Kornimate/medical-research-clean huggingface dataset:
does coffee intake reduce postoperative ileus after elective colorectal surgery

Conditions: Postoperative Ileus

Summary: the aim of the study is to investigate if postoperative coffee intake decreases the time until first bowel movement in elective colorectal surgery with primary anastomosis.

postoperative ileus after colorectal surgery is a frequent problem which significantly prolongs hospital stay and increases perioperative costs. postoperative therapeutic interventions vary significantly between different hospitals due to missing evidence-based guidelines. coffee is a safe, cheap and simple agent without significant side effects which can positively influence the bowel function. the aim of the investigators is to evaluate in an own study if coffee consumption has an influence on the duration of postoperative ileus. the present trial is designed to evaluate if postoperative coffee intake decreases the time until first bowel movement in colorectal surgery with primary anastomosis. this study would be the second study which evaluates the described questions under randomized conditions.

Eligibility criteria:
inclusion criteria: patients scheduled for elective laparoscopic or open colorectal surgery due to benign or malignant colorectal disease, which need a large bowel resection with primary anastomosis * age equal or greater than 18 years * patients that are able to give informed consent * elective surgery * anastomosis above 6 cm from anal verge exclusion criteria: * participation in other studies * additional small bowel anastomosis * need for extended adhesiolysis * need for a stoma (e.g. protective ileostomy) * emergency operation with diffuse peritonitis or preexisting ileus * preoperative radiation * known hypersensitivity or allergy to coffee * expected lack of compliance * impaired mental state or language problems

Keywords: coffee postoperative ileus colorectal surgery
can dexmedetomidine for procedural sedation in knee arthroplasty reduce postoperative pain? a randomized control study

Conditions: Total Knee Arthroplasty

Summary: dexmedetomidine has been often used for procedural sedation. it has also has been shown to have a pain sparing effect. therefore the investigators propose that if dexmedetomidine is used for sedation in total knee replacements done under spinal anesthetic, the patients will have less pain up to 24 hours after the procedure.

randomization will occur prior to patient being brought into operating room (by pharmacy or by the anesthesia research coordinator). a third anesthetist not involved in the project will mix up the syringe based on instructions in an opaque envelope, and provide the syringe to the attending anesthetist. the current standard of care entails patients receiving a midazolam bolus for sedation during the operation. the investigators propose to substitute a syringe of dexmedetomidine or saline to be run as an infusion throughout the case for sedation. a midazolam bolus will be available at anesthetist discretion to achieve a moderate sedation score as defined by the american society of anesthesia. standardized medication protocol pre-op: tylenol and naproxen spinal: marcaine .75%, 1.7cc (12.75mg) fentanyl 10 micrograms sedation 1. st arm- dexmedetomidine, drawn up into a 50cc syringe of saline, thereby making it 5ug/ml. 2. nd arm- receives normal saline syringe plan for bolus of 0.5microgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr (can be titrated from 0.2-0.7 microgram per kg per hr to achieve moderate sedation as defined by the asa both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation. post op- initial setting of patient-controlled-analgesia pump to be set at morphine 1 mg, lockout of 8 minutes, to be increased to 1.5 mg with lockout of 6 minutes if pain not controlled. the investigators will increase the pump dose by 0.5 mg/dose/1 hr until pain controlled. risks the most common treatment-emergent adverse reactions for dexmedetomidine, occurring in 2% of patients in both icu and procedural sedation studies, include- hypotension, bradycardia and dry mouth. to minimize the risks to participants, an anesthesiologist will always be present in the room while the infusion is running, will monitor the patient, and will be allowed to treat as they see fit any of these risks. data collection data collection will be performed primarily by ian chan, anesthesiology resident. primary outcome: total morphine consumption in the first 24 hours

Eligibility criteria:
inclusion criteria: * total knee arthroplasty american society of anesthesiologist score of 1-3 age 18-85 elective total knee arthroplasty under spinal anesthetic. exclusion criteria: * contraindication to dexmedetomidine. (second or third degree heart block, renal or hepatic dysfunction) contraindication to spinal anesthetic pain being treated by opioids prior to operation contraindication to premedication previous total knee arthroplasty
detection of an endovascular treatment target in patients with an acute, spontaneous intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage; Nontraumatic Intracerebral Hemorrhage

Summary: this study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ich.

hemorrhagic stroke caused by an intracerebral hemorrhage (ich) is a common (roughly 15% of all strokes) and devastating disease with high rates of mortality and morbidity. the most important potentially modifiable prognostic factor after acute diagnosis of an ich is hematoma expansion. the investigators hypothesize that in hyperacute ich patients a treatment target can be detected with a diagnostic, cerebral dsa. the dsa is the goldstandard for the visualization of brain vessels. a treatment target would be a vessel from which contrast media extravasates as a sign of an active bleeding. if such a target could be identified, it could lay the rationale for future trials which would evaluate if stopping the bleeding directly at the origin improves patient outcomes. the only intervention in this study is an additional diagnostic cerebral dsa. this study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ich.

Eligibility criteria:
inclusion criteria: * diagnosis of an acute spontaneous ich based on non-contrast ct * time from symptom onset to anticipated start of cerebral dsa of under 3 hours * agreement of the treating physician to perform dsa * informed consent documented by signature or fulfilling the criteria for emergency consent procedures (deferral of consent) exclusion criteria: * high probability that the etiology of the bleeding is a ruptured aneurysm, an arteriovenous malformation or an amyloid angiopathy as judged by the treating physician * any time critical surgical or minimal invasive intervention is planned * evidence of an ongoing pregnancy, a negative pregnancy test is mandatory in all persons of childbearing potential * contraindications against the use of iodine contrast media * known severe kidney insufficiency (glomerular filtration rate \< 30 ml/min)

Keywords: digital subtraction angiography (dsa) hemorrhagic stroke hematoma expansion cerebral dsa
study with rupatadine in mosquito-bite allergic adult subjects

Conditions: Allergy

Summary: the study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.

mosquito-bite symptoms include wheals and pruritic bite papules. oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials. subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.

Eligibility criteria:
inclusion criteria: * recent history of suffering from mosquito-bite reactions. * at least 5 mm diameter mosquito-bite wheal from aedes aegypti laboratory mosquitoes exclusion criteria: * pregnancy or lactating females * oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (nsaid) use within two weeks before the study. * severe or moderate systemic illness * allergy to rupatadine or other antihistamines * anaphylaxis from mosquito bites
safety and effectiveness of an anti-hiv drug combination taken twice daily

Conditions: HIV Infections

Summary: the purpose of this study is to see whether taking indinavir (idv) plus ritonavir (rtv) plus stavudine (d4t) plus lamivudine (3tc) 2 times each day is safe and can lower the level of hiv in the blood.

patients take idv plus rtv plus d4t plus 3tc twice daily for 24 weeks. every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and cd4 cell counts and plasma viral rna are measured. at week 24, the proportion of patients with plasma viral rna below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. an observed response proportion of 80% or higher will be considered clinically meaningful.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a cd4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. * are age 16 or older (consent of a parent or guardian required if under 18). * agree to practice abstinence or use barrier methods of birth control (such as condoms). * are willing to stop taking all anti-hiv drugs except study drugs. (patients may be able to continue taking drugs for other infections.) exclusion criteria patients will not be eligible for this study if they: * have cancer, lung disease, severe hepatitis, or active aids-related infections. (certain aids-related infections such as kaposi's sarcoma may be allowed). * have ever taken 3tc, abacavir (abc), or a protease inhibitor (such as idv or rtv). * have changed their medications in the last 2 weeks. * are allergic to idv, rtv, d4t, or 3tc. * have used certain medications (see the technical summary for more detail). * are pregnant or breast-feeding.

Keywords: drug therapy, combination stavudine hiv protease inhibitors ritonavir lamivudine indinavir reverse transcriptase inhibitors anti-hiv agents viral load
prospective study of profile of hepatic osteodystrophy in patients with non-choleastatic liver cirrhosis and impact of bisphosphonate supplementation

Conditions: Cirrhosis

Summary: background and objectives: patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (hod). it includes both osteopenia and osteoporosis and may lead to increased fracture risks. there is scanty data on prevalence of hod in indian population and its treatment outcome. the investigators aimed to determine prevalence of hod, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis. patients and methods: consecutive patients with liver cirrhosis admitted at sir ganga ram hospital, new delhi between august 2012 and july 2013 were enrolled. patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. bone mineral density (bmd) was measured by dual-energy x-ray absorptiometry (dexa) at the lumbar spine and femoral neck. osteopenia and osteoporosis were defined according to who criteria. all patients also underwent 25-hydroxy-vitamin-d, sex hormone (testosterone in male and lh and estradiol in female) and parathyroid hormone (pth) along with routine investigations. transient elastography was also done in all patients. ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and dexa scan repeated.


Eligibility criteria:
inclusion criteria: 1. liver cirrhosis 2. age 18-70 years 3. informed and written consent exclusion criteria: 1. chronic renal failure 2. prolonged steroid use more than 3 months 3. patients on immunosuppressive therapy 4. primary hyperparathyroidism 5. post menopausal women 6. pregnancy 7. cushing's syndrome 8. malignancy 9. hiv co-infection
the use of pramipexole and other dopamine agonists and the risks of heart failure and pneumonia

Conditions: Heart Failure

Summary: study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy


Eligibility criteria:
inclusion criteria: * all patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009 exclusion criteria: * patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ace) inhibitors/angiotensin receptor blocker (arb), and diuretic drug classes prior to cohort entry
mp1032 treatment in patients with moderate to severe covid-19

Conditions: COVID-19

Summary: the purpose of this study is to evaluate the efficacy and safety of mp1032 with standard of care (soc) verses placebo with soc in hospitalized adults participants with moderate to severe coronavirus disease 2019 (covid-19).


Eligibility criteria:
key inclusion criteria: * participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) test by standard reverse transcription-polymerase chain reaction (rt-pcr) assay or equivalent test * participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with covid-19 key exclusion criteria: * participant, in opinion of the investigator, is not likely to survive \>=48 hours beyond day 1 * participant has a diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 on day 1 * participant has a documented medical history of infection with hepatitis a, b, c, or with human immunodeficiency virus (with a detectable viral load and cd4 count \<500 cells per micro liter), or a documented active infection with tuberculosis. * the participant has clinically significant electrocardiogram (ecg) abnormalities at screening other protocol defined inclusion/exclusion criteria may apply

Keywords: covid-19 mp1032
evaluating of the efficacy and safety of vardenafil in subjects with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: erectile dysfunction (ed) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. an ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. the purpose was the evaluation of efficacy and safety of 10 mg oral vardenafil in nigerian subjects with erectile dysfunction (ed).


Eligibility criteria:
inclusion criteria: * men \>/= 18 years of age * erectile dysfunction exclusion criteria: * history of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * nitrate therapy * other exclusion criteria apply according to the summary of product characteristics

Keywords: erectile dysfunction vardenafil
study to demonstrate the preliminary safety and effectiveness of ipbs in performing mri-guided targeting and intervention of breast tissue in female patients indicated for mri-guided breast biopsy

Conditions: Breast Cancer Screening; MRI Guided Breast Biopsy; Breast Cancer Diagnosis

Summary: a preliminary demonstration of the safety of ipbs in positioning a vacuum assisted biopsy (vab) tool to enable an mri-guided automated breast biopsy. this will consist of 10-15 biopsy procedures facilitated by the mri-guided system. patients will be followed after the procedure to assess clinical outcomes.


Eligibility criteria:
inclusion criteria: * female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual mri-guided breast biopsy for diagnosis and staging. * individuals capable of giving a free and informed consent. exclusion criteria: * any patient for whom the manual mri-guided breast biopsy procedure would not be possible (size of patient, etc.). * patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion. * patients who are not suitable for the procedure will be excluded at the investigators discretion. * patients unwilling to complete associated study questionnaires or follow up visits. * women who are pregnant or who plan to become pregnant within the study duration.
a study of dexlansoprazole modified release (mr) in gastroesophageal reflux disease (gerd) participants in the russian federation

Conditions: Gastroesophageal Reflux Disease

Summary: the primary purpose of the study is to evaluate effect of dexilant treatment among gerd participants in the russian federation.

this is an observational, prospective non-interventional study of participants with gerd. this study will evaluate the effect of dexlansoprazole treatment among participants with gerd. the study will enroll approximately 1500 participants. due to non-interventional design of the study, the decision about gerd treatment strategy for the participant is taken by attending treating physician. all participants will be enrolled in one observational group: dexlansoprazole. prospective data will be collected for a period of 2 months. the frequency of the visits will be assigned by each physician according to their routine practice. the multi-center trial will be conducted in russia. the overall duration of study will be approximately 2 months.

Eligibility criteria:
inclusion criteria: 1. male and female participants 18 or older years of age by the time of enrolment. 2. confirmed gerd diagnosis (non-erosive reflux disease (nerd) or erosive reflux diseases (erd)) on the base of typical clinical features (symptoms), upper endoscopy within last 12 months prior to inclusion and/or gerdq. 3. participants diagnosed with gerd less than (\<) 3 years prior to study entry, with or without treatment with other gerd medications. 4. participants without concomitant gastrointestinal (gi) conditions of the gastrointestinal tract and with concomitant gi conditions of the gastrointestinal tract as well as other organ systems concomitant conditions. 5. the physician decides to prescribe dexilant: * as monotherapy or * as a part of combined therapy 6. written informed consent, signed before the participation in the study begins. exclusion criteria: 1. contraindications for proton-pump inhibitors (ppis) of respective approved local packaging leaflets. 2. existence of upper gastrointestinal bleeding. 3. history of surgery on esophagus, stomach or duodenum. 4. primary esophageal motility disease, achalasia, scleroderma, esophageal / pyloric stricture, primary esophageal spasm, infectious or inflammatory bowel disease, severe malabsorption, severe chronic heart failure, serve cardiovascular disease, renal failure, chronic obstructive pulmonary disease (copd), asthma, liver cirrhosis. 5. malignant disease of any kind any system or organ within 5 years, except completely recovered skin cancer. 6. needs in antibiotics due to severe infection. 7. alanine transaminase (alt) or aspartate aminotransferase (ast) \>=upper limit of normal range\*3. 8. current, previous (within the last one year) or planned (for the next one year) participation in interventional clinical trial. 9. presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 10. any other condition, which on the opinion of the investigator may interfere the participant's participation in the study.

Keywords: drug therapy
the feasibility of bilateral intermediate cervical plexus block for thyroidectomy/parathyroidectomy

Conditions: Parathyroid Adenoma; Thyroid Nodule

Summary: the aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery.

bilateral intermediate cervical plexus blocks have been reported for thyroid/parathyroid surgery. this technique combined with intravenous sedation has used with safety in patients undergoing simple thyroid or parathyroid surgery. simple surgery is defined as the thyroid conditions are not cancer, redo or substernal goiter.

Eligibility criteria:
inclusion criteria: * patient underwent thyroid/parathyroid surgery under nerve blocks and sedation exclusion criteria: * incomplete opioid consumption or pain score record.

Keywords: intermediate cervical plexus block
treatment of obstructive sleep apnea (osa) with the da vinci® sp™ surgical system

Conditions: Obstructive Sleep Apnea

Summary: it is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

it is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. the objective of this study is to evaluate the clinical utility of the da vinci® sp™ surgical system, instruments and accessories in tors benign base of tongue resection procedures for the treatment of moderate to severe osa. da vinci® sp™ surgical system, instruments and accessories are the approved medical device product by mfds (ministry of food and drug safety, republic of korea).

Eligibility criteria:
inclusion criteria: * subject is between 18 and 80 years old * subject with bmi ≤ 35 * subject with moderate to severe sleep apnea, defined as 15 or more ahi events/hour * subject who has failed or is unable to tolerate cpap therapy * subject diagnosed with osa due to redundant base of tongue tissue * subject must be a suitable candidate for base of tongue resection surgery * subject who is willing and able to provide written informed consent * subject who is willing and able to comply with the study protocol requirements exclusion criteria: * subject with a poor mouth opening or trismus * subject with evidence of any primary cancers or metastatic disease, other than skin cancers * subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer * subject with congenital malformations in the larynx, throat or tongue * subject with an american society of anesthesiologists (asa) score of grade 4 or above during preoperative evaluation * subject for whom any additional surgeries are planned for osa within the study period, after the surgery in which the da vinci sp system was used * subject who is mentally handicapped or with a psychological disorder or severe systemic illness, that would preclude compliance with study requirements or ability to provide informed consent * subject is pregnant or suspected to be pregnant

Keywords: osa