Kornimate/medical-research-clean huggingface dataset:
extended protective curtain under table to reduce operator radiation dose in percutaneous coronary procedures

Conditions: Radiation; X-rays; Effects; Coronary Disease

Summary: radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. the radiation dose seems particularly high at pelvic level. we prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. the aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level

interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the "as low as reasonably achievable" (alara) principle. moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses). operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. so, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition. during transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition. aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level

Eligibility criteria:
inclusion criteria: all patient undergoing percutaneous coronary procedures through transradial access exclusion criteria: 1. interventions performed through a different vascular access 2. procedures performed in patients with st elevation acute myocardial infarction 3. haemodynamic instability 4. lack of written informed consent 5. age \< 18 years old 6. previous coronary artery by-pass

Keywords: transradial coronary x-ray radiation curtain
the effects of escitalopram on cytokines

Conditions: Depression

Summary: the association of cytokines with escitalopram has not been investigated in patients with major depressive disorder (mdd). hence, the investigators will examine this association.

in addition to serotonin, inflammatory process has been suggested in the development of major depressive disorder (mdd) and in its associated treatment. escitalopram is an antidepressant that has been widely used in patients with mdd because of the promising results. the association of cytokines with escitalopram has not been investigated in patients with mdd. hence, the investigators will examine this association.

Eligibility criteria:
inclusion criteria: 1. dsm-iv-defined major depressive disorder, single episode 2. age 20-65 3. drug-naive 4. hamilton depression rating scale exceeding 14 scores exclusion criteria: 1. major medical disorders 2. substance use 3. pregnant 4. allergy to escitalopram

Keywords: cytokine, depression, escitalopram
a phase 3 study of recombinant anti-il-17a humanized monoclonal antibody in chinese participants with moderate-to-severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-il-17a humanized monoclonal antibody in chinese participants with moderate-to-severe plaque psoriasis.

study ssgj-608-pso-iii-01 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the effect of 2 dose regimens of recombinant anti-il-17a humanized monoclonal antibody versus placebo in chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. during the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse following treatment.

Eligibility criteria:
inclusion criteria: * must be 18 years to 75 years, both male and female. * chronic plaque psoriasis (pso) for at least 6 months prior to the randomization. * psoriasis area severity index (pasi) \>=12 and body surface area (bsa) affected by pso \>=10% and static physician global assessment (spga) score \>=3. * according to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment). * fertile female subjects and male subjects (and their female partners) must take effective contraceptive measures within at least 6 months from the screening period to the last medication. the subjects have no fertility, sperm donation and egg donation plans within at least 6 months from the screening period to the last medication. exclusion criteria: * forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline. * drug-induced psoriasis. * ongoing use of prohibited treatments. * have previously received any drug that directly targets il-17 or il-17 receptor, or il-12 / il-23, or il-23. * biological agents or their biological analogues were used before randomization, including but not limited to: etanercept \< 28 days; infliximab, adalimumab or afacet \<60 days; golimumab \<90 days; or other biological agents \< 5 half lives. * pregnant or lactating women.
safety and efficacy of turoctocog alfa (n8) in prevention and on-demand treatment of bleeding episodes in subjects with haemophilia a: an extension to trials nn7008-3543, nn7008-3545, nn7008-3600, nn7008-3893 and nn7008-4015

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted in asia, europe, japan, oceania, north america and south america. the aim of the trial is to investigate the safety and efficacy of turoctocog alfa (n8) in haemophilia a patients. the trial is an extension to trials nn7008-3543 (start: march 2009, stop: september 2011) and nn7008-3545 (start: may 2010, stop: november 2011) and the pharmacokinetic trials nn7008-3600 (start: november 2010, stop: october 2011), nn7008-3893 (start: june 2011, stop: september 2011) and nn7008-4015 (start: august 2012, stop: march 2013).


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * completion of trial nn7008-3543 or paediatric trial nn7008-3545 or japanese trial nn7008-3600 or pharmacokinetic trial nn7008-3893 or nn7008-4015 exclusion criteria: * previous participation in the current trial (defined as withdrawal) or withdrawn subjects from nn7008-3522, nn7008-3543, nn7008-3545, nn7008-3600, nn7008-3893 or nn7008-4015 after administration of trial product
a study of chs-1000 in participants with advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: the primary purpose of this trial is to assess the tolerability and safety of chs-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.


Eligibility criteria:
key inclusion criteria: * histopathologically or cytologically confirmed diagnosis of advanced or metastatic unresectable solid tumors (excluding glioblastoma multiforme (gbm)) by tissue biopsy or archival tumor specimen. unresectable tumors are defined as tumors with lesions in which clear surgical excision margins cannot be obtained, in close proximity to major blood vessels, not with oligometastatic and with advanced organ and lymph node (ln) involvement, and not leading to significant functional compromise as determined by surgical consult or tumor board. * participants must have been previously treated or be ineligible for, or intolerant of, available approved standard therapies known to confer clinical benefit (including immunotherapy), or for whom no effective standard therapy exists. * at least 1 measurable lesion based on response evaluation criteria in solid tumors (recist) v1.1 as determined by the investigator. key exclusion criteria: * concurrent enrollment in another clinical study or participation in another clinical study within 28 days prior to the 1st dose of chs-1000, except for observational (noninterventional) studies or the follow-up period of an interventional study. * current or prior use of systemic anticancer treatment, including but not limited to chemotherapy, immunotherapy, biologic treatment, hormone therapy, and targeted therapy, if within 8 weeks or 5 half-lives (whichever is shorter) for biologic therapies, or if within 28 days for most other anticancer therapies, prior to the 1st dose of chs-1000. * concurrent or prior radiotherapy within 28 days prior to the 1st dose of chs-1000 or unresolved treatment-related radiation toxicity. limited local radiotherapy for palliative intent (eg, to a single site of metastatic disease) is permitted within 28 days prior to the 1st dose of chs-1000 provided that the participant has no evidence of or has recovered from any treatment-related radiation toxicity. note: other protocol-defined inclusion and exclusion criteria may apply.

Keywords: chs-1000 tumors toripalimab ilt4 lilrb2
mifepristone to treat uterine fibroids

Conditions: Uterine Fibroids

Summary: objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. the hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone. the diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. the possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.

Eligibility criteria:
inclusion criteria: * symptomatic uterine leiomyomata * reproductive age or premenopausal * accepting the use of non hormonal contraception * conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone * agreeing to have ultrasound examinations in every follow-up or evaluation visit * agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination exclusion criteria: * pregnancy or desire to become pregnant * breastfeeding * hormonal contraception or any hormonal therapy received in the last three months * signs or symptoms of pelvic inflammatory disease * adnexal masses * abnormal or unexplained vaginal bleeding * suspected or diagnosed malignant neoplastic disease * signs or symptoms of mental illness * adrenal disease * sickle cell anemia * hepatic disease * renal disease * coagulopathy * any other severe or important disease * any contraindication to receiving antiprogestins

Keywords: leiomyoma, fibroid, mifepristone, antiprogestins
pilot study comparing 10hz vs theta burst stimulation

Conditions: Major Depressive Disorder

Summary: this pilot study aims at exploring the efficacy of itbs compared to 10hz protocol and explore potential biomarkers of treatment response


Eligibility criteria:
inclusion criteria: * outpatients * voluntary and competent to consent * mini-international neuropsychiatric interview (mini) confirmed diagnosis of major depressive disorder (mdd), single, recurrent between ages 18-65 * failed to achieve a clinical response to an adequate dose of an antidepressant based on an antidepressant treatment history form (athf) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (athf 1 or 2) * have a score of ≥ 18 on the hamilton depression rating score 17-item (hdrs-17) * have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule * pass the tms adult safety screening (tass) questionnaire * have normal thyroid functioning based on pre-study blood work exclusion criteria: * have a history of substance dependence or abuse within the last 3 months * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * have active suicidal intent * are pregnant * have a lifetime mini diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms * have a mini diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than mdd
safety study and therapeutic effects of umbilical cord blood treg on autoimmune diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory t cells on autoimmune diabetes.

the regulatory t cells (treg) used in this study will be produced from human umbilical cord blood. the umbilical cord blood will be freshly collected and immediately separated to buffy coat in a gmp laboratory, thus to be further sorted into treg and other subsets. then the treg will be expanded ex-vivo for approximately 14 days until tested for its surface markers and suppressive ability. during the time of ex-vivo expansion, eligible autoimmune diabetes patients will be recruited and admitted to our hospital in order to go through required examinations. once the treg product has reached the safety and efficacy standards, the patient will receive the treg product infusion under close surveillance of doctors and then go through regular follow-ups to investigate the safety and therapeutic effect of the treg product on autoimmune diabetes patients.

Eligibility criteria:
inclusion criteria: 1. autoimmune diabetes patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of american diabetes association 2. diagnosis of autoimmune diabetes within 3 years of screening 3. between 6 to 60 years of age 4. positive for at least one of the anti-islet autoantibodies: gada, ia2a, znt8a 5. fasting or postprandial plasma c-peptide more than 200 pmol/l 6. written informed consent from the patient or the patient's parents for patients under the age of 18 years exclusion criteria: 1. any clinically significant diseases in liver (alt and ast over 2 times upper normal limit), kidney (scr over 133umol/l), and heart 2. presence of anemia (hb ≤100g/l), leukopenia (\<3.5×10\^9/l) 3. presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets \<100×10\^9/l) 4. presence of acute metabolic disorders; in the case of acute ketone acidosis, with blood ketone over 0.3mmol/l and ph lower than 7.30 5. presence of any kind of chronic infection or immune deficiency, including hepatitis b, hepatitis c, hiv, syphilis or tuberculosis 6. chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months 7. any history of malignancy 8. female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years afer recruitment 9. presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory track infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving treg product infusion 10. presence of diabetic microvascular or macrovascular diseases 11. presence of hypertension 12. any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial

Keywords: autoimmune diabetes umbilical cord blood cell regulatory t lymphocyte cell therapy
a study of ep0031 in patients with advanced ret-altered malignancies

Conditions: Advanced Solid Tumor

Summary: the aim of this study is to assess the safety, side effects and effectiveness of ep0031 in patients with advanced ret-altered malignancies

ep0031 is being investigated in this modular, interventional phase i/ii dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced ret-altered malignancies. currently there are no approved ret-targeted treatments for patients who progress on first-generation sris. however, it is proposed that ep0031 can overcome resistance mechanisms to first generation sris, as ep0031 is a potent and selective ret inhibitor with broad activity against common ret fusions and mutations. phase i (dose escalation and optimization) has completed and a rp2d has been selected for phase ii.

Eligibility criteria:
inclusion criteria: applicable to all patients: 1. must be ≥18 years of age, with documented ret-altered cancers 2. patients should be well informed and consented about alternative treatment options including approved ret-targeted therapies 3. ecog performance status of 0 or 1 and life expectancy \>3 months at screening 4. ability to understand and provide written informed consent and able to participate in all required evaluations and procedures 5. additional cohort specific criteria apply exclusion criteria: patients with any of the following will not be included in the study: 1. any known major driver gene alterations other than ret. 2. spinal cord compression or brain metastases. patients with stable brain metastases can be enrolled. 3. active infection requiring systemic antibiotic, antifungal, or antiviral medication 4. severe or uncontrolled medical condition or psychiatric condition 5. chronic glomerulonephritis or renal transplant 6. patients with active hepatitis b infection or active hepatitis c 7. patients with active hiv infection. patients living with hiv may be eligible if they have adequate cd4+ t-cell count and no history of aids-defining opportunistic infections in the past 12 months 8. receipt of any strong inhibitor or inducer of cyp3a4 9. impaired hepatic or renal function, inadequate bone marrow reserve or organ function 10. any clinically important abnormalities in rhythm, conduction, or morphology on resting ecg or any factor that increases the risk of qtc prolongation or of arrhythmic events , or congestive heart failure grade ii-iv according to the new york heart association, myocardial infarction, or unstable angina within the previous 6 months 11. uncontrolled hypertension 12. corneal ulceration at screening

Keywords: selective ret-inhibitor
oral misoprostol for labor augmentation: a pilot study

Conditions: Arrest of Dilation in Labor

Summary: a phase i, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.


Eligibility criteria:
inclusion criteria: * nulliparous * gestational age of at least 36 weeks * singleton gestation * cephalic presentation * reassuring fetal heart rate * 4 cm or greater cervical dilation * ruptured membranes with clear amnionic fluid * intrauterine pressure catheter in place * less than 200 mvu's exclusion criteria: * non-reassuring fetal heart rate * meconium-stained amnionic fluid * previous uterine incision * maternal fever * pregnancy-induced hypertension or other pregnancy-related complications * known fetal anomalies * placenta previa or unexplained vaginal bleeding * estimated fetal weight of 4,500 grams or greater * evidence of cephalopelvic disproportion * any moderate or severe preexisting disease * contraindication to the use of prostaglandins

Keywords: oral misoprostol labor augmentation arrest of dilation nulliparous
effectiveness of a valsartan based versus an amlodipine based treatment strategy in naïve patients with stage 1 or stage 2 hypertension or in patients uncontrolled on current monotherapy

Conditions: Hypertension

Summary: the population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy. the purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.


Eligibility criteria:
inclusion criteria stage/grade 1 or stage/ grade 2 hypertension, mssbp ≥ 140 mm hg, and/ or msdbp ≥ 90 mm hg, at visit 1 and 2 in untreated patients or patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm hg at visit 1 and visit 2 exclusion criteria current treatment with a ccb mssbp ≥ 180 mm hg or msdbp ≥ 110 mm hg at any time between visit 1 and visit 2 history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures evidence of a secondary form of hypertension cerebrovascular accident or myocardial infarction during the last 12 months, prior to visit 1 other protocol-defined inclusion/exclusion criteria may apply

Keywords: valsartan, amlodipine, hydrochlorothiazide
efficacy of ripc to reduce aki for patients undergoing pci

Conditions: Acute Kidney Injury

Summary: the purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing percutaneous coronary intervention.

acute kidney injury negatively impacts on prognosis after pci, and only hydratation have shown to reduce this complication. remote ischemic preconditioning has been demonstrated to reduce periprocedural mi, while impact on aki remains to be assessed

Eligibility criteria:
inclusion criteria: * undergoing pci with stenting for all clinical indications * carrying (with) a renal clearance less than 60 ml/min/1.73 m2 and more than 30 ml/min/1.73 m2 (evaluated through mdrd); ù * younger than 85 years old. exclusion criteria: * st segment elevation myocardial infarction (stemi), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;