring: parents with a history of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, and other degenerative brain diseases; parents with a history of intellectual disability exclusion criteria for healthy control subjects: * any psychiatric diagnosis * any family history of bipolar disorder, psychotic disorder, schizophrenia, or schizoaffective disorder in a first-degree relative * any family history of a neurological condition in a first-degree relative. * mental retardation/intellectual disability * severe neurological disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis) * schizophrenia * uncontrolled or severe medical problem per investigator judgement exclusion criteria for annual visits: * autism spectrum disorders (asd) * intellectual developmental disorder * severe neurological disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis) * schizophrenia * uncontrolled or severe medical problem per investigator judgement
e-biomatrix 6 month dapt france

Conditions: Coronary Artery Stenoses; Stable Angina; Ischemia; NSTEMI - Non-ST Segment Elevation MI; STEMI

Summary: prospective, multi-center observational study to be conducted in up to 30 french interventional cardiology centers. the purpose of this observational study is to capture, in french centers, clinical data of the biomatrix flex™ and biomatrix neoflex™ drug eluting coronary stents system (biolimus a9, ba9™-) in normal practice, in patients treated with 6-month dapt, and to compare the outcomes to those of previous e-biomatrix registries with longer dapt durations. the patients will be followed up for 2 years for data collection.


Eligibility criteria:
inclusion criteria: * "real world, all comer" patients 1. age ≥18 years; 2. patients that need a treatment with a biomatrix flex™ drug- eluting stent or a biomatrix neoflex™drug-eluting stent; 3. presence of one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents; 4. no limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements; 5. patient with dapt indication after pci. exclusion criteria: 1. inability to provide informed consent; 2. patients needing additional stent not of the biomatrix flex™ or neoflex™ types; 3. patients receiving next to the biomatrix flex™ or biomatrix neoflex™ also other coronary vascular interventions, for example, balloon dilation; 4. pregnant or planning to become pregnant patient; 5. des and bms implantation less than 6 months before screening;
effect of amlodipine on the lipid profile of newly diagnosed hypertensive patients

Conditions: Hypercholesterolemia; Hypertension; Cholesterol Deposition

Summary: in this study, amlodipine has been used to study its effects in newly diagnosed hypertensive patients.

the incidence of hypertension is on the rise in developing countries like pakistan. different medications are used to decrease blood pressure with amlodipine as one of the first-line drugs. it was proposed that due to interaction with calcium and thus luminal cholecystokinin releasing factor; amlodipine might increase the cholesterol level and thus cause dyslipidemia. objective: in this regard, this study was conducted to look into the effects of amlodipine in newly diagnosed cases of hypertension that had received no medication previously. methodology: experimental study with a healthy control group with the sample size calculated out to be 80, comprising of an equal number of enrolment into case and control groups.

Eligibility criteria:
inclusion criteria for cases. 1) newly diagnosed mild to moderate hypertensive. (2) non-obese individuals. 3) must not have received antihypertensive treatment previously. 4) has elevated serum cholesterol levels. exclusion criteria for cases 1) any other major illness. inclusion criteria for controls 1. normal lipid profile. 2. normotensive (bp \< 140/90mmhg). exclusion criteria for controls 1) any major illness.

Keywords: hypercholesterolemia hypertension
effectiveness study of physical therapy as an adjunct to a lumbar therapeutic selective nerve root block

Conditions: Sciatic Neuropathy; Radiculopathy; Intervertebral Disk Displacement

Summary: the purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).

recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. the management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. the effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.

Eligibility criteria:
inclusion criteria: * mri evidence of disk herniation in the lumbar spine consistent with clinical presentation * pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment * scheduled to receive a therapeutic selective nerve root block exclusion criteria: * any lumbar surgery within six months of the baseline examination * any prior lumbar surgery involving fusion * medical red flags indicating a serious pathology such as neoplasm, infection, or fracture

Keywords: sciatic neuropathy physical therapy spinal injections
early oral intake after pancreaticoduodenectomy in the age of eras

Conditions: Periampullary Carcinoma Resectable; Pancreaticoduodenectomy

Summary: early oral intake after pancreaticoduodenectomy is recommended strongly according to the eras guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. specific clinical study on early oral intake after pd is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing pd in the age of eras.

enhanced recovery after surgery (eras) is an interdisciplinary, multimodal concept and has become an important focus of pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. early oral diet without restrictions after operation is recommended strongly according to eras guideline. however, several studies demonstrated that only half validated the true practice of the postoperative oral diet. furthermore, oral intake tolerance after pd is controversial. only 23% of patients were able to take solid food at day 3. it appears that adequate nutritional intake only via oral diet is a severe challenge. besides, studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. importantly, specific clinical study on early oral intake after pd is very limited. therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing pd in the age of eras.

Eligibility criteria:
inclusion criteria: * periampullar carcinoma * pancreaticoduodenectomy * eras protocol implemented exclusion criteria: * preoperative radiotherapy/chemotherapy * unresectable primary cancer * palliative surgery * new york heart association class\>3
pilot deprescribing n-of-1 trials for beta-blockers in hfpef

Conditions: Heart Failure; Heart Failure, Diastolic; Heart Failure With Preserved Ejection Fraction; Cardiac Failure; Heart Disease

Summary: in this study, we will test the feasibility of n-of-1 trials for deprescribing beta-blockers in patients with heart failure with preserved ejection fraction. to achieve this objective we will conduct 16 4-period n-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. the n-of-1 trials will be iteratively refined in real-time based on this feedback.


Eligibility criteria:
inclusion criteria: * ambulatory adults ≥65 years of age with heart failure with preserved ejection fraction (hfpef) according to acc/aha guidelines: (signs and symptoms of heart failure \[hf\] and ejection fraction \[ef\] ≥50%) * taking beta blocker exclusion criteria: * alternate causes of hfpef syndrome: 1. severe valvular disease 2. constrictive pericarditis 3. high output heart failure 4. infiltrative cardiomyopathy * other compelling indication for beta blocker: 1. prior ef \< 50% 2. hypertrophic cardiomyopathy 3. angina symptoms 4. acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year 5. history of ventricular tachycardia 6. atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year 7. sinus tachycardia \> 100 beats per minute (bpm), atrial arrhythmia with ventricular rate \>90 bpm, systolic blood pressure \> 160 mmhg * clinical instability (n-of-1 trials are appropriate for stable conditions only) 1. decompensated hf 2. hospitalized in past 30 days 3. medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at pi discretion * estimated life expectancy \<6 months * moderate-severe dementia or psychiatric disorder precluding informed consent * any condition that, in principal investigator's opinion, makes the patient unsuitable for study participation
a study of endochoice's upper&lower endoscopic systems utilizing a full spectrum optical technology

Conditions: Gastrointestinal Diseases

Summary: endochoice's fuse system enables a wider view range via 1-2 additional cameras (depending on the model). these optical properties are to be examined and reviewed in this trial (mainly usability and safety)

endochoice full spectrum optical technology (fsot) in gastrointestinal endoscopy enables a 330 degree field of view. fsot powers endochoice's fda, ce and amar (israeli medical device authority) approved endoscopic systems (gastroscope and colonoscope). the intent of this study is to evaluate the safety, performance and usability of additional versions of fsot- powered gastroscopes and colonoscopes.

Eligibility criteria:
inclusion criteria: * male and female patients ages of 18-70 * the patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance. * signed informed consent exclusion criteria: * patients with inflammatory bowel disease; * patients with a personal history of polyposis syndrome; * patients with suspected bowel stricture potentially precluding complete endoscopy * patients with a history of diverticulitis or toxic megacolon * patients with a history of radiation therapy to neck, abdomen, pelvis; * patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study. * patients with gi bleeding, that has not been corrected prior to endoscopy