Kornimate/medical-research-clean huggingface dataset:
the effect of upneeq (oxymetazoline hydrochloride 0.1%) on eyelid position, eye redness, and eye appearance

Conditions: Ptosis, Eyelid; Conjunctiva Inflamed; Eye Manifestations

Summary: the purpose of the research is to see if upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.


Eligibility criteria:
inclusion criteria: * adults age 18 and above able to provide informed consent to participate * subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention exclusion criteria: * adults unable to consent * individuals less than 18 years of age * prisoners * pregnant women. * known contradictions or sensitivities to study medication (oxymetazoline) * ocular surgery within the past 3 months or refractive surgery within the past six months * grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery * variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm) * any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters * presence of an active ocular infection * prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents * inability to sit comfortably for 15 - 30 minutes
randomized controlled trial of percutaneous and intradermal bcg vaccination.

Conditions: Tuberculosis

Summary: an open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of japanese (tokyo) 172 bcg, in the prevention of tuberculosis during the first two years of life.

this is an open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of japanese (tokyo) 172 bcg, obtained from the bcg laboratory in tokyo, japan, in the prevention of tuberculosis, with bacteriological or histological confirmation, or meeting strict clinical criteria, during the first two years of life. the comparison of the two methods is necessary because the intradermal method is almost universally preferred, without direct evidence from a clinical trial. the intradermal method provides for more accurate dosing and produces a higher rate of tuberculin skin test conversion, but neither of these factors has been shown to correlate with efficacy of bcg vaccination. the percutaneous method is much simpler and, if shown to be equally effective, could become a preferred method. the japanese strain was chosen because it is the one commercially available strain produced for both intradermal and percutaneous administration, and because a seed lot from this strain was previously used to produce bcg for the south african bcg vaccination program.

Eligibility criteria:
inclusion criteria: 1. the child must be eligible to receive routine bcg vaccination. 2. the child must be born at one of the five hospitals taking part in the study and be a resident in the study area. 3. the mother must have had an opportunity to become informed about the study, either through pre-natal classes and a follow-up visit or, if time and the situation permits, after the mother presents at the hospital or birthing facility and before or after the child is born. 4. after being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form. exclusion criteria: 1. the mother fails to give informed consent. 2. the child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams). 3. the infant is hospitalized outside of the study area before vaccination has been given (e.g. transferred to a hospital in cape town because of respiratory distress).

Keywords: tuberculosis. children. vaccine. bcg.
effective measurement of risperidone treatment outcome for persons with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the objective of study a is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of berderline personality disorder (bpd)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. the secondary objective of this study (study b)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with bpd, the uab borderline rating scale(brs).

study a: an open-label, prospective trial of the efficacy and safety of risperidone in the treatment of bpd.the study is 8 weeks in duration, with a screening visit and follow-up visits at the end of weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. a full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. a psychosocial assessment will be conducted during the screen. study b: the ofjective is to validate the uab brs by administering the brs and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with bpd.

Eligibility criteria:
inclusion criteria: * diagnosis of bpd exclusion criteria: * any other axis i diagnosis except dysthymia, ptsd, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.

Keywords: risperidone
family-based intervention study of the effects of environmental exposures on breast tissue composition

Conditions: Breast Cancer Risk

Summary: this research study is being conducted to find out whether changes in household and personal behavior aimed at reducing exposure to environmental chemicals in dust (increased house dust removal efforts/cleaning and hand washing) and consumer products (increased us of personal care and beauty products that are free of chemicals including phthalates, parabens, and phenols) results in lower exposure to environmental chemicals including polycyclic aromatic hydrocarbons (pahs) and endocrine disrupting chemicals including phthalates, parabens and phenols. these chemicals may have harmful health effects, as they can interfere with normal functions of the body. this study will also assess changes in breast tissue composition to understand the role of environmental exposures in breast cancer risk.


Eligibility criteria:
inclusion criteria: * participant of columbia's breast cancer research and the environment (bcerp) study that recruited from the columbia children's center for environmental health (ccceh) mothers and newborns cohort. * mother did not smoke or use illicit drugs prior to or during pregnancy (referring to pregnancy for participating daughter). * mother was 18-35 years at time of daughter's delivery. * mother registered in the prenatal clinics by the 20th week of pregnancy. * mother free of diabetes, hypertension and reported hiv infection. * mother resided in northern manhattan or the south bronx neighborhoods of new york city for at least one year prior to pregnancy. * mother self-identified as african-american or dominican. * only participants in the ccceh birth cohort who answered in the affirmative to the question "i would like to be contacted about future studies" on the consent form of the mothers and newborns study will be contacted to participate in this intervention. exclusion criteria: • none

Keywords: breast cancer xenoestrogen household intervention
procalcitonin to shorten antibiotics duration in icu patients

Conditions: Sepsis

Summary: the trial is aimed to show that implementation of a procalcitonin-guided antibiotics algorithm may result in shortened antibiotics course in icu sepsis patients without inferior outcome as compared to the conventional therapy

the duration of antibiotic therapy in patients with sepsis is largely empirical. an extended treatment course for up to two weeks is a common practice for patients with sepsis in the icu, despite lack of evidence for this duration of therapy. procalcitonin (pct) is a new biomarker that has high negative predictive value for systemic bacterial infection. the purpose of this trial is to evaluate whether serial pct measurements can shorten antibiotic treatment duration in patients with sepsis in the icu. specific aims 1. to show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may result in shortened antibiotics course in icu sepsis patients 2. to show that implementation of a procalcitonin-guided antibiotics stewardship algorithm may not result in inferior outcome as compared to conventional therapy

Eligibility criteria:
inclusion criteria: * all patients with laboratory- or image-confirmed severe infection at admission or during stay in icu will be eligible for inclusion. definition of laboratory- or image-confirmed severe infection: 1. two or more of four signs of inflammation * temperature \> 38.3℃ or \< 36℃ * heart rate \> 90 beats/min * respiratory rate \> 20 breaths/min or paco2 \< 32 mmhg * wbc \> 12,000 cells/mm3, \ 10% bands 2. initial procalcitonin \> 0.5 ng/ml 3. presence of either laboratory or image evidence of infection laboratory evidence: sign of inflammation in urine, csf, ascites, pleural effusion or local abscess image evidence: compatible findings on chest x ray、ultrasound、ct、or mr image exclusion criteria: * age less than 20 years * known pregnancy * presence of dnr order * expected icu stay less than 3 days * neutropenia (anc count \< 500/mm3) * specific infections for which long-term antibiotic treatment is strongly recommended: lung abscess or empyema, bacterial meningitis, osteomyelitis, infective endocarditis, local abscess, mediastinitis

Keywords: procalcitonin sepsis icu antibiotic antibiotic duration antibiotic treatment duration
study of 2 doses of hrv vaccine given concomitantly with routine epi vaccinations including opv in healthy infants

Conditions: Infections, Rotavirus

Summary: the main objectives of this study is to determine vaccine efficacy against severe rotavirus (rv) gastroenteritis (ge) during the period starting from 2 weeks after dose 2 until one year of age.

the study has two groups: group hrv and group placebo. two oral doses administered to healthy infants who are 6-12 weeks of age at the time of dose 1, according to a 0, 1 to 2-month schedule. routine epi vaccinations are given at the discretion of the investigator and according to local national plans of immunisation schedule in each participating country.

Eligibility criteria:
inclusion criteria: * healthy infants 6 -12 weeks old at dose 1 with written informed consent. exclusion criteria: * allergic reaction to vaccine components; * clinically significant history of chronic gi disease (uncorrected gi congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; * immunocompromised.
the effect of dexmedetomidine on kidney function in evar

Conditions: Acute Kidney Injury; Dexmedetomidine; Endovascular Aortic Repair

Summary: this study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing evar under general anesthesia

this study will compare the incidence of aki after elective evar conducted under general anesthesia with and without administration of dexmedetomidine. the aki will be evaluated through measuring ngal and c-cystatin.

Eligibility criteria:
inclusion criteria: * elective evar under general anesthesia * adult patients 18- 85 years old * american society of anesthesiologists (asa) physical status i - iv exclusion criteria: * refusal to participate or sign the informed consent form * gfr \< 50ml/mim * bradyarrhythmia \<50/min * hemodynamic instability * known allergy to dexmedetomidine * severe hepatic insufficiency

Keywords: acute kidney injury, dexmedetomidine, evar
multimodal equipment for teleophthalmology assessment (meta)

Conditions: Eye Diseases

Summary: we have developed a multimodal equipment for teleophthalmology assessment (meta) device. this novel device is compact, portable and suitable for packaging and express delivery. with this device, there is a potential to implement a new concept of "hospital-at-home" eye care model. the present study is designed to validate the meta device for future clinical usage and investigation. we will compare the performance of the meta device with those provided by commercial devices in terms of image quality of optical coherence tomography (oct), anterior segment and fundus camera, and evaluate the level of agreement in lesion detection and quantitative measurements between meta and other commercial devices (e.g., heidelberg spectralis oct, haag-streit bq900 slit-lamp imaging, canon cr-2 fundus imaging, zeiss iol master 500).

the meta is an innovative and non-invasive examination instrument for a variety of common eye diseases. the integrated multimodality device combines digital slit lamp, fundus camera, oct, refractometer, optical biometry and visual acuity test (near and distance) that facilitate a comprehensive ophthalmic examination. in the current study, all participants will undergo the measurements provided by the meta and by traditional examination modalities (including digital slit lamp, fundus camera, oct, refractometer, optical biometry and visual acuity test) in a random order. the participants will need to complete several questionnaires to investigate their preference and confidence to receive the meta exams in the future.

Eligibility criteria:
inclusion criteria: * 18 years of age and older. * participants with healthy eyes, or patients diagnosed with one or more common eye diseases, including anterior segment eye diseases (conjunctivitis, keratitis, corneal opacity or cataract), fundus diseases (age-related macular degeneration or diabetic retinopathy) and/or refractive error (myopia, high myopia, hyperopia, anisometropia, or presbyopia). * willing and able to participate in all examinations related to this study * visual acuity of 20/400 or better in the study eye(s). exclusion criteria: * ocular trauma or postoperative eyes within 3 months. * study eye(s) with dilated pupil.
patterns of relapse after neoadjuvant chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: this study aims to identify patterns of relapse after neoadjuvant chemotherapy (nac) for breast cancer to refine follow up recommendations.

neoadjuvant chemotherapy (nac) is usually used to facilitate breast-conserving surgery and improve surgical outcomes for breast cancer patients \[1\]. in addition, nac can help to eradicate micrometastatic disease and serve to test chemosensitivity while providing similar survival benefits to adjuvant chemotherapy \[2-5\] . pathologic complete response (pcr) after neoadjuvant chemotherapy is associated with superior survival outcomes, with higher rates of pcr in human epidermal growth factor receptor 2 positive (her2+) and triple negative breast cancer (tnbc) subtypes compared to hormone receptor (hr)-positive subtypes \[6-7\] . patients who achieve pcr also remain at signifcant risk of relapse, with studies reporting 5-year disease-free survival (dfs) rates of 75-87% \[2,8-10\] . retrospective study of 88 japanese patients who achieved pcr reported a recurrence rate of 13.6% and all relapses occurred within 32 months from diagnosis \[11\]. there for, little is known about the patterns of relapse after nac especially in the real world. there are currently no specific guidelines for post-treatment follow-up of patients treated with nac and variations in practice exist. so, this study aims to evaluate the relapse risks in different subgroups of breast cancers treated with nac and determine the associated time trends and patterns of relapse in these patients. these findings may potentially lead to the development of risk-adapted surveillance strategies for patients treated with nac

Eligibility criteria:
inclusion criteria: 1. female patients aged \>= 18 2. pathologically proved breast cancer 3. ps 0-1 (ecog) 4. patients indicated to receive nac exclusion criteria: 1. patients with metastatic disease at diagnosis 2. patients who did not undergo subsequent curative intent surgery 3. those who received neoadjuvant hormonal treatment 4. those that had incomplete treatment information
sequential intensive chemotherapy followed by ric for refractory and relapse aml

Conditions: Acute Leukemia

Summary: patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell transplantation. in our previous retrospective study, the overall survival is 14.6+/-8.8% while 90% patients eventually relapsed with marrow ablative conditioning mostly standard iv-bu-cy or cy-tbi. the accumulated trm is 29.5+/-11.5%. thus our data suggested that the conventional transplantation approach may not be able to overcome the refractory disease. a new strategy to combined a low dose regimen following intensive chemotherapy for tumor reduction seems to be effect in both relapsed. high-risk and refractory aml or all. in this study, we focus on a new treatment strategy for particular refractory aml patients.

this is a single arm phase ii trial to test the efficacy and feasibility of new sequential intensive chemo and transplantation approach for refractory leukemia. patients with refractory acute myeloid or lymphoblastic leukemia are enrolled in this trial. patients will received intensive chemotherapy including fludarabine, cytarabine and idarubicin as (flag-ida). seven days after the chemotherapy, sequential transplantation conditioning regimen as fludarabine and busulfan will be given.

Eligibility criteria:
inclusion criteria: * adult patients with refractory or relapse acute myeloid leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse * age 16-60 years * with inform consent * no contraindication for allogeneic transplantation: active infection, allergy to flu/bu/ctx, liver and renal function damage * hla matched related (6/6) or unrelated donors (at least 8/10) exclusion criteria: * age less than 18 years or over 61 years * liver function/renal function damage (over 2 x upper normal range) * with mental disease

Keywords: feasibility, effective and safety intensive chemotherapy ric regimen refractory or relapse leukemia allogeneic stem cell transplantation
combination osteogenic therapy in established osteoporosis

Conditions: Osteoporosis, Post-Menopausal

Summary: this study is designed to determine if combining parathyroid (pth 1-34) with fluoride (mfpsr) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of pth therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

this is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. patients will be assigned to 1 of 3 groups: 1) pth 1-34; 2) fluoride; 3) pth and fluoride. the treatment period is 3 years with 3-month cycles of therapy. pth will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle.

Eligibility criteria:
* female, aged 60-80, * postmenopausal greater than or equal to 5 years, * bmd -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture. * vertebral fracture 0-1. exclusion criteria: * more than 1 vertebral fracture in lumbar spine or more than 4 fracture in the t-l spine. * weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight. * present cardiac disease present. * diseases or conditions known to affect bone metabolism. * therapies with drugs that affect bone metabolism within 6 months. * fluoride or biophosphonates at any time.

Keywords: osteoporosis
effect of hand holding on pain and anxiety

Conditions: Pain and Anxiety

Summary: it was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

this study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. the research will be carried out in the adult emergency service of the ministry of health of the republic of turkey, konya city hospital. patients will be randomly divided into two groups: handholding (52) and control group (52). for the hand holding group: after the patient is positioned appropriately, the patient's hand will be held by the researcher. once the intramuscular injection is completed, the patient's hand holding will be stopped. for the control group: no application will be made during intramuscular injection in the control group. the primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. the secondary outcome is to determine the anxiety levels of patients.

Eligibility criteria:
inclusion criteria: * having vitamin b 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment, * being literate, * are between the ages of 18-65, * no visual, hearing, sensory or motor loss or cognitive impairment, * not using centrally or peripherally acting analgesics or sedatives, * there is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area, * having a body mass index between 18.5 and 29.5, * injected into the ventrogluteal area, * individuals who agree to participate in the research will be included. exclusion criteria: * those with chronic pain, * having a psychiatric disorder, * foreign nationals, * patients with contact-communicable diseases will be excluded from the study.