Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of the combination of aliskiren (300 mg) and amlodipine (10 mg) compared to amlodipine (10 mg) monotherapy in patients with moderate to severe hypertension

Conditions: Moderate to Severe Hypertension

Summary: this study will compare the blood pressure (bp) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (mssbp) after 8 weeks of treatment.


Eligibility criteria:
inclusion criteria: * outpatients ≥ 18 years of age * patients with a diagnosis of moderate to severe hypertension, defined as mssbp ≥ 160 mmhg and \< 200 mmhg at visit 2 exclusion criteria: * mild to moderate hypertension * pregnant or nursing (lactating) women * women of child-bearing potential * previous or current diagnosis of heart failure new york heart association(nyha) class ii-iv. * serum potassium ≥ 5.3 meq/l (mmol/l) at visit 1. * uncontrolled type 1 or type 2 diabetes mellitus * hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures * history of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention * patients on a combination of 3 or more antihypertensive medications other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension systolic blood pressure cardiovascular disease aliskiren amlodipine
how does the addition of adductor canal block to local infiltration affect recovery in patients undergoing total knee arthroplasty? a feasibility study.

Conditions: Knee Osteoarthritis; Arthritis Knee; Knee Disease; Opioid Use

Summary: the use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. the aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.

this study is a double blinded, randomized control trial. in order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (acb) and a periarticular injection (pi). all syringes will be non-identifiable to the surgeon, anesthetist and the patient. specifically, the two arms are: arm 1: pi (ropivacaine + ketorolac + epinepherine) + acb (ropivacaine) arm 2: pi (ropivacaine + ketorolac + epinepherine) + acb (normal saline) the aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. the investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.

Eligibility criteria:
inclusion criteria: 1. patients requiring primary total knee arthroplasty 2. patients interested in being part of the study 3. eligible to receive spinal anesthesia exclusion criteria: 1. age \< 18 years 2. bmi \> 40 kg/m2 3. deemed unsuitable for regional anesthesia 4. planned general anesthesia 5. hepatic insufficiency/intolerance to acetaminophen 6. renal insufficiency (defined by egfr \<60) 7. chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine, per hour for greater than 1 month) 8. sulpha allergy 9. allergy or intolerance to trial medications 10. clinical frailty scale score \> 4 11. surgery scheduled on a weekend

Keywords: quality of recovery-15 survey peripheral nerve block local infiltration adductor canal block periarticular injection regional anesthesia total knee arthroplasty orthopedics total knee replacement
effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units

Conditions: Delirium; Intensive Care Unit; Randomised Controlled Trial

Summary: the goal of this clinical trial is to evaluate the effectiveness of a vr-based sensory stimulation system in preventing icu delirium in patients. the main questions it aims to answer are: is the vr-based sensory stimulation system more effective in preventing icu delirium compared to usual care? does vr sensory stimulation improve patient psychological well-being and clinical outcomes in the icu? participants will: experimental group: engage in vr-based sensory stimulation sessions involving visual or/and auditory stimulation. control group: receive usual care without additional vr-based interventions. comparison: researchers will compare the outcomes between the experimental group (receiving vr-based sensory stimulation) and the control group (receiving usual care) to determine the effects of vr sensory stimulation on icu delirium prevention, as well as its impact on patient psychological well-being and clinical outcomes.


Eligibility criteria:
inclusion criteria: * all icu patients admitted to the study setting will be recruited if they are have: (1) ≥ 18 years, (2) the first time admitted to icu and (3) a richmond agitation-sedation scale (rass) score ≥-3 exclusion criteria: * patients will be excluded if they have: (1) been diagnosed with dementia, delirium or acute psychiatric illness at admission, (2) been diagnosed with end-stage cancer, (3) severe hearing impairment and cannot be corrected by hearing aids and (4) been admitted to icu with radioactive material.

Keywords: delirium intensive care unit randomised controlled trial sensory stimulation virtual reality
comparison of intralipid with smof lipid following hsct

Conditions: Leukemia; HSCT

Summary: the goal of this clinical trial is to have a successful engraftment in after bone transplantation. acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. primary hypothesis is patients receiving smof lipid will have better grafts than patients receiving intralipid. also, complications after surgery and malnutrition will be less in this group.

patients will be randomly divided into two groups: the intervention group (tpn based on smoflipid) and the control group (tpn based on intralipid). at baseline (before hsct) and after obtaining informed consent and assent, blood samples will be collected to test for biochemical markers, including total cholesterol, tg, ldl, hdl, fbs, alb, na, k, ph, ca, mg, crp, il-6, bun, cr, and cbc. furthermore, data on nutritional intake (total energy and protein) and appetite status will be gathered. the primary outcomes are neutrophil and platelet engraftment, defined as \&gt;500 for neutrophils and \&gt;20,000 for platelets, respectively. the possibility of oral intake, as well as the achievement of oral + ons and total oral nutrition alongside tpn duration, will be recorded. on days +15 and +30, biochemical and anthropometric markers will be collected again. furthermore, clinical outcomes such as acute gvhd, cholestasis, bleeding, infections, hospitalization, and mortality will be reported.

Eligibility criteria:
inclusion criteria: * willingness to cooperate and complete the informed consent form by the legal guardian of the child; * age ≤ 18 years; * definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation; * eligible for parenteral nutrition support; * no contraindications for parenteral nutrition; * no history of allergy to egg or soy protein; * absence of severe organ failure or impaired liver function test (bilirubin \&gt; 2.5 mg/dl). exclusion criteria: * death of the child earlier than 5 days from the start of the intervention; * unwillingness to continue cooperation during study; * occurrence of side effects during the study; * in case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.

Keywords: mortality smof intralipid engrafment complications
clinical trial to evaluate the safety and pharmacokinetic/pharmacodynamic characteristics of dw1903

Conditions: Gastritis

Summary: a randomized, open-label, oral in healthy male volunteers


Eligibility criteria:
inclusion criteria: * healthy volunteers who are ≥19 years old * bmi between 18 and 30 kg/m2 * body weight ≥50kg exclusion criteria: •clinically significant medical history
early versus late intervention after biliary tract injury post cholecystectomy

Conditions: Biliary Fistula

Summary: bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. it should be regarded as preventable. the advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). it has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. it should be regarded as preventable. the advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). it has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

Eligibility criteria:
inclusion criteria: * all patients with post cholecystectomy biliary tract injury admitted at assuit university hospital at the period of the study exclusion criteria: * any case with biliary leakage not post cholecystectomy
study evaluating the safety and efficacy of piperacillin/tazobactam and ampicillin/sulbactam in patients with diabetic foot infections

Conditions: Diabetes Mellitus; Diabetic Foot

Summary: phase iv open-label foot infection study is being conducted to generate comparative efficacy and safety data in diabetic inpatients.


Eligibility criteria:
inclusion criteria * patients with diabetes mellitus * inpatient * have 1 or more infected ulcer(s) below the ankle exclusion criteria * must not have gangrene or severely impaired arterial supply in your foot * must not have a bone infection in the area of your ulcer * must not have allergies to penicillins

Keywords: diabetes
topical ketoprofen versus placebo in patients with ankle sprain

Conditions: Ankle Sprain

Summary: the aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.

patients, 18-65 years old, presented with ankle sprain are enrolled into the study. pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. the study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. the study drugs are identical in colour, form and smelling. after an eligible patient presented to the ed, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. physicians, nurses and patients are blinded to the study drug. pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.

Eligibility criteria:
inclusion criteria: * patient presented with ankle sprain to the emergency department. * patients between 18-65 years old. exclusion criteria: * pain over 24 hours, * pain intensity lower than 40 mm, * allergy to the study drug, * drug alcohol abuse * pregnancy or breastfeeding are the exclusion criteria.

Keywords: ankle sprain topical ketoprofen non-steroidal anti-inflammatory drug emergency department
the effect of perioperative intravenous magnesium on pain after endoscopic submucosal dissection for gastric neoplasm: prospective randomized double-blind placebo controlled study

Conditions: Gastric Neoplasm

Summary: endoscopic submucosal dissection (esd) is an effective treatment for early gastric cancer or premalignant lesions in the stomach. esd enables en bloc resection of gastrointestinal neoplasms, increases the rates of histologically complete resections, and also reduces local recurrence rates. despite these advantages, esd is thought to induce various complications. wellknown esd-related complications include perforation, postoperative bleeding, or stricture. in addition, minor adverse events after esd are also commonly noticed. pain is one of these frequently noticed minor esd related complications, is the main reason for prolongation of the hospital stay, and is related to patients' compliance; however, there is a tendency to neglect or underestimate post-esd pain. the causes of pain associated with esd are thought to be associated with transmural burn or transmural air leak. some studies have tried to control localized pain during and after esd using local lidocaine, single dose postoperative intravenous dexamethasone or a transdermal fentanyl patch. magnesium has been reported to alter the perception and duration of pain and produce important analgesic effects. it is included the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of n-methyl-d-aspartate receptors in the central nervous system. also, magnesium may prolong neuromuscular blockade after administration of neuromuscular blocking drugs, increase sedation and contribute to serious cardiac morbidity. and magnesium as a hypotensive anaesthesia technique supply objectively better operative field, reduction in the duration of surgery and reduced blood loss. there have been no previous trials on the use of magnesium specifically for pain control following esd. thus, the purpose of this study was to assess the efficacy of intravenous magnesium for pain relief after esd.


Eligibility criteria:
inclusion criteria: 1. asa 1\~2, 2. age of 40- 80 years exclusion criteria: 1. patients who cannot read, 2. patients refusing the study 3. allergy to magnesium 4. chronic pain 5. chronic abuse of opioid or nsaid 6. neuromuscular block 7. atrioventricular conductance block 8. liver failure,

Keywords: perioperative intravenous magnesium endoscopic submucosal dissection
diagnostic, therapeutic and reproductive aspects of patients with mullerian anomalies (mulan)

Conditions: Mullerian Anomaly of Vagina; Mullerian Anomaly of Uterus, Nec; Mullerian Anomaly of Cervix

Summary: the purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of mullerian anomalies.

mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. this causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. however, the diagnosis can be made more accurately with improved diagnostic tools. moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women. the purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of mullerian anomalies.

Eligibility criteria:
inclusion criteria: * women with a uterus * presence of a mullerian variation * maximum age 45y exclusion criteria: * women without a uterus * aged \>45y

Keywords: mullerian anomaly diagnostic tools surgical treatment reproductive function obstetric complications
simple bed exercises for reducing postoperative ileus in colorectal surgical patients.

Conditions: Postoperative Ileus

Summary: the purpose of this study is to examine the effect of simple bed exercises for reducing postoperative ileus among colorectal surgical patients who have completed colorectal surgery and are experiencing postoperative ileus. the research team will recruit participants in list of elective colorectal surgeries from the department of surgery in the united christian hospital. the potential participants will first be assessed for eligibility by completing a simple screening assessment, which may take 10 minutes at facilities within the united christian hospital. if the patients meet the inclusion criteria, they will continue to take part in the study. the participants will be assigned randomly (1:1) to either group 1 or group 2 via computer randomization. participants of group 1 will receive education for simple bed exercises after colorectal surgery. participants will be asked to have simple bed exercises for 15 minutes, three times a day starting from postoperative day one, until passing the first stool after surgery. all sessions will be conducted by surgical nurse in the united christian hospital. surgical nurses will educate simple bed exercises with exercise video. participants will be instructed to practise the simple bed exercises 3 times per day for 15 minutes each time at before breakfast, before lunch and before dinner, on top of the standard usual care. participants in group 2 will be placed under control group to receive standard usual care. all participants are required to record defecation, flatus and tolerance of oral intake starting from postoperative day one. records will take place at 3-time points for both groups: at breakfast, at lunch and at dinner time. each time participants must complete one set of record on the logbook provided by nurses. if necessary, clinical records including medical history and follow-up appointment time will be retrieved from electronic medical records.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>/=18 years, * patients who are diagnosed with colorectal problems that require elective colorectal surgical intervention either anastomosis or stoma, either open or laparoscopic, and the use of any type of postoperative analgesic, * orientate to have informed consent and who have signed informed consent. exclusion criteria: * patients who are not in the list of elective colorectal surgeries * patients who require intraoperative and long postoperative intensive care \>1 day, * with a history of mental disorder or confusion, * patients with any active limitation which affects adherence to the study procedures like severe dementia and physical limitation.

Keywords: postoperative ileus exercise
retinal imaging in neurodegenerative disease

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Parkinson's Disease; Multiple Sclerosis; Huntington Disease; Lewy Body Dementia; Frontotemporal Dementia; Amyotrophic Lateral Sclerosis (ALS); APOE-4 Positive; Traumatic Brain Injury; Concussion; Post-Traumatic Stress Disorder; Down Syndrome; Neuro-Degenerative Disease; Normal Cognition

Summary: this study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (oct) and oct angiography (octa) as well as ultra-widefield (uwf) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (mci) and alzheimer's disease (ad), parkinson's disease (pd), or other neurodegenerative disease, diseases as outlined.

using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. the investigators propose to develop and evaluate imaging biomarkers from oct, octa, and uwf fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals. the investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using oct and octa, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases. this study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging. the protocol for this study was amended and the record was updated accordingly.

Eligibility criteria:
inclusion criteria: * adults with neurodegenerative disease ((mci, pd, ad, ftd, dlb, als, ms, hd, tbi, concussion, ptsd and other neurodegenerations as well as down syndrome) * adults without neurodegenerative disease exclusion criteria: * inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition. * eyes that have had intraocular surgery, other than cataract surgery. if two eyes satisfy the inclusion criteria, both eyes will be included in the study. if one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.

Keywords: oct angiography (octa) optical coherence tomography (oct) vessel density superficial capillary plexus retinal microvasculature scanning laser ophthalmoscopy ultra-widefield (uwf) imaging perfusion density retinal nerve fiber layer ganglion cell inner plexiform layer choroidal vascularity index