Kornimate/medical-research-clean huggingface dataset:
conjunctival flora patterns after serial intravitreal injections in diabetic patients

Conditions: Diabetic Retinopathy; Diabetic Macular Edema

Summary: the aim of this study is to investigate the conjunctival bacterial flora and antibiotic resistance patterns following serial intravitreal injections of anti-vegf in diabetic patients, using a povidone-iodine preparation without preinjection or postinjection topical antibiotics.

the study is designed to enroll patients with diabetes mellitus over 18 years of age with diagnosis of diabetic retinopathy and diabetic macular edema, who were determined by their treating physician to require at least 3 serial injections with an anti-vegf agent. after signing an informed consent, conjunctival cultures will be performed from the participants' both eyes at baseline and at each subsequent injection. prior to each injection and the use of povidone-iodine drops, a conjunctival culture will be taken by swabbing the inferior fornix. another culture will be taken twenty minutes after the injection. we will culture the swab samples on blood and chocolate agar plates. all patients will be asked to complete a questionnaire regarding their signs and symptoms after the injection (like burning sensation, itching, discharge, tearing etc). the following routine procedure will be used in all intravitreal injections: local anesthesia using oxybuprocaine hydrochloride, ocular surface and eyelids sterilization with topical povidone-iodine 4%. intravitreal injection of 3.5 mm will be performed posterior to the limbus in pseudophakic patients and 4 mm injection will be performed posterior to the limbus in phakic patients using a 30 gauge needle. the exclusion criteria will consist patients who had received a prior intraocular injection in either eye, current use of contact lenses, chronic use of any ophthalmic medication, ocular surgery within the past 6 months, use of systemic antibiotics within the past 6 months and known allergy or contraindication to povidone-iodine or proparacaine. the study is planned to enroll 50 patients.

Eligibility criteria:
inclusion criteria: * age above 18 * patients with diabetes mellitus * patients with diabetic macular edema exclusion criteria: * patients who had received a prior intraocular injection in either eye, * current use of contact lenses, * chronic use of any ophthalmic medication, * ocular surgery within the past 6 months, * use of systemic antibiotics within the past 6 months, * known allergy or contraindication to povidone-iodine or proparacaine.

Keywords: diabetic macular edema intravitreal injection conjunctival flora
the effect of oral niacinamide on serum phosphorus levels in hemodialysis patients

Conditions: Hyperphosphatemia

Summary: elevated phosphorus levels are a common problem in dialysis patients. however, it is associated with an increase in death and hospitalizations. current treatment is comprised of dietary modifications and phosphorus binders - though this is often not enough for many of our patients. our trial investigates the use of niacinamide, a form of vitamin b, in decreasing serum phosphorus levels.

this is a prospective, randomized, double-blind, placebo-controlled crossover study comparing niacinamide versus placebo in the reduction of serum phosphorus in hemodialysis patients. a determination of baseline laboratory values (serum phosphorus, calcium, albumin, bipth, uric acid, complete blood count (cbc), and an nmr lipid panel) will precede the administration of the study drugs. the study will span a period of 21 weeks during which phosphorus levels will be checked on a weekly basis. phosphorus binder dose will remain unchanged unless for safety reasons. for the first 8 weeks of treatment, patients will be randomized to either placebo or niacinamide. both medications will be administered with a starting dose of one capsule twice per day (bid). niacinamide and placebo will be formulated in 250 mg capsules. placebo will be packaged to resemble the study drug in all physical attributes. the dose of niacinamide or placebo will be increased to 500 mg (2 capsules) bid at week 3 and 750 mg (3 capsules) bid at week 5. if hypophosphatemia (\< 3.5 mg/dl) is present, then titration will not occur and the previous dose will be continued. however, titration will resume in subsequent weeks if the serum phosphorus is greater than 3.5 mg/dl. after 8 weeks, patients will undergo a 2 week washout period, then crossover from treatment arm to placebo, or vice versa, at week 11. at the beginning of week 11, patients will cross over to the other treatment arm (either placebo or niacinamide) at one capsule (250 mg) twice per day. subsequent titration will occur at week 13 and week 15. the treatment phase will be completed at the end of week 18. a set of labs will be drawn at the start of week 19, followed by a two week washout period.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. capable of giving informed consent 3. duration of chronic hemodialysis \> 90 days 4. dose of phosphorus binder(s) stable over previous 2 week period 5. serum phosphorus \> 4.9 mg/dl based on most recent laboratory data within 1 month of enrollment exclusion criteria: 1. pregnancy 2. known liver disease 3. active peptic ulcer disease 4. treatment with carbamazepine 5. intolerance to niacinamide 6. current medication regimen including niacin or niacinamide-containing vitamins 7. more than 1 missed hemodialysis session in the last 30 days 8. planned or expected surgical procedure in the next 4 months 9. patients in nursing homes or extended care facilities where administration of the study drug may not be appropriately given

Keywords: hyperphosphatemia end stage renal disease renal osteodystrophy
kefir on bone mineral density and bone metabolism in osteoporotic patients

Conditions: Osteoporosis

Summary: in a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (caco3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with caco3 alone without kefir supplements. bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. bmd values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (dxa) at baseline and at 6 months.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteoporosis patients exclusion criteria: * any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.
evaluation of the 1999 and 2018 periodontal disease classifications: a retrospective study

Conditions: Diabetes Mellitus; Smoking; Periodontal Diseases

Summary: the aim of present study was to evaluate how the 2018 classification reflects the severity, extent and progression of the disease, taking into account the risk factors for periodontal disease, smoking and diabetes, when compared with the 1999 classification.


Eligibility criteria:
inclusion criteria: * patients with a complete periodontal chart and full mouth radiographic series at baseline * diabetes mellitus:patients who consulted by an internist/endocrinologist and underwent hba1c measurements in the last three months. * smoking status:all current smokers who had smoked more than 100 cigarettes in their lifetimes and used cigarettes for more than five years * patients meeting the case definition of periodontitis * relative radiographic bone loss(in %) was assessed on peri-apical radiograph films exclusion criteria: * individuals with a systemic disease other than diabetes * smokers not reporting the number of cigarette/days or patient(s) with diabetes that do not report hemoglobin a1c (hba1c) test results for diabetes. * individuals who do not suffer from periodontitis * patients with inaccessible files because of bad debt, destroyed record, or deceased.
pyrotinib plus fulvestrant in patients with hr+/her2+ metastatic breast cancer (pyrotinib+fulvestrant )

Conditions: Breast Cancer; HER2-positive Breast Cancer

Summary: pyrotinib is an oral tyrosine kinase inhibitor targeting both her1, her2 and her4 receptors. this study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy hr+/her2+ metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. women aged 18-75 years old; hr positive and her2 positive (immunohistochemistry or fish test confirmed). 2. ecog score ≤ 2, expected survival ≥ 3 months. 3. histology or cytology confirmed as breast cancer. 4. prior to trastuzumab and endocrine therapy and progression/recurrence. 5. at least one recist 1.1 defined measurable lesions. 6. normal function of major organs. exclusion criteria: 1. pregnant or lactating women 2. patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. except for endocrine therapy. 3. severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline). 4. rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) 5. patients with central nervous system disorders or mental disorders 6. bone metastasis lesions only, no other measurable lesions. 7. hypertension (systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 100 mmhg) without ideal control. 8. uncontrolled heart disease. 9. have congenital long or short qt syndrome or have a family history or personal history of brugada syndrome. 10. uncontrolled rain metastasis.

Keywords: metastatic breast cancer, pyrotinib, fulvestrant
study of tilpisertib fosmecarbil in participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the goal of this study is to learn if tilpisertib fosmecarbil (formerly known as gs-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. the study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. the primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving clinical response at week 12.


Eligibility criteria:
key inclusion criteria: * individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit. * ulcerative colitis (uc) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past and a minimum disease extent of 15 cm from the anal verge. documentation of endoscopy and histology consistent with the diagnosis of uc must be available in the source documents prior to the initiation of screening. * moderately to severely active uc as determined during screening with a modified mayo clinic score based on the sum of stool frequency, rectal bleeding, and endoscopic finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader). * previous treatment history of approved uc therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action. * a surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with uc. key exclusion criteria: * current diagnosis of crohn's disease (cd) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis. * individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy. * requirement for ongoing therapy with or prior use of any prohibited medications. * active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks. of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization. * history of opportunistic infection. * current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon. note: other protocol-defined inclusion/exclusion criteria may apply.
safety and effect on memory of pym50028 in mild alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to assess the effect of pym50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to alzheimer's disease.


Eligibility criteria:
inclusion criteria: * at least 50 years of age * diagnosis of possible or probable alzheimer's disease * mini mental state examination score at least 16 * good understanding of both written and verbal english * a recent head scan that is consistent with the diagnosis of alzheimer's disease exclusion criteria: * recent history or clinical evidence of significant neurological disease other than dementia due to alzheimer's disease * known to have another condition that is associated with dementia * use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine) * hormone replacement therapy started or changed within the previous 6 months * received any investigational drugs within the previous 12 weeks

Keywords: dementia memory hopkins verbal learning test paired associated learning
emr defaults to nudge opioid prescribing

Conditions: Pain, Acute; Opioid Use, Unspecified

Summary: the investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (emr) affect opioid prescriptions for patients discharged from emergency departments (eds).

in two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. these changes were made without announcement, and providers were not informed of the study itself.

Eligibility criteria:
inclusion criteria: * discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen. exclusion criteria: * none
selective av nodal vagal stimulation for reduction of the ventricular rate during atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the study will enroll patients that are already in af and in which open-heart surgical intervention has been scheduled. in these patients avn-vns will be delivered briefly (minutes) after the incision as a proof-of-concept therapy, with concomitant monitoring of the effects on the ventricular rate.

rate control during af can be achieved by drugs (ca++ blockers, digoxin, beta-blockers), or by av nodal ablation. drugs, as usual, have limitations, while the radical destruction of the av node renders the patient permanently pacemaker-dependent. in series of animal studies the investigators employed avn-vns delivered to the so-called av nodal fat pad. electrical stimulation of the fat pad resulted in release of neuromediator (acetylcholine) within the av nodal domain. the investigators have demonstrated that this approach successfully and substantially slowed the ventricular rate during af in both acute and chronic experiments without inflicting any damage on the av node. it is our hypothesis that temporary delivery of selective avn-vns in patients with af will provide the benefits of reduced ventricular rate during the ongoing af. the proposed study will be limited only to patients that are already in af and in which open-heart surgical intervention has been scheduled. in these patients avn-vns will be delivered briefly (minutes) after the incision as a proof-of-concept therapy, with concomitant monitoring of the effects on the ventricular rate. based on the information obtained in this study, the investigators intend subsequently to test the avn-vns in a group of patients that develop af post-operatively and remain in this status for several days after the surgery. a protocol for a separate study will be submitted if and when this becomes feasible.

Eligibility criteria:
inclusion criteria: * patients undergoing open heart surgery * able to give informed consent and * permanent/persistent or currently in atrial fibrillation exclusion criteria: * minimally invasive incisions * previous open heart surgery * bleeding diathesis * creatinine levels greater than 2.0 mg/dl * active infections, i.e. endocarditis * implanted icd * pregnancy and nursing * incompetence and/or other conditions, which do not allow the patient to understand the nature, significance and scope of the study * patients on drugs that have cholinesterase inhibitor activity (e.g., physostigmine-like substances).
green tea mouthwash on the oral health status in oral cancer patients

Conditions: Oral Cancer

Summary: objectives: to evaluate the effectiveness of green tea mouthwash on the oral health status (ohs) in oral cancer patients undergoing anticancer treatment. materials and methods: this was a prospective, single-blind, randomized, controlled trial. patients were randomly assigned to 2 groups: mouthwash with green tea (intervention) group or tap water (control) group. the intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily, and the control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily. the primary outcome was ohs, which was evaluated according to the oral assessment guide and measured at seven time points by the same researcher. time 0 (t0) corresponded to baseline, and time 1-6 (t1-t6) corresponded to monthly outpatient follow-ups until six months.


Eligibility criteria:
inclusion criteria: * patients who were \> 20 years * newly diagnosed with oral cancer by a physician * just received oral surgery and follow-up with or without chemotherapy or radiation therapy. exclusion criteria: * patients with mental illness * an acute and a severe illness status * no teeth in the whole mouth * the ability of mouth opening less than 1 cm.
effect of intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages

Conditions: Mechanical Ventilation Complication

Summary: endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. subglottic secretion drainage can be either continuous or intermittent. however, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. subglottic secretion drainage can be either continuous or intermittent. however, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours. tracheal mucosa injuries will be assessed by tracheal fibroscopy. secondary endpoints are the volume of daily secretions suctioned, the occurrence of difficulties or impossibilities of secretion drainage, and the occurrence of ventilator-associated pneumonia.

Eligibility criteria:
inclusion criteria: * adult aged 18 years or more * patients hospitalized in intensive care unit * patients requiring endotracheal tube with an expected mechanical ventilation duration of more than 24 hours exclusion criteria: * pregnant or breast-feeding women * previous known tracheal lesions * persons deprived of freedom

Keywords: secretion drainage ventilator-associated pneumonia tracheal fibroscopy
influence of the communication between nursing staff and patients on the analgesic response following caesarean section

Conditions: Acute Pain

Summary: effective management of postoperative pain is a priority for women undergoing cesarean delivery. despite availability of modern analgesics, postoperative pain management remains a challenge. one opportunity to enhance the analgesic effect of the pharmacological treatments given to people suffering from pain (and not just pain) is through increasing the expectations for pain relief following treatment. although much knowledge has been accumulated about the significant effect of expectations on pain, virtually all evidence are based on experimental studies carried out in laboratory settings, and there is a need to investigate how this knowledge could translated into improved clinical care. the aim of the current study is to examine whether the communication style between the nursing staff and the patient during analgesic administration will affect the results of pain relief treatment in the mother-newborn ward after cesarean section. as another goal, the study will examine whether relevant patient's characteristics will predict the effectiveness of the treatment.

the study will be carried out in the maternity ward at carmel hospital. the study population will include patients who are about to undergo an elective caesarean section under spinal anesthesia. the recruitment will be done pre-surgery. following consent, participants will receive an explanation about how to assess pain and will fill out the research questionnaires. communication is the independent variable in this study , which has 2 levels - the increased communication arm and the normal communication arm. each arm will include 40 patients that will be randomly divided between the arms. the dependent variable is the treatment efficacy, based on the changes in the intensity of the patient's pain one hour after the administration of analgesic. the self-consciousness scale (scs-r) and the short suggestibility scale (sss) will be used to assess relevant personality traits.

Eligibility criteria:
inclusion criteria: * be able to provide signed and dated written informed consent and to be compliant with the schedule of protocol assessments. * females aged 18 till 50 * undergoing cesarean section exclusion criteria: \* mental retardation and cognitive impairment study.
courses emergency psychiatric strasbourg

Conditions: Psychiatric Emergency

Summary: describe and analyze routes and modes of care for patients in emergency consultant in various emergency care and public psychiatric outpatient devices to provide useful information to optimize trajectories taken into psychiatric load on the eurométropole territory upstream and downstream of where they viewed urgently.


Eligibility criteria:
inclusion criteria: * all patients, men and women, adults and minors of 11 years and more, seen for psychiatric consultation request emergency (unscheduled and requiring specialized psychiatric consultation within 72 hours) exclusion criteria: * will not be included in the study psychiatric consultations requested by internal hospital services other than emergency services, patients with psychiatric emergencies revised for post-emergency consultations