Kornimate/medical-research-clean huggingface dataset:
comparing misoprostol alone to dilapan with misoprostol and comparing buccal to vaginal misoprostol

Conditions: Second Trimester Abortions

Summary: this randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to dilation and evacuations (d\&es) at 14 0/7 to 19 6/7 weeks gestational age. in total, 160 woman will be randomized to misoprostol alone or dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. a total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). another 80 women will have dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). four to six hours later, the dilation and evacuation (d\&e) procedure will be performed.

the primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day dilapan with 400-mcg misoprostol for cervical preparation prior to d\&e at 14 0/7 to 19 6/7 weeks. patients will first be randomized to misoprostol alone or misoprostol-dilapan, and then separately randomized to use the misoprostol buccally or vaginally. the primary outcome measure is total procedure time. secondary outcomes include d\&e procedure time, initial cervical dilation (measured by the largest hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction. the investigators have chosen a randomized controlled trial with a factorial design to be conducted at washington hospital center and planned parenthood of metropolitan washington. a total up to 180 english speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. the study will enroll healthy women, over the age of 18, eligible for non-urgent d\&e at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. the women will be randomized to receive either misoprostol alone or dilapan with misoprostol. women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. computer generated randomization will be utilized to assign treatment arms. approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations: 1. misoprostol 400-mcg vaginally 2. misoprostol 400-mcg buccally 3. dilapan insertion with 400-mcg misoprostol vaginally 4. dilapan insertion with 400-mcg misoprostol buccally

Eligibility criteria:
inclusion criteria: * healthy pregnant women * 18 years of age or older * eligible for non-urgent dilation and evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram. exclusion criteria: * women who do not speak english. * fetal demise * intolerance, allergy or contraindication to misoprostol or dilapan.

Keywords: cervical dilation dilation and evacuation misoprostol misoprostol-dilapan abortion
improving brain function after breast cancer study

Conditions: Breast Cancer Survivors

Summary: this study will explore the feasibility and potential effects of a simple, home-based daily meditation intervention on breast cancer survivors' cognitive and psychological functioning as well as inflammatory regulation.

this study will compare two home based 8-week interventions (kirtan kriya meditation vs. relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed chemotherapy 3 months to 5 years prior.

Eligibility criteria:
inclusion criteria: * individuals with a history of non-inflammatory breast cancer (stages i-iv): * received chemotherapy as part of their treatment * completed chemotherapy treatment 3 months to 10 years prior to study enrollment * individuals who have report cognitive deficits exclusion criteria: * breast cancer survivors with a history of metastases to the brain * a physician diagnosis of: dementia, a learning disability, unmanaged major depression, psychosis, schizophrenia, bipolar, traumatic brain injury, cancer of the central nervous system, diabetes, arthritis * taking oral steroids within 30 days of enrolling * a regular meditation practice (greater than 1 time per week) * currently taking immune modifying medications
impact of vitamin d on diabetic kidney disease in african americans

Conditions: Diabetic Kidney Disease

Summary: this purpose of this project is to evaluate the effectiveness of vitamin d supplementation over 12 months in vitamin d deficient african american adults with type 2 diabetes.

diabetic kidney disease is increasing in prevalence and is associated with significant morbidity and mortality. health disparities exist in the progression of diabetic kidney disease, with minorities being more affected even when adjusting for treatment, glycemic and hypertensive control, and medical coverage. secondary prevention of the progression of diabetic kidney disease is hindered by a lack of easily modifiable risk factors. based on animal and observational human studies, vitamin d deficiency is potentially a novel, modifiable risk factor that may interrupt or delay the progression of diabetic kidney disease through direct effects as well as by helping to ameliorate kidney disease risk factors, such as hyperglycemia, hypertension and inflammation. in addition, based on minorities having a higher prevalence of vitamin d deficiency, it may also potentially impact the differential progression of diabetic kidney disease in minorities. however, clinical trials evaluating the impact of vitamin d supplementation on diabetic kidney disease are lacking. thus, this pilot study funded as an r03 through the national institute of diabetes and digestive and kidney diseases (niddk) has the following specific aims: (1): to evaluate the impact of vitamin d supplementation (vitamin d3 at 400 iu/d versus 4000 iu/d) on the proportion of individuals with progression of albuminuria over 12 months in a sample of african american participants with vitamin d deficiency in a randomized controlled trial. (2): to identify whether kidney disease risk factors such as blood pressure and glycemic control mediate the impact of vitamin d supplementation on the progression of albuminuria over 12 months in a sample of african american participants with vitamin d deficiency in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * african american race * diagnosis of type 2 diabetes * stage 1 or 2 kidney disease with detectable microalbuminuria \>4.0 (mg/g) 25(oh)d level \<20 ng/ml exclusion criteria: * type 1 diabetes --\> stage 3 kidney disease, or history of dialysis, kidney transplantation or nephrolithiasis * unable to provide informed consent or contact information * pre-existing calcium or parathyroid condition, including serum calcium \>10.2 mg/dl * sarcoidosis, active tuberculosis, or malignancy * known hypersensitivity to vitamin d or any of its analogues and derivatives * current pregnancy or planning to become pregnant in next 15 months

Keywords: diabetes kidney disease vitamin d
comparative efficacy, safety, and tolerability of rivastigmine 10 and 15 cm^2 patch in patients with alzheimer's disease (ad) showing cognitive decline

Conditions: Alzheimer Disease

Summary: the purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of alzheimer's disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm\^2.


Eligibility criteria:
inclusion criteria: * male or female patients between 50 and 85 years of age with a diagnosis of probable alzheimers disease, * baseline mini-mental state examination (mmse) score 10-24 inclusive, * a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient's condition throughout the study, and for providing input into efficacy assessments. * for double blind only: meet the decline criteria of functional (as assessed by the investigator) and cognitive (assessed by a 1 point reduction in mini-mental state examination) score between visits or a 3 point reduction from baseline) decline at weeks 23, 36 or 48. exclusion criteria: * presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk, * any medical or neurological condition other than alzheimers disease that could explain the patient's dementia, * a diagnosis of probable or possible vascular dementia, * a current diagnosis of unsuccessfully-treated depression, or any other mental disorder that may interfere with the evaluation of the patient's response to study medication, * a history or current diagnosis of cerebrovascular disease (e.g. stroke), * a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: alzheimer's patch cognitive decline
cognitive markers in prodromal ms

Conditions: Multiple Sclerosis

Summary: the focus of this work is the evaluation of a measure of cognitive functioning- intra-individual variability (iiv) - derived from a computer-based continuous reaction time (rt) task (cogstate) as an early marker of prodromal ms.

this study is a prospective observational clinical study, where the researchers will recruit adults with early ms (n=60) to complete a cognitive assessment and an optional gait assessment using runscribe and g-sensor. thirty-five \[35\] participants will also have a single 60-minute investigational mri combined with 20 minutes of simultaneous tdcs. the mri will repeat the protocol from the researchers' current study (clinicaltrials.gov identifier: nct03564496, irb i18-00548) using simultaneous transcranial direct current stimulation (tdcs) during the imaging acquisition.

Eligibility criteria:
inclusion criteria: * ages 23-59 years old (inclusive) * prodromal ms (defined by radiologically isolated syndrome ≤ 6 months from first mri or clinically isolated syndrome ≤ 3 months from first clinical event) exclusion criteria: * below average estimated premorbid cognitive functioning (based on wrat-4 reading recognition standard z-score \< 85). * presence of severe cognitive impairment (based on sdmt age normative z-score \<-3.0). * primary psychiatric disorder that would influence ability to participate. * current uncontrolled seizure disorder. * current substance abuse disorder. * history of head trauma in the past year (e.g., head injury, brain surgery) or medical device implanted in the head (such as deep brain stimulator) or in the neck (such as a vagus nerve stimulator). * pregnant or breastfeeding additional exclusion criteria for tdcs-mri participants * extreme claustrophobia * any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed) * treatment for a communicable skin disorder currently or over the past 12 months * have any irremovable piercings, metallic based-tattoos, or mri-contraindicated implants (e.g. pacemakers and defibrillators)
multiple dose-escalation study of ama0076 in patients with ocular hypertension or primary open-angle glaucoma

Conditions: Glaucoma; Ocular Hypertension; Eye Disease

Summary: the objective of this dose-escalation study is to evaluate the safety, tolerability and efficacy of ama0076 in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle glaucoma.


Eligibility criteria:
inclusion criteria include: 1. adults 30-85 years of age 2. diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes 3. not receiving medication for iop, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease 4. elevated iop (≥ 24 and ≤ 34 mm hg at 8 am and ≥ 21 and ≤ 34 mm hg at 10 am on screening two visit and baseline visit in one or both eyes off treatment exclusion criteria include: 1. uncontrolled intraocular hypertension defined as \>34 mm hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy). 2. receiving more than one medication for iop at time of screening. 3. central corneal thickness of less than 500 µm or greater than 620 µm. 4. bcva worse than 20/200 in either eye 5. significant visual field loss (ie, mean deviation \> 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study. 6. acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.
insulin glargine benefits in japanese pts outside of japan (us or brazil)

Conditions: Diabetes Mellitus

Summary: to estimate the efficacy of combination therapy with lantus plus amaryl in controlling blood glucose in japanese patients with type 2 diabetes having failed oad therapy, and document the ability to preserve the endocrine pancreatic function with lantus plus amaryl combination therapy


Eligibility criteria:
inclusion criteria: * all patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (niddm) (type 2 diabetes) and were not able to maintain good metabolic control with oads. * enrolled patients could be male or female, of documented japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.
randomized placebo-controlled pilot trial of prebiotics+glutamine in hiv infection

Conditions: HIV

Summary: a rapid and almost complete loss of cd4+ t cells from the gut associated lymphoid tissue (galt) occurs early in hiv infection, with a permanent damage in the intestinal barrier, changes in gut microbiota, increased bacterial translocation and persistent immune activation, changes that are not restored after the initiation of antiretroviral therapy. the investigators hypothesize than an intervention targetting the enterocyte barrier and the gut microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and improve markers of bacterial translocation, inflammation, immune activation and endothelial dysfunction.

this is a randomized placebo-controlled clinical trial to evaluate the safety and effectiveness to modify gut microbiota, bacterial translocation, immune activation and markers of endothelial dysfunction of a dietary supplement (prebiotics + glutamine) during a period of six weeks. the study will enroll four cohorts: 1) hiv-infected, treatment naive individuals; 2) hiv-infected subjects, currently on art, with \>350 cd4+ t-cells/ul; 3) hiv-infected subjects, currently on art, with \<350 cd4+ t-cells/ul; 4) hiv negative healthy controls.

Eligibility criteria:
inclusion criteria: * after receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies. * aged over 18 years. * group 1: hiv+, not receiving art and no previous exposure to art, at least 2 years since hiv diagnosis. * group 2: hiv+, currently receiving art for more than 2 years, hiv-1 rna levels less than 40 copies/ml and more than 350 cd4+ t-cells/ul. * group 3: hiv+, currently receiving art for more than 2 years, hiv-1 rna levels less than 40 copies/ml and less than 350 cd4+ t-cells/ul. * group 4: hiv-, healthy controls. exclusion criteria: * major cardiovascular risk factors. * concomitant acute diseases. * gastrointestinal disorders. * pregnancy. * antibiotic exposure in the previous month. * regular use of foods or supplements containing prebiotics or probiotics within the 2 weeks prior to initiation of the study.

Keywords: hiv immunoactivation bacterial translocation prebiotics glutamine microbiota
prospective randomized study efficacy three-dimensional reconstructions segmentectomy

Conditions: Lung Cancer; Lung; Node

Summary: with this project we want to study the effectiveness of 3d reconstruction of preoperative ct to reduce operating times, blood loss and conversions after segmentectomy performed in thoracoscopy / robotics.

pulmonary segmentectomy is the surgery of first choice in malignant lung tumors with a diameter \<2 cm in diameter. patients who are candidates for this type of treatment perform usually a preoperative ct scan with two-dimensional reconstructions (2d: axial, coronary and sagittal). today it is possible to perform a preoperative three-dimensional reconstruction (3d: volume rendering) of the vessels and bronchi using special software. objectives of the study is to analyze, in these patients, the benefits of 3d reconstruction of vessels and bronchi compared to 2d reconstruction, analyzing intra- and post-operative data.the study aims to randomize 288 patients over 36 months. study design: prospective, randomized, controlled study. in 50% of patients the preoperative study of anatomical structures will be performed with the standard 2d method, in the remaining 50% with a 2d and 3d reconstruction. the assignment will take place through access to an online feature on the study website. evaluations and statistical methods the statistical analysis will be carried out using parametric and nonparametric descriptive, inferential statistical methods, while the main outcome will be carried out using the analysis of variance (anova) and covariance (ancova) techniques. ethical aspects. the study will be conducted in accordance with applicable current legislation. approval by all relevant ethics committees will be required. each patient will provide a written consent to participate in the study, after being properly informed.

Eligibility criteria:
inclusion criteria: * segmentectomy performed through a minimally invasive approach (vats or rats). * pathologically proven nsclc on the resected specimen. * age ≥18 * signed written informed consent exclusion criteria: * prior homolateral cardiothoracic surgery. * allergy or any other contraindication to iodinated contrast media. * segmentectomy performed through an open approach (thoracotomy) * histology different than nsclc. * pregnancy

Keywords: lung segmentectomy ct 3d recostruction vats rats
pain perception and wound healing after laser-assisted frenectomy in children

Conditions: Frenulum; Hypertrophy

Summary: this study is based on the records of the patients treated for labial frenectomy with a dental laser at the department of padiatric dentistry from january 2017 to december 2017. patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. the analyzed data included age, gender, frenelum insertion type, type of dental laser, and postoperative pain perception.

this study is based on the records of the patients who received laser-assisted frenectomy treatment due to mucogingival problems at pediatric dentistry department during two year period. twenty-two patients treated with either er,cr:ysgg laser 2780 nm or 940 nm diode laser were selected who fulfilled the study's inclusion criteria. the analyzed data included age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and wound healing. post-operative pain was reported with wong-baker faces pain rating scale after 3 hours 1, 7 and 14 days. wound surface healing was evaluated through photography. images were uploaded to the software and the changes in the wound area were measured in square millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.

Eligibility criteria:
inclusion criteria: * aged between 8-13 * patients with high frenulum insertion * patients without any systemic condition * patients treated with either treated er:cr;ysgg or 940 nm diode laser for labial frenectomy * patients who were followed up after day 1,7 and 14 for wound healing. * patients who were followed up after 3 hours, 1,7,14 days for pain perception exclusion criteria: * patients with systemic condition * patients who were not treated with er:cr;ysgg or 940 nm diode laser for labial frenectomy * patients whose follow up was not properly completed
evaluation of residual neuromuscular blockade and of late recurarization in the post anesthesia care unit in patients undergoing videolaparoscopic cholecystectomy

Conditions: Neuromuscular Block, Residual

Summary: neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and also to facilitate the performance of surgeries involving mainly the abdominal cavity. the introduction of neuromuscular blockers in clinical practice optimized the execution of mechanical ventilation. since the use of these drugs, increased intercurrences such as prolonged muscle paralysis and respiratory complications have been observed, resulting in unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the occurrence of these complications. the present study aims to evaluate the incidence of residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room in patients submitted to videolaparoscopic cholecystectomy.

this is an observational and prospective study in which patients aged 18-50 years classified as asa (american society of anesthesiologists) i and ii, body mass index below 35 and who will undergo cholecystectomy will be included. patients will be allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie in group c patients will participate in the administration of cisatracurium and the group r will consist of the patients in whom rocuronium was administered. general anesthesia and assessment of muscle function will be performed by measuring the four-stimulus sequence (sqe) / train of four (tof) at pre-established times. a residual neuromuscular block is considered to be the patient presenting the value of the four-stimulus sequence of t4 / t1 of less than 0.9.

Eligibility criteria:
inclusion criteria: * patients submitted to videolaparoscopic cholecystectomy under balanced general anesthesia. asa (american society of anesthesiologists) patients, class i and ii, age group of 18 to 50 years, body mass index below 35. exclusion criteria: * patients asa iii or higher; asa ii patients with respiratory comorbidities. patients with neuromuscular diseases or severe renal or hepatic diseases. patients submitted to total venous anesthesia. patients with body temperature below 36 ° c. replication of the neuromuscular blocker. use of drugs that accentuate neuromuscular blockade such as calcium channel blockers, inorganic ions (mg ++, li ++), aminoglycoside antibiotics, halogenated anesthetics (except sevoflurane), local anesthetics (except lidocaine), benzodiazepines and opioids (except morphine or remifentanil) .