Kornimate/medical-research-clean huggingface dataset:
postoperative radiotherapy plus iressa or radiotherapy plus cisplatin and iressa for advanced head & neck cancer

Conditions: Head and Neck Cancer

Summary: to evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and iressa


Eligibility criteria:
inclusion criteria: * written informed consent * age over 18 years * histologically proven squamous cell cancer of the head \& neck (scchn) * indication for postoperative radiotherapy: pt3, pt4, pn2b, pn2c, pn3 exclusion criteria: * hypersensitivity to zd1839 or any of the excipients of this product * tumour stage m1 * co-existing malignancies diagnosed within the last 5 years. exceptions: basal cell carcinoma, cervical cancer in situ * absolute neutrophil counts \<1.5 x 109

Keywords: squamous cell cancer of the head & neck gefitinib iressa egfr inhibitor egfr-tyrosine kinase inhibitor subjects with histologically proven squamous cell cancer of the head & neck cohort 1:qualifying for postoperative radiotherapy (pt3, pt4, pn2b, pn2c, pn3). cohort 2:qualifying for definite chemoradiotherapy (lateral oropharynx, tonsils: t1n2b-3, t2n1-3, t3any n; base of tongue, vallecula: t1n1-3, t2-4 any n; oral cavity, glottic and supraglottic larynx; any tn1-3, t3-4 any n; hypopharynx: t1n1-3, t2-4 and n)
safety study of zimura in combination with anti-vegf therapy in patients with neovascular amd

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the primary objective is to assess the safety of intravitreal (ivt) zimura® administered in combination with anti-vegf therapy (avastin®, eylea®, or lucentis®) in anti-vegf treatment experienced subjects with neovascular age-related macular degeneration (amd)


Eligibility criteria:
inclusion criteria: * treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-vegf therapy given within the past 8 weeks for neovascular age-related macular degeneration (nvamd) in the study eye. there must be \< 0 letters of improvement in snellen (not etdrs snellen equivalent) visual acuity since the start of anti-vegf treatment. * presence of subfoveal active choroidal neovascularization (cnv) exclusion criteria: * intravitreal treatment in the study eye prior to the day 1 visit, regardless of indication, with the exception of the 1 prior anti-vegf injections. * presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. * non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry. * prior thermal laser in the macular region, regardless of indication. * ocular or periocular infection in the past twelve weeks. * history of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant. * previous therapeutic radiation in the region of the study eye. * evidence of diabetic retinopathy

Keywords: neovascular age-related macular degeneration (nvamd)
assessment of color vision in diabetic patients

Conditions: Retinopathy, Diabetic

Summary: assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema


Eligibility criteria:
inclusion criteria: * having diabetic retinopathy with macular edema exclusion criteria: * not having diabetic retinopathy with macular edema
bioequivalency study of naratriptan hydrochloride 2.5 mg under fasted conditions

Conditions: Migraine

Summary: the objective of this study was to prove the bioequivalence of naratriptan hydrochloride tablet under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.
indocyanine-green mediated photosensitizer vs aloe vera gel: adjunct therapy to scaling and root planing in patients with chronic periodontitis

Conditions: Periodontitis; Periodontal Inflammation

Summary: for proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. the main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (pdt) and aleo vera (av) extract when used as an adjunct therapy to scaling and root planning (srp) for treatment of chronic periodontitis. one hundred and fifty patients included in this study were randomly distributed in three treatment groups group i (srp), group ii (srp+pdt) and group iii (srp+av). four clinical parameters plaque index (pi), bleeding on probing (bop), periodontal (pd) pocket depth and clinical attachment level (cal) were evaluated at three time points baseline, 3rd and 6th month respectively. additionally the amount of three inflammatory cytokines il-6, il-8 and tnf- α in gingival crevicular fluid (gcf) was identified using enzyme linked immune-sorbent assay (elisa) technique.


Eligibility criteria:
inclusion criteria: * age of ≥ 30 years; * ≥ 20 natural teeth; and * chronic-periodontitis (≥ 3 mm of cal and pd pocket depth respectively on at least 30% of dental sites). exclusion criteria: * chronic systemic diseases; * pd therapy during last 6 months; * habitual use of chewable and non-chewable tobacco (smoking); * alcohol consumers; or * use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)
comparison of two spinal manipulation treatments in patients with chronic mechanical neck pain

Conditions: Neck Pain

Summary: there is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.


Eligibility criteria:
inclusion criteria: * symptom persistence for more than 12 weeks. * age from 18 to 55 years. * localized pain in the cervical spine. * symptoms are caused by cervical movement or sustained postures. exclusion criteria: * stage acute of symptoms. * any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency). * patients with previous neck trauma or cervical spine surgery. * patients diagnosed with cervical radiculopathy. * patients diagnosed with fibromyalgia. * have been treated with manual therapy in the last 3 months. * receiving other treatment during the course of the study.

Keywords: disability evaluation musculoskeletal manipulations neck pain spinal manipulation
dexmedetomidine in topical versus peribulbar anesthesia for cataract surgery

Conditions: Dexmedetomidine; Cataract Surgery; Peribulbar; Anesthesia

Summary: the aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

ocular surgery may be performed under topical, regional, or general anesthesia. the first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an austrian ophthalmologist. davis and mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (la) than a retrobulbar block. but the peribulbar block is away from intra-conal space and so produce fewer complication. dexmedetomidine is used as adjuvant to la drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. a more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an iop decrease similar to iv dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification i or ii who scheduled for eye surgery exclusion criteria: * patients who are younger than 18 years * the usual contraindications for regional anesthesia such as patients refusing la * clotting abnormalities * impaired mental status * allergy to any of the study medications * patients had the severe cardiac disease * chronic obstructive lung disease and a history of sleep apnea * contraindications to the use of dexmedetomidine * history or significant cardiovascular disease risk factors * significant coronary artery disease or any known genetic predisposition * history of any kind of drug allergy * drug abuse * psychological or other emotional problems * special diet or lifestyle * clinically significant abnormal findings in physical examination * electrocardiographic (ecg) or laboratory screening * known systemic disease requiring the use of anticoagulants.
periodontitis stage iii and iv and oral health related quality of life

Conditions: Periodontitis

Summary: patients diagnosed with stage iii or iv periodontitis during routine visits at the department of periodontology will undergo a validated questionnaire to understand the impact of the disease on their quality of life.

the purpose of this study is to evaluate the impact of stage iii and stage iv periodontitis on the quality of life of patients and to evaluate the differences of the results between the two forms of the disease. patients who presents to our periodontology department for routine follow-up visits, if diagnosed with one of these two forms of periodontitis, will be asked if they intend to answer a short questionnaire with the intent to understand how the disease affects their daily activities and interactions. the questionnaire that will be used is the short-form oral health impact profile (ohip-14), which consists of 14 questions each one formulated in the following way: "how often (impact item) because of problems with your teeth, mouth, or dentures?" the impact items belong to seven different impact domains: (a) functional limitations, (b) physical pain, (c) psychological discomfort, (d) physical disability, (e) psychological disability, (f) social disability, and (g) handicap. each question could be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often. the impact items are: had trouble in pronouncing words felt that sense of taste had worsened had painful aching in your mouth found it uncomfortable when eating food been feeling self-conscious have you felt tense diet has been unsatisfactory had to interrupt meals found it difficult to relax been a bit embarrassed been irritable with other people had difficulty during usual jobs felt that life less satisfying been totally unable to function overall mean scores as well as for each question and for each impact domain will be calculated and compared with two ways anova statistical analysis.

Eligibility criteria:
inclusion criteria: * patients affected by periodontitis stage iii * patients affected by periodontitis stage iv exclusion criteria: * patients affected by periodontitis stage i * patients affected by periodontitis stage ii

Keywords: periodontitis ohip14 quality of life questionnaire
hiv-tb confections among hiv patients

Conditions: HIV

Summary: a cross sectional study would be done for prevalence of hiv-tb. co infection among patients of hiv enrolled at art centre, khagaria, india, during june' 2015 to may' 2016. a comparative study of cd4 (cluster of differentiation 4) t cell count among hiv-tb. co infected patient and hiv patients would be taken in account.

introduction hiv infection increases the susceptibility of mycobacterium tuberculosis (m.tb.) infection, and hastens its progression due to changes in immune status of the patients. in fact, tuberculosis is now the most common opportunistic infection in patients, who die from aids. immune response in tuberculosis and other infections induces cytokines that enhance replication of hiv, and derives the patient to full blown aids. the prevalence of hiv/tb co-infections have been reported to 0.4% to 20.1% from different regions of northern part of india. india is one of the six countries, those are accounted for 60 percent new cases of tuberculosis, and the brics countries collectively account for approximately 50 perce nt cases of worldwide tuberculosis. the prevalence of multidrug resistant tuberculosis(mdr-tb.) is two-threefold higher in hiv co-infected patients; as hiv infected people rapidly acquire the active disease including resistant strain of m. tb. and rapidly transmit the disease among population including plhiv, who in turn, manifest the active drug resistant tuberculosis. methods * this is cohort study among patients of hiv, attending art (antiretroviral therapy) center khagaria, bihar, india during june' 2015 to may' 2016. * patients enrolled at the centre were subjected to screening for mycobacterium tuberculosis infection by doing esr, mantoux test, chest x-ray, sputum examination for acid fast bacillus (afb) and nucleic acid amplification test. * hiv/tb co infected patients were given cotrimoxazole. * patients' data-for example, age, sex, co infection with tuberculosis would be recorded. * sputum positivity, radiological features, and extra pulmonary manifestations would be recorded and statistical analysis would be done * statistical analysis, such as, mean, standard deviation(sd), student t test, p-values would be done. p-value significance would be measured at p \< .05.

Eligibility criteria:
inclusion criteria: * patients of hiv+ enrolled art centre exclusion criteria: * lost to follow up patients (lfu) * patients died before the treatment started * children below 5 years

Keywords: hiv hiv-tb co infection cd4 cell
study of tlk199 hcl liposomes for injection in myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to determine the safety and efficacy of tlk199 in patients with myelodysplastic syndrome (mds).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of mds * adequate liver and kidney function * ineligible for, or refusing, allogeneic bone marrow transplant * at least 18 years of age * discontinuation of growth factors (e.g., g- csf) at least 2 weeks prior to study entry exclusion criteria: * failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry * pregnant or lactating women * history of allergy to eggs * other investigational drugs within 14 days of study entry * chemotherapy, radiotherapy or immunotherapy within 14 days of study entry * concomitant steroids or hormones for the treatment of neoplasms
a novel social emotional learning curriculum for youth with epilepsy

Conditions: Epilepsy

Summary: youth with epilepsy (ywe) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. this is a serious health concern. poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. as ywe are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of ywe specifically. the research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide ywe with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (sem). the proposed study is a pilot of this intervention to test its acceptability and appropriateness according to ywe participants ages 12 to 26. the intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. the goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. the investigators want to research the impact of this program. from this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of ywe.


Eligibility criteria:
inclusion criteria: * able to read, write, and communicate in english at 3rd grade level * active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication) * epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment * the pediatric neurologist feels the patient would benefit from program participation. * able to consistently join meetings on zoom with functional audio and video reception exclusion criteria: * during the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded.

Keywords: youth with epilepsy (ywe) positive youth development social-emotional learning social ecological model youth thrive framework perceived social support health-related quality of life adult epilepsy self-management measurement instrument
integrating patient reported outcomes (i-pro) study for multidisciplinary pain care

Conditions: Chronic Noncancer Pain

Summary: the purpose of this study is to assess the impact of clinician education, electronic health record integrated patient reported outcomes, and electronic health record integrated decision support on pain-related care quality, outcomes, and service utilization.

the initiative has three components to aid clinicians' care of patients with chronic noncancer pain: (1) education, (2) standardized patient reported outcomes data collection, and (3) evidence-based brief treatment reminders. practices will be randomized to either receive the three novel components (treatment group) or continue with usual care (control group). providers in the treatment group will be asked (a) to complete a series of six online education modules in pain care, (b) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (c) asked to review this data and related care recommendations during the patient visit, and (d) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain. primary study outcomes include comparison of treatment and control group provider and patient satisfaction surveys. secondary outcome measures include provider referral rates, patient outcomes, patient treatments recommended/ordered, and patient service utilization/costs.

Eligibility criteria:
inclusion criteria: * providers at one of six active community health and family medicine locations in the university of florida health system gainesville service area (hampton oaks, eastside, jonesville, and haile) between may 1, 2014 and september 1, 2015 * doctor of medicine (md), doctor of osteopathic medicine (do), advanced registered nurse practitioner (arnp), physician assistant (pa) or other faculty professional providing primary care services exclusion criteria: * residents or other trainees at one of four active community health and family medicine locations in the university of florida health system gainesville service area (hampton oaks, eastside, jonesville, and haile) between may 1, 2014 and september 1, 2015

Keywords: chronic noncancer pain musculoskeletal pain neuropathic pain headache pain
mindfulness in the or

Conditions: Performance at Work

Summary: the purpose of this research study is to understand the effect of a short mindfulness video on self perceived performance in the or. specifically, assessing the effectiveness of brief mindfulness intervention on physician focus, anxiety and perceived performance at the time of a procedure through a survey containing a modified flow state scale and modified applied mindfulness process scale


Eligibility criteria:
inclusion criteria: * practicing physicians or medical trainees * employed in a hospital setting * providing surgeries in an operating room setting. exclusion criteria: • practitioners involved in counseling roles
hiv + service delivery and telemedicine through effective pros

Conditions: HIV/AIDS; Mental Health Issue; Substance Use Disorders

Summary: this study will examine the impact of using a multicomponent intervention (patient reported outcomes, training, and telemedicine) to assist with the management of mental health (mh) and substance use disorders (sud) among people living with hiv (plwh) engaged in care at uab hiv clinic, university of alabama family clinic (birmingham, al), thrive federally qualified health services center (huntsville), health services center (anniston), and medical advocacy and outreach (montgomery). the study will employ a hybrid type 2 implementation design. because this intervention will be employed as the new standard of care at participating sites, all plwh receiving care at the sites will receive this intervention. patient-reported outcomes (pros) will be integrated into routine care to screen plwh for substance use and mental health disorders during routine clinical encounters. training will be delivered to frontline clinicians so that they receive targeted knowledge on best practices for treatment of mh and sud along with clinic-specific protocols for response to pros on mh and sud including treatment and referrals. telemedicine services for mh and sud will be offered to patients in need of expanded access to services due to a lack of clinic-level resources or additional barriers to traditional clinic visits such transportation, stigma, or substance using behaviors.


Eligibility criteria:
inclusion criteria: * 18 years or older and receiving hiv care at one of the five participating sites exclusion criteria: * below 18 years of age

Keywords: telemedicine patient reported outcomes focused training