Kornimate/medical-research-clean huggingface dataset:
isonicotinic acid hydrazide pretreatment with misoprostol induction of abortion in first-trimester missed miscarriage

Conditions: Abortion, Missed

Summary: this study compares the success rate of adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

in the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . misoprostol is a synthetic analogue of prostaglandin e1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.

Eligibility criteria:
inclusion criteria: * gestational age less than 70 days gestation (\<10 wks). * hemoglobin \>10 g/dl. * bmi between 18.5 kg/m2 and 30 kg/m2. * missed abortion * previous one or more cesarean deliveries exclusion criteria: * molar pregnancy * fibroid uterus. * uterine anomalies. * coagulopathy * medical disorder that contraindicate induction of abortion (e.g. heart failure). * previous attempts for induction of abortion in the current pregnancy. * allergy to misoprostol or inh.
factor xa - inhibition in renal patients with non-valvular atrial fibrillation - observational registry

Conditions: Non-valvular Atrial Fibrillation (NVAF); Chronic Kidney Disease (CKD)

Summary: the multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (nvaf) and chronic kidney disease (egfr 15-49 ml/min per 1.73 m2). the overall objective of this registry is to assess chronic kidney disease (ckd) progression and clinical outcomes with regard to anticoagulation strategies in nvaf patients with egfr 15-49 ml/min per 1.73 m2 in routine clinical practice.

this is a prospective registry allowing a structured, non-interventional collection of data. participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. all patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines. this registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in germany, austria, switzerland, france, belgium and luxembourg. the registry will collect clinical data of approximately 1600 patients with ckd (egfr 15-49 ml/min per 1.73 m2) and nvaf receiving rivaroxaban, oac with vka, or no ac therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months). the plan of the registry is to include at least 1600 patients with ckd and nvaf and rivaroxaban therapy or vka therapy or no ac therapy. the aim is to include at least 700 patients with rivaroxaban therapy and vka therapy, respectively. into the exploratory treatment arm of patients receiving no ac therapy about 100 patients will be included.

Eligibility criteria:
inclusion criteria: * male and female patients, age ≥ 18 years * ckd with egfr 15 - 49 ml/min per 1.73 m2 * non-valvular atrial fibrillation (nvaf) with indication for anticoagulation therapy * a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or vka (oac cohorts) or no anticoagulation (no ac cohort) * informed consent * availability for follow up * life expectancy of ≥6 months exclusion criteria: * exclusion criteria according to the local product information for the respective anticoagulation treatment * planned treatment with other anticoagulants * expected renal-replacement therapy within the next 3 months
longitudinal clinical evaluation of the hpv assay on the bd viper lt system with cervical specimens

Conditions: Cervical Neoplasms; Human Papillomavirus

Summary: the purpose of the study is to assess the cumulative disease detection of greater than or equal to cervical intraepithelial neoplasia 2 (cin2) and greater than or equal to cervical intraepithelial neoplasia 3 (cin3) in the subjects over 3 years using the subject's hpv status and cytology status from the bds-ushpv baseline results


Eligibility criteria:
inclusion criteria: * subject enrolled into the protocol bds-ushpv and identified as eligible for the longitudinal protocol • subjects enrolled into protocol bds-ushpv with a baseline colposcopy and biopsy procedure and not treated. exclusion criteria: * subjects with prior complete or partial hysterectomy involving removal of the cervix * subjects on whom conization, leep, cervical laser surgery, or cryosurgery has been performed since enrollment into the bds-ushpv study * year 3 visit can not exceed 3 years and 6 months from the baseline visit
ask questions in gynecologic oncology (asq-gyo)

Conditions: Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Gestational Trophoblastic Disease

Summary: the goal of this clinical trial is to determine the effectiveness of the ask questions in gynecologic oncology question prompt list (asq-gyo qpl) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. also to determine the acceptability of the asq-gyo qpl with new gynecologic oncology patients.

* potential participants who are scheduled for a new patient appointment will be contacted via phone or email to determine if they are interested in participating. * if a participant is interested, they will choose their preferred method of consenting (phone, email, or in person) and if they would like to complete the pre-visit survey now or at a later time prior to their appointment * if consented, all participants will be provided with the pre-survey questionnaire. if eligible, participants will then be randomized to usual care or the intervention (ask questions in gynecologic oncology question prompt list (asq-gyo qpl) * if randomized to receive the asq-qyo qpl, they will be emailed this document and given a paper copy of the asq-gyo qpl in the waiting room prior to their visit to ensure they have received the intervention. * directly after the participant's visit, all participants will be asked to complete the post-visit survey on a tablet in the clinic waiting room, or via a secure link in an email within 1 week of the appointment. * after completion of the post-visit survey and within one month of their visit, participants who were not randomized to receive the asq-gyo qpl will be sent the asq-gyo qpl via email so that they may also have access to this resource.

Eligibility criteria:
inclusion criteria: * 18 years of age * understands spoken and written english * able to consent to study participation * biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, or vaginal cancer or gestational trophoblastic disease) or have imaging and/or laboratory findings highly concerning for a cancer diagnosis and have not seen a gynecologic oncologist exclusion criteria: * pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial) * history and/or imaging/laboratory findings more indicative of a non-cancer diagnosis * previous treatment discussion with a gynecologic oncologist
examining the feasibility of implementation, patterns of association, and outcomes in hrv biofeedback (hrvb) intervention and music listening control (mlc) on alzheimer's disease (ad) family caregivers (fcgs) public title: caring relationship expression study

Conditions: Alzheimer's Disease and Related Dementias Family Caregivers

Summary: in a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (hrvb) intervention vs music listening control (mlc) for 30 family caregivers 18 years and older (fcgs) of alzheimer's disease (ad) (and related dementias: adrd) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.


Eligibility criteria:
inclusion criteria: * 18 years and above * primary, unpaid family caregiver for adrd patient for 6 months or more * owns and operates a smartphone with a data plan * greater than of equal to 4 on caregiver burden scale exclusion criteria: * regular mind-body practice * under 18 years old * pacemaker * conditions or medications that interfere with heart rate variability
a single arm study of ipilimumab monotherapy in patients with previously treated unresectable stage iii or iv melanoma

Conditions: Melanoma

Summary: the purpose of this clinical research study is to evaluate the best overall response rate (borr), (as per modified who criteria) in patients with previously treated melanoma-stage iii (unresectable) or stage iv melanoma receiving 10 mg/kg of ipilimumab. the safety of this product will also be evaluated.


Eligibility criteria:
inclusion criteria: * patients with previously treated stage iii (unresectable)or stage iv melanoma

Keywords: previously treated melanoma unresectable stage iii stage iv
treatment of peri-calcification edema in neurocysticercosis (ncc)

Conditions: Neurocysticercosis

Summary: three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis

this study will evaluate 24 patients with calcified ncc and edema in three treatment arms to compare the reduction in edema volume

Eligibility criteria:
inclusion criteria: * calcified ncc * perilesional edema on ct or mri * normal lab values exclusion criteria: * viable neurocysticercosis * status epilepticus * symptomatic intracranial hypertension * tuberculosis * more than 7 days after seizure * pregnancy
study to compare conivaptan in subjects with mild & moderate liver impairment versus subjects with normal liver function

Conditions: Liver Disease; Hyponatremia

Summary: a study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function


Eligibility criteria:
inclusion criteria: * subjects with normal hepatic function: * weighs at least 45 kg * body mass index between 18 and 40 kg/m2 inclusive * must have normal hepatic function * hepatic impaired subjects: * weighs at least 45 kg * meets criteria for mild or moderate hepatic impairment defined by child-pugh method * body mass index between 18 and 40 kg/m2 inclusive exclusion criteria: * subjects with normal hepatic function: * smokes more than 10 cigarettes per day * known to be hiv positive or has hiv antibodies * has clinically significant history or presence of illness, malignancy, or immunodeficiency * is hepatitis a, b, or c positive * has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration * history of substance abuse within 6 months prior to screening * hepatic impaired subjects: * has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis * is hypovolemic or has evidence of orthostatic hypotension * smokes more than 10 cigarettes per day * known to be hiv positive or has hiv antibodies * has clinically significant history or presence of illness, malignancy, or immunodeficiency * has clinically significant history or presence of gi symptoms other than those associated with moderate hepatic impairment * has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration * history of substance abuse within 6 months prior to screening

Keywords: pharmacokinetics protein binding conivaptan vaprisol liver disease
evaluation of flash continuous glucose monitoring to reduce hyperglycemia in people with t2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a multi-center, randomized, prospective, non-significant risk study to compare the impact of the freestyle libre flash glucose monitoring system with and without a food logging smartphone application on reducing time above 180 mg/dl in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. subjects will be randomized to use either the freestyle libre flash glucose monitoring system or freestyle libre flash glucose monitoring system with a food logging smartphone application to manage their diabetes. the subsequent impact on reducing the amount of time spent above 180 mg/dl will be assessed.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * subject has been diagnosed with type 2 diabetes. * hba1c greater than or equal to 7.5% and less than or equal to 12% * subject is on at least 1 diabetes medication in the classes of metformin, sglt-2 inhibitors, glp-1 agonists and dpp-4 inhibitors. * subject owns a compatible smartphone * subject agrees to a 3-month period of no diabetes medication changes. * subject is willing to make diet and lifestyle changes in response to education and glucose data exclusion criteria: * subject is currently on insulin therapy or sulfonylurea-based medications. * subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. * subject is known to be pregnant at the time of study enrollment (applicable to female subjects only). * subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
prediction of pao2 values using the properly ii database

Conditions: Invasive Ventilation

Summary: four prospective observational studies of ventilation in critically ill patients were harmonized and pooled.

the individual data from four observational studies ('epidemiology of respiratory insufficiency in critical care study' \[ericc\], the 'large observational study to understand the global impact of severe acute respiratory failure' \[lung safe\], 'practice of ventilation in critically ill patients without ards' \[provent\], 'practice of ventilation in critically ill patients in middle-income countries' \[provent-imic\]) were harmonized and pooled into a database named 'properly ii'. this database will be used to address various issues in diverse patient categories.

Eligibility criteria:
ericc included patients aged 18 years or older that received ventilatory support for at least 24 hours during the first 48 hours of icu admission at the participating icus. ericc excluded patients with a tracheostomy, patients admitted for routine uncomplicated postoperative care, readmissions and patients with a terminal condition. ericc enrolled patients during 2-months period. lung safe included patients aged 16 years or older that received invasive or noninvasive ventilation. lung safe excluded patients without informed consent. lung safe enrolled patients during a 4-week period in the winter months. provent included patients aged 18 years or older that received invasive ventilation. provent excluded patients in whom ventilation was started before the study recruitment week, patients receiving only noninvasive ventilation, and patients that were transferred to the icu from another hospital under ventilation. provent enrolled patients during 4-week period. provent-imic included patients aged 18 years or older that started with invasive ventilation. they excluded patients that received only noninvasive ventilation, patients whose invasive ventilation started before the inclusion phase of the study, and patients transferred from another hospital while under ventilation. provent-imic enrolled patients during 4-week period.

Keywords: intensive care invasive ventilation pao2 prediction risk stratification p/f s/f
the effects of use of auditory stimulation methods on cardiac patients' clinical outcomes

Conditions: Chest Pain; Anxiety; Sleep

Summary: this study will be used to compare the effects of two auditory stimulation methods on improving vital signs parameters, reducing the severity of chest pain, and improving the sleep quality of cardiac patients.

this study aims to to evaluate the relative efficacy of two auditory stimulation techniques in enhancing cardiac patients' vital sign assessments. * this study aims to examine two auditory stimulations for their ability to alleviate chest pain in patients with heart conditions. * the goal of this study is to evaluate two audio stimulations for their potential to help heart patients have a better night's rest. this research made use of two different therapies including audio stimulation. group a used familiar auditory stimulus, which was a spoken message, and group b used sounds of nature. patients with preexisting cardiac conditions who were admitted to a predetermined critical care unit and who subsequently intended to have percutaneous coronary artery intervention (pci)

Eligibility criteria:
inclusion criteria: * adult (aged≥18 years). * diagnosed with cardiac disease. * patient with hemodynamic stability * consciousness and ability to communicate. exclusion criteria: * patients unable to comply with study interventions * patients with cognitive impairment * patients with severe unstable cardiac condition * having a history of hearing loss or the use of a hearing aid.
perioperative local anesthesia block in spine surgery

Conditions: Lumbar Spine Disease; Lumbar Disc Herniation; Lumbar Spinal Stenosis

Summary: the purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. the study will consist of a retrospective analysis of a cohort of patients who underwent lumbosacral surgery patients between june 2018 and march 2021 with or without a preoperative fluoroscopically-guided dorsal ramus (dr) block placed by the operative neurosurgeon.

spine surgery poses unique challenges in postoperative pain management. local anesthetic blocks, namely the erector spinae plane and thoracolumbar interfacial plane blocks, placed by anesthesia under ultrasound guidance have been shown to reduce postoperative pain after spinal surgery and decrease perioperative opioid requirements by as much as 50%. nonetheless these procedures are not routinely performed, likely due to logistical hurdles and lack of widespread knowledge of the procedure by anesthesiologists. a preoperative dorsal ramus block performed by the operative neurosurgeon under fluoroscopy shows promise as an alternative approach to perioperative pain control. the objective of this retrospective observational study is to evaluate the feasibility, safety, and efficacy of a dorsal ramus block block performed by a neurosurgeon under x-ray guidance prior to lumbar surgery. the study will include a cohort of patients who have undergone lumbar spine surgery with or without the x-ray guided dorsal ramus block. a retrospective chart review of these patients will be performed to assess for postoperative pain control, postoperative opioid requirements, time to block completion, length of stay, and adverse events. descriptive and comparative statistics will be performed. no new data will be gathered from the subjects beyond pre-existing data within the medical record, and no new procedures will be performed as part of the study. if the current study suggests that a dorsal ramus block performed by the operative neurosurgeon is feasible, safe, and effective, it will serve as a foundation for a randomized clinical trial of such a block among patients undergoing lumbar surgery.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * patients undergoing lumbar spine surgery at any spinal level from l1 to sacrum (including decompression, discectomy, posterior fusion, interbody fusion, wound revision or washout, intradural tumor resection, treatment of vascular spinal lesion, tethered cord release, repair of cerebrospinal fluid (csf) leak, hardware removal) exclusion criteria: * patients undergoing surgery that includes thoracic levels * patients from whom pain scores could not be elicited in the immediate postoperative period due to mental status (e.g. prolonged intubation requirement, etc.)

Keywords: lumbar spine surgery local anesthesia local anesthetic block
dsaek- postoperative positioning and transplant dislocation

Conditions: Corneal Transplantation; Descemet Stripping Automated Endothelial Keratoplasty; Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary

Summary: corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). one type of lamellar keratoplasty is dsaek (descemet's stripping automated endothelial keratoplasty), where only the damaged posterior section of the cornea is replaced. the purpose of this study is to investigate how immediate postoperative positioning of the patient affects the dislocation rate of the corneal graft. since this is a new surgical method, little scientific documentation has been published in this area.

corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). one type of lamellar keratoplasty is dsaek (descemet's stripping automated endothelial keratoplasty), where only the damaged posterior section of the cornea is replaced. to get the graft in the right position inside the eyes anterior chamber, the anterior chamber is fully filled with air, and the patient is placed in a supine position looking facing up for different amount of time depending on the surgeon. in this way the air bubble will press the graft in the right position and prevent dislocation. our experience is that since the anterior chamber of the eye already is fully filled with air, it does not matter how the patient is positioned postoperatively regarding graft dislocation. our hypothesis is that the immediate postoperative positioning is insignificant. if this can be significantly proved this may enhance the patients comfort postoperatively.

Eligibility criteria:
inclusion criteria: * corneal dystrophy requiring corneal transplantation * patients written permission * pseudophakia exclusion criteria: * uncontrolled glaucoma * phakia or aphakia * shallow anterior chamber * fibrotic cornea * demented patients * claustrophobic patients * patients that do not want to participate
implantable cardioverter-defibrillator use in the va system

Conditions: Cardiomyopathies

Summary: despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. in this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.


Eligibility criteria:
inclusion criteria:meeting published criteria for receipt of an implantable cardioverter defibrillator exclusion criteria:provider is not affiliated with the va health care system