Kornimate/medical-research-clean huggingface dataset:
efficiency of two glucose sampling protocols for maintenance of euglycemia

Conditions: Brain Neoplasms; Intracranial Aneurysm

Summary: what is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? the investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.

intraoperative blood glucose levels will be maintained in the target range of 90-110 mg/dl (euglycemia) using the protocol. the target serum glucose ranges chosen (90-110 mg/dl) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose \< 108 mg/dl) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose \< 128 mg/dl) and gross neurologic deficits (serum glucose \< 152 mg/dl). because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies. each patient will be randomly assigned to one of two frequency of intervention groups-group 30 will have the insulin dose adjusted every 30 minutes and group 60 will have the insulin dose adjusted every 60 minutes. blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective intraoperative insulin \& glucose data sheet (appendix 2 and 3 for group 30 and group 60, respectively). regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). the interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is \< 70 mg/dl, at which time the patient will receive 25 ml of 50% dextrose solution. for these rescued patients, the protocol will be continued as scheduled. on the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol-q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)

Eligibility criteria:
inclusion criteria: * all english speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms. exclusion criteria: * patients under 18 years of age, patients who are pregnant, patients with diabetes, bmi \> 33 kg/m2.

Keywords: euglycemia craniotomy neurosurgery hypoglycemia insulin
comparison of the hologic genius digital diagnostics system with the liquid-based cytology (lbc) manual microscopy

Conditions: Cervical Cancer Screening

Summary: quality assurance of the laboratory examinations. prospective non-interventional study with thinprep slides collected during the german co-screening program and routinely sent to the lab to prospectively evaluate the clinical performance of the hologic genius digital cytology (dc) system vs. the liquid-based cytology (lbc) manual microscopic approach

the cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (hpv). cytology has been the gold standard for cervical screening since the introduction of routine screening with the pap test in the 1950s due to its effect on mortality in regions with screening programs. since that time, there have been several technological advances (lbc, imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. the hologic's genius digital diagnostics system is a ce-ivd (ce-marked in vitro diagnostic device) marked digital cytology platform. for quality assurance and to prospectively evaluate the hologic genius digital cytology (dc) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (lbc) manual microscopic approach. only anonymized results will be evaluated.

Eligibility criteria:
inclusion criteria: * lbc thinprep® samples are collected by gynaecologists and sent routinely to cytology laboratory zotz \& klimas as part of the german cervical cancer screening program.
post-pci:cardiac imaging in patients with diabetes to detect coronary artery blockages previously opened by angioplasty

Conditions: Diabetes Mellitus, Type 2; Coronary Restenosis

Summary: the purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with cardiolite.


Eligibility criteria:
inclusion criteria: * type ii diabetes on medication \& angioplasty within the past 6 months. exclusion criteria: * myocardial infarction or repeat angioplasty with the past 5 months. * unable to perform exercise or pharmacologic stress test.
effect of helmet type, home-use low-level light therapy device for chemotherapy-induced alopecia

Conditions: Breast Cancer; Chemotherapy-induced Alopecia

Summary: as far as breast cancer is concerned, chemotherapy (ct) is an important treatment. however, there are many adverse effects impairing the patient's quality of life (qol), in which chemotherapy-induced alopecia (cia) affects up to 65% of the patients. this condition is reversible. nevertheless, it takes several months after ct for visible hair regrowth. different characteristics of the new hair are common; for example, 65 percent of the patients have experienced a graying, curling, or straightening effect. besides, the emotional trauma due to alopecia can not be neglected. currently, scalp cooling is the only available and verified management for prevention. unfortunately, the success rate of scalp cooling is variable, especially among the patients receiving anthracycline-based combinations. low-level light therapy (lllt) has been proven as a therapeutic technique for adrenergic alopecia. recently, investigators have checked the validity of lllt for the cia. although the preliminary outcome showed failure at accelerating hair recovery, technical progress of lllt may improve the end result. specifically, lllt is a technique that utilizes laser diodes (ld) or light-emitting diodes (led) to promote tissue repair. the light source from ld is coherent while led is an incoherent light source. therefore, lds can deliver energy to tissues more efficiently than leds. to comprehensively evaluate the beneficial effect of lllt in treating cia, we conduct a clinical trial with a more advanced device equipped with 69 lds. the project aims to explore the effect of low-level light therapy in chemotherapy-induced alopecia. we expect the therapy will lead to an improvement in the patient's hair count, hair width, and quality of life after chemotherapy.


Eligibility criteria:
inclusion criteria: * age: 20 to 75 years * informed consent as documented by signature. * able to read and converse in chinese * female * diagnosis of breast cancer * they completed chemotherapy no more than 2 weeks * treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen. * life expectancy was at least 6 months. * diagnosed with cia grade 2 according to common terminology criteria for adverse events (ctcae) exclusion criteria: * scalp tumor or melanoma * having any serious mental illness or history, or taking psychotropic drugs * a medical history of dermatosis * severe liver and kidney damage * pregnancy * take any of the following medications for 6 months prior to initiation of the study: topical minoxidil, and spironolactone, and topical calcitriol * receiving scalp cooling during chemotherapy
extension study investigating the long-term safety and tolerability of repeat doses of fe200486 in prostate cancer patients

Conditions: Prostate Cancer

Summary: an open-label, multi-center, extension study investigating the long-term safety and tolerability of repeat doses of fe200486 in prostate cancer patients

degarelix was not fda regulated at the time of the trial. after completion of the trial degarelix has been approved by the fda and is thus an fda regulated intervention (fda regulated intervention is therefore ticked "yes"). the data include participants from both the main study (fe200486 cs07; nct00818623) and the extension study fe200486 cs07a.

Eligibility criteria:
inclusion criteria: * males aged 18 or over * histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) * has completed study fe200486 cs07 * has not met a withdrawal criteria at visit 9 (day 28) in study fe200486 cs07
effect of led photobiomodulation on analgesia during labor

Conditions: Labor Pain

Summary: the aim of this study is to valuate the effects of led photobiomodulation on analgesia during labor.ight-emitting diode (led) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.n total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. the participants will be randomized into two groups: intervention group \[analgesia with led therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\].

background: labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. pharmacological and nonpharmacological analgesia methods are used to control labor pain. epidural analgesia is the most commonly used pharmacological analgesia method. however, it may have side effects on the fetus and the mother. light-emitting diode (led) photobiomodulation is an effective and noninvasive alternative to pharmacological methods. objectives: to evaluate the effects of led photobiomodulation on analgesia during labor. methods: in total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. the participants will be randomized into two groups: intervention group \[analgesia with led therapy (n = 30)\] and control group \[analgesia with bath therapy (n = 30)\]. the perception of pain will be assessed using the visual analogue scale (vas), with a score from 0 to 10 at baseline, i.e., before the intervention. in both the groups, the procedures will last 10 min and will be performed at three time points during labor: during cervical dilation of (1) 4-5 cm, (2) 6-7 cm, and (3) 8-9 cm. at all three time points, pain perception will be evaluated using vas shortly after the intervention. in addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points. expected outcomes: the use of led photobiomodulation will have an analgesic effect superior to that of the bath therapy.

Eligibility criteria:
inclusion criteria: * women who request analgesia during labor * nulliparous and multiparous * women with term gestation * women without previous diseases, including diabetes, neurological diseases. exclusion criteria:t * women whose labor is induced with medications; * women who request drug analgesia during labor; * women who undergo cesarean delivery

Keywords: labor pain
pretreatment with mifepristone prior to mirena insertion

Conditions: Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena

Summary: hypothesis: pretreatment with mifeprsitone prior to mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of mirena use.

the levonorgestrel releasing intrauterine system (ius), mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. furthermore mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with mirena and corresponds to the most important factor that negatively influences the acceptability of the ius. up to today no standard treatment has been suggested to resolve this issue. by inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system. the purpose of the present study is to evaluate the bleeding pattern during the first months of use of mirena in patients treated with mifepristone compared to placebo in women using mirena for contraception. the study will also address the effect of mifepristone on endometrial morphology and breast tissue.

Eligibility criteria:
inclusion criteria: * pre-menopausal women, \>/= 18 years of age. * desire of mirena for contraception * good general health (as judged by; general physical examination * willing and able to participate after giving informed consent exclusion criteria: * any hormonal treatment or iud use within 2 months prior to study start * history of malignant disorder of the breast * any contraindication to mifepristone * pregnancy or breast feeding within 2 months prior to study start

Keywords: lng-ius mirena contraception bleeding hormonal effects in the breast
efficacy and safety of ranibizumab intravitreal injections versus dexamethasone intravitreal implant in patients with branch retinal vein occlusion (brvo)

Conditions: Visual Impairment; Macular Edema; Branch Retinal Vein Occlusion

Summary: this clinical trial is designed to compare ranibizumab in comparison with dexamethasone implant after 6 months of treatment. in the study arm ranibizumab will be given monthly in a pro re nata scheme whereas the comparator dexamethasone implant is given once at month 0 with sham injections prn afterwards.


Eligibility criteria:
inclusion criteria: * patients diagnosed with visual impairment due to macular edema following brvo * diagnosis of brvo at maximum 6 months prior to screening * bcva using etdrs charts of 20/40 to 20/400 in the study eye exclusion criteria: * media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs * central retinal thickness (crt) \< 250 µm in the study eye * prior episode of rvo in the study eye * active formation of new vessels in the study eye * anti-vegf-treatment in the study or the fellow eye 3 months prior to baseline * iop ≥ 30mmhg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment * improvement of \> 10 letters on bcva between screening and baseline other protocol-defined inclusion/exclusion criteria may apply

Keywords: visual impairment macular edema branch retinal vein occlusion dexamethasone implant ranibizumab
rotation stability of toric intraocularlens (iol) compared sitting against lying after cataract operation

Conditions: Astigmatism

Summary: to assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

to assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Eligibility criteria:
inclusion criteria: * cataract * age 21 and older * regular corneal astigmatism ≥ 1.5 d * written informed consent prior to surgery exclusion criteria: * relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. marfan syndrome) * high myopia (\> 29 mm al) * irregular corneal astigmatism on corneal topography * in case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
effect of perioperative intravenous lidocaine infusion on postoperative recovery in patients undergoing arthroscopic rotator cuff repair under general anesthesia

Conditions: Rotator Cuff Tears

Summary: arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. the most commonly used analgesic for acute postoperative pain is opioids. however, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. as of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. however, the existing evidence is mostly focused on laparoscopic procedures. the present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: 1. asa class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair exclusion criteria: 1. known allergies to lidocaine or propofol 2. cardia arrhythmia 3. history of epilepsy or seizures 4. liver/kidney failure 5. history of recent strong opioid use
efficacy evaluation of intravenous brivaracetam and phenytoin in subjects with nonconvulsive electrographic seizures

Conditions: Nonconvulsive Electrographic Seizures

Summary: the primary objective of this study is to compare the efficacy of brivaracetam and phenytoin, both administered intravenously, in adult subjects experiencing nonconvulsive electrographic seizures.


Eligibility criteria:
inclusion criteria: * subjects ≥16 years. subjects under 18 years may only be included where legally permitted and ethically accepted * subjects in the neurological intensive care unit (nicu) (or equivalent closely monitored environment) having brain insult including traumatic brain injury and having nonconvulsive electrographic seizures (nces) confirmed by electroencephalogram (eeg), lasting a minimum of 10 seconds but not \>30 minutes (minimum of 1 seizure in the last 6 hours) and treatment with an antiepileptic drug (aed) is required according to the physician's clinical judgment * subject is expected to be under ceeg monitoring with video surveillance in the neuro icu for at least 36 hours from the first administration of study drug exclusion criteria: * subject has history of severe adverse hematologic or cutaneous reaction to any drug * subject presenting with status epilepticus or nonconvulsive status epilepticus (ncse) (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting \>30 minutes during visit 1) * subject has been diagnosed with anoxic brain injury * subject has a known history of status epilepticus during the 6 months preceding visit 1 * subject is currently treated with levetiracetam (lev) or phenytoin (pht) or has been treated within the last 30 days before visit 1 with lev or pht * subject is on felbamate with \<18 months' exposure before visit 1 * subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly progressing process such that the subject is not expected to survive \>48 hours * subject has any clinical condition that would impair reliable participation in the study or necessitate the use of medications not allowed by the protocol

Keywords: brivaracetam phenytoin nonconvulsive electrographic seizures
emr chemotoxicity risk calculator to decrease chemotherapy toxicity

Conditions: Oncology; Chemotherapeutic Toxicity; Metastatic Solid Tumor

Summary: this study will formally test the quality improvement intervention of an emr based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.


Eligibility criteria:
inclusion criteria: * new outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment. * aged \> 65 will be included. exclusion criteria: * patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out. * patients with no ehr data after initial oncologist appointment.
poppy seed use in gastroenteric fistula diagnosis

Conditions: Gynecologic Cancers; Fistula

Summary: primary objective of the present study is to compare the diagnostic efficacy of oral poppy seed ingestion versus the classic abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast in diagnosis of gastrointestinal fistulas in gynecologic oncology practice.

gastrointestinal fistulas are pathologic epithelial bridgings and connections between various loops or intestines and abdominal cavity, bladder, vagina, skin or any other organ. fistulas are potentially dangerous since they may cause electrolyte imbalance, sepsis and abscesses and malnutrition. however, their diagnosis may not be easy since the sensitivity of the abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast is around 60% percent which is low for such an life threatening emergency. in gynecologic oncology large and small intestine procedures including resection and anastomoses are frequently performed. these procedures may rise suspicions the integrity of anastomoses and may lead to dilemma to intervene or not in case of a diversion from usual clinical progress. poppy seed ( pappaver somniferum) is a small (about 1 mm each), non digestible cultivable plant seed used in various foods. it is innocent and does not contain any opium or related ingredient. when ingested with yogurt or soup in small amounts it is not absorbed or ingested within intestine and appears as small gray-blue small spheric seed in abdominal drains, vaginal fluid, urine or skin depending on the fistula formation. poppy seed was first used in diagnosis of intestinal fistulas by lippert et al. in 1984. various studies followed in various fields of surgical medicine. however, there have been no reported studies using poppy seen in diagnosis of enteric fistulas in gynecologic oncology practice. the aim of the present study is to compare the diagnostic efficacy of orally ingested poppy seed and computed tomography in diagnosis of fistulas related to gynecologic malignancies.

Eligibility criteria:
inclusion criteria: * pre and postsurgical gynecologic oncology patients who were suspected to have fistulas connecting gastrointestinal system and skin, bladder, vagina. exclusion criteria: none -