Kornimate/medical-research-clean huggingface dataset:
impact of topical tranexamic acid in breast reconstruction

Conditions: Breast Cancer

Summary: improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of tranexamic acid (txa) in many surgical fields. this trial tests how well applying tranexamic acid (txa) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). the formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. txa is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. applying txa topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients. participants will be recruited from patients undergoing bilateral mastectomy at university of california, san francisco.

primary outcomes: i. to investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population. ii. to evaluate the impact of txa on seroma rates compared to control. secondary outcomes: i. to evaluate the impact of txa on patient and provider rating of bruising, comparing the txa side to the control side. ii. to evaluate the impact of txa on total drain output in the first post operative day. iii. to evaluate the impact of txa on total drain duration. outline: participants will only be treated intra-operatively at the time of surgery with topical txa to one breast pocket. each participant will serve as own internal control, with one side receiving saline and the other txa. participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed breast malignancy or increased risk for breast cancer 2. age \>= 18 years 3. scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction 4. ability to understand a written informed consent document, and the willingness to sign it 5. at least 4 weeks post-completion of chemotherapy or radiation therapy exclusion criteria: 1. any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study 2. any history of thromboembolic disease 3. current anticoagulant use 4. current use of chlorpromazine due to label contraindication 5. current use of any prothrombotic medical products due to label contraindication 6. documented or reported allergic reaction to tranexamic acid 7. male participants

Keywords: breast reconstruction
hypertonic saline injection for urinary incontinence

Conditions: Urinary Stress Incontinence

Summary: the investigators aimed to evaluate the effectiveness and safety of periurethral hypertonic saline (10% nacl) injection for the treatment of stress urinary incontinence (sui) and stress-predominant mixed urinary incontinence (mui) in women.

this single-center prospective pre-post interventional study was conducted between january 2014 and april 2018 with 65 women (44 sui, 21 mui). quality of life was evaluated with the incontinence quality of life scale (i-qol) and the lower urinary tract symptoms of women were evaluated with the international consultation on incontinence questionnaire female lower urinary tract symptoms modules (iciq-fluts). incontinence status was assessed via the stamey incontinence grade scale. patients with mui also were evaluated using the urinary distress inventory-6 (udi-6). the need for additional treatment (re-injection, other surgical approaches, etc.) was recorded. participants were followed up to 24 months after intervention. all outcomes of interest and complications were evaluated/recorded at six preplanned visits (postoperative 1st, 3rd, 6th, 12th, 18th, 24th months).

Eligibility criteria:
inclusion criteria: the patients who described stress urinary incontinence or mixed urinary incontinence, those who had incontinence during the valsalva maneuver, patients with positive marshal-marchetti test, and those with post-void residual urine volume ≤100 ml were included in the study. exclusion criteria: temporary urinary incontinence, delirium, urinary tract infection, urethritis, pure urge incontinence, nocturnal enuresis, decreased bladder compliance and detrusor contraction in the urodynamic study, leakage of urine with low bladder pressure, psychiatric conditions (severe depression and anxiety), body mass index (bmi) \>35 kg/m2, and using drugs that may influence bladder storage or emptying

Keywords: female stress urinary incontinence stress-predominant mixed incontinence hypertonic saline injection therapy
linkage of transgender individuals to prep

Conditions: HIV Seronegativity; Linkage

Summary: cctg 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to prep using a community-based transgender prep outreach worker (t-powr) versus standard of care (soc).

up to 500 self-identified transgender / gender non-conforming persons seeking daily pre-exposure prophylaxis (prep) for the prevention of hiv will be enrolled into this study. each participant will be followed up to 28 weeks after enrollment. the primary endpoint, successful linkage to a prep evaluation visit, will be measured after 30 days of enrollment. participants expressing interest in prep will be referred to the regional transgender prep outreach work (t-powr) via phone call. enrolled participants will be randomized (1:1) to either soc prep linkage vs t-powr facilitated prep linkage. participants randomized into the soc arm will receive an hiv risk assessment, prep education, and an appointment for a linkage visit. participants randomized into the t-powr arm will receive soc and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services. participants will be contacted at week 4 to verify linkage, and at weeks 16 and 28 to assess prep and hiv status, and access to referred services.

Eligibility criteria:
inclusion criteria: * age 18 years or older * self-identifies as a transgender or gender non-conforming person * self-identifies as hiv-negative or unknown status * ability to provide informed consent * english or spanish speaking exclusion criteria: * severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent

Keywords: prep pre-exposure prophylaxis truvada client-centered case management transgender gender non-conforming
gluten-free diet in women with autoimmune thyroiditis

Conditions: Autoimmune Thyroiditis

Summary: the purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition. the main questions it aimed to answer were: * does the gluten-free diet worsen the gut microbiome composition? * does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (tsh), thyroid hormones thyroxine (ft4) and triiodothyronine (ft3), thyroid peroxidase antibodies (tpoab) and thyroglobulin antibodies (tgab)? * does the gluten-free diet improve the quality of life? participants: * followed normocaloric gluten-free diet for 8 weeks * after first 4 weeks were randomly assigned to one of two groups. one group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo). blood and stool samples were collected before diet (t0), after 4 weeks (t1) and after 8 weeks of diet (t2) (total of 3 samples per participant). also each participant completed the thypropl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (t0), after 4 weeks (t1) and after 8 weeks of the diet (t2).


Eligibility criteria:
inclusion criteria: * autoimmune thyroiditis diagnosed by endocrinologist based on increased tpoab and/or tgab levels; * stabilized thyroid function, i.e. thyroid hormones within normal range; * bmi indicating correct body mass, i.e. within 18.5 - 24.9 kg/m\^2. exclusion criteria: * newly diagnosed autoimmune thyroiditis and unregulated thyroid hormones (hypothyroidism or hyperthyroidism); * concomitant celiac disease and / or wheat allergy; * gluten-free diet followed during 6 months prior to enrollment; * intestinal disorders; * antibiotic or probiotic therapy during 6 months prior to enrollment.

Keywords: diet gut microbiome thyroid gluten-free diet
stillbirth risk identification using multiparametric ultrasound

Conditions: Perinatal Hypoxia

Summary: the goal of this observational study is to identify a novel biomarker for stillbirth. specifically the aim is to predict perinatal hypoxia using quantitative ultrasound from the placenta (qus-p) between 35 and 37 weeks gestation.

funding: wellcome leap, in utero program primary outcome: perinatal hypoxia background: perinatal hypoxia is an inadequate supply to or utilization of oxygen by the fetus. it is typically diagnosed at delivery and can lead to serious medical complications, including encephalopathy, and ultimately stillbirth. fetal hypoxia represents 23% of neonatal deaths worldwide. aim: to predict perinatal hypoxia using quantitative ultrasound from the placenta (qus-p) between 35 weeks gestation and delivery. methods: raw radio frequency data is collected during ultrasounds between 35 and 37 weeks gestation using clariustm (handheld ultrasound). all scans take place at bc women's hospital. qus-p parameters are derived from the raw radio frequency data and analyzed using linear regression. impact: the ability to identify perinatal hypoxia as early as 35 weeks gestation will allow for additional monitoring as well as efforts to prepare for immediate intervention if necessary (e.g. c-section, resuscitation, neonatal cooling), prevent progression to encephalopathy, and ultimately stillbirth.

Eligibility criteria:
inclusion criteria: 1. pregnant with singleton 2. age 19 years or older 3. provision of informed consent 4. planning to deliver at bc women's hospital 5. 38 weeks gestation or less exclusion criteria: 1. pregnant with multiples 2. not planning to deliver at bc women's hospital 3. less than 19 years of age 4. greater than 38 weeks gestation

Keywords: quantitative ultrasound placenta stillbirth fetal hypoxia
efficacy of neothermo-radio-chemotherapy for la rectal cancer before laparoscopic tme: prospective phase ii trial

Conditions: Locally Advanced Rectal Cancer

Summary: the investigators start this prospective study to evaluate the efficacy of laparoscopic total mesorectal excision after concurrent chemo-radiation therapy with hyperthermia in locally advanced rectal cancer.

the current standard treatment of locally advanced rectal cancer is neoadjuvant concurrent chemo-radiation therapy (ccrt) followed by total mesorectal excision (tme). recently, laparoscopic surgery is getting substitute open surgery based on the advantages of early recovery, short admission, less pain, less blood loss, and little scar without compromising oncologic outcomes. it is reported that hyperthermia is effective in synthetic (s) phase, low oxgen pressure, acidic, and low perfusion site which are known as radio-resistant. because of these characteristics, it considered as the most valuable radiosensitizer in cancer treatment, theoretically. furthermore, mild hyperthermia (41 to 41.5 ºc) can promote tumor reoxygenation. based on those background, the investigators start this prospective study to evaluate the efficacy of laparoscopic tme after ccrt with hyperthermia in locally advanced rectal cancer.

Eligibility criteria:
inclusion criteria: * 20 years or older * pathologically confirmed rectal cancer * eastern cooperative oncology group performance status 0 to 2 * candidate of laparoscopic tme * optimal bone marrow function * locally advanced rectal cancer confirmed by magnetic resonance imaging exclusion criteria: * extrapelvic metastasis * previous pelvic irradiation * current status of pregnant or breast feeding * confirmed other malignancy within two years except thyroid cancer
wegent - comparison of methotrexate or azathioprine as maintenance therapy for anca-associated vasculitides

Conditions: Systemic Wegener's Granulomatosis

Summary: remission of anca-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. however, relapses are frequent. this point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. the optimal drug in this indication is not determine. we decided therefore to compare the 2 most used drugs in this indication. induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - d1, 15 and 30), then every 3 weeks (0.7 g/m2). once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). at that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.


Eligibility criteria:
inclusion criteria: * patients aged over 18 years-old with newly diagnosed systemic wegener's granulomatosis, * microscopic polyangitis with at least one factor of poor prognosis according to the five factors score (proteinuria \> 1 g/day, renal insufficiency defined as a serum creatininemia \> 140 µmol/l, specific cardiomyopathy, gastrointestinal tract and/or cns involvement). exclusion criteria: * mpa patients with no poor prognosis factor; * localized wg; * relapse of previously known wg or mpa; * treatment with corticosteroids for more than 1 month prior to diagnosis and start of immunosuppressant; * co-existence of another multi-system autoimmune disease; * malignancy (unless considered in complete remission and with no therapy for at least 3 years); * contra-indication to corticosteroids or study immunosuppressants; pregnancy or no use of contraception in non-menopaused women; * infection with human immunodeficiency virus; mental or physical disturbances not permitting to give consent.

Keywords: wegener's granulomatosis, microscopic polyangiitis, anca-associated vasculitis, methotrexate, azathioprine
palonosetron and hydroxyzine to reduce opioid withdrawal

Conditions: Substance-Related Disorders

Summary: opioid medications are commonly used for pain relief. when given over time, physical dependence can occur. this results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. we are interested in knowing if a medication named ondansetron can help ease or prevent symptoms associated with opioid withdrawal. we are also interested in knowing if a similar (but more potent fda-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).

we hope to learn if palonosetron and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. if we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.

Eligibility criteria:
inclusion criteria: * healthy males * ages 18-35 * no allergies to morphine or palonosetron * no history of addiction or substance abuse exclusion criteria: * female * younger than 18 or older than 35 * history of substance abuse * raynaud's disease or coronary artery disease * allergies to morphine or palonosetron

Keywords: palonosetron hydroxyzine acute opioid withdrawal
sodium tungstate in obesity

Conditions: Obesity

Summary: the purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade i and ii).


Eligibility criteria:
inclusion criteria: * bmi: 30-39.9 kg/m2 * in case of male gender, 18 to 65 years old * in case of female gender, diagnosis of menopause * body weight changes \< 3 kg in the last 3 months * in case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months exclusion criteria: * in case of female gender, absence of menopause * evidence of secondary causes of obesity * diabetes, type ii * concomitant treatment with drugs affecting body weight * previous surgical intervention of obesity
breath-actuated nebulizer versus conventional continuous-output nebulizer in pediatric asthma patients

Conditions: Asthma

Summary: a breath-actuated nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. it is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. this study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.


Eligibility criteria:
inclusion criteria: * children 1-17 years old with known history of asthma * children must be presenting to the emergency department for treatment of acute asthma * children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm exclusion criteria: * concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia * no prior history of asthma * pregnancy * reported history of drug allergy to albuterol or ipratropium bromide * previous participation in the study within the preceding three weeks * vital sign instability/need for immediate emergency intervention to prevent clinical deterioration

Keywords: asthma pediatric emergency department nebulizer
shnaghai shengkang medical center

Conditions: Vascular Diseases

Summary: the process of population aging that is occurring in developed societies represents a major challenge for the health system. the aim of this study is to analyze factors that have an influence on early vascular aging (eva), estimated by carotid-femoral pulse wave velocity (cf-pwv) and cardio ankle vascular index (cavi), and to determine differences by gender in a chinese population.


Eligibility criteria:
inclusion criteria: * • patients aged 35 to 85 years who agree to participate in the study and do not meet any of the exclusion criteria. exclusion criteria: * • subjects who are in terminal condition, who cannot travel to the health centers to undergo the corresponding examinations, and those who do not wish to sign the informed consent. * subjects with a history of cvd (ischemic heart disease or stroke, peripheral arterial disease or heart failure), diagnosed renal failure in terminal stages (glomerular filtration rate below 30%), chronic inflammatory disease, or acute inflammatory process in the past three months. * patients treated with estrogens, testosterone, or growth hormone.
minocycline in patients with huntington's disease

Conditions: Huntington's Disease

Summary: this is a study to determine whether treatment with minocycline is safe and tolerable in patients with huntington's disease (hd) and whether minocycline reduces symptoms of hd in these patients.

huntington's disease (hd) is a dominantly inherited disorder. it is uniformly progressive and there is no known effective treatment or cure. the pathogenesis is largely unknown; however, recent studies implicate caspase activation, glutamate excitotoxicity, and free radical toxicity as possible causes of hd. pharmacological agents that block these pathways may be therapeutic in hd. minocycline is an antibiotic that also inhibits caspase-1 and caspase-3 expression, and inducible nitric oxide synthetase activity, which are factors that may play an important role in the mechanisms of neuropathology in hd. two dosages of minocycline or placebo will be given to ambulatory patients with hd over an 8-week period and the tolerability will be compared. additional measures of safety and the change in motor, behavior, cognitive, and function features will be examined.

Eligibility criteria:
inclusion criteria: * clinical features of huntington's disease (hd) and a confirmatory family history of hd and/or a cag repeat expansion of at least 37 * stage i, ii, or iii of illness (tfc greater than or equal to 5) * ambulatory and not requiring skilled nursing care * patients must use effective birth control * concurrent psychotropic medications must be at stable dose for at least 4 weeks prior to study * wbc count at least 3,800/mm3 * creatinine no greater than 2.0 * alanine aminotransferase (alt) no greater than 2 times upper limit of normal exclusion criteria: * prior minocycline use within 2 months of baseline visit * history of known sensitivity or intolerability to minocycline or any other tetracycline * history of vestibular disease * use of any investigational drug within 30 days of baseline visit * treatment with any drug that may cause lupus-like symptoms (e.g., procainamide or hydralazine) within 4 weeks of baseline visit * pregnant or nursing * underlying hematologic, hepatic, or renal disease * evidence of unstable medical illness * illness that requires use of coumadin * unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of baseline visit, or suicidal ideation * substance (alcohol or drug) abuse within 1 year of baseline visit * history of systemic lupus erythematosis (sle) or a history of sle in a first-degree relative * positive ana screening (at or above 1:80)

Keywords: tetracyclines dose-response relationship, drug