Kornimate/medical-research-clean huggingface dataset:
study of panitumumab efficacy in patients with recurrent and/or metastatic head and neck cancer

Conditions: Recurrent and/or Metastatic Head and Neck Cancer

Summary: the purpose of this study is to determine the treatment effect of panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.


Eligibility criteria:
inclusion criteria: * man or woman at least 18 years old. * histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck. * diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy. * subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy. * measurable and non-measurable disease. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * history or known presence of central nervous system (cns) metastases. * history of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization. * nasopharyngeal carcinoma. * prior systemic treatment for metastatic and/or recurrent scchn * prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy * prior anti-egfr (epidermal growth factor receptor) antibody therapy or treatment with small molecule egfr inhibitors * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (ct) scan. * symptomatic peripheral neuropathy grade ≥ 2 based on the ctcae v3.0 * grade ≥ 3 hearing loss based on the common terminology criteria for adverse events (ctcae) v3.0 auditory/ear (hearing \[without monitoring program\])

Keywords: squamous cell carcinoma epidermal growth factor epidermal growth factor receptor scchn metastatic head and neck cancer egfr head and neck cancer recurrent head and neck cancer
comparison of retinal perfusion between diabetic and non-diabetic patients with oct angiography after cataract surgery.

Conditions: Diabetes Mellitus Type 2; Age Related Cataracts

Summary: this study aims to compare the retinal perfusion between diabetic and non-diabetic patients with optical coherence tomography（oct） angiography after cataract surgery, to thoroughly evaluate the retinal state of diabetics after surgery, and to find out the relationship between postoperative complications occurred in retina and diabetes.

in this study, we perform a completely comparison of retina state characteristic including the foveal avascular zone(faz),perifovea vessel density,parafovea vessel density,macular thickness,perifovea thickness,parafovea thickness in superficial and deep layers of retina with oct angiography after cataract surgery,and analysis on the differences of egf,ifn-γ,il-10,il-12,il-1β,il-6,il-8,ip-10,mcp-1,vegf in aqueous humor before surgery between diabetic and non-diabetic patients and to explore the potential correlations between postoperative complications occurred in retina and diabetes.

Eligibility criteria:
inclusion criteria: 1. patients with age-related cataract and with willing to improve visual acuity by undergoing phacoemulsification and intraocular lens implantation surgery. 2. type 2 diabetes diagnosis according to american diabetes association# standards of medical care in diabetes -2017(ada, american diabetes association) 3. willing to sign the consent form. exclusion criteria: 1. having known maculopathy, proliferative diabetic retinopathy(pdr), diabetic macular edema. 2. with high myopia of spherical equivalent greater than -6.0 diopters or axial length (axl) greater than 26 mm in either eye. 3. preexisting vein or artery occlusion,glaucoma, previous uveitis, a history of ocular trauma, laser treatment, intravitreal injections or intraocular surgeries. 4. patients who had complications during cataract surgery. elimination criteria: 1. poor compliance 2. voluntary withdrawal 3. any other kind of situation that researchers consider not suitable for further study.

Keywords: diabetes oct angiography cataract surgery
oral aprepitant and lower dose dexamethasone versus aprepitant alone for preventing postoperative nausea and vomiting (ponv) after elective laparoscopic surgeries

Conditions: Nausea; Vomiting

Summary: the combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

postoperative nausea and vomiting (ponv) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. ponv is multifactorial, and the treatment is multimodal. preoperative treatment should target the specific mechanism of ponv to minimize its incidence/consequences to the benefit of the patients. aprepitant, a selective antagonist of neurokinin-1 (nk-1) receptors, blocks the emetic effects of substance p.5 substance p action on the nk-1 receptors in the central nervous system (cns) is one of the final pathways to an emetic response. dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. the commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for ponv in patients undergoing laparoscopic surgeries. based on the literature review, occurrence of ponv does not significantly differ at dosing of dexamethasone equal or higher than 4 mg. this study compares the incidence of nausea, vomiting, need for rescue medication, prolonged pacu time, and unplanned hospital admission in patients with high risk for ponv treated with oral aprepitant and dexamethasone or aprepitant alone preoperatively.

Eligibility criteria:
inclusion criteria: * at least 18 years old * asa physical status i-iii * must have at least 2 risk factors for ponv exclusion criteria: * pregnant or breast feeding patients * antiemetic medication in previous 24 hours * allergy or other contraindication to study medications

Keywords: laparoscopic surgery postoperative nausea vomiting aprepitant dexamethasone postoperative nausea, postoperative vomiting
auricular acupuncture for analgesia during total hip arthroplasty

Conditions: Acute Pain; Total Hip Arthroplasty

Summary: the aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty


Eligibility criteria:
inclusion criteria: 1. patients with an american society of anesthesiologists physical status of i to iii scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia. 2. surgery time does not exceed 100 minutes. 3. patients without previous opioid medication. 4. patients ranged 45-85 years old. 5. patients who have given informed consent. exclusion criteria: 1. pregnant or nursing females. 2. recidivist alcoholics. 3. local or systemic infection. 4. age \ 85 years. 5. surgery time more than 100 minutes. 6. intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines). 7. patients consumed opioid medication before surgery. 8. patients with prosthetic or damaged cardiac valves. 9. patients who are unable to understand the consent form. 10. history of psychiatric disease.
study of pralatrexate with vitamin b12 and folic acid supplementation for previously treated recurrent or metastatic head and neck squamous cell cancer (hnscc)

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin b12 might be an effective treatment for head and neck cancer. the reason we are doing this study is because another drug called methotrexate has been used for a long time to treat head and neck cancer patients. pralatrexate was designed by scientists to be a new drug that works better than methotrexate. laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells. pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. the results from those studies were promising. pralatrexate was recently approved by the food and drug administration (fda) as a new treatment for a cancer called peripheral t cell lymphoma.


Eligibility criteria:
inclusion criteria: * patients must have histopathologically confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck, including unknown primary squamous cell carcinomas of the neck. confirmation of biopsy/diagnosis will be performed at mskcc or at participating sites (nyu cancer institute/nyu medical center/ bellevue hospital center). * patients must be at least 18 years of age. * ecog performance status must be ≥ 0 or 1. * disease must be measurable by recist version 1.1 criteria. * patients must have been previously treated with systemic chemotherapy (i.e., chemotherapy and/or targeted therapies such as cetuximab for recurrent/metastatic hnscc,. * at least four weeks must have elapsed from previous radiation therapy. patients must have recovered from the acute toxic effects of treatment prior to study enrollment. * patients must have adequate organ function, as follows: adequate bone marrow reserve: absolute neutrophil count (anc) \> 1,000 cells/mm3, platelets \> 100,000 cells/mm3, and hemoglobin \> 9 g/dl hepatic: ast and alt ≤ 3 x upper limit of normal (uln); ast and alt ≤ 5 x uln if liver metastasis present; total bilirubin ≤ 1.5 x uln unless gilbert's disease is present renal: serum creatinine ≤ 1.5 mg/dl or creatinine clearance (by either 24 hour urine collection or cockcroft-gault equation) \> or = to 55 ml/min * both women and men and members of all races and ethnic groups are eligible for this trial. * women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. both men and women must agree to use a reliable method of birth control until 30 days following the last dose of study drug. exclusion criteria: * history of any brain metastases unless resected with no evidence for \> 12 weeks and not on steroids * women who are lactating * other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis * patients who have undergone an allogeneic stem cell transplant

Keywords: pralatrexate vitamin b12 folic acid 10-112
a prospective study of acute cardiovascular effects of first-line sunitinib in metastatic renal cell carcinoma patients (sunitinib prospective cardiovascular effect)

Conditions: Renal Cell Carcinoma; Cardiotoxicity; Heart Failure; Hypertension

Summary: while sunitinib can be very helpful to treat kidney cancer, these medications can also cause side effects, including heart damage. studies performed in the past did not look at heart function in detail, so the investigators do not know what happens to the heart when people start sunitinib treatment. the aim of the study is to prospectively study acute effects of sunitinib on heart function, overall fitness and blood markers of heart disease.

participants will undergo cardiac mri, maximal exercise testing(vo2 peak), blood and urine samples before and after 2 treatments of sunitinib. an extra blood sample will be collected the 2nd week of the first treatment to check blood levels of sunitinib. we will also examine routine ct scans to study body composition.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of metastatic renal cell carcinoma * eligible to receive first-line sunitinib * willingness to attend cross cancer institute and university of alberta for study-related assessments * karnofsky performance status (kps)82 ≥ 70 * age ≥ 18 years of age * adequate creatinine clearance to receive gadolinium * all patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to cpet; * fluent in english language * no contraindication to mri or other concern eg., metallic implants, claustrophobia exclusion criteria: * prior systemic therapy for mrcc * documented history of major cardiac event in last year i.e. mi, unstable angina, cabg, symptomatic chf, cva or tia, or pulmonary embolism * pregnancy * other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate * unstable brain metastases

Keywords: sunitinib cardiac mri maximal exercise testing biomarkers pharmacokinetics
patient navigation for lung screening at mgh community health centers

Conditions: Lung Cancer

Summary: to develop and implement a patient navigator (pn) program for lung screening and smoking cessation in community health center primary care practices. this program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

the specific aims of this study are: specific aim 1: to develop a patient navigator (pn) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (chcs) affiliated with mgh. specific aim 2: to evaluate the effectiveness of the new lung screening pn program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial. specific aim 3: to demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest ct results, comparing eligible smokers from chcs with eligible smokers from other practices within the mgh primary care network.

Eligibility criteria:
inclusion criteria: 1. adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and 2. receive care at one of the five massachusetts general hospital community health centers. exclusion criteria: 1. patients who have previously received a diagnosis of lung cancer, 2. have undergone a chest ct within 18 months before enrollment, 3. are subsequently identified as having died prior to the study intervention, 4. deemed by their primary care provider as not eligible for lung screening.

Keywords: lung screening low-dose computer tomography patient navigation
a multiple ascending dose study of ro4905417 in healthy volunteers and patients with peripheral arterial disease (pad).

Conditions: Peripheral Arterial Disease (PAD)

Summary: this single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ro4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. three groups of 10 healthy volunteers will receive ro4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. in addition, two groups of 6 pad patients will receive ro4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 pad patients will receive 20mg/kg ro4905417 or placebo iv every 28 days for a total of three infusions. the study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. all subjects will receive 3 doses of ro4905417 or matching placebo at 28 day intervals. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * healthy males and females aged 18-65 years (arms 1,2,5,6,9,10); * bmi 18-30kg/m2 (arms 1,2,5,6,9,10); * males and females aged 45-75 years with confirmed stable pad (arms 3,4,7,8,11,12); * on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (arms 3,4,7,8,11,12); * bmi 17.5-35kg/m2 (arms 3,4,7,8,11,12). exclusion criteria: * patients with pain at rest and/or local complications; * history of any cardiovascular event within the previous 6 months; * treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel); * evidence of hepatic or renal impairment; * history of bleeding disorders.
investigation of the effect of motor imagery training in individuals with cervical discogenic pain

Conditions: Image, Body; Neck Pain; Disc Herniation

Summary: in this study, motor control exercises including cervical region, upper extremity and scapular region muscles will be applied routinely in individuals with chronic neck pain. the application will been investigating, called motor imagery training, will been carried out together with motor control exercises.

this training is a mental exercise method based on imagining exercises that are performed actively without any interventional application inside or outside the body, in a comfortable environment and without fatigue. it is thought that motor imagery training applied together with motor control exercises will contribute to the management of chronic neck pain due to cervical disc herniation and symptoms related to pain. all individuals with cervical discogenic pain who met the inclusion criteria were assigned to '1. group' and '2. it will be divided into two groups. it is planned to include approximately 20 individuals with cervical discogenic pain in each group. the sample size of the study will be determined by the power analysis to be made as a result of the pilot study to be carried out on 10 patients with the support of biostatistics usa. group 1: (estimated) 20 individuals with cervical discogenic pain group 2: (estimated) 20 individuals with cervical discogenic pain

Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 65, * having a diagnosis of cervical disc herniation based on mri findings, clinical, and physical examination, * experiencing neck pain for 3 months or longer, * having a resting pain intensity rated 3-7 (moderate severity) on the "visual analog scale" for pain assessment (36), * classifying neck pain according to the 'neck pain task force' clinical classification system as grade 3 (neck pain with accompanying neurological symptoms) or above, * having a mini-mental test score of 24 or higher for the evaluation of cognitive functions. exclusion criteria: * having a history of spinal tumor, spinal deformities, congenital malformation, or head trauma, * undergoing cervical spine surgery in the last 6 months, * having a presence of systemic, cardiorespiratory, central nervous system, or rheumatic diseases, any musculoskeletal or craniocervical disorders, or a history of headache.

Keywords: imagery neck pain disc herniation exercise training awareness
pharmacokinetic profiles of amoxicillin 2000 mg and clavulanate 125 mg in adolescent patients

Conditions: Infections, Respiratory Tract

Summary: clinical research study to test amoxicillin and clavulanate tablet formulation for use in acute bacterial sinusitis (abs) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. abs is an acute bacterial infection of the sinus. the purpose of this study is to find out how children tolerate augmentin xr and what happens to augmentin xr in the body after it has been swallowed by children.


Eligibility criteria:
inclusion criteria: * patient weighs at least 40 kg. * younger than 16 years old (no older than their 16th birthday). * suspected acute bacterial sinusitis. * able to swallow amoxicillin/clavulanate tablets. exclusion criteria: * personal or family history of adverse reactions or hypersensitivity or allergy to any penicillin or cephalosporin antibiotics. * history of reaction to multiple allergens (if considered clinically relevant by the principal investigator). * patient is participating in another clinical trial or has received or anticipates receiving an investigational drug, vaccine, or medical device prior to the first dose of study medication or during the conduct of the study. * history or presence of gastrointestinal, hepatic or renal disease or other conditions known to or that may interfere with the absorption, distribution, metabolism or excretion of study medication. * treatment with probenecid or allopurinol within 7 days of study entry. * female patients with a positive urine hcg (human chorionic gonadotropin) test at screening, or who are lactating (breast feeding) or are unwilling to be abstinent until completion of the follow-up visit. * history of diarrhea due to clostridium difficile following treatment with antibiotics. * history of hypersensitivity or allergy to heparin or related preparations (if the clinical research unit uses heparin to maintain intravenous cannula patency). * patient is diagnosed with mononucleosis. * estimated glomerular filtration rate (gfr) \<40 ml/min.

Keywords: abs acute bacterial sinusitis bacterial sinusitis
muco-ciliary cleansing of lungs in copd with and without a salt particle inhaler

Conditions: COPD; Copd Bronchitis

Summary: cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in copd patients as measured by lung scintigraphy.

stable copd patients will be examined twice with minimum two, maximum 14 days interval. in randomized order the patients will inhale from a salt particle inhaler with (active) or without (placebo) content.

Eligibility criteria:
inclusion criteria: * copd grade 1, 2 and 3 in stable condition (less than 10% change of fev1 ratio between investigation visits exclusion criteria: * pregnant or lactating women * patients exposed to radionuclear isotopes within one month * patients under antibiotic treatment * patients with known hyper reactive airways