Kornimate/medical-research-clean huggingface dataset:
proximal molecular effects of concurrent chemoradiotherapy on head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (crt) on the expression of potential therapeutic target molecules in head and neck squamous cell carcinoma (hnscc). specifically, this study proposes to evaluate the extent to which crt induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (egfr) signaling pathways.


Eligibility criteria:
inclusion criteria: * untreated hnscc (\> stage i) amenable to transoral biopsy. * scheduled for concurrent crt (cisplatin or carboplatin/5-fu based) as definitive primary treatment * older than 18 years of age. * understand and sign informed consent. exclusion criteria: * any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study. * breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, iud, birth control pills, or spermicidal gel with diaphragm or condom) since last menses. * history of chronic inflammatory disease (e.g. ulcerative colitis, crohn's disease, rheumatoid arthritis or pancreatitis). * corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays. * nsaid (including celecoxib) or aspirin (\> 81 mg/day) use within 1 week of enrollment. * investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.

Keywords: head and neck squamous cell carcinoma chemoradiotherapy molecular effects 05-016
a double-blind, randomized, parallel group, fase iii comparative study with rose hip powder powder and placebo given to patients with mild to moderate osteoarthritis in the knee or/and hip

Conditions: Pain; Activities of Daily Living; Quality of Life

Summary: the trial is an investigator-initiated, double-blind, randomized, placebo-controlled phase iii study. after the patient has receiving information about the study and after given written informed consent, the patient will be screened. all patients are randomized to receive standardized rose hip powder or matching placebo for 3 weeks followed by half the dose standardized rose hip (or placebo) for the remaining 12 weeks of the study. the patient's medical history and demographic information will be recorded. the patient will then be asked questions in accordance to the study questionnaires, and they will also be asked to complete questionnaires regarding quality of life - and finally they be instructed on how to complete the diary. investigator or study nurse will take telephone contact with the subject after 3 and 6 weeks of treatment, subjects will be asked about how things are going and to remember to take the capsules and whether they have completed the diary. the contact taken after 6 weeks by phone is mainly to guide the subject on how complete the questionnaires including vas scales. the last patient visit will take place after 12 weeks. any side effects will be reported to and reviewed with hybenvital aps in collaboration with medical experts.


Eligibility criteria:
inclusion criteria: * men and women aged 40 + years * osteoarthritis symptoms with duration of more than 6 months * one womac-pain visual analogue scale score (vas score) there are at least 35 mm at rest * subjective morning joint stiffness * clinical symptoms of arthritis diagnosed by the acr (american college rheumatology) criteria exclusion criteria: * patients who have been treated with rose hip extracts or powder within 3 months before screening. * patients who have been treated with ginger, avocado or soybean extracts or powder within 3 months before screening * patients on steroids, tnfalpha or dmard prior to trial. * patients receiving irregular medical treatment for osteoarthritis. * patients suffering from other joint diseases other than osteoarthritis. * patients who abuse alcohol * patients with a current psychiatric illness, drug and / or alcohol abuse * patients with known allergy to rose hips * presence of other clinically significant medical conditions * patients scheduled for joint or major surgery during the trial. * patients participating in another clinical trial, or have participated in another clinical trial within 3 months before this study. * patients with known compliance problems or who are uncooperative. * pregnant or lactating women.

Keywords: osteoarthritis
study of sunitinib in combination with docetaxel vs docetaxel in patients with advanced breast cancer

Conditions: Breast Neoplasms

Summary: this is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * breast cancer with evidence of unresectable locally recurrent, or metastatic disease * her-2 negative tumors exclusion criteria: * patients for whom docetaxel is contraindicated * clinical presentation of inflammatory carcinoma with no other measurable disease

Keywords: advanced breast cancer sunitinib docetaxel phase 3
efficacy, safety, tolerability, and pharmacokinetics of indacaterol maleate via concept1 or simoon devices

Conditions: Asthma

Summary: this study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the concept1 device and one administered via the simoon device. the study aimed to determine whether the novel formulation (simoon) had a similar profile to that of the established formulation (concept1).

this study was double-blind with regards to the concept1, where placebo for the lactose-blended indacaterol was available. however, with regards to the simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the pulmosphere formulation. hence, the overall designation of the study was partially-blind.

Eligibility criteria:
inclusion criteria: * patients with persistent asthma with a forced expiratory volume in 1 second (fev1) ≥ 50% * patients using inhaled corticosteroid (with or without long-acting beta agonist) exclusion criteria: * asthma exacerbations in previous 6 months * chronic obstructive pulmonary disease (copd) or other pulmonary disease * excessive use of short-acting beta agonists other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: asthma qab149 indacaterol pulmonary function
epidemiological study of floating hip injuries in assiut university hospitals

Conditions: Hip Fractures; Hip Injuries

Summary: aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in assiut university hospitals trauma centre to help reach the best approach to plan treatment for these severe and difficult injuries.

floating hip injuries are defined as ipsilateral fractures of the pelvis, acetabulum and femur . the term "floating" is used in orthopedic literature to describe certain patterns of skeletal injuries that share one common character which is disruption and discontinuity of bones above and below a joint. this type of injury is very rare and occurs due to high-energy trauma most commonly road traffic accidents and falls from height. patients of the floating hip injuries are usually poly-trauma patients with other associated potentially serious injuries in the head , chest or abdomen or fractures in other sites. complication rates are high in these patients due to the severe and unstable nature of this injury. the femoral fracture may be associated with pelvic, acetabular fracture or both, this pattern was classified by liebergall et al into 3 types; a, b and c with type a involving pelvic fracture associated with an ipsilateral femoral fracture and type b involving an acetabular fracture associated with an ipsilateral femoral fracture and type c involving fractures to both the pelvis and acetabulum. the lack of common terminology , probably because of their rarity and relative low incidence of associated vascular injuries , could have been the reason for the underappreciation of the peculiarity of these injuries. previous studies have been limited in number without deep analysis of the current practice patters and incidence of complications.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 to 60) with ipsilateral fractures of the pelvis, acetabulum and femur exclusion criteria: * ages below 18 or above 60 * pathological and fragility fractures

Keywords: floating hip pelvic fractures acetabular fractures femur fractures trauma
effectiveness and cost-effectiveness of a tele-rehabilitation program in the treatment of chronic musculoskeletal pain

Conditions: Chronic Pain

Summary: the aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

chronic pain is a major burden on the individual and society. it is estimated that about one third of the adult population worldwide suffer from chronic pain, with higher prevalence rates reported for low-income countries. internet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. however, there is still little research on the development and testing of remotely-delivered programs for the management of chronic musculoskeletal pain, especially in low and mid-income countries. the aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years * seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 pain numerical rating scale * able to read and understand portuguese * with internet access. * chronic pain will be defined as pain lasting more than 12 weeks. exclusion criteria: * present neurological symptoms (nerve root compromise, or sensation deficits) * present serious spinal pathologies (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases) * present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes) * recent orthopaedic surgery (over the last 12 months) * scheduled to undergo surgery in the next 6 months, or pregnancy * if have any contraindication to exercise * we will perform a pre-screening for physical activity participation at baseline using the physical activity readiness questionnaire (par-q) portuguese version to rule out any contraindication to participate in physical activity.

Keywords: chronic pain telerehabilitation telemedicine physical therapy
efficacy and safety of 7 versus 14 days of antibiotic treatment for pseudomonas aeruginosa bacteraemia

Conditions: Bloodstream Infection

Summary: phase iv, open-labeled, randomized and multicenter clinical trial to demonstrate the superiority of antibiotics with authorized indication for 7 days versus 14 days in the treatment of bloodstream infections produced by p. aeruginosa (bsi-pa).

the project is designed to determine the optimal duration of antibiotic treatment for pseudomonas aeruginosa bacteremia, by comparing an adequate antibiotic treatment regimen of 7 days (experimental arm) with another of 14 days (control arm). the evaluation of infection recurrences, mortality, number of free days of antibiotic treatment, adverse events and superinfections are included as secondary objectives. active antibiotic treatment will be considered any treatment with proven in vitro activity against the strain responsible for the patient's bacteremia, regardless of the administered dose. clinical rules are included in order to stop antibiotic treatment or continuation and re-evaluation in each arm of treatment. this is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. final contact and final visit for the study will be performed at 90 days after the first positive blood culture.

Eligibility criteria:
main inclusion criteria: * adult patients with diagnosis of bsi-pa who have received 6 days (+/- 1) of active antibiotic treatment from the date of extraction of the first positive blood culture and until the moment of randomization. * informed consent signed. main exclusion criteria: * bacteremia source not adequately controlled at least 72h before randomization. * bacteremia secondary to an infection that necessarily requires prolonged antibiotic treatment more than 7 days * coexistence of a different infection at the time of diagnosis of bacteremia that also requires antibiotic treatment. * bacteremic pneumonia in severely immunosuppressed patients * bacteremia of any origin in patients with severe neutropenia (\<500 cells / mm3) at the time of randomization.

Keywords: bacteremia pseudomonas aeruginosa bloodstream infection door / radar analysis antimicrobial stewardship
high myopia macular hole and retinal detachment treated with double ilm flaps

Conditions: High Myopia; Macular Holes; Retinal Detachment

Summary: from july 2015 to december 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ilm flap insertion into the hole were retrospectively reviewed. the anatomical and function outcomes were assessed.

from july 2015 to december 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ilm flap insertion into the hole were retrospectively reviewed. the anatomical and function outcomes were assessed. patients with a history of trauma or concurrent peripheral breaks were excluded. the anatomical and function outcomes, including the status of the macular hole and retina were assessed.the study was approved by the ethnic committee and research board.

Eligibility criteria:
inclusion criteria: * macular hole with retinal detachment in high myopia exclusion criteria: * history of trauma, peripheral retinal breaks
reverse phototherapy with super light-emitting diode(super-led) for hyperbilirubinemia in term and late preterm infants

Conditions: Neonatal Hyperbilirubinemia

Summary: the aim of this study is to compare the efficacy of super-led reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.

this is a randomized controlled clinical trial with hospitalized infants in the professor fernando figueira medicine institute(imip), who require phototherapy as an indication of the medical team. following the sample calculation, 144 patients will be randomized according to gestational age (350/7-376/7 or 380/7-416/7 weeks) to receive super-led reverse phototherapy or fluorescent reverse phototherapy with spectral irradiance of 8-12 microwatts/cm2/nm.the bilirubin will be determined by micromethod with bilirubinometer, after blood collection in heparinized capillary until bilirubin reaches level that indicates suspension of therapy.

Eligibility criteria:
inclusion criteria: * newborns in the maternity professor fernando figueira medicine institute(imip) * gestational age between 350/7 and 416/7 weeks * birth weight greater than 2200g * absence of congenital malformations * indication of phototherapy after 48 hours of life * terms of consent signed by parent or guardian exclusion criteria: * total bilirubin level indicative of phototherapy intensive or exchange transfusion * rh incompatibility hemolytic disease * mother's refusal to continue to participate in the study * unavailability of the two types of phototherapy equipment for randomization * mother or newborn who received phenobarbital

Keywords: jaundice hyperbilirubinemia phototherapy and super-led fluorescent lamps
pain prevalence after cesarean section in siriraj hospital

Conditions: Pain, Postoperative

Summary: spinal morphine has been widely provided for acute postoperative analgesia. however, the analgesic effect of spinal morphine usually last 12-24 hours. therefore the investigators are interested in the pain characteristics during the 2nd postoperative day. the investigators will also explore the regimens for pain therapy in our hospital.


Eligibility criteria:
inclusion criteria: * patients undergoing cesarean section exclusion criteria: * history of drug addict

Keywords: pain
air-impingement manipulation to clear subglottic secretion to prevent vap in prolonged intubated patients

Conditions: Ventilator Associated Pneumonia

Summary: ventilator-associated pneumonia (vap) is the most frequent infection occurring in patients who are admitted to the icu. the accumulation of respiratory secretions in the subglottic space is a well-proven cause of vap. investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

ventilator-associated pneumonia (vap) is the most frequent infection occurring in patients who are admitted to the icu. the accumulation of respiratory secretions in the subglottic space is a well-proven cause of vap. therefore, prevention should include the aspiration of secretions from the subglottic space. investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. this method has been granted as a patent by chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 chinese icus have used it everyday. investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

Eligibility criteria:
inclusion criteria:should meet all the criteria: * intubation less than 24 hours before admitting respiratory intensive care unit; * anticipated intubation for more than 72 hours; * anticipated survival time is more than 2 weeks exclusion criteria:meet any of these criteria: * peep≥10cmh2o or fio2≥0.8; * unstable hemodynamics; * severe bulla and pneumothorax; * enrolled in other study; * cuff leak test is positive.

Keywords: ventilator associated pneumonia subglottic secretion drainage manual air-impingement operation
prophylactic peptide vaccine in advanced alk+ nsclc

Conditions: NSCLC Stage IV; ALK Fusion Protein Expression

Summary: the purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced alk+ lung cancer patients currently on alk targeted therapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of stage iv nsclc (or recurrent nsclc not a candidate for definitive multimodality therapy) 2. documented alk rearrangement as detected by: (1) fluorescence in situ hybridization (fish), (2) immuno-histochemistry (ihc), (3) tissue next-generation sequencing (ngs), or (4) circulating tumor dna (ctdna) ngs 3. ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months 4. no known presence of the specific alk acquired resistance alterations targeted by the study vaccine 5. eastern cooperative oncology group (ecog) performance status of 0 to 1 6. males or females at least 18 years old exclusion criteria: 1. known additional malignancy that is progressing or has required active treatment within the past 3 years. adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed. 2. cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine 3. anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine 4. systemic immune suppression: 1. use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted) 2. other clinically relevant systemic immune suppression 5. symptomatic central nervous system (cns) metastasis. asymptomatic cns disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted 6. current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). patients with leptomeningeal disease and without cord compression are allowed
group integrative mindfulness over the internet using an online platform

Conditions: Pain, Chronic

Summary: this is a one-year study designed to improve upon the latest version of an education website for adult chronic pain patients called our whole lives for chronic pain (owl-cp). we will gain feedback from stakeholders, beta test new versions, and add the ability to conduct live medical group visits through and on the virtual platform we are creating, gemini.

the objectives are: 1. to create a wireframe version of the group integrative mindfulness over the internet (gemini) website, based on feedback from previous projects, for further beta testing. 2. to engage 8 patients with chronic pain in a focus group or individual meeting (utilizing the video-conferencing tool, zoom) to obtain feedback on the wireframe version of gemini through a usability test and qualitative, semi-structured interview (cohort 1). 3. to create a prototype of the gemini system, using all previously collected feedback data (mentioned above), for further beta testing with both patients and providers. 4. to engage 16 patients with chronic pain in focus group(s) to collect feedback on the patient portal side of the tool, through holding a non-intervention, gemini telehealth session using the prototype website. no personal health information (phi) or medical record data will be collected or recorded during this faux session (cohort 2). 5. to engage 8 health care providers in evaluating the provider portal through asking them to conduct a gemini telehealth session with study staff role-playing as chronic pain patients (cohort a). 6. to end the project with a tested, active prototype of the gemini chronic pain management/education/telehealth tool.

Eligibility criteria:
inclusion criteria: * 18 years of age or older (patients and healthcare providers (hcp)) * self-reported chronic physical pain for at least 12 weeks (patients) * average pain intensity for the previous week \>4 on a 0 to 10 numerical rating scale (patients) * english fluency enough to follow instructions and answer survey questions (patients and hcps) * providers who treat patients for pain will be eligible for inclusion (hcps) exclusion criteria: * subjects who are not willing or unable to participate in a focus group or individual appointment over a video conferencing platform/on the university of massachusetts (umass) worcester campus and watch a computer screen and give feedback (patients * hcp) * fetuses, prisoners, and other vulnerable populations are not eligible (patients \& hcp) * providers/medical students or residents directly supervised by or reporting to the primary investigator (hcp)

Keywords: widespread chronic pain pain, chronic