Kornimate/medical-research-clean huggingface dataset:
icotinib as consolidation therapy after chemoradiotherapy in egfr-mutant stage iiia-iiib non-small cell lung cancer

Conditions: EGFR Gene Mutation; Non Small Cell Lung Cancer Stage IIIA; Non Small Cell Lung Cancer Stage IIIB

Summary: the main purpose of this study is to evaluate the relapse free survival of patients who have egfr-mutant stage iiia-iiib non-small cell lung cancer and receive icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.

this is a single center, single arm, open label and prospective clinical study. patients who have egfr-mutant stage iiia-iiib and unresectable lung adenocarcinoma will receive icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy. the primary objective of this study is relapse free survival. the secondary objectives are overall survival, the frequency of adverse events and patients' quality of life.

Eligibility criteria:
inclusion criteria: * unresectable stage iiia-iiib non-small cell lung cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with egfr 19 del and/or 21 l858r gene mutation detected by amplification refractory mutation system method * before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head mri, bone scan, chest enhanced ct scan and the abdominal (including dual adrenal) enhanced ct scan * only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced ct showed no progressive disease (including complete response, partial response and stable disease ) * platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin) * 3dcrt or imrt radiotherapy technology with a dose of 95% ptv 60-66gy, 2gy once daily, 5 times weekly, up to 30-33 times * ecog score 0-1 * able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy * expected survival more than 12 weeks exclusion criteria: * other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma * in addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy * any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease * upper vena cava syndrome at baseline * idiopathic pulmonary fibrosis detected by ct at baseline * definite neurological or psychiatric disorders, including epilepsy or dementia * pregnant or lactating women
the foley's catheter balloon to the bleeding from placenta previa

Conditions: Postpartum Hemorrhage

Summary: post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation. although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality . hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. uterine packing considers as a line of treatment before performing surgical procedures in postpartum hemorrhage resulting from placental site bleeding. it can save life, avoid laparotomy and save uterus. nowadays, the use of intrauterine balloons have been developed and become effective for the control of placental site bleeding not responding to medical treatment. the 2-way foley's cather has many advantages over the gauze packing; first, it allows drainage of blood so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the foley's cather balloon is easy and not a painful, third, the removal of 2-way foley's cather could be gradually as a test of its effectiveness before complete removal .


Eligibility criteria:
inclusion criteria: * patients with placenta previa * delivered by cesarean section exclusion criteria: * patients with sever uncontrolled uterine bleeding after delivery * placenta accreta
programed intermittent epidural bolus interval 90 (ei90) of 10 ml, 0.0625% bupivacaine plus 2 μg/ml fentanyl

Conditions: Labour Pain

Summary: multiple studies showed the numerous advantages of implementing programmed epidural bolus (pieb) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (cei). the advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.the theory behind pieb is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.different approaches using different timings and volumes for pieb have been proposed to achieve the optimal regimen. many studies showed evidence that 10 ml boluses of bupivacaine 0.0625% with fentanyl 2 μg/ml delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (ei90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.


Eligibility criteria:
inclusion criteria: * patients of asa physical status 2-3 with a singleton pregnancy * gestational age \> 37 weeks * regular uterine contractions occurring at least every 5 min; * cervical dilation 2-5 cm * pain \> 5 (visual analogue score (vas) 0-10) at the time of request for epidural analgesia . exclusion criteria: * refusal to concent * contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl * patients who had opioids or sedatives within 4 h preceding epidural insertion. * unintentional dural puncture. * patient who deliver within 1 h after initiation of epidural clinician bolus. * the inability to achieve as vas score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.
creation of a clinical database for the study of phenotypic variability in motor neuron diseases

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: study description: characterization of motor neuron disease phenotypes the goal of this observational study is to understand the clinical presentation of motor neuron disease (mnd) in patients attending the neurology department of the istituto auxologico italiano. the main questions it aims to answer are: * what are the specific clinical phenotypes associated with mnd? * how can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy? participants will undergo: * clinical evaluation using validated scales * neurophysiological and neuroradiological instrumental assessment * neuropsychological evaluation * collection of biological materials for genetic screening and biomarker assessment, if necessary.


Eligibility criteria:
inclusion criteria: * diagnosis of als or other motor neuron disease exclusion criteria: * refusal to participate to the study
efficacy of integrated nano-technology in revascularization of immature necrotic teeth

Conditions: Immature Teeth; Necrotic Pulp

Summary: this trial aims to study the effect of photoactivated disinfection using diod laser (810 nm) to activate photosensitive nanoparticle chitosan as an endodontic irrigant versus sodium hypochlorite followed by saline and then edta 17% on 1) postoperative pain and 2) the success of revascularization in patients with necrotic immature maxillary anterior teeth using a randomized clinical trial design.

randomized clinical trial will be conducted to investigate and compare the efficacy of photosensitized nano-chitosan 2% as an endodontic disinfectant during revascularization versus sodium hypochlorite, followed by edta 17% according to the standardized protocol of the american association of endodontics. twenty individuals with necrotic, immature permanent anterior teeth will be recruited. they will be randomly assigned into two groups according to the received intervention: control group and test group. pain will be evaluated as a primary outcome at 24 hours and one week post-intervention using numerical rating scale (nrs). in addition, the root development in terms of change in root length and apical foramen diameter and periapical bone healing will be evaluated as secondary outcomes using cone beam tomography.

Eligibility criteria:
inclusion criteria: * o immature necrotic maxillary incisor with open apex greater than 1 mm. * teeth where pulp space are not needed for post and core. * a restorable tooth. * patients should be free from any systemic disease that may affect normal healing and predictable outcome. * patients who will agree to the consent and will commit to follow-up period. exclusion criteria: * o non-restorable teeth. * teeth with root fractures, internal or external root resorption. * teeth with mature fully developed root with closed apex * patients with any systemic disease that may affect predictable outcome

Keywords: regenerative endodontic procedure
a phase 3 study of ganetespib in combination with docetaxel versus docetaxel alone in patients with advanced nsclc

Conditions: Non-Small-Cell Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic

Summary: the purpose of this study is to determine whether combining ganetespib (sta-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced nsclc. a phase 2b/3 study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in nsclc. study 9090-08 is ongoing. results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival (os) has been observed. update: an independent data monitoring committee (dmc) was established to review accumulating unblinded safety data, and efficacy data at two specified interim analyses. the dmc monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. the study was stopped after the first interim analysis due to futility. the efficacy portion of this report is based on a 05 october 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. the safety portion is based on the final database locked on 23 december 2015.

Eligibility criteria:
inclusion criteria: * advanced stage iiib or iv non-small-cell lung cancer (nsclc) * eastern oncology cooperative group (ecog) performance status 0 or 1 * prior therapy defined as 1 prior systemic therapy for advanced disease * documented disease progression during or following most first line therapy for advanced disease * adequate hematologic, hepatic, renal function exclusion criteria: * epidermal growth factor receptor (egfr) mutations * anaplastic lymphoma kinase (alk) translocations * predominantly squamous, adenosquamous or unclear histologic type * active or untreated central nervous system (cns) metastases * active malignancies other than nsclc within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin * serious cardiac illness or medical conditions * pregnant or lactating women * uncontrolled intercurrent illness
phase i study of safety and pharmacokinetics of topical solution in subjects with androgenetic alopecia

Conditions: Androgenetic Alopecia

Summary: this study will be a single center, open-label study of a single concentration of anr- 001.1. the solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.

at screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. screening data will include demographics, medical history, concomitant medications, physical examination, weight, o2 sat, vital signs laboratory evaluation (cmp, cbc, ua), and ecg. at day 1, a physical exam, weight, o2 sat, vital signs (including bp, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed. if criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). if there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). the study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for study days 1, 2, 3, 4, 5, 6, and 7. daily subject visits will include vital signs, review of adverse events and concomitant medications. pk draws and ecgs will take place at study days 1, 2, 7 and 8, following the first dose and the last doses, respectively.

Eligibility criteria:
inclusion criteria: males between age 18 to 65 years, in general good health. good health is defined as a subject without any active diseases. not included in active diseases are: * migraines * non-hospitalized depression o asthma * cholecystectomy * gilbert's syndrome * clinical diagnosis of aga with grade ii to vi hair loss on norwood hamilton classification system * subjects of any fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the investigator's opinion, interfere with study assessments. * no known allergy to anr-001.1 or any of its components. * subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study. exclusion criteria: if subjects have a bmi outside of the range of 18-35kg/m2 * subjects using a minoxidil product (e.g., rogaine or generic rogaine) or a latanoprost product (e.g., xalatan or generic xalatan) within 30 days of the start of day 1 of the study. * subjects whose vital signs, ecg, safety labs or physical exam results are clinically significant in the opinion of the investigator. * subjects have a skin condition that, in the investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation. * subjects with an active or recent (within 30 days before day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.). * subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment. * current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
effect of smoking cessation on salivary il-1β and pge-2 levels following non-surgical periodontal therapy

Conditions: Periodontal Diseases; Smoking Cessation

Summary: the aim of this study is to evaluate the effect of smoking cessation on inflammatory markers following non-surgical treatment of periodontal disease. this is to assess the period of smoking abstinence needed before any periodontal surgery in order to reverse the negative effects of the reported increased levels of inflammatory markers (il-1β and pge2 in this study) associated with smoking on the healing and the periodontium.


Eligibility criteria:
inclusion criteria: * patients with advanced chronic periodontitis upon clinical examination with clinical attachment loss (cal) more than 5 mm. * patients willing to quit smoking to be included in two groups, while patients unwilling to quit smoking to be included in the third group, and the non-smokers as the fourth group. exclusion criteria: * any systemic illness known to affect the outcome. * systemic antimicrobial or anti-inflammatory drug therapy within the last 3 months prior to the study. * patients unable to perform routine oral hygiene procedures. * patients using other forms of tobacco.

Keywords: smoking cessation periodontal diseases inflammatory markers interleukin-1beta prostaglandin e2 non-surgical therapy smoking
prevention of breast cancer-related lymphedma with tacrolimus

Conditions: Lymphedema

Summary: breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. tacrolimus ointment may prevent lymphedema by inhibition of cd4+t cells.


Eligibility criteria:
inclusion criteria: * female * breast cancer with planned alnd * postmenopausal or use of contraceptives * good general health condition * read and understand danish exclusion criteria: * pregnant, breastfeeding it wishing to conceive with the next year * bilateral breast cancer * known allergy to tacrolimus or macrolides * known lymphedema * other malignant disease apart from keratinocyte cancer * in medical treatment for diabetes mellitus * known psychiatric condition which may influence participation * known renal or hepatic function
protocolised early de-resuscitation in septic shock (reduce)

Conditions: Septic Shock

Summary: background: recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. while several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. the combination of both strategies yet warrants systematic evaluation. aim: this study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. we hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after icu admission. study intervention: patients admitted to the icu with confirmed or suspected septic shock (sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. in the intervention arm, patients are managed according to the reduce fluid management protocol during resuscitation and de-resuscitation.


Eligibility criteria:
inclusion criteria: * patients admitted to icu with the diagnosis of septic shock as defined according to the sepsis-3 criteria (suspected or confirmed infection and vasopressor/inotrope ongoing to maintain map ≥ 65 mmhg and lactate ≥ 2 mmol/l in the last 6 hours exclusion criteria: * age \<18 years * septic shock for more than 12 hours at the time of screening * acute burn injury \>/= 10% of the body surface area * known pregnancy or lactating women * consent not obtainable due to national legislation * patients on chronic dialysis * patients that are known to be allergic to furosemide or metolazone

Keywords: septic shock fluid resuscitation
immunogenicity and safety study of a gsk influenza vaccine candidate in adults.

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and immunogenicity of gsk influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.


Eligibility criteria:
inclusion criteria: * healthy subjects as established by medical history and clinical examination before entering into the study. * subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 18 and 60 years of age at the time of the vaccination. * written informed consent obtained from the subject. * if the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine. * administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination. * confirmed influenza infection within a year preceding the study start. * administration of an influenza vaccine during northern hemisphere season 2007-2008. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * history of hypersensitivity to a previous dose of influenza vaccine * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * acute disease at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions. * history of chronic alcohol consumption and/or drug abuse. * any condition which, in the opinion of the investigator, prevents the subject from participating in the study. * history of administration of experimental/licensed vaccine.

Keywords: primary study immunogenicity safety