Kornimate/medical-research-clean huggingface dataset:
effectiveness of low energy laser treatment in oral mucositis induced by chemotherapy and radiotherapy in head and neck cancer

Conditions: Oral Mucositis

Summary: the purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with squamous cell carcinoma of the oral cavity. * patients aged between 18 and 80 years. * patients who are to receive one of the following treatment * combined radiotherapy (conventional fractionation 70 gy reaching the tumor and affected lymph nodes, and 50 gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 iv on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. regardless of whether they have received previous surgical treatment. * treatment with radiotherapy of 70 gy in 35 daily sessions 2gy/día consecutive. * patients who voluntarily express their intention to participate by informed consent. exclusion criteria: * patients who denied informed consent. * patients who have hypersensitivity or allergy to any of the components included in the study. * patients diagnosed with hiv, and autoimmune diseases.
artificial intelligence assists surgeons' decision making

Conditions: Rectal Cancer

Summary: this study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.

anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. however, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.

Eligibility criteria:
inclusion criteria: 1. aged older than 18 years and younger than 85 years. 2. primary rectal adenocarcinoma confirmed by preoperative pathology result. 3. expected curative resection via total mesorectal excision procedure. 4. american society of anesthesiologists (asa) class i, ii, or iii. 5. written informed consent. exclusion criteria: 1. pregnant or breastfeeding women. 2. severe mental disorder or language communication disorder. 3. hartmann surgery or colostomy is performed intraoperatively. 4. interrupted of surgery for more than 30 minutes due to any cause. 5. malignant tumors with other organs

Keywords: artificial intelligence, rectal cancer temporary ileostomy anastomotic leakage
epidemiology and outcome of anaphylactic shocks admitted to intensive care unit

Conditions: Anaphylaxis

Summary: anaphylaxis is a severe life-threatening reaction following exposure to an antigen. its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. although rare, this condition is often associated with a significant morbidity and mortality. the mortality rate has been recently estimated at 0.84 (95% ci, 0.79 to 0.88) per million per year in the french adult population. age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. however, the risk factors for death after icu admission have not been elucidated yet.


Eligibility criteria:
inclusion criteria: * being \> 18 years old * suffered an anaphylactic reaction, regardless of the location or causative allergen * transferred alive in an icu exclusion criteria: * dead within less than one hour after admission

Keywords: fluid management mortality
cozaar xq re-examination study (mk-0954-349)

Conditions: Hypertension

Summary: this survey is conducted for preparing application material for re-examination under the pharmaceutical affairs law and its enforcement regulation; its aim is to reconfirm the clinical usefulness of cozaar xq through collecting the safety and efficacy information according to the re-examination regulation for new drugs.


Eligibility criteria:
inclusion criteria: * participant with essential hypertension * participant who is treated with cozaar xq within local label for the first time exclusion criteria: * participant who is treated with cozaar xq before contract and out of enrollment period * participant who has a contraindication to cozaar xq according to the local label

Keywords: hypertension
developing novel circulating epigenetic biomarkers for early detection of lung cancer

Conditions: Lung Cancer

Summary: the investigators aim to identify novel circulating methylated biomarkers for early lung cancer detection as well as to develop new technologies that are clinically applicable with high sensitivity and specificity.

lung cancer is the leading cause of cancer death, accounting for 2.09 million cases in 2018 worldwide. there is a huge demand globally for sensitive and reliable assays to intercept lung cancer at early stages when it can be cured. past studies have shown that circulating cell-free tumor dna (ctdna) shed from tumor cells contains the same mutations and methylation patterns as the original tumor cells. emerging evidence has indicated the presence of systemic immune dysregulation in cancer patients, and that tumor-reactive t cells carry a distinct molecular profile compared to other bystander cells. thus, molecular abnormality of ctdna and tumor-reactive t cells may be one of the early signs that hint the presence of malignancy, and it may serve as a promising target for development of blood-based assays in early lung cancer for its convenience and non-invasiveness as opposed to invasive tumor biopsy, or imaging-based methods that are limited by unsatisfactory sensitivity/specificity. the investigators aim to identify novel markers for early lung cancer detection as well as to develop new technologies that are clinically applicable with high sensitivity and specificity. the objectives of this proposal are multifaceted: (1) the investigators will generate genome-wide methylation atlas of circulating cell free dna and of circulating t cells in lung cancer patients vs. non-cancer subjects. (2) the investigators will develop an enriched method to enhance the performance of multiplex droplet digital pcr (ddpcr) technology with increased sensitivity and decreased input dna requirement. (enriched methylation-specific droplet digital pcr, ems-ddpcr) (3) the investigators will develop a single-cell, locus-specific dna methylation detection system that is bisulfite-free and non-pcr-based. the system can be coupled with flow cytometry or mass cytometry to enable cell-type specific methylation detection. (single-cell, locus-specific methylation detection, sclsm-facs) (4) the investigators will identify a novel methylation signature consisting of tumor-derived and immune-derived biomarkers for early detection of lung cancer.

Eligibility criteria:
inclusion criteria: * subjects suspected or confirmed diagnosis of lung cancer. * subjects who had indeterminate sub-centimeter pulmonary nodules or ground glass opacities discovered by computed tomography. * non-cancer subjects: including healthy volunteers and chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc. * subjects age over 20. exclusion criteria: * pregnancy. * subjects with hiv infection. * unable to or unwilling to give informed consent.

Keywords: lung cancer cell-free dna dna methylation t cell methylome cell-free tumor dna (ctdna)
study of defibrillation testing in patients undergoing initial icd implantation

Conditions: Ventricular Arrhythmias

Summary: the primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial icd implantation.

implantable cardioverter-defibrillators (icds) are the most effective treatment for the primary and secondary prevention of sudden cardiac death (scd). at the time of icd implantation, ventricular fibrillation (vf) is typically induced to demonstrate effective arrhythmia termination by the implanted device. although defibrillation threshold (dft) testing with induction of vf at time of icd insertion is currently considered the "standard of care," and instructions for usage of devices approved by the food and drug administration (fda) include labeling with dft testing, the value of defibrillation testing with modern-day devices has been questioned. defibrillation testing can be associated with serious complications and may add to the cost of the procedure. it is hypothesized that patients who do not undergo defibrillation testing will have outcomes similar to those who do undergo defibrillation testing at the time of initial implantation. this pilot study is being performed to determine the feasibility of performing a larger, multi-center clinical trial with longer follow-up to investigate whether or not defibrillation testing will have any impact on overall mortality, implant complications, or long-term first shock efficacy during clinical follow-up.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * initial icd implantation (single, dual, or crt) for a standard class i or class ii indication according to the acc/aha/hrs practice guidelines * anticipated life expectancy \>6 months exclusion criteria: * contraindications to defibrillation testing as determined by the managing physician\* * icd replacement implants * right-sided pectoral implants * abdominal implants * chronic oral amiodarone therapy (for \>6 weeks and continued need for amiodarone) * inability to give informed consent * contraindications to defibrillation testing include the following: hemodynamic instability, la thrombus, atrial fibrillation without adequate anticoagulation, lv thrombus, recent cva or tia, severe unrevascularized coronary artery disease or unstable angina, severe aortic stenosis, inotropic dependence, patient refusal, other patient-specific medical conditions that are deemed as contraindications, as determined by the implanting physician.

Keywords: implantable cardioverter defibrillator defibrillation threshold testing
the effect of exposure to informative video before cesarean delivery on maternal anxiety

Conditions: Maternal Distress (During Labor); Anxiety

Summary: the incidence of cesarean deliveries (cd) worldwide is increasing, around 30% in united states. although very common surgery women undergoing non emergent cd still experience fear and anxiety. it is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation. this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.

a multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Eligibility criteria:
inclusion criteria: * hebrew speaking * informed consent * first cesarean delivery * non emergent elective cd exclusion criteria: * non hebrew speaking * refuse to participate * emergency cd

Keywords: cesarean delivery anxiety informative-video
antenatal allopurinol during fetal hypoxia

Conditions: Fetal Hypoxia; Reperfusion Injury

Summary: a former study (submitted) in 32 severely asphyxiated infants participating in a randomized double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after birth) was administered to reduce free radical formation and consequently reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol. it was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with (imminent) hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage.


Eligibility criteria:
inclusion criteria: * gestational age of 36 weeks or more * non-reassuring ctg, significant events on the stan-monitor and/or fbs \< 7.20 exclusion criteria: * chromosomal abnormalities

Keywords: allopurinol neuroprotection reperfusion injury fetal hypoxia post hypoxic-ischemic reperfusion damage
a prospective analysis of long-term clinical outcomes and 3d spine growth in anterior vertebral body tethering

Conditions: Scoliosis Idiopathic

Summary: anterior vertebral body tethering (avbt) is a novel, minimally invasive, growth modulation technique that was recently approved by the fda under a humanitarian device exemption (hde). the goal of avbt is to control curve progression by applying compression on the convex side of the spine deformity. while there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. the purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with avbt, specifically: 1. the effect on three-dimensional spine growth as compared to normal controls 2. maintenance of major cobb angle less than or equal to 50 degrees at skeletal maturity 3. complications associated with both the procedure and the device


Eligibility criteria:
inclusion criteria: skeletally immature patients that receive avbt surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. specifically: * diagnosis of idiopathic scoliosis * planned recipient of avbt surgical treatment * skeletally immature * major cobb angle ≥30° and ≤65° * osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging * failed or intolerant to bracing exclusion criteria: * presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site * prior spinal surgery at the level(s) to be treated * evidence of documented poor bone quality * any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician * unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and informed consent * unwillingness to sign informed consent form and participate in study procedures

Keywords: anterior vertebral body tethering
detecting lung cancer based on exhaled breath

Conditions: Carcinoma; Lung Cancer; NSCLC; Lung Neoplasms

Summary: early detection is critical to improve the overall survival of lung cancer. endogenous volatile organic compounds (vocs) can be derived from many different metabolic pathways. on the other hand, cancer cells have different metabolism patterns compared with normal cells. thus, detecting vocs in exhaled breath using highly sensitive mass spectrometry would be a promising approach for lung cancer detection.

endogenous volatile organic compounds (vocs) can be derived from many different metabolic pathways. vocs can be transported to the alveoli through the blood circulation and expelled by exhalation. changes in vocs production, clearance, and alterations in lung air-blood exchange functions can lead to aberrant vocs profiles in the exhaled breath. testing exhaled breath has the advantages of being completely non-invasive and easy to collect, and has been considered as a perfect approach for disease diagnoses and therapeutic monitoring. many clinical studies have found that vocs in exhaled breath are closely related to disease status. specific vocs alterations have been identified in many tumors, especially lung cancer. in this study, we use a highly sensitive mass spectrometry to detect exhaled vocs of lung cancer patients and healthy people. a lung cancer diagnosis model based on mass spectrometry data and support vector machine will be initially established and validated.

Eligibility criteria:
inclusion criteria for inpatient : * pulmonary nodules in competed tomography images * plan to receive thoracic surgery inclusion criteria for controls : * have planned physical examination every year * plan to receive low-dose computed tomography exclusion criteria: * history of malignant tumors. * receive anti-tumor treatment such as radiotherapy, chemotherapy, targeted therapy before surgery * with infections or liver disease

Keywords: volatile organic compounds exhaled breath biomarker
sciatic nerve block, adductor canal block, or ipack block

Conditions: Post Operative Pain

Summary: comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (ipack) versus adductor canal block (acb) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.


Eligibility criteria:
inclusion criteria: * asa i or ii physical status * undergoing elective major knee surgery exclusion criteria: * refusal of the patients to give informed consent, * preexisting coagulation disorders, * known allergies to aminoamide local anesthetics, * local infection at the site of the block, * morbid obesity, * hepatic and renal diseases * patients with psychological disorders

Keywords: ipack , sciatic nerve block , adductor canal block
comparison of ipilimumab manufactured by 2 different processes in participants with advanced melanoma

Conditions: Advanced Melanoma

Summary: the purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes


Eligibility criteria:
inclusion criteria: * histologic diagnosis of malignant melanoma * eastern cooperative oncology group (ecog) performance status 0-1 * measurable/evaluable disease per modified world health organization (mwho) criteria exclusion criteria: * active brain metastasis * primary ocular or mucosal melanoma * prior autoimmune disease * inadequate hematologic, hepatic or renal function * use of immunosuppressants * prior treatment with a cd137 agonist or cytotoxic t lymphocyte antigen 4 (ctla-4) inhibitor
effect of transcutaneous electrical nerve stimulation (tens) on spasticity in adult patients with spastic cerebral palsy

Conditions: Cerebral Palsy

Summary: background: cerebral palsy (cp) is a neurodevelopmental disorder caused by damage of the developing brain and marked by impairments such as increased muscle tone. physical therapy (pt) is an important element for spasticity management include some modalities as transcutaneous electrical nerve stimulation (tens). purpose: to determine the effect of tens on inhibition of upper limb spasticity in adult patients with spastic cerebral palsy. methods: twenty-four adult spastic cp patients aged from 18 to 45 years old with grade 2 to 3 spasticity according to modified ashworth scale will be randomly assigned into two equal groups: tens group and conventional therapy group. both groups will receive conventional therapy, while tens group in addition will receive tens over elbow flexors with parameter setup of (pulse frequency= 100 hz, pulse duration= 250 μs, time=30 mints) 3 sessions per week for successive 4 weeks. outcome measures: modified ashworth scale for the spasticity and digital goniometer for elbow joint range of motion, barthel index scale for upper limb activity of daily living. follow-up measures will be calculated three times (preintervention, post 2 weeks, and post 4 weeks).


Eligibility criteria:
inclusion criteria: * male and female patients aged from 18 to 45 years old * diagnosed with spastic cp (upper limb is affected) * elbow flexor muscles spasticity grade 2 to 3 according to modified ashworth scale * good cognition (patient able to follow the instruction) exclusion criteria: * patient with epilepsy * under antispastic medication * severe psychological or behavioral problem * sensory abnormalities * orthopedic surgery or severe deformities in upper limb * injected by botulinum toxin (botox) in the past 6 months in upper limb.

Keywords: cerebral palsy adult spasticity transcutaneous electrical nerve stimulation tens conventional therapy
kras mutation and incidence of the colorectal carcinoma in martinique between 2007 and 2009

Conditions: Colorectal Carcinoma

Summary: * there is no data at present concerning the kras mutation in patients from martinique with colorectal cancer. despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. this study has a descriptive purpose, allowing a comparison of the population from martinique to other populations. * a study of incidence of colorectal cancer, overseen by the association from martinique for the epidemiological search on cancer (amrec), also leads to a better knowledge of the local characteristics of the colorectal cancer. * these two descriptive characteristics of colorectal cancer in martinique will be useful data for the health professionals to provide their patients better care.

* the colorectal carcinogenesis is complex. it influences among others, the egfr (epidermal growth factor receptor) which activation leads to tumoral proliferation, differentiation and invasion. the binding of the egf (epidermal growth factor) or of another ligand to the egfr is responsible for the activation of the ras- raf and pi3k pathways. * the mutation of the genes kras, braf or pik3ca results in their continuous activation, independently of the activation or of the pharmacological blocking of egfr. the most frequently found mutation affects the kras gene (20 to 50 % of the cases). 90 % of these mutations are situated on codons 12 and 13 of this gene (70 % codon 12 and 30 % codon 13). these mutations are responsible for a decrease of the gtpase activity of the ras protein, which stays then in active conformation bound to the gtp. this leads to the blocking of the pathway and to the inactivity of the pharmacological blocking of egfr.

Eligibility criteria:
inclusion criteria: * for the study of the kras mutation: 250 patients drawn by lots among the cases of colorectal carcinoma diagnosed between january 1st, 2007 and december 31st, 2009 in martinique * for the study of incidence: patient for whom was diagnosed a colorectal carcinoma between january 1st, 2007 and december 31st, 2009 * patient unopposed and in free agreement to participate in this study * patient having his main home in martinique at the time of the diagnosis * patient 18 years old and over exclusion criteria: * patient whose diagnosis is prior to 2007 and later in 2009 * patient having shown opposition to the participation in this study * patient minor or under guardianship * patient not having his main home in martinique at the time of the diagnosis

Keywords: kras mutation colorectal carcinoma martinique