Kornimate/medical-research-clean huggingface dataset:
a study to assess the effect of tocilizumab + methotrexate on signs and symptoms in patients with moderate to severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (mtx). in patients with moderate to severe active rheumatoid arthritis (ra) who currently have an inadequate response to mtx. patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age with moderate to severe active ra for at least 6 months; * inadequate response to a stable dose of mtx; * patients of reproductive potential must be using reliable methods of contraception. exclusion criteria: * major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; * prior treatment failure with an anti-tumor necrosis factor agent; * women who are pregnant or breast-feeding.
everolimus in de novo kidney transplant recipients

Conditions: Kidney Transplantation

Summary: the purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.


Eligibility criteria:
key inclusion criteria: * patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure; * men or women ≥18 years at transplant; * recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor \> 14 years; key exclusion criteria: * patients who are recipients of multiple organs transplant, including two kidneys; * historical or current peak pra \> 50%. patients with already existing antibodies against the donor; * thrombocytopenia (platelets \< 75,000/mm³), absolute neutrophil count \<1,500/mm³, leucopenia (leucocytes \< 2,500/mm³) or hemoglobin \< 7 g/dl; * body mass index (bmi) \> 30 kg/m2;

Keywords: immunosuppression kidney transplantation everolimus safety
safety and efficacy of crs-207 with pembrolizumab in gastric, gastroesophageal junction or esophageal cancers

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma

Summary: the purpose of this study is to determine whether crs-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior chemotherapy regimens for advanced disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis with confirmed histology of one or more of the following: * histologically-confirmed gastric or gastroesophageal junction (gej) adenocarcinoma (siewert type ii/iii classification), or * histologically-confirmed inoperable superior, medial, or distal third esophageal adenocarcinoma (siewert type i classification may be included, provided there is no mixed histology) 2. confirmed recurrent or metastatic disease 3. received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease. 4. her-2/neu negative or, if her-2/neu positive, disease must have previously progressed on treatment with trastuzumab; prior treatment must have included a platinum and a fluoropyrimidine. 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. can provide tissue for pd-l1 and mesothelin biomarker analysis 7. adequate organ and marrow function at screening exclusion criteria: 1. diagnosis of squamous or undifferentiated gastric cancer 2. individuals with inaccessible tumors or for whom biopsy is contraindicated 3. participated in any other study in which receipt of an investigational new drug or investigational device occurred within 28 days of first dose of study drug 4. receiving tumor necrosis factor (tnf) pathway inhibitors, pi3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug 5. clinical evidence of ascites by physical exam 6. prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug or has not recovered from adverse effects due to agents administered more than 4 weeks earlier 7. prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug, or has not recovered from adverse effects due to a previously-administered agent 8. subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. other common devices such as venous access devices (e.g. port-a-cath or mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.

Keywords: stomach cancer gastric cancer esophageal cancer digestive system diseases gastrointestinal diseases stomach diseases
effects of duloxetine on pathological worry in patients with generalized anxiety disorder: a fmri study

Conditions: Worry; Anxiety

Summary: (1) to compare the differences of neural activation of pathological worry between pre-treatment gad patients and normal subjects; (2) to measure the differences of brain activation on worry in gad patients before and after duloxetine treatment

the study will recruit 20 gad patients and 20 healthy controls. both patients and controls receive a medical and psychiatric screening procedure at visit 1 and are asked to complete three self-rating questionnaires and one health questionnaire at visit 1. all qualified participants will receive functional magnetic resonance imaging (fmri) at baseline. the patients will begin treatment with duloxetine 30 mg/day at visit 2 and will be titrated to 60 mg/day at visit 3 (2 week since drug dispensed). the dosage will be maintained on 60 mg/day for 6 more weeks. during the period, the patients will receive periodic evaluations at visit 2 (0 week drug dispensed), 3 (2 week since drug dispensed), 4 (4 weeks since drug dispensed), and 5 (8 weeks since drug dispensed). the patients will receive fmri examination at baseline and at the end of the 8-week treatment.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria of generalized anxiety disorders with moderate degree * participants above 18 years old exclusion criteria: * major depression * panic disorder * obsessive-compulsive disorder * post-traumatic disorder * eating disorders * psychotic disorders; and * alcohol or other substance use disorders * neurological disease * cardio-vascular disease * respiratory disease * head trauma

Keywords: generalized anxiety disorder fmri worry
effectiveness of propolis mouthwash on gingivitis

Conditions: Gingivitis

Summary: mouthrinses have been in used for centuries as breath fresheners, medicaments, and antiseptics. recently, propolis has caught the eyes of dentists worldwide and researches are being carried out to infuse the usage of propolis in the dental health care treatments. there is belief that propolis may have a role as a tooth decay prophylaxis and help heal oral ulcers. propolis is used as mouthwash, toothpaste, oral gel, and throat lozenges because of its proclaimed antibacterial and anti-inflammatory properties. propolis has shown activity against common periodontal microorganisms, such as candida species and the streptococci mutans in vitro studies. till date, no study has evaluated the clinical and microbiological effects of malaysian propolis as a mouthwash. thus, the present study is designed to evaluate the effectiveness of propolis as a mouthwash in the reduction of plaque and gingivitis.the aim of the study is to assess and compare the effectiveness of propolis mouthrinse with chlorhexidine mouthrinse.

the randomized controlled clinical study with latin-square cross-over design would be used to assess and compare the effectiveness of propolis and chlorhexidine mouthrinse on gingivitis. subjects with chronic generalized gingivitis with age group of 18-30 years will be selected for the study as the target population. subjects who meet the inclusion and exclusion criteria will be selected and screened for the plaque and gingival status before including them in the study. they will be randomly divided into three groups. group 1: 15 subjects (placebo mouthwash) group 2: 15 subjects (propolis mouthwash) group 3: 15 subjects (chlorhexidine mouthwash)

Eligibility criteria:
inclusion criteria: * gingival index \>1 * periodontal pocket depth ≤ 3 mm * clinical attachment loss "0" * provision of written informed consent * good systemic health. exclusion criteria: * severe periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession * any condition that requires antibiotic premedication for the administration of a dental prophylaxis. * self-reported pregnancy, intent to become pregnant during the study, or breast-feeding. * any diseases or condition that could be expected to interfere with the safe completion of the study. * history of antibiotic use in the previous 3 months. * individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation.
a study on non-invasive early diagnosis of gastrointestinal stromal tumors and differentiation of benign and malignant nodules

Conditions: Gastrointestinal Stromal Tumor

Summary: gastrointestinal stromal tumors (gist) is the most common mesenchymal tumor of the gastrointestinal tract, and the incidence rate in china has increased year by year in recent years.gastrointestinal stromal tumors are not sensitive to radiotherapy and traditional infusion chemotherapy. currently, they are generally treated with surgery, but they are prone to recurrence and metastasis.for nodules with a particle size between 2 and 5 cm, there may be both benign and malignant, and there is still a lack of fast and accurate methods for distinguishing benign and malignant.many benign nodules were removed (in the pathological examination of postoperative resected tissue). in addition, if it is found to be late, there is a possibility of invading surrounding tissues and metastasis, so that it is impossible to cure. therefore, early diagnosis and early surgery and benign and malignant differentiation of small nodules are the key to the clinical diagnosis and treatment of gastrointestinal stromal tumors.at present, second-generation gene sequencing (ngs) and liquid biopsy are rarely reported in the field of gist. a few domestic and foreign studies have found that it can detect rare mutation types, and may find secondary gene mutations early, which has potential applicability, but overall, the clinical guidance of these ngs-based studies focuses on prognosis and drug resistance , as well as some studies based on low-throughput platforms. therefore, early diagnosis and benign and malignant discrimination based on high-throughput sequencing and liquid biopsy have significant clinical significance for the diagnosis and treatment of gastrointestinal stromal tumors.


Eligibility criteria:
inclusion criteria: * patients who are scheduled for stromal tumor resection * signed informed consent exclusion criteria: * the vital signs are not stable * unconscious * unwilling to cooperate
research on translational outcomes of alcohol (project retro)

Conditions: Alcohol Drinking

Summary: the primary aim of the current study is to assess the effect of a single dose of carbidopa-levodopa on ad libitum alcohol consumption and alcohol craving in young adults with a history of binge drinking.

this is a small (n = 42) 2-arm, double-blind, randomized controlled pilot study to assess the effect of a single dose of immediate release carbidopa-levodopa (50mg/500mg) to acutely reduce alcohol consumption and craving in college students with a history of heavy episodic drinking. participants will be between 21-24 years old from 2- and 4- year colleges in the seattle metropolitan area. interested students will contact the study line and provide verbal consent to be sent a link to an online screening survey. eligible participants will be scheduled to come in for the ad libitum alcohol administration. participants will receive either the carbidopa-levodopa or a placebo and complete the alcohol administration protocol.

Eligibility criteria:
inclusion criteria: * enrolled in 2- or 4-year college program * currently living in the seattle metropolitan area * have at least two or more episodes of heavy episodic drinking (4/5 or more drinks in a 2 hours for women/men) in the past 30 days. exclusion criteria: * exclusion criteria include: * past-month severe alcohol or other substance use disorders, * mood or anxiety disorder * suicidal ideation * risk of psychotic disorders * excessive alcohol use reaching a blood alcohol level greater than .30% * history of serious medical conditions, regular use of prescription psychotropic or pain medication * history of negative reactions to alcohol * history of treatment for alcohol use disorder * pregnancy or nursing. * use of non-selective monoamine oxidase inhibitors in the past 2 weeks. * narrow-angle glaucoma * undiagnosed skin lesions, * have a history of melanoma, cardiac issues or peptic ulcer. * currently taking or prescribed any form of levodopa or d2 agonists, d2 antagonists, isoniazid, methylphenidate, bupropion, viagra, or phosphodiesterase inhibitors.
bupivacaine vs placebo for unilateral mastectomy surgical site post-operative pain control

Conditions: Breast Cancer

Summary: the purpose of this study is to compare using fda-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. the addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. this study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * patients undergoing unilateral mastectomy with or without slnb or axillary dissection * patients scheduled for surgery at the jrsc or msk monmouth * previously enrolled patients \> 6 months from contralateral mastectomy exclusion criteria: * patients who are non-english speaking * patients having any immediate breast reconstructive procedure * patients are having bilateral mastectomy * patients who report a baseline pain score \> 3, unrelated to a breast procedure * patients who take long acting opioid medication use * patients will be excluded if they are having their mastectomy performed with tumescence * patients weighing \< 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose * patients within 6 months of previous enrollment for surgery for contralateral mastectomy

Keywords: bupivacaine mastectomy sentinel lymph node biopsy slnb 17-576
quantitative non-invasive brain imaging using qute-ce mri

Conditions: Cerebrovascular Disorders

Summary: this trial will evaluate a non-invasive brain imaging technique qute-ce mri and validate the method with first-in-human studies.

this trial will evaluate a non-invasive brain imaging technique qute-ce mri using ferumoxytol as a contrast agent, and validate the method with first-in-human studies. subjects who are already scheduled to receive ferumoxytol infusion will undergo mri scans after the infusion. the ferumoxytol infusion itself is not a part of the study. the project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Eligibility criteria:
inclusion criteria: * between the ages of 18 to 80; * able to understand written consent document and hipaa authorization prior to initiation of study related procedures. exclusion criteria: * known allergy to ferumoxytol or any intravenous iron preparation; * iron saturation above the upper limit of normal; * individuals with a contraindication to mri, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator); * individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease; * individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.

Keywords: magnetic resonance imaging ferumoxytol
modified salt score for alopecia areata

Conditions: Alopecia Areata

Summary: patchy alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, msalt score and dermoscopy.


Eligibility criteria:
inclusion criteria: * localized scalp aa ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent. exclusion criteria: * • pregnant, and lactating females * alopecia totalis or universalis or ophiasis or cicatritial alopecia * usage of systemic treatment of alopecia areata 2 months prior to the study. * any scalp lesion within the treated area * bleeding diathesis, severe anemia or platelet disorders * medical conditions such as autoimmune diseases.
light emitting diode in the treatment of vulvodynia

Conditions: Vulvodynia

Summary: vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. the main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. photobiomodulation has been described in the literature as an alternative to treat pain. our group has studied blue led for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. a pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. the following questionnaires will be used: female sexual function index (fsfi), sexual quotient - female version, vulvar pain assessment questionnaire. after answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. pain assessments will be quantified by the visual analogue pain scale (vas), which ranges from 0 (no pain) to 10 (maximum pain). at the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "what is your perception of improvement" and "what is your level of satisfaction with the treatment?". the answers will be giving according to a likert scale of five points. the led application protocol will be carried out with external use equipment model antares, from the company ibramed (amparo, são paulo, brazil), with a cluster g2 applicator. the power will be 450mw/cm2 and dose 5j/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). the treatment consists of eight sessions, carried out daily, except on weekends.


Eligibility criteria:
inclusion criteria: * vulvodynia diagnosis exclusion criteria: * patients diagnosed with vaginal infection * difficulty in understanding the proposed instruments * patients with chronic degenerative neurological diseases * pregnant women

Keywords: vulvodynia light-emitting diode
autologous cord blood cells for brain injury in term newborns

Conditions: Hypoxic Ischemic Encephalopathy

Summary: this is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. the cord blood used is fresh (not frozen and then thawed).

the purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. for this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. mri brain will be obtained at 1-2 weeks and 4-6 months old.

Eligibility criteria:
inclusion criteria: 1. autologous umbilical cord blood available 2. \>36 weeks gestation 3. brain injury that satisfies criteria for therapeutic hypothermia 4. parental informed consent exclusion criteria: 1. inability to enroll by 3 postnatal days of age. 2. presence of known chromosomal anomaly. 3. presence of major congenital anomalies. 4. severe intrauterine growth restriction 5. infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. 6. parents refuse consent. 7. attending neonatologist refuses consent. 8. failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Keywords: hypoxic ischemic encephalopathy autologous cord blood