Kornimate/medical-research-clean huggingface dataset:
reproducibility of intratumor distribution of 18f-ef5 in head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the results of previous studies suggest further development of \[18f\]ef5 as a pet tracer for imaging hypoxia. this is a non-randomized prospective study to obtain information on reproducibility of \[18f\]ef5 intratumor distribution using repeated pretreatment pet/ct scans.

all patients will undergo normal diagnostic and staging procedures, including a conventional 18f-fdg pet/ct scan for the purpose of rt or surgical planning. in addition to that, an 18f-ef5 pet/ct scan will be performed on a separate day. the patients receive intravenous injection of 250-350 mbq of \[18f\]ef5. after that, a venous blood sample will be obtained for measurement of plasma radioactivity. a low-dose ct (helical) will be performed for attenuation correction and anatomical reference. after that, a pet scan will be performed (starting at 3 h after injection). the second 18f-ef5 scan will be performed in a similar way 4-7 days after the first scan. a representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis. patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. follow-up information (event-free survival and overall survival) will be gathered.

Eligibility criteria:
inclusion criteria: * performance status: karnofsky score 70 or better or who performance status 2 or better * diagnosis: histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck * primary tumor diameter as determined clinically or from contrast enhanced ct or t1-weighed mri scan must be at least 15 mm * patients with nodal neck metastases of head and neck cancer are eligible * mental status: patients must be able to understand the meaning of the study * the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff * patient, if female, must not be pregnant or lactating at the time of the study exclusion criteria: * patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. * patient must have no history of previous chemotherapy or biological therapy or rt for treatment of head and neck cancer. * patient must not have an uncontrolled serious infection * patients with organ metastases in liver, bone, brain or lung.

Keywords: 18f-ef5 pet/ct reproducibility
treatment of meibomian gland dysfunction prior to cataract surgery

Conditions: Blepharitis; Dry Eye Syndrome

Summary: the purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (mgd) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

this is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the lipiflow system in patients with meibomian gland dysfunction prior to planned bilateral cataract surgery. all subjects undergo examination to determine study eligibility and to capture the baseline status prior to surgery. subjects are randomized to receive lipiflow treatment (pre-treatment group) one month before cataract surgery or no lipiflow treatment (untreated control group). cataract surgery is performed on both eyes of each subject with the second eye surgery completed within two months of the first eye. all subjects are evaluated at one month and three months after cataract surgery on the second eye with comparison of the study endpoints between the pre-treatment and untreated groups. to facilitate subject recruitment, the untreated control group receives crossover lipiflow treatment for mgd (post-treatment group) three months after cataract surgery on the second eye.

Eligibility criteria:
inclusion criteria: * 55 to 85 years of age * must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other mgd or dry eye treatments during the study; and attendance at all study visits * meibomian gland dysfunction in both eyes based on total meibomian gland score * none to mild dry eye symptoms based on ocular surface disease index score * tear film interferometry assessment of 100 units or less exclusion criteria: * systemic disease conditions that causes dry eye * use of systemic medications known to cause dry eye * use of other mgd or dry eye treatments except for over the counter lubricants or dietary supplements * history of any of the following ocular conditions in the past 3 months: surgery, trauma, herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion * presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity * participation in another ophthalmic drug or device trial in the past month
comparison of two different lightwand intubation techniques in cervical immobilized patients

Conditions: Intubation; Difficult or Failed

Summary: this study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.

this study compares two approaches in lightwand intubation techniques in cervical immobilized patients. one is a conventional approach that involves scooping movement with mandible protraction. the other is a face-to-face approach that inserts lightwand with a front-facing position. this study is conducted as a randomized, prospective, single-blinded design.

Eligibility criteria:
inclusion criteria: * adults with american society of anesthesiologists physical status 1-3 * patients who received scheduled spine surgery under general anesthesia exclusion criteria: * patients with body mass index \ 35.0 kg/m2, * patients who previously had head and neck surgery, * patients who are at high risk of aspiration, * patients with pathologic conditions such as tumors, polyps, or inflammation in the airway, * patients who cannot sit due to severe spine deformity, * patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease
descemet stripping (automated) endothelial keratoplasty (dsek or dsaek)

Conditions: Corneal Dystrophies, Hereditary

Summary: to evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in descemet stripping endothelial keratoplasty (dsek) or descemet stripping automated endothelial keratoplasty (dsaek).

please see above.

Eligibility criteria:
inclusion criteria: * corneal endothelial disorders exclusion criteria: * n/a

Keywords: corneal transplantation, descemet membrane, endothelium
factors predicting blood pressure change with interscalene block

Conditions: Systolic Blood Pressure (20% or Greater Increase)

Summary: the primary aim of this study is to identify potential anthropometric features that predict the relationship between the interscalene block procedure and changes in blood pressure

this prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo isb for shoulder surgery anesthesia will be included in this study. evaluation of the patients before isb and anthropometric measurements before and after interscalene block will be performed by an anesthesiologist who is not involved in the study.

Eligibility criteria:
inclusion criteria: * asa i-iii, elective shoulder surgery will be performed exclusion criteria: * presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease * history of chronic opioid or benzodiazepine use * presence of allergy to the local anesthetic drugs used * isb contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area). * presence of high level anxiety * patients with a hospital anxiety and depression scale (hads) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale

Keywords: interscalene block blood pressure change anterior scalene muscle thickness hypertensive patient
a study of cdx-0159 in patients with chronic inducible urticaria

Conditions: Chronic Inducible Urticaria

Summary: the purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (cdx-0159) in patients with chronic inducible urticaria who remain symptomatic despite the use of h1-antihistamines.

the purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with chronic inducible urticaria (cold urticaria \[coldu\] or symptomatic dermographism \[sd\]) who remain symptomatic despite the use of h1-antihistamines. there is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Eligibility criteria:
key inclusion criteria: 1. males and females, \>/= 18 years of age. 2. diagnosis of chronic coldu or sd \>/= 3 months. 3. diagnosis of coldu or sd despite the use of a stable regimen of second generation non-sedating h1-antihistamine as defined by: 1. recurrent pruritic wheals with or without angioedema due to coldu or sd for \>/= 6 weeks at any time prior to visit 1 despite the use of h1-antihistamines. 2. must be on a stable regimen of second generation non-sedating h1-antihistamine for \>/= 4 weeks prior to study treatment and agree to stay on through trial. 3. uct \< 12 during the 14 days prior to treatment. 4. positive provocation test 1. for coldu patients: developing a wheal at the test site within 10 min after using temptest® at any temperature at both screening (visit 1) and randomization (visit 3) 2. for sd patients: developing a wheal at the test site within 10 min after using frictest® with ≥ 3 pins at both screening (visit 1) and randomization (visit 3) 5. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. 6. willing and able to complete a daily symptom electronic diary and comply with study visits. key exclusion criteria: 1. women who are pregnant or nursing. 2. active chronic spontaneous urticaria or other forms of cindu besides coldu or sd that may interfere with study assessments. 3. active, pruritic skin condition in addition to cindu. 4. medical condition that would cause additional risk or interfere with study procedures. 5. known active hiv, hepatitis b or hepatitis c infection. 6. vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). inactivated vaccines are allowed such as seasonal influenza injection or covid-19 vaccine. 7. history of anaphylaxis there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159 barzolvolimab
the effect of different schedules of functional task practice for improving hand and arm function after stroke

Conditions: Cerebrovascular Accident; Hemiplegia

Summary: the first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. the second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.

intense skill practice with the affected arm after stroke has the potential to improve upper extremity (ue) function resulting from neuroplastic changes in the motor cortex. however, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. delineation of the most efficacious and efficient therapy for promoting ue recovery post-stroke is necessary before effective clinical implementation of this therapy. in this study, using parallel group design methodology, we will test the effect of 2 practice parameter (i.e. spacing of practice and number of repetitions per task practiced per session) modifications on ue function following skill practice. forty subjects will complete multiple baseline testing and then be randomized, using random number table, to one of 4 groups: condensed functional task practice modeled after constraint-induced movement therapy (6 hours of practice/day, 5 days/week, 2 weeks), condensed functional task practice with a restricted number of tasks practiced, distributed, distributed functional task practice (monday, wednesday, friday, 6 hours/session, 10 sessions), distributed functional task practice with a restricted number of tasks practiced. during therapy sessions, subjects will practice performing common activities with their paretic upper extremity. they will wear a mitt on their non-paretic upper extremity for up to 90% of their waking hours. post-testing sessions will follow within one week of completing therapy with an additional follow-up testing session 3 months later.

Eligibility criteria:
inclusion criteria: * hemiparesis due to unilateral stroke at least 3 months prior * 18-90 years of age * able to extend the paretic wrist 200 and at least 1 finger 100 * able to follow 2-step commands * score \< 3 on the motor activity log amount of use scale exclusion criteria: * have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy * have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.

Keywords: motor skills occupational therapy physical therapy techniques rehabilitation upper extremity stroke
a study to investigate the effect of a natural dietary supplement on peri-menopausal symptoms

Conditions: Menopause

Summary: this is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.


Eligibility criteria:
inclusion criteria: * age group between 45 and 65 at the time of informed consent. * physician diagnosis of menopause. * history of substantial hot flashes \> 4 episodes /day for last 2 weeks. * being post-menopausal with an intact uterus. * subject has provided signed and dated written informed consent before admission to the study. exclusion criteria: * concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit. * women currently or previously on anticoagulants, vitamin k antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future. * women involved in other clinical studies within the last 30 days. * any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
oral health education and message framing effect on oral health status of refugees in egypt

Conditions: Knowledge, Attitudes, Practice; Caries,Dental; Plaque, Dental; Gingivitis; Pocket, Periodontal

Summary: refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. oral health is considered a prominent factor that contributes to quality of life. therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in alexandria, egypt. a three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. the primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. in addition, oral health knowledge, attitudes, and practices of refugees will be assessed.


Eligibility criteria:
inclusion criteria: * refugees older than 18 years old. * from arabic speaking countries. * has been resident in alexandria, egypt for at least 6 months. * having mobile phones to receive text messages. * agrees to participate in the study. exclusion criteria: * planning to move away during 1 year study period. * participating in any kind of oral health education and promotion programs.

Keywords: dental caries plaque kap gingivitis
treatment of chronic cluster headache with tens and ons

Conditions: Chronic Cluster Headache; Primary Headache Disorder; Headache; Cluster Headache; Pain; Cephalgia; Trigeminal Autonomic Cephalgia

Summary: the study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (tens) and occipital nerve stimulation (ons) on attack frequency and severity in patients with chronic cluster headache (ch). study outline month 1: baseline. establishment of a baseline profile of the participants ch attacks (severity, duration, medicine utilization etc), health-related quality of life (qol) and symptoms of anxiety and depression. no active treatment. follow-up visit after 30 days. months 2-4: tens period. all participants will receive tens-treatment. clinical follow-up visit by the end of month four. months 5-7: double-blinded, randomized experimental period. all participants will have an ons-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ons or 2) placebo (deactivated ons system). clinical follow-up visit by the end of month seven. months 8-10: open label period. all participants will receive tonic (conventional, paresthesia-inducing) ons. clinical follow-up visit by the end of month ten. during every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.


Eligibility criteria:
inclusion criteria: 1. age 18 years and above 2. signed informed written consent 3. diagnosed with chronic ch according to the ichd-3 criteria 4. 15 or more ch attacks per month 5. stable use of preventive headache medication one month prior to enrollment exclusion criteria: 1. other ongoing neuromodulation therapy 2. current alcohol and/or drug abuse 3. severe psychiatric disorder 4. other chronic primary or chronic secondary headache disorder (e.g. chronic migraine) 5. major posterior neck surgery in c2-c3 level and above 6. pregnancy 7. treatment with oral steroids or gon injection within one month of study participation

Keywords: occipital nerve stimulation neuromodulation transcutaneous electrical nerve stimulation
evaluation of safety and tolerability of fetal mesencephalic dopamine neuronal precursor cells for parkinson's disease

Conditions: Idiopathic Parkinson Disease; Primary Parkinsonism

Summary: the purpose of clinical trials is to evaluate safety and tolerability of fetal mesencephalic dopamine neuronal precursor cells as a treatment for patients with parkinson's disease.

this study is phase i/ii clinical trials which is accessible to those involved in the study and conducted by only bundang cha hospital. the progress of the clinical trails is reported to and evaluated by data monitoring committee before the enrolment of next human subject.

Eligibility criteria:
inclusion criteria: 1. female patients with idiopathic or primary parkinson's disease 2. hoehn and yare (hy) stage iii or iv 3. more than 33% improvement part iii updrs score after one injection of levodopa in the morning 4. patients aged less than 70 5. great decrease of dopamine uptake in putamen, particularly posterior part, in positron emission tomograph(pet) before surgery exclusion criteria: 1. atypical or secondary parkinsonism 2. medical history of severe depression with beck depression inventory(bdi) scores greater than 30 3. psychological disorders (illusion, delusion, schizophrenia) 4. dementia with k-mmse(korean mini-mental state examination) scores less than 24 5. epilepsy 6. medial history of brain surgery 7. medical history of other brain diseases 8. hemorrhagic tendency 9. severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer 10. experience of participating in clinical trial within 30 days 11. female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls 12. pregnant or lactating women 13. patients who are not considered to be eligible to participate in clinical trial
evaluation of hospital readmissions among hospitalized non-valvular atrial fibrillation (nvaf) patients in the us

Conditions: Nonvalvular Atrial Fibrillation

Summary: the overall objective of this proposal is to execute a real-world database analysis to evaluate hospital readmissions among hospitalized nonvalvular atrial fibrillation (nvaf) patients in the u.s primary objective: to determine the proportions of nvaf patients with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of nvaf patients treated with the new oral anticoagulants (noacs), dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting secondary objectives: * to determine the cost associated with bleeding-related hospital readmissions that occur within 30 days of the hospitalization of nvaf patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting * to determine the proportions of nvaf patients with all cause hospital readmissions and the associated costs that occur within 30 days of the hospitalization of nvaf patients treated with dabigatran, rivaroxaban, apixaban or warfarin in the inpatient setting.


Eligibility criteria:
inclusion criteria: * have a primary or secondary diagnosis of af identified by international classification of diseases, ninth revision, clinical modification (icd-9-cm) codes from the premier hospital database between january 1, 2012 and december 31, 2013 * age 18 years or older as of initial hospitalization with af diagnosis exclusion criteria: * have any primary or secondary diagnosis code or procedure code for valvular disease during the study period. this exclusion criterion is consistent with that used in other previous bms heor studies and is used to ensure that the study populations are nvaf patients * received multiple types of noacs during the index hospitalization. preliminary analysis showed that very few patients receive multiple types of new oral anticoagulants (noacs) during the same hospitalization. this exclusion criterion will allow to cleanly group patients into the different noac usage groups

Keywords: anticoagulation