Kornimate/medical-research-clean huggingface dataset:
to determine if diphenhydramine works for nasal congestion at two different doses

Conditions: Nasal Congestion

Summary: the study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in phase of the study on day -7 (prerandomization, visit 1). baseline symptom scores were established during this run-in phase. subjects with moderate nasal congestion who took at least 80% of their study medication during the run-in phase were eligible for enrollment in the two-week double-blind phase of the study and were randomized on day 1 (randomization, visit 2). they were treated for two weeks with their assigned medication. the severity of signs/symptoms were evaluated by the subjects every morning and night and by the investigator at each visit on day 7 and day 14. in addition, the subject and investigator provided a global evaluation of response to treatment on day 7 and day 14. safety was evaluated by adverse events reported during the study, vital signs, and the incidence of somnolence.

Eligibility criteria:
inclusion criteria: * otherwise healthy males and females * 12 to 65 years of age * hypersensitivity to specific pollens for a minimum of 2 years prior to study start * appropriate sar sign/symptoms scores exclusion criteria: * pregnancy, lactation and contraception issues * contraindicated medications or therapies * evidence of clinical, dietary, lifestyle or psychiatric issues, which in the opinion of the investigator, could increase the risk to the subject or research staff, or interfere with the interpretation of study results

Keywords: seasonal allergic rhinitis, nasal congestion
natural history of coronary atherosclerosis

Conditions: Coronary Artery Disease Progression; Radial Wall Strain; Atherosclerotic Lesion; Optical Coherence Tomography

Summary: the present study sought to explore the predictive value of radial wall strain (rws, derived solely from angiograms) for coronary artery lesion progression compared with lesion vulnerability assessed by optical coherence tomography (oct). the lesion progression at 1 year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary angiography (qca) evaluation.

the recently developed angiography-derived maximum rws (rwsmax) was computed as the maximum deformation of lumen diameter throughout the cardiac cycle, expressed as a percentage of the largest lumen diameter. this approach offers a quantitative assessment of the biomechanical attributes of coronary lesions. consequently, it allows for the identification of lesion vulnerability, potentially compensating for the limitations of intravascular imaging in assessing lesion stability and optimizing strategies for identifying high-risk vulnerable plaques in patients. in the present multicenter, prospective cohort of individuals with acute myocardial infarction, we assessed the predictive significance of identifying vulnerable lesions using an rwsmax threshold of ≥13%. the investigation aimed to determine the capacity of these identified lesions to predict the progression of the disease at 1 year. furthermore, the study validated that predictive capacity of rwsmax was on par with, and not inferior to, lesion vulnerability assessed by oct in tracking lesion progression.

Eligibility criteria:
inclusion criteria: * general inclusion criteria: 1. age ≥18 years 2. acute myocardial infarction ≤ 45 days 3. planned coronary angiography examination or potential interventional treatment * angiographic inclusion criteria: 1. the presence of at least 1 non-flow-restricting lesion (visually estimated diameter stenosis: 30%-80%; qfr \> 0.80) in any non-infarct related artery with rvd ≥2.5 mm by visual assessment exclusion criteria: * general exclusion criteria: 1. cardiogenic shock 2. pregnant or woman of child-bearing potential 3. life expectancy less than 1 year for non-cardiac causes 4. unable to tolerate contrast agents or anticoagulant/antiplatelet therapy 5. prior cabg or planned cabg * angiographic exclusion criteria: 1. poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to qfr or rws measurement 2. an interrogated lesion require surgical bypass grafting 3. unable to judge culprit lesion or infarct-related artery according to current evidence
imiquimod 5% cream in plaque-type morphea: a pilot, prospective open-label study

Conditions: Morphea

Summary: localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . we propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. twenty adults will be enrolled for a pilot study. a screening and baseline clinic visit will be required for each patient enrolled in the study. each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. one morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. patients will be asked about side effects (local and systemic). patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).


Eligibility criteria:
inclusion criteria: * adults and children \> 6 years with plaque-type morphea * subject has not participated in previous study involving imiquimod for three months * in the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment * subject has provided informed written consent * female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment * sexually active subjects agree to practice effective birth control throughout the duration of the study exclusion criteria: * patients with a non-morphea skin disorder in the region of interest * subjects previously undergoing morphea therapy within four weeks of the study * subjects have a known hypersensitivity to imiquimod or component of the cream preparation * subjects who are pregnant or nursing

Keywords: localized scleroderma
prospective evaluation of breast cancer at brazilian institutions - project amazona iii

Conditions: Breast Cancer

Summary: the principal goal of this study is to describe the epidemiology of breast cancer in the brazilian population

the principal goal of this study is to describe the epidemiology of breast cancer in the brazilian population. other specific goals are: * to evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history. * characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, her2, ki67. * describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis. * describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy. * describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others. * evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan. * evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events. * analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.

Eligibility criteria:
inclusion criteria: * woman ≥ 18 years old * invasive breast cancer stage i to iv proven by histology or cytology * patients with new pathological diagnosis of invasive primary bc after the site activation date * pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included) * new primary cancer on the same breast or contralateral breast. * patient's medical chart is available and adequate for data collection * patient properly signed the informed consent form

Keywords: breast cancer
choep + high dose therapy + auto sct for t-cell lymphoma

Conditions: T-cell Non-Hodgkin Lymphoma

Summary: the current standard of care for the frontline treatment of peripheral t-cell lymphomas (ptcl) is induction chemotherapy followed by autologous stem cell transplantation (asct). however, many patients are unable to get to asct or relapse after asct, with a poor prognosis. recently, a novel asct conditioning regimen of gemcitabine, busulfan and melphalan (gem/bu/mel) has been reported to lead to favorable outcomes in this disease. we therefore designed a frontline regimen of choep induction followed by gem/bu/mel asct, and report the results of a phase 2 study of this regimen in patients with ptcl.

objectives: primary * to estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy secondary * to estimate the response rate (complete remission (cr) and partial remission (pr)) after choep x 6 and after gem/bu/mel asct * to estimate overall survival (os), progression-free survival (pfs), cumulative incidence of relapse (cir), and non-relapse mortality (nrm) * to estimate the toxicity (grade 3 and above) * to estimate the rate of successful stem cell mobilization after choep in responding patients * to estimate the proportion of patients who can successfully complete the entire treatment regimen * to estimate the time to engraftment of neutrophil and platelet engraftment after asct * to determine whether tumor dna can be detected in peripheral blood of patients before therapy * to evaluate the changes and prognostic relevance in detectable tumor dna in peripheral blood after induction chemotherapy (choep) and after gem/bu/mel asct

Eligibility criteria:
inclusion criteria: * diagnosis of t-cell lymphoma with mandatory pathologic review at brigham and women's hospital or massachusetts general hospital * measurable disease * candidate for autologous stem cell transplant exclusion criteria: * prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of chop or up to 2 prior cycles of choep) * pregnant or breastfeeding * alk-positive acl * significant neuropathy precluding vincristine administration * known hypersensitivity to any of the agents used in the treatment * uncontrolled intercurrent illness * receiving other investigational agents * history of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin * hiv positive on anti-retroviral therapy

Keywords: t cell lymphoma
mechanisms of mindfulness intervention：rumination behavioral experiments

Conditions: Emotional Distress

Summary: this study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress

in recent years, mindfulness-based interventions (mbis) have seen extensive application in both clinical and non-clinical settings. studies show that mindfulness training improves emotional regulation and processing, contributing to better emotional health. mbis have proven effective in reducing anxiety and depression among patients with conditions like multiple sclerosis, enhancing personal well-being, and alleviating chronic pain. given the mounting evidence supporting its benefits, mbis have become widely adopted across various settings. nonetheless, the precise mechanisms through which mindfulness alleviates emotional distress remain poorly understood. rumination, a transdiagnostic process, plays a critical role in the development and persistence of emotional distress. empirical evidence supports the effectiveness of mbis in reducing rumination. however, the role of rumination in mediating the effects of mbis on emotional distress remains inconsistent across studies. kazdin (2007, 2009) outlined criteria for evaluating mechanisms and mediators, yet existing studies lack sufficient evidence to meet these standards. this study aims to explore the mechanistic role of rumination using behavioral experiments, focusing on the consistency criterion

Eligibility criteria:
inclusion criteria: * - subjects with scores greater than 21 on the kessler psychological distress scale. * - aged 18-55 years old. exclusion criteria: * - subjects who could not access the internet; * - subjects with insufficient chinese ability; * - subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week; * - subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder; * - subjects with high risk of suicide.
effect of pectoral nerve block on post-op pain in patients undergoing mastectomy and immediate reconstruction

Conditions: Breast Neoplasm

Summary: patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block. post-operative pain, nausea/vomiting scores will be assessed.

patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block after induction of general anesthesia and prior to the start of surgery. post-operative pain scores and post-operative pain medication usage will be recorded. post-operative nausea/vomiting scores and post-op anti-emetic medication usage will be recorded. the clinical impact of pectoral nerve block on this expanding population of patients will be determined.

Eligibility criteria:
inclusion criteria: 1. patients age 18-90 years old 2. subjects able to read and understand the informed consent 3. american society of anesthesiologists (asa) physical status i and ii 4. subjects scheduled to undergo unilateral or bilateral mastectomy with immediate breast reconstruction with submuscular placement of tissue expander or permanent implant under general anesthesia, including: * subjects diagnosed with breast cancer * subjects diagnosed with atypia or other high risk proliferative breast disease * subjects with a family history who are considered at high risk for breast cancer (including those with hereditary or genetic predisposition) exclusion criteria: 1. subjects unable to read or understand the informed consent 2. asa physical status iii or iv 3. subjects with an allergy to local anesthetic 4. subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection 5. subjects with a pre-existing submuscular implant 6. subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction 7. subjects scheduled to undergo mastectomy without immediate reconstruction 8. subjects with a history of chronic pain or chronic opioid use
transcranial magnetic stimulation (tms) for crps

Conditions: Complex Regional Pain Syndrome (CRPS)

Summary: the purpose of this pilot study is to test the durability of response to transcranial magnetic stimulation (tms) for the symptoms of complex regional pain syndrome (crps). the investigators will test various methods of tms for varying lengths of time in a pilot study to investigate what the clinical impact.


Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of crps (complex regional pain syndrome) * average pain level reported on numerical rating scale meets entry criteria * ability to perform the experimental task and procedures. exclusion criteria: * mri contraindication (metal implants or devices, claustrophobia) * tms contraindication (eg metal implant or devices near the site of stimulation) * history of epilepsy * history of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. * neurologic illness that would interfere with brain integrity * current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. * currently pregnant or planning to become pregnant. * on going legal action or disability claim.
intra-operative radiotherapy for women with ductal carcinoma in situ breast cancer

Conditions: Breast Neoplasms

Summary: whether the patients with low grade ductal carcinoma in situ breast cancer should accept radiationtherapy is uncertain.radiation therapy uses high-energy x-rays to damage tumor cells. giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.the clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.the clinical trial is conducting to find out the effectiveness of radiation therapy during surgery in treating women who have undergone breast-conversing surgery for low grade ductal carcinoma in situ breast cancer.

Eligibility criteria:
inclusion criteria: * tumor diameter \< 5 cm * low grade ductal carcinoma in situ * candidate for breast-conserving surgery * must have undergone lumpectomy with negative margins or minimal margin involvement * currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection * no evidence of metastatic disease * informed consent exclusion criteria: * no informed consent * tumor size \> 5 cm * intermediate or high grade ductal carcinoma in situ * invasive carcinoma * no indication for a boost

Keywords: intermediate and high grade ductal carcinoma in situ （dcis）
iotasoft pediatric study

Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Unilateral

Summary: prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotasoft insertion system when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.


Eligibility criteria:
inclusion criteria: * candidate for unilateral or bilateral cochlear implantation according to indications for use with fda approved cochlear implant devices * age 9 months to less than 12 years old at the time of ci surgery * willingness to participate in the study and able to comply with the follow-up visit requirements exclusion criteria: * prior cochlear implantation in the ear to be implanted * ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion * craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations * deafness due to lesions of the acoustic nerve or central auditory pathway * diagnosis of auditory neuropathy. * active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease * absence of cochlear development * additional medical concerns that would prevent participation in evaluations as determined by the investigator * planned or current participation in a clinical study of an investigational device or drug
to evaluate the safety and efficacy of acetaminophen 650 mg and 1000mg in dental pain after surgery

Conditions: Pain

Summary: the objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

this trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Eligibility criteria:
inclusion criteria: * must be at least 16 and less than 51 years of age * must weigh at least 100 lbs with a body mass index of at least 18 and less than 30 * must have up to four of their back teeth (third-molars) pulled exclusion criteria: * cannot be allergic to acetaminophen (tylenol) * cannot be pregnant (or planning to be pregnant) or nursing a baby * cannot have any other medical conditions that the investigator determines might compromise your safety or the study results
the influence of prn omega-3 nutritional supplement on visual acuity

Conditions: Cataract, Dry Eye Disease

Summary: this is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the prn omega-3 nutritional supplement in subjects undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * presence of nuclear or cortical lens opacities in one/both eyes * physician diagnosis of age related cataract * good overall physical constitution * all participants must be follow the same regimen for surgery related medications, both pre and post surgery. (antibiotic, nsaid and steroid eye drops) exclusion criteria: * subjects requiring premium iols/multifocal implants * advanced cataract * severe age-related macular degeneration presence or history of glaucoma * presence or history of diabetes mellitus * any retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc * vision loss due to central retinal artery occlusion or central retinal vein occlusion * vision loss due to presence of large pituitary tumors or aneurysms * vision loss due to optic tract lesions * vision loss due to bleeding into aqueous or vitreous chamber * vision loss due to drug toxicity: amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen * major cardiovascular or cerebral events in the past 12 months * allergy to fish oil or safflower oil * pregnancy or lactation at any time during the study * newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of screening or at any time during the study * participation in any other study involving an investigational drug or device within the past 30 days