Kornimate/medical-research-clean huggingface dataset:
intramyocardial haemorrhage in patients with primary stemi

Conditions: Myocardial Infarction; STEMI; Myocardial Necrosis; Myocardial Injury

Summary: the purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary stemi and different reperfusion strategies.

the study non-randomized, opened, controlled. in half of patients despite on carried in-time reperfusion therapy intramyocardial haemorrhage determined after a long-term period of severe ischemia. earlier, definition of intramyocardial haemorrhage was possible only by autopsy. nowaday, cardiac contrast mri is the best diagnostic method, which allows to assess the regional and global function of the lv, structural changes in myocardial tissue and also in t2 mode it became assessable to reveal intramyocardial haemorrhage. taking into account the results of previous researches, it can be concluded that the intramyocardial haemorrhage was determined in half of patients with primary pci \[1\]. an influence of fibrinolytic therapy to the intramyocardial haemorrhage was conducted in small group of patients in one trial, and therefore further data will be actual and useful \[2\]. it is planned to study 60 patients with primary stemi using standard therapy. the patients will be divided into 2 groups. patients of the 1st group will be treated by pharmaco-invasive strategy. the 2nd group will be treated by primary pci. patients in all groups after reperfusion strategies will be conducted cardiac contrast mri for detection intramyocardial haemorrhage within 2 days onset. at day 7 and through 3 months, the clinical condition of the patients will be assessed and cardiac ultrasound will be performed for the evaluation of myocardial contractile function and 2d global longitudinal strain. also, the incidence rate of secondary endpoints will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of randomization (18 years and older); * acute myocardial infarction; * reperfusion of the infarct-related coronary artery in terms within 12 h of symptom onset; * written the informed consent to participate in research; exclusion criteria: * inability to obtain informed consent; * patients previously undergone endovascular / surgical revascularization of coronary artery; * severe comorbidity; * history of myocardial infarction; * history of intracranial haemorrhage; * pulmonary edema, cardiogenic shock; * creatinine clearance \<30 ml/min or dialysis; * unable to undergo or contra-indications for mri; * allergy for contrast agent; * indication or use of oral anticoagulant therapy; * major bleedind; * atrio-ventricular block ii and iii degree; * active gastroduodenal ulcer; * aortic dissection; * acute psychotic disorders

Keywords: intramyocardial haemorrhage myocardial infarction st elevation myocardial infarction primary percutaneous coronary intervention pharmaco invasive strategy fibrinolytic therapy global longitudinal strain myocardial necrosis coronary artery disease
an extension of the horizon protocol evaluating the safety of dimebon (latrepirdine) in subjects with huntington disease

Conditions: Huntington Disease

Summary: an open-label extension study of the horizon protocol evaluating the safety of dimebon (latrepirdine)in subjects with huntington disease.


Eligibility criteria:
inclusion criteria: * successful completion of 26 weeks of blinded treatment in the horizon study exclusion criteria: * any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.
comparison of different treatments for overactive bladder syndrome

Conditions: Overactive Bladder; Overactive Bladder Syndrome; Overactive Detrusor

Summary: this study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder


Eligibility criteria:
inclusion criteria: * women * being volunteered to participate * diagnosed as overactive bladder exclusion criteria: * pregnant women * patients with a comorbid neurological disorder * a mental problem that may prevent cooperation and evaluation * acute infection * sensory loss * malignancy

Keywords: pelvic floor muscle exercise kinesio taping electric stimulation
tofacitinib ointment for chronic plaque psoriasis

Conditions: Psoriasis Vulgaris; Psoriasis

Summary: the study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. the safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.


Eligibility criteria:
inclusion criteria: * have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to baseline * at baseline, have plaque psoriasis covering 2% to 20% of total body surface area (bsa) on the trunk and limbs (excluding palms, soles, and nails) * if received certain treatments, should be off treatment for a minimum period of time (washout) exclusion criteria: * currently have non-plaque forms of psoriasis or drug-induced psoriasis * require treatment with or cannot stop medication(s) prohibited during the study * have certain laboratory abnormalities at baseline * current or history of certain infections * females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Keywords: plaque psoriasis vulgaris topical treatment skin diseases papulosquamous tofacitinib cp-690550 xeljanz psoriasis moderate severe itch nail psoriasis
platelet reactivity after tavi: a multicenter pilot study

Conditions: Severe Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Replacement

Summary: a high platelet reactivity in patients with severe symptomatic aortic stenosis (as) selected for tavi (transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (dapt) with clopidogrel and acetylsalicylic acid (asa) do not achieve consistent and adequate suppression of platelet reactivity. the purpose of this study is evaluate the efficacy of ticagrelor alone versus dapt with clopidogrel and aspirin for the suppression of high platelet reactivity following tavi.


Eligibility criteria:
inclusion criteria: for inclusion in the study subjects should fulfill the following criteria: 1. provision of informed consent prior to any study specific procedures. 2. adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial. 3. patients with degenerative symptomatic severe as accepted for tavi after evaluation of the heart team of each center. 4. patients who are not participating in any other clinical trial or research study (registries allowed). exclusion criteria: subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. recent stroke \ 70% stenosis) or life expectancy \< 12 months 2. patients under chronic oral anticoagulation 3. patients with proven allergy to aspirin, clopidogrel or ticagrelor 4. patients that after tavi cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-tavi medical indication 5. known pregnancy or breast-feeding 6. concomitant oral or intravenous therapy with potent inhibitors of cytochrome p450 3a (cyp3a) that cannot be suspended during the course of the study. medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice. 7. thrombocytopenia (\<50,000 platelets u/l) well documented and clinically relevant. 8. patients with documented moderate or severe hepatic insufficiency 9. any condition that may put the patient at risk or influence the outcome of the trial 10. patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days. 11. patients who cannot attend follow up visits scheduled in the study

Keywords: aortic stenosis tavi tavr transcatheter aortic valve implantation ticagrelor antiplatelet reactivity
metformin in combined with cisplatin plus paclitaxel with advanced esophageal squamous cell carcinoma (ecmtpneo)

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is an open-label phase ii trial investigating the effect of metformin in combined with cisplatin plus paclitaxel as neoadjuvant therapy with advanced esophageal squamous cell carcinoma.

in this prospective phase ii study, eligible patients are received cisplatin plus paclitaxel for 2-4 cycles combined with metformin orally. the investigators aim to compare the tumor metabolic pathway and tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples.

Eligibility criteria:
inclusion criteria: * having signed informed consent. * age 18 to 70 years old * histologically confirmed esophageal squamous carcinoma * computed tomography (ct) or magnetic resonance imaging (mri) confirmed advanced escc which need neoadjuvant chemotherapy before surgical resection. * measurable disease according to the response evaluation criteria in solid tumors (recist) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral ct or mri, more than 20mm by common ct, the date of image should be less than 21 days before enrollment) * life expectancy of ≥3 month * eastern cooperative oncology group (ecog) 0-1 * body mass index (bmi) ≥18.5kg/m2 * wbc\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, hb\>9g/dl，bilirubin level \< 1.5 times uln，serum creatinine \<1.5 times uln，alt and ast\<2.5 times uln ，akp \< 2.5 times uln ，(≤5 times uln in patients with liver metastases)(within 7 days before enrollment) * no sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃. * good compliance exclusion criteria: * have used metformin or biguanide in the past * contraindications of metformin * unable to take metformin orally because of esophageal stenosis * currently receiving other effective regimens * previous anticipate other clinical trial within 4 weeks before entering this study * no measurable lesions, eg. pleural fluid and ascites\\ * only with other previous malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ * heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only brain or bone metastasis * mentally abnormal or disable cognition,including central nervous system (cns) metastasis * hiv infection, active hepatitis b or hepatitis c * unstable systemic diseases such as poorly controlled diabetes * interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in x-ray/ct * known hypersensitivity to study drugs * pregnancy or lactation period

Keywords: advanced esophageal squamous cell carcinoma neoadjuvant therapy metformin cisplatin paclitaxel
soi ts3 surface in patients with and without type 2 diabetes

Conditions: Dental Implant; Dental Implant-Abutment Design

Summary: the aim of this prospective cohort study is to compare clinical and radiographic data of osstem implants with soi surface placed in patients with or without diabetes.


Eligibility criteria:
inclusion criteria: * patients of at least 18 years old able to sign an informed consent. * patients with at least a single tooth loss in the maxilla or mandible. patient will provide only one site for the research. implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length. * smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). * patients with a plaque index (pi) of less than, or equal to 25% at the time of surgery. * in case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. * only in the test group, patients with controlled type 2 diabetes mellitus with at least 2 years of disease evaluation of hba1c values between 6% and 10 % at the time of implant placement will be included. * only in the control group, healthy patients without any sign of type 2 diabetes mellitus will be included exclusion criteria: * general contraindications to implant surgery (except for type two diabetes in test group). * patients irradiated in the head and neck area. * immunosuppressed or immunocompromised patients (except for type two diabetes in test group). * patients treated or under treatment with intravenous amino-bisphosphonates. * patients with untreated periodontitis. * patients with poor oral hygiene and motivation. * previous guided bone reconstruction at the intended implant sites. * uncontrolled diabetes (except for type two diabetes in test group). * pregnancy or nursing. * substance abuser. * psychiatric problems or unrealistic expectations. * lack of opposite occluding dentition in the area intended for implant placement. * patients with infection and or inflammation in the area intended for implant placement. * patients participating in other studies, if the present protocol cannot be properly adhered to. * patients referred only for implant placement and cannot be followed ant the treating centre. * patients unable to be followed for 5 years.

Keywords: dental implant diabetics patients soi surface
nivolumab, bms-936558 in combination with relatlimab, bms-986016 in patients with metastatic melanoma naïve to prior immunotherapy in the metastatic setting

Conditions: Melanoma

Summary: the main goal of this study is to evaluate the antitumor activity of relatlimab and nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy.

this study will evaluate the antitumor activity of anti-lag3 monoclonal antibody relatlimab and the anti-pd1 monoclonal antibody nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy. the trial is designed with a lead-in phase of 2 cycles (4 week) treatment of either nivolumab, relatlimab, or the combination of nivolumab/relatlimab, followed by a combination phase of nivolumab/relatlimab treatment in all subjects. this lead-in design with accompanying tumor biopsies and peripheral blood analyses will enable mechanistic analyses of the effect of lag3 and pd1 blockade alone and in combination to enhance understanding of mechanisms of response and resistance. duration of response, progression free survival, and safety will be assessed as secondary objectives.

Eligibility criteria:
inclusion criteria: • men or women 18 years of age or older meeting ajcc 8th edition criteria for unresectable stage iiib, stage iiic, stage iiid, or stage iv melanoma who have not received treatment with immunotherapy in the metastatic setting exclusion criteria: * known or suspected cns metastases, with the following exceptions: * subjects with controlled brain metastases will be allowed to enroll. controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment at the time of consent. subjects must be off steroids for at least 2 weeks prior to randomization. * subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging. * active autoimmune disease requiring treatment, with the exception of type 1 diabetes mellitus, vitiligo, resolved childhood asthma/atopy, controlled hyper/hypothyroidism, hypoadrenalism or hypopituitarism. * prior systemic treatment in the metastatic setting, including anti-pd1, anti-pdl1, anti-pdl2, anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell costimulation or immune checkpoint pathways; or chemotherapy. * prior adjuvant treatment with anti-pd1, anti-pdl1, and/or anti-lag3 antibody. note that prior adjuvant treatment with targeted therapy (e.g. braf/mek inhibition), anti-ctla4, or treatment not otherwise specified above would be permitted. * ocular melanoma

Keywords: stage iiib stage iiic stage iiid stage iv immune checkpoint blockade (icb) lymphocyte activation gene-3 (lag3; cd223) immunotherapy
a study of the effects of lumacaftor/ivacaftor (lum/iva) on exercise tolerance in subjects with cystic fibrosis (cf), homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: this is a phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with cf who are homozygous for the f508del-cftr mutation. this study is designed to evaluate the effect of lum/iva on exercise tolerance in subjects with cf, homozygous for the f508del-cftr mutation.


Eligibility criteria:
inclusion criteria: * homozygous for the f508del-cftr mutation * confirmed diagnosis of cf defined as a sweat chloride value ≥60 mmol/l by quantitative pilocarpine iontophoresis * stable cf disease as judged by the investigator * forced expiratory volume in 1 second (fev1) at least 40% and not greater than 90% of predicted exclusion criteria: * history of any comorbidity that might confound the results of the study, interfere with the use of cardiopulmonary exercise tests (cpets) as an assessment, or pose an additional risk in administering study drug to the subject * any previous exposure to lum or iva * history of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or other clinically significant cardiac condition, or medical condition requiring chronic use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac medication known to affect exercise tolerance * history of solid organ or hematological transplantation * for subjects under 18 years of age at screening, except those who have had bilateral lens removal, selected findings on a screening ophthalmologic examination will be exclusionary * using or expected to require any concomitant medication that is prohibited in this study * history of alcohol or drug abuse, as deemed by the investigator, in the past year, including but not limited to cannabis, cocaine, and opiates * participation in an investigational drug study within 30 days before the screening visit * pregnant or nursing females; males with a female partner who is pregnant or nursing * colonization with organisms associated with a more rapid decline in pulmonary status
multiple dose asm8 in mild asthmatics

Conditions: Asthma

Summary: to determine the safety and efficacy of multiple doses of asm8 antisense oligonucleotides in asthmatics.

this is a double-blind, placebo-controlled, crossover trial to evaluate the safety, tolerability and efficacy of inhaled asm8 for the treatment of allergen-induced asthma. individuals with stable, mild to moderate allergic asthma by american thoracic society (ats) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrolment. the study is divided into 2 parts.

Eligibility criteria:
inclusion criteria: * part 1: men and women 18 to 65 years of age; generally good health; mild to moderate, stable, allergic asthma as defined by ats criteria (1); history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (fev1) at baseline ≥70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form. part 2: methacholine challenge at baseline (pc20 ≤16 mg/ml); positive skin-prick test to common aeroallergens (cat, dust mite, grass, pollen) and positive allergen-induced early and late airway bronchoconstriction. exclusion criteria: * part 1 and part 2: significant acute or chronic medical or psychiatric illness; known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks; use of inhaled or oral corticosteroids within the last 28 days, antihistamines, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed); use of medications that may interact with asm8; investigational drug use within 30 days; any clinically significant abnormality on screening laboratory determinations; current tobacco use in previous 3 months or 10 pack-years; pregnant or lactating women; women actively seeking pregnancy or who are not using adequate contraception; history of serious adverse effect (sae) or hypersensitivity to any drug; 20% decrease in fev1 or fvc with baseline saline in methacholine challenge during screening.

Keywords: mild asthma
study of durvalumab with chemoradiotherapy for women with locally advanced cervical cancer (calla)

Conditions: Locally Advanced Cervical Cancer

Summary: this is a randomized, multi-center, double-blind, placebo-controlled, global, phase iii study to determine the efficacy and safety of durvalumab + chemoradiotherapy versus chemoradiotherapy alone as treatment in women with locally advanced cervical cancer

women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (soc) or placebo + soc, followed by durvalumab/placebo maintenance for 24 months.

Eligibility criteria:
inclusion criteria: for inclusion in the study, patients should fulfill the following criteria: 1. female 2. aged at least 18 years 3. documented evidence of cervical adenocarcinoma or squamous carcinoma figo (2009) stages ib2 to iib node positive or figo (2009) iiia-iva any node 4. no prior chemotherapy or radiotherapy for cervical cancer 5. who/ecog performance status of 0-1 6. at least 1 lesion, not previously irradiated, that qualifies as a recist 1.1 target lesion at baseline. exclusion criteria: patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer 2. intent to administer a fertility-sparing treatment regimen 3. undergone a previous hysterectomy 4. evidence of metastatic disease per recist 1.1 including lymph nodes ≥15 mm (short axis) above the l1 cephalad body, in the inguinal region or outside the planned radiation field. 5. history of allogeneic organ transplantation 6. active or prior documented autoimmune or inflammatory disorders 7. uncontrolled intercurrent illness 8. history of another primary malignancy and active primary immunodeficiency

Keywords: durvalumab chemoradiotherapy locally advanced cervical cancer