Kornimate/medical-research-clean huggingface dataset:
laparoscopic myomectomy with morcellation or transvaginal extraction of surgical specimens.

Conditions: Myoma;Uterus

Summary: laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy. despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments). unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery. in addition, on 24 november 24 2014 the food and drug administration updated a safety communication about power morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis. considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. in this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned safety communication by the food and drug administration) or transvaginal extraction (after the issuing of the abovementioned safety communication by the food and drug administration) of the surgical specimens.


Eligibility criteria:
inclusion criteria: * women affected by single or multiple uterine myomas. * signed informed consent. exclusion criteria: * human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery. * women with obliteration of the cul-de-sac. * women with the suspected cancer of gynecological origin. * women who had never experienced complete sexual intercourse before the operation.

Keywords: laparoscopy power morcellation transvaginal extraction
visual focused play intervention for children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is a single-center, randomized, double-blind, sham-controlled study that will recruit children with attention deficit hyperactivity disorder and randomly assign them to a test group and a control group. the patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect. treatment will be required at least 5 times per week for 2 weeks, with each game or video session lasting 30 minutes. clinical scales and functional near-infrared spectroscopic imaging will be performed before and at the end of the 2 weeks of treatment, respectively.


Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for adhd in the u.s. diagnostic and statistical manual of mental disorders, 5th edition (dsm-5); * aged 6-14 years old; * right-handedness (habitual or good use of the right hand in daily life, work, study and labor activities); * voluntarily agree to sign an informed consent form; exclusion criteria: * wechsler intelligence scale for children (wisc) \<80 points; * the cranial ct or mri found that there are clear infarction foci, soft foci, occupations and other organic lesions; * suffering from serious physical diseases or other severe mental diseases, such as schizophrenia, bipolar disorder, etc; * inability to cooperate with fnirs data collection
adalimumab for the induction and maintenance of clinical remission in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to test whether adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active crohn's disease when compared to placebo (a substance containing no medication)


Eligibility criteria:
inclusion: * males and females between the ages of 18 and 75 who are diagnosed with moderate to severe crohn's disease defined by a cdai score of \>= 220 and \<= 450, normal laboratory parameters, * are willing and able to give informed consent, and * are able to self-inject or have a designee or healthcare professional who can inject the study medication. exclusion: * history of certain types of cancer, diagnosis of ulcerative colitis, * female or breast feeding subjects, * surgical bowel resection(s) with in the past 6 months, * history of listeria, * human immunodeficiency virus (hiv), * central nervous system demyelinating disease or untreated tb, * history of a poorly controlled medical condition, * unsuccessful response to infliximab or any anti-tnf agent use in the past.
use of platelet-enriched plasma during auricular reconstruction

Conditions: Ear Cartilage; Platelets; Microtia-Anotia

Summary: in this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. the intervention will be blinded to the surgeon and the surgical team. the main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame.


Eligibility criteria:
inclusion criteria: * microtia tanzer ii-a * patients aged 8-12 years * haemoglobin \> 10 gr/dl * history of first stage of auricular reconstruction exclusion criteria: * associated endocrinopathies * desnutrition (\<2.5 gr/ dl)
a study to define the ecg effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women using a blinded ecg evaluator: a thorough ecg trial

Conditions: Spasticity

Summary: this is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ecg effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. the study will be conducted in a phase 1 unit with sufficient facilities to house subjects as required by the protocol.


Eligibility criteria:
inclusion criteria: * women of childbearing potential should have a negative urine pregnancy test prior to screening and day -2 of the trial * all subjects of childbearing potential must practice a highly effective method of birth control excluding oral contraceptives for the duration of the trial and up to 3 months after the last dose of investigational product. oral contraceptives are not allowed, based on the precaution listed in the zanaflex package insert. * have a body mass index (bmi) ranging between 19 and 30 kg/m2 * comprehend and be able to provide written informed consent * be willing and able to comply with all trial requirements exclusion criteria: * female who is either pregnant, breastfeeding or planning to become pregnant * history of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any of the tablet components * any condition possibly affecting drug absorption, metabolism or excretion including previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or pancreas * history of long qt syndrome or a first-generation relative with this condition * evidence or history of clinically significant allergies except for untreated, asymptomatic, seasonal allergies at time of dosing, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease. determination of clinical significance is to be made at the investigator's discretion * history or presence of any malignant or benign neoplasm considered by the investigator to be clinically significant * history of drug or alcohol abuse or dependence within the last year * have an active infectious disease
ear acupuncture reducing pain and improving balance

Conditions: Chronic Low Back Pain

Summary: the aim of the present project is to examine the effects of single session of french ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain. we hypothesize that: i) the application of french ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain. ii) the pain reduction would be greater for those individuals with low back pain who receive application of french ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment. iii) the application of french ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.


Eligibility criteria:
inclusion criteria: * complaints of back pain lasting more than 12 weeks * pain referred larger than 4 according to the 11-points pain scale exclusion criteria: * no other musculoskeletal injury, * individuals diagnosed with structural damage * individuals who performed a spine surgery * individuals who have sensory abnormalities or dizziness. * individuals may not be in physical therapy for reducing low back pain. * painkillers or anti-inflammatories use 24 hours before the experimental procedure.

Keywords: low back pain french auriculotherapy postural control balance posture
insomnia and rumination in late pregnancy and the risk for postpartum depression

Conditions: Insomnia; Post Partum Depression

Summary: the primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (ppd) symptoms. additionally, the investigators will also determine the effectiveness of digital/internet-based cognitive behavioral therapy for insomnia (dcbti) in reducing the risk for ppd.

the purpose of this study is to 1) explore the relationship between prenatal insomnia, ruminative thinking and the severity of ppd symptoms. and 2) determine the effectiveness of digital cognitive behavioral therapy (dcbti) in reducing the risk for postpartum depression in pregnant mothers entering into their third trimester. dcbti is an online form of cognitive behavioral therapy (cbt) that is used with people who experience trouble sleeping at night (insomniacs). as pregnant women are especially vulnerable to sleep problems during this period, this study will help us determine whether dcbti is helpful in improving sleep and reducing the risk for ppd in this population. pregnant women entering their third trimester will be recruited from the henry ford health system through the hfhs electronic medical record (epic). they will receive an email from study personnel describing the study, and encouraged to schedule a phone call to discuss study details. participants will then complete a consent and an online screening survey. upon meeting inclusion criteria, participants will complete weekly surveys and randomized into one of 2 active online insomnia treatment conditions. each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete. subjects will complete weekly online surveys beginning at week 30 of pregnancy, and continuing through 6 weeks after giving birth.

Eligibility criteria:
inclusion criteria: * must be entering their 3rd trimester of pregnancy * must deny any concerns or indications of a high risk pregnancy associated with increased risk for the mother or fetus for negative health outcomes exclusion criteria: * age \< 18 years old * bipolar or seizure disorders (due to risk in cbti) * known sleep disorders other than insomnia (eg narcolepsy, restless legs syndrome, obstructive sleep apnea) * women already in their 3rd trimester * women who are not pregnant * women with high risk pregnancy

Keywords: insomnia post partum depression (ppd) digital cbti (dcbti) online cbti rumination
evaluation of sirolimus-eluting, heparin-coated cocr stent in the treatment of de novo coronary artery lesions in small vessels(evolution)

Conditions: Coronary Artery Disease

Summary: the objective of this study is to assess the performance and safety of a sirolimus-eluting, heparin-coated, cobalt chromium balloon-expandable stent (small vessel stent) in patients with de novo native coronary artery lesions in small vessels as compared to historical data from small vessel patients in the ravel trial receiving the sirolimus-eluting bx velocity™ stent.


Eligibility criteria:
inclusion criteria: 1. the patient must be minimum 18 years of age; 2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii-iii) or patients with documented silent ischemia; 3 treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target vessels are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion; 4. the target lesion is \>/=2.0 mm and \</=2.5mm in diameter (visual estimate); 5. the target lesion can be covered with a single 18mm stent; 6. target lesion stenosis is \>50% and \<100% (timi i) (visual estimate); exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck\>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remain above normal at the time of treatment; 2. target lesion is due to in-stent restenosis; 3. ejection fraction 30%; 4. totally occluded vessel (timi 0 level); 5. impaired renal function (creatinine \> 3.0 mg/dl);
the association between preoperative sepsis and the mortality after hip fracture surgery

Conditions: Sepsis; Hip Fractures

Summary: the worldwide occurrence of hip fracture is high with an annual incidence of approximately 100 per 100.000 people. mortality for patients undergoing hip fracture surgery is high with a 30-day mortality rate varying between 4.5 and 13.3 %. it is agreed that non-modifiable factors such as age, gender and pre-existing comorbidities contribute to early death of hip fracture patients. however, not many studies have focused on preoperative sepsis as a potential risk factor. hip fracture patients are commonly identified with sepsis after surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated. being able to identify patients at higher risk of postoperative mortality could potentially improve outcome and extensive hospital registries of vital signs and cultures allow identification of preoperative sepsis. the aim of this study is to assess the association between preoperative sepsis and the 30-day mortality after hip fracture surgery.

this study will be a retrospective analysis of a set of data collected prospectively. data on relevant cultures, blood samples, co-morbidities, time to surgery and 30-day mortality will be extracted from patient records and clinical databases to examine the pre- and postoperative status of the patients.

Eligibility criteria:
inclusion criteria: * patients with one of the following icd-10 diagnoses for hip fracture: ds720(fracture of neck of femur), ds721 (pertrochanteric fracture), ds721a(intertrochanteric fracture), ds721b (trochanteric fracture), ds722 (subtrochanteric fracture) * patients who underwent surgery for hip fracture. * age \> 18 years exclusion criteria: * patients with a pathologic hip fracture related to an underlying metastatic disease (icd-10: dm907). * patients with incomplete preoperative data. all patients must have at least one record of each of the following variables within 72 hours prior to hip fracture surgery: temperature, heartrate, respiratory rate and blood leukocytes.

Keywords: sirs, systemic inflammatory response syndrome hip fracture surgery sepsis mortality
improving participation in universal school meals (usm)

Conditions: Food Deprivation; Obesity, Childhood

Summary: the purpose of this study is to assess the impact of an implementation strategy on participation in universal school meals (usm).

the purpose of this cluster randomized trial is to test the effectiveness of an implementation strategy on implementation and student health outcomes of universal school meals (usm). this will be completed by developing and tailoring of an implementation strategy and testing its effectiveness though a cluster randomized design. primary implementation outcomes of this trial are acceptability, cost, feasibility, penetration, and sustainability. secondary student health outcomes are changes in diet quality (district-wide survey for students), food insecurity (usda 6-item screener), and weight status. exploratory descriptive models will be run to assess differences between intervention and control schools. to provide evidence for approaches in adolescents at highest risk for poor dietary intake, food security, and obesity risk, racial and ethnic minority adolescents from the school district of philadelphia will comprise the majority of the sample. the principal investigator has just completed a year-long needs assessment with 8 schools across the district. we will aim to recruit 4 schools to be randomized to 1 of 2 conditions. recruitment is underway, final recruitment details will be added once randomization is complete. from these schools, we aim to randomize (2 intervention; 2 waitlist comparison) for the development and tailoring of an implementation strategy. at baseline and throughout the 2-year trial period, we aim to collect interview data and surveys, and analyze data on diet quality, food security, and weight status.

Eligibility criteria:
inclusion criteria: * an elementary/middle or high school within the school district of philadelphia (sdp) that provides free breakfast and lunch to students * school is willing to be randomized to either a treatment or waitlist comparison condition * school has a team of teachers, administration, and food service staff who are willing to complete interviews and surveys for data collection * school has valid data for student body mass index, meal participation, and food insecurity (parent reported). * students currently enrolled in a sdp elementary/middle/high school * students willing to participate in an interview and complete surveys * students have participated in school meals in the last year. exclusion criteria: * charter schools and private schools * students not enrolled in school full time; students under 11 years of age.
a safety & efficacy study of treatment with ap1189 in rheumatoid arthritis patients naïve to dmard treatment

Conditions: Rheumatoid Arthritis

Summary: the study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg ap1189 in ra patients who are to start up-titration with methotrexate (mtx).


Eligibility criteria:
main inclusion criteria: * confirmed diagnosis of ra according to the 2010 acr/eular ra classification criteria and are acr class i-iii * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts). * candidate for mtx treatment * is about to begin treatment with mtx * must meet at least one of the following parameters at screening: 1. positive result for anti-ccp or rf 2. serum crp ≥ 6 mg/l * highly active ra (cdai \> 22) at screening and baseline * negative quantiferon-in-tube test (qfg-it) * females of child-bearing potential must use of highly effective birth control method main exclusion criteria: * major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization * rheumatic autoimmune disease other than ra, including systemic lupus erythematosus (sle), mixed connective tissue disease (mctd), scleroderma, polymyositis, or significant systemic involvement secondary to ra. sjögren's syndrome with ra is allowable * prior history of or current inflammatory joint disease other than ra * subjects with fibromyalgia * use of hydroxychloroquine within 4 weeks prior the screening visit * initiation of, or change in existing nsaid treatment within 2 weeks prior to the baseline visit * corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening * evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * have prior renal transplant, current renal dialysis, or severe renal insufficiency * uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids * evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured) * neuropathies or other painful conditions that might interfere with pain evaluation * body weight of \>150 kg * hbsag positive and/or anti-hbc with sign of current infection.
comparison of outcomes between the use of silverlon® dressing and aquacel® ag dressing post cardiac device implant

Conditions: Infections; Wounds and Injuries

Summary: the purpose of this study is to learn how effective each of the two dressings, silverlon® and aquacel® ag, are in preventing post cardiac implantable electronic devices (cied) procedure wound infections.

this is a single center, prospective, 2-arm randomized, non-blinded study. a total of 100 participants will be assigned to the silverlon arm and 100 to the aquacel ag arm. the number of procedures to implant cied has risen in recent years. with this rise has also brought a rise in post-procedure infections. infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. wound coverage with appropriate dressings is one aspect that needs to be studied in cied implant patients. silverlon and aquacel ag are two options of dressings available for these patients. this study will look to see if one of the two is a better option for post-operative cied implant patients.

Eligibility criteria:
inclusion criteria: * patients who are scheduled for a cied implant, generator change, or upgrade at the university of kansas hospital * able to give informed consent exclusion criteria: * patients who are already on antibiotics for another reasons * immunocompromised patients such as those on immunosuppressant's and hiv positive patients * patients who are post device explant for lead infection * patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components

Keywords: cardiac implantable electronic device implant
treatment for patients with non-small cell lung cancer who developed anemia due to chemotherapy

Conditions: Non-Small Cell Lung Cancer; Anemia

Summary: the purpose of this study is to validate a patient satisfaction questionnaire for anemia treatment (psq-at) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rhuepo) for anemia due to chemotherapy.


Eligibility criteria:
inclusion criteria: - subjects receiving multi-cycle chemotherapy for non-small cell lung cancer - anemia due to chemotherapy (hgb less than or equal to 11.0 g/dl) - expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - karnofsky performance scale (kps) greater than or equal to 50% - adequate renal function - adequate liver function exclusion criteria: - iron deficiency - unstable cardiac disease - known positive test for human immunodeficiency virus (hiv) infection

Keywords: non-small cell lung cancer darbepoetin alfa amgen