Kornimate/medical-research-clean huggingface dataset:
shr-a1811 and thpy in first or second line for her2 positive advanced breast cancer brain metastases

Conditions: Breast Cancer

Summary: the aim of this project is to evaluate whether the sequence of trastuzumab，pyrotinib and nab-paclitaxel in first line followed by shr-a1811 in second line is superior to the sequence of shr-a1811 in first line followed by trastuzumab，pyrotinib and nab-paclitaxel in second line for her2 positive breast cancer brain metastases.


Eligibility criteria:
inclusion criteria: 1. females ≥18 yrs old 2. pathologically confirmed her2-positive advanced breast cancer; 3. newly diagnosed brain metastes,at least one measurable intracranial lesion 4. not received any systemic treatment for advanced stage 5. radiotherapy was allowed in patients with an urgent need for control of intracranial symptoms 6. adequate function of major organs 7. willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up. exclusion criteria: 1.has leptomeningeal metastasis or cystic metastatic lesions confirmed by mri or lumbar puncture; 2.existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage; 3.has received whole brain radiotherapy, chemotherapy, surgery within 2 weeks before first dose of study therapy; 4.has known clinically significant lung disease, that is, moderate-to-severe lung disease which severely affects respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonitis. prior ≥ grade 3 interstitial lung disease is not allowed to enrolment; 5.has received full-dose anticoagulants or thrombolytics within 10 days before enrolment, or non-steroid anti-inflammatory drugs with platelet inhibition 6.previous treatment with trastuzumab deruxtecan (ds-8201a) or any other antibody drug conjugate (adc) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 7.participated in other drug clinical trials within 4 weeks before admission; 8.other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. -

Keywords: breast caner her2 positive
management of pain in lumbar arthrodesis

Conditions: Pain, Postoperative

Summary: ketamine and dexametasone in the management of pain in lumbar arthrodesisphase iv prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

the need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.

Eligibility criteria:
inclusion criteria: * male or female * age\> 18 years * asa i-iii. * lumbar arthrodesis. * patients who have signed the preoperative informed consent for participation in the study. exclusion criteria: * unstable coronary heart disease * glaucoma * history of allergy to ketamine, dexamethasone, or morphic chloride * dementia or inability to understand ic and study * pluricomplicated diabetes mellitus difficult to control * patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
gingival depigmentation by diode laser

Conditions: Laser-induced Hypopigmentation

Summary: physiologic gingival pigmentation(pgp) is the most common type of gingival pigmentation and cosmetic concern particularly in gummy smile patients. laser therapy is an effective and noninvasive treatment option. the aim of this study was to evaluate the efficacy of diod laser on the treatment of pgp in patients.

preoperative and postoperative photographic and clinical observations about the gingival melanin pigmentation were made according to dummett-gupta oral pigmentation index scoring criteria given by dummett c.o. in 1964 the investigators classified pigmented gingiva in patients as: 1. mild:pink to slightly brown 2. moderate:deep brown or black 3. severe:mixed in color score in each tooth was taken including one full inter dental papilla. observations were made in natural light. the assessment of the scoring of the pigmentation index were done by all the three examiners, and the agreed upon score was assigned to prevent individual variations. the investigators compared the intensity of pigmentation in each patient in recall sessions after 1month and 3mounth postoperative.

Eligibility criteria:
inclusion criteria: * 19 adult patients who had been referred to oral medicine department of shahid beheshti dental school with the chief complaint of melanin pigmentation were selected for inclusion in this study. exclusion criteria: 1. hyperpigmentation that was associated with systemic disease or drug administration,disease that could compromise wound healing (uncontrolled diabetes, autoimmune disease) 2. pregnancy or lactation 3. evidence of relationship between hyperpigmentation and malignancy 4. history of previous treatment of hyperpigmentation 5. smoking 6. periodontal problems
study 3: minocycline decreases microglia activation

Conditions: Hypertension

Summary: this study is a mechanistic study that will enroll 9 subjects who are participating in nct02133885 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in pet and mri imaging.

this study will recruit 9 subjects from nct02133885 who will agree to undergo additional autonomic testing and imaging studies at baseline and after 3-6 months of study treatment. specialized imaging of the brain using magnetic resonance imaging (mri) and positron emission tomography (pet) scanning will be conducted at the montreal neurological institute, in montreal canada.

Eligibility criteria:
inclusion criteria: * subjects participating in irb approved protocol #102-2013 will be eligible to participate. * (for study 3 participants only) willing to travel to montreal, canada for specialized imaging of the participant's brain using magnetic resonance imaging (mri), positron emission tomography (pet) scanning, autonomic nervous system testing and blood drawing- if participant qualifies exclusion criteria for control and resistant hypertensive subjects include: * currently pregnant or have been pregnant in the last 6 months; * antibiotic treatment within 2 months of study enrollment; * currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications); * unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection); * history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.

Keywords: resistent hypertension
tvmr with the innovalve system trial - twist-be twist-pilot-be

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Summary: study to evaluate the safety and performance of the innovalve mitral valve replacement system


Eligibility criteria:
inclusion criteria: * clinically significant, symptomatic mitral regurgitation * high risk for open-heart surgery * meets anatomical criteria exclusion criteria: * unsuitable anatomy * patient is inoperable * ef \<30%
16 week efficacy and 5 year long term efficacy, safety and tolerability of secukinumab in patients with active ankylosing spondylitis

Conditions: Anklyosing Spondylitis

Summary: this study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to nsaids, dmards and / or tnfα inhibitor


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female patients * diagnosis of moderate to severe as with prior documented radiologic evidence (x-ray) fulfilling the modified new york criteria for as (1984) * patients should have been on nsaids with an inadequate response * patients who were regularly taking nsaids as part of their as therapy are required to be on a stable dose * patients who had been on an anti-tnfα agent (not more than one) must have experienced an inadequate response exclusion criteria: * chest x-ray (or mri) with evidence of ongoing infectious or malignant process * patients with total ankylosis of the spine * patients previously treated with any biological immunomodulating agents except for those targeting tnfα * previous treatment with any cell-depleting therapies

Keywords: ankylosing spondylitis as chronic inflammatory disease inflammatory back pain secukinumab prefilled syringe pfs subcutaneous injection ain457 ain457f ain457f2310 adult
social cognition in patients with amyotrophic lateral sclerosis

Conditions: Social Cognition

Summary: amyotrophic lateral sclerosis, also known as charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. the clinical hallmark of amyotrophic lateral sclerosis is the combination of upper and lower motor neuron signs and symptoms. the most recent studies suggest that up to 50% of amyotrophic lateral sclerosis patients demonstrate mild to moderate cognitive disturbance. impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of amyotrophic lateral sclerosis, with crucial implications for patients' and caregivers' training. however, studies remain scarce and the data acquired must be supported. the evolution of these manifestations during the disease is still poorly understood. in this study the investigators aim to assess the social cognition capacities of patients with amyotrophic lateral sclerosis compared to healthy matched control subjects.


Eligibility criteria:
inclusion criteria: patient amyotrophic lateral sclerosis : * education of at least 7 years * native language: french * patients amyotrophic lateral sclerosis * signature of informed consent to participate in the study * accompanied patient control subject : * people without any pathology * education of at least 7 years * native language: french * signature of informed consent to participate in the study exclusion criteria: patient amyotrophic lateral sclerosis and control subject : * simultaneous participation in another interventional protocol with experimental treatment * inability to perform cognitive study tests * pregnant, lactating or parturient women * persons deprived of their liberty by administrative or judicial decision * persons under psychiatric care under duress * persons subject to legal protection measures * persons out of state to express their consent * people not affiliated or not beneficiaries of a social security scheme * history likely to disturb cognition
local sensory nerve block in the treatment of vestibular migraine

Conditions: Vestibular Migraine

Summary: there is no standard approach to the treatment of vestibular migraine. agents used in the treatment of migraine are frequently used. in treating migraine, local anesthetic agents, nerve-blocking methods, and botulinum toxin local injection is commonly applied, and successful results are obtained. adapting the nerve-blocking method used in the treatment of migraine to the treatment of vestibular migraine is the purpose of the study.

patients between 18-75 diagnosed with/without aura or chronic migraine according to ihcd-3 diagnostic criteria and who describe dizziness during or between attacks will be evaluated in the ent clinic. patients included in the study will be recorded as definite vestibular migraine or probable vestibular migraine according to criteria defined in the barany community and ihcd-3. differential diagnosis of vertigo will be made with pure tone audiometry, caloric test, vhit, videonystagmography, and cvemp. midas (migraine disability scale), dhi (dizziness handicap inventory), vss (vertigo symptom scale), dasö-21 anxiety test, and allodynia symptom checklist (askl) forms will be filled. patients will be randomly divided into two groups. patients in the control group will be given beta-blocker therapy, the standard treatment. the local anesthetic agent bupivacaine will be injected into the greater/small occipital nerves and supratrochlear/ supraorbital nerves. patients in the study group will be asked to keep a diary of pain, dizziness, and painkiller use for one month. at the end of the 1st month, the scoring will be repeated, and the patients who show a decrease in half will be accepted to the next stage, botulinum toxin application. bont/a botulinum toxin a (botox; allergan) will be injected bilaterally into the same regionns. all scoring will be repeated in the 1st, 3rd and 6th months.

Eligibility criteria:
inclusion criteria: * vestibuler migraine(ihcd3) * probable vestibular migraine (ihcd3) exclusion criteria: * systemic disorders unsuitable for injection administration * keloidal scarring * neuromuscular disorders * botulinum toxin allergies * body dysmorphic disorder * pregnancy * breastfeeding * amyotrophic lateralizing sclerosis myopathies
skin tracker: a mobile health app to monitor skin disease activity and treatment use

Conditions: Atopic Dermatitis; Eczema

Summary: design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis.

mobile health technology, including smartphone apps and wearable monitors, has tremendous potential to transform clinical research. recording of patient outcomes on a smartphone device and camera in the home setting can greatly reduce the number of in person research visits, saving tremendous costs, time, and effort associated with data entry. this also allows for easier recruitment of study subjects, who can be enrolled in geographic locations beyond academic research centers. after fda approval of a therapy, mobile health technology can help researchers understand how that particular therapy is being used in a real-world setting, including frequency of use, adverse events, and impact of use on disease symptoms and patient quality of life. in this study, the investigators will create a mobile app to help the atopic dermatitis community understand the types of data and quality of data that can be gathered from atopic dermatitis patients longitudinally. a review of existing atopic dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able to fully capture high-quality research data. the investigator proposed app is specifically geared for research, and thus fills an important gap. the research team will develop skintracker, a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting.

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and comply with the protocol. 2. at least 13 years of age. 3. diagnosis of atopic dermatitis by dermatologist for at least 6 months. 4. physical exam within clinically acceptable limits. 5. own or have access to a mobile device that is compatible with study mobile application skintracker. exclusion criteria: 1. subject is unable to provide written informed consent or comply with the protocol. 2. unable to input data into skintracker mobile app. 3. subject is younger than 13 years of age. 4. serious known infection. 5. history of immunosuppression (including human immunodeficiency virus (hiv)). 6. history of malignancy within 5 years prior to screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. 7. severe concomitant illness. 8. physical exam not within clinically acceptable limits. 9. subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere
a multiple-dose study of rhumab 2c4 and docetaxel in the treatment of advanced solid tumors

Conditions: Solid Tumor

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhumab 2c4 (perjeta) and docetaxel (taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. participants will be enrolled and evaluated for dose-limiting toxicities (dlts) in escalating-dose cohorts in order to determine the maximum tolerated dose (mtd).


Eligibility criteria:
inclusion criteria: * adults at least 18 years of age * easter cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy at least 12 weeks * locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy * human epidermal growth factor receptor 2 (her2)-negative among participants with breast cancer * negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential * adequate hematologic, hepatic, and renal function * signed informed consent, histologically or cytologicall confirmed advanced solid tumor, adequate cardiac function as documented by lvef \>50% by echo or muga exclusion criteria: * clinical evidence of central nervous system (cns) metastases * prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study day 1 * history of neuropathy grade 2 or worse, or any unresolved residual chemotherapy effects * prior her2-active agents or docetaxel * any investigational agent within 28 days of study drug * prior cumulative doxorubicin dose greater than (\>) 360 mg/m\^2 or equivalent * significant cardiovascular disease * active/uncontrolled concurrent illness or infection- * major surgery or trauma within 4 weeks of study day 1
study to assess the efficacy of anti-bet v 1 monoclonal antibodies in adults to reduce symptoms of seasonal allergic rhinitis

Conditions: Allergic Rhinitis; Conjunctivitis

Summary: the primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (csms) during birch pollen season after a single dose of regn5713-5714-5715 versus placebo.


Eligibility criteria:
key inclusion criteria 1. documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years 2. positive skin prick test (spt) with birch pollen extract in the screening period, as defined in the protocol 3. positive allergen-specific ige (sige) tests for birch pollen and bet v 1 in the screening period, as defined in the protocol 4. willing and able to comply with clinic visits and study-related procedures key exclusion criteria: 1. participation in a prior regn5713-5714-5715 clinical trial 2. recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator 3. participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator 4. persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. participants may be re-evaluated for eligibility after symptoms resolve 5. documentation of active sars-cov-2 infection, as defined in the protocol 6. a clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year 7. history of birch allergy immunotherapy as defined in the protocol 8. use of anti-ige or other biological therapy in treatment of asthma or allergy within 6 months prior to screening note: other protocol defined inclusion/exclusion criteria apply

Keywords: birch allergy
quantification of balance in acutely concussed athletes

Conditions: mTBI; Concussion; Mild Traumatic Brain Injury

Summary: the purpose of this pilot project is to determine whether using inertial sensors placed on the waist during routine clinical balance testing (i.e. balance error scoring system) (bess), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild traumatic brain injury (mtbi). the investigators are also trying to observe if the sensors can be used to detect balance recovery after a mtbi. the investigators hypothesis is that collegiate atheltes with mtbi injury will have different recovery periods between their cognitive testing(impact) and their balance measures.

the purpose of this pilot project is to determine whether using inertial sensors (ipod like device) placed on the waist during routine clinical balance testing (i.e. balance error scoring system (bess), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild traumatic brain injury (mtbi). the investigators are also trying to observe if the sensors can be used to detect balance recovery after a mtbi. the participants will be recruited through the local university's athletic department. the participants will undergo balance tests from the bess test while wearing a sensor around their waist.the bess consists of different balance tests; such as balancing on one leg and tandem standing. the participants will also answer questionnaires about their daily lives and cognitive tests. if the participant has had a mtbi they will complete questionnaires about symptoms from their injury and may perform an additional impact test which is a computerized cognitive tests used by coaches, athletic trainers and managing physicians. along with the clinical balance tests and questionnaires, the project will use a small sensor placed on the waist to detect sway during quiet stance. an automatic analysis will occur which will provide us with immediate feedback on how stable the participant is during testing.

Eligibility criteria:
inclusion criteria: * collegiate athlete exclusion criteria: * not a current collegiate athlete, * recent orthopedic surgery

Keywords: mtbi concussion mild traumatic brain injury athlete college football soccer