Kornimate/medical-research-clean huggingface dataset:
ocular pharmacokinetics after a single drop instillation of t1225 0.5, 1, 1.5% in 91 healthy volunteers

Conditions: Eye Infections, Bacterial

Summary: to evaluate azithromycin tear concentrations after instillation of one drop of one of the three t1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

the aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different t1225 concentrations in order to determine early azithromycin tear concentration and to assess the t1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Eligibility criteria:
inclusion criteria: * male/female aged from 18 to 45 years; * written informed consent; * healthy volunteers without any subjective ocular symptom; * corrected visual acuity \>= 6/10; * registered in the national register of healthy volunteers exclusion criteria: * ocular trauma, infection or inflammation within the last 3 months; * conjunctival hyperaemia (score \>= 2); * folliculo-papillary conjunctivitis (score \>= 2); * topical ocular treatment within the last month; * ocular surgery, including lasik and prk, within the last 12 months; * other ocular laser within the last 3 months; * zithromax® and azadose® within the last 3 months; * medication during the study (except: paracetamol, contraceptives
waitlist-control trial of smartphone cbt for major depressive disorder (mdd), withdrawn

Conditions: Major Depressive Disorder

Summary: the investigators are testing the efficacy of smartphone-delivered cognitive behavioral therapy (cbt) treatment for major depressive disorder (mdd). the investigators hypothesize that participants receiving app-cbt will have greater improvement in qids-c scores than those in the waitlist condition at treatment endpoint (week 8).

the primary aims of this study are to test the efficacy of a smartphone-based cbt treatment for adults with mdd recruited nationally. eligible subjects (n=112) will be randomly assigned to 8 weeks of smartphone-delivered cbt for mdd either immediately, or after a 8-week long waiting period (50-50 chance). the investigators hypothesize that smartphone-delivered cbt for mdd will be feasible and acceptable to individuals with mdd, and that it will lead to greater reductions in mdd symptom severity compared to the passage of time (waitlist control).

Eligibility criteria:
inclusion criteria: * at least 18 years of age * current diagnosis of primary dsm-5 mdd, based on mini * currently living in the united states exclusion criteria: * psychotropic medication changes within 2 months prior to enrollment (participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period) * past participation in ≥ 4 sessions of cbt for depression * current severe substance use disorder * lifetime bipolar disorder or psychosis * acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the c-ssrs * concurrent psychological treatment * does not own a supported mobile smartphone with a data plan * lack of technology literacy that would interfere with ability to engage with smartphone treatment
non-invasive ultrasound diagnosis of chronic liver diseases in hepatology consultation

Conditions: Liver Diseases; Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease

Summary: early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. to achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. the objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).

the study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment. performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment. repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.

Eligibility criteria:
inclusion criteria: * patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care). * patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights * patient who is registered to the french social security program exclusion criteria: * adult patients under guardianship * adult patients not being under guardianship, unable to express consent for participation * pregnant women * breastfeeding women * patients under deprivation of liberty * in-hospital patients not having given their consent to participate, or admitted in emergency * patients admitted in social and care centers for other reasons than those of the research * patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.

Keywords: elastography attenuation sound speed ultrasound
ipick blocking for tka with moderate flexion contracture

Conditions: Knee Osteoarthritis; Flexion Contracture of Knees; Anesthesia, Local

Summary: clinical effect of intermittent multiple ipick blocking on tka for knee osteoarthritis with flexion contracture between 5 ° and 10 °

from october 2020 to january 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with adductor canal block + infiltration between the popliteal artery and capsule of the knee, and 20 patients are treated with adductor canal block alone.

Eligibility criteria:
inclusion criteria: 1. the diagnosis was knee osteoarthritis 2. the flexion contracture was between 5 and 10 degrees 3. asa grade i-iii exclusion criteria: 1. lower extremity neuropathy. 2. contraindications of nerve anesthesia or regional anesthesia. 3. unable to cooperate, allergic to the drugs used in this study. 4. non steroidal anti-inflammatory drugs are not tolerated. 5. chronic opioid consumption (daily or almost daily use)

Keywords: ipack knee osteoarthritis flexion contracture of knees
screening for glucose metabolism disorders in cardiac rehabilitation

Conditions: Diabetes

Summary: because prevalence of glucose metabolism disorders is high in patients with coronary disease, the oral glucose tolerance test (ogtt) is recommended in all patients without diabetes after an acute coronary syndrome (acs). however, there are some concerns about its performance in clinical practice. the aim of our study was to evaluate, after an acute coronary syndrome (acs), the feasibility and efficacy of the ogtt in a cardiac rehabilitation (cr) center in comparison with its real application in the whole french population.

we will select all the patients referred to our cardiac rehabilitation center after an acs. hba1c will be measured in each patient included in the study. the ogtt will be prescribed in all the patients without known diabetes and with hba1c \< 6.5%. in order to perform a "real life" study, the ogtt will not performed in the cr center but will prescribed in each patient who will be asked to perform it in an external biological laboratory. the ogtt will be performed in the morning after a 12 hour fast, with 75g oral glucose load. plasma glucose will be measured at baseline and 120 min after the oral glucose load. the results will be classified according to the who criteria: diabetes is defined as fasting plasma glucose (fpg) greater or equal to 7.0 mmol/l (126 mg/dl) or glucose level 2h (2hpg) after the ogtt greater or equal to 11.1mmol/l (200mg/dl); impaired fasting glucose (ifg) is defined as fpg greater or equal to 6.1 mmol/l (110mg/dl) and less than 7.0 mmol/l and impaired glucose tolerance (igt) is defined as a 2hpg greater or equal to 7.8 mmol/l (140 mg/dl) and less than 11.1mmol/l. in parallel, screening for glucose metabolism disorders with the ogtt after an acs will be evaluated in the whole french population from a representative sample of 1/97ème french population of the "national health insurance inter-regime information system" (sniiram) which collects individual hospital and non-hospital data for health care consumption.

Eligibility criteria:
inclusion criteria: * patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks exclusion criteria: * none

Keywords: cardiac rehabilitation prediabetes
prospective data collection of elderly patients with dlbcl receiving at the time of diagnosis vgm

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: prospective data collection of a consecutive series of elderly patients with large b-cell lymphoma newly diagnosed, receiving before the start of treatment multidimensional geriatric assessment (vgm) through the use of activity of daily living (adl), instrumental activity of daily living (iadl) and cumulative illness rating scale for geriatrics (cirs-g).

prospective data collection of a consecutive series of elderly patients with large b-cell lymphoma newly diagnosed, receiving before the start of treatment multidimensional geriatric assessment (vgm) through the use of activity of daily living (adl), instrumental activity of daily living (iadl) and cumulative illness rating scale for geriatrics (cirs-g) to be defined in 3 categories: * elderly fit (adl 6; iadl 8; 0 score= 3-4, \< 5 score=2) * elderly unifit (adl 5; iadl 6-7; 0 score= 3-4, 5-8 score=2; ≥ 80 fit) * elderly frail (adl ≤ 4; iadl ≤ 5; 1 score= 3-4, \> 8 score=2; ≥ 80 unfit)

Eligibility criteria:
inclusion criteria: * patient with large b-cell lymphoma * age ≥ 65 years * informed consent exclusion criteria: * violation of inclusion criteria * abscence of data considered essential for the study * withdrawal of consent
interpolated flap study

Conditions: Skin Cancer, Non-Melanoma; Skin Cancer Melanoma; Mohs Micrographic Surgery

Summary: the primary purpose of this study is to address the limited knowledge regarding patient well- being and nasal function after interpolated flap repair of post-mohs surgical defects on the nose. improved understanding of the patient experience will allow providers to better counsel their patients pre-operatively and potentially identify patients who may benefit from additional interventions.

this project is a multi-center prospective cohort study evaluating postoperative complication rates, quality of life outcomes, and nasal function after interpolated flap repair of post-mohs surgical defects of the nose. our primary outcome is the incidence of short-term complications(within 4 weeks of surgery) defined by the american college of mohs surgery as: death, bleeding requiring additional intervention, functional loss attributable to surgery, hospitalization for an operative complication, and surgical site infection. secondary outcomes will include incidence of flap necrosis and evaluation of quality of life at 1, 4 and 16 weeks after repair. quality of life will be investigated using the skin cancer index (sci)- a skin cancer specific quality of life instrument and the nasal appearance and functional evaluation questionnaire (nafeq). previous literature has demonstrated that mohs surgery in the outpatient setting has a very low complication rate but this literature is generally limited to single-institution studies or studies examining smaller repairs. furthermore, it has been proven that receiving a skin cancer diagnosis is stressful and patient satisfaction with skin cancer surgery is related to their appearance and scarring or changes in appearance can decrease quality of life. our study serves to fill the current literature knowledge gaps by examining repair of large defects and looking at both complications and quality of life outcomes. data collection will begin pre-operatively on patients 18 and older who require an interpolated flap repair of a post-mohs surgical defect. these patients will then be followed and asked to complete sci and nafeq surveys as well as complication questionnaires at prescribed intervals. all data will be stored via a secure redcap database.

Eligibility criteria:
inclusion criteria: * patients 18 years or older who are able to provide informed consent and may require interpolated flap repair of their post-mohs surgical defect exclusion criteria: * people who are not adults, not able to give informed consent, or who's wounds are not being repaired by a fellowship trained mohs surgeon
reverse breech extraction versus push technique for fetal delivery when fetal head is deeply impacted in the pelvis during cs on a fully dilated cervix

Conditions: Obstructed Labor at Second Stage of Labor

Summary: management of impacted fetal head during second stage cesarean requires careful and gentle attention to various surgical steps for delivery of a fetus without adverse maternal and neonatal outcomes, mostly by an experienced surgeon as in such situations, the lower uterine segment may be over-distended and indistinguishable from the vagina. therefore, the uterine incision may inadvertently be placed too low, or in the vagina. also, it may be difficult for the operating surgeon to maneuver his hand below the deeply engaged fetal head, which may be further compounded by the presence of molding and edema on the fetal head (caput succedaneum). this prospective controlled study was conducted at labor ward of department of obstetrics and gynecology at ain shams university maternity hospital to compare between the two techniques. a total of 70 pregnant women were enrolled and divided into two equal groups.


Eligibility criteria:
inclusion criteria: * • singleton pregnancies. * cephalic presentation will undergo cesarean section in advanced labor with the fetal head deeply engaged in the pelvis defined as fully dilated cervix and vertex at or below zero station exclusion criteria: * • twins pregnancies. * breech or transverse presentation. * woman has other obstetric indication to cs ex, fetal distress. * woman has risk factor for bleeding ex, bleeding disorders
effect of antimalarial treatment on gametocyte carriage in asymptomatic p. falciparum

Conditions: Asymptomatic P.Falciparum Malaria

Summary: treatment of uncomplicated p.falciparum malaria with sulfadoxine-pyrimethamine (sp) is followed by a marked increase in the density of gametocytes. to determine whether treatment with sp enhances gametocyte carriage, we randomized asymptomatic carriers of p.falciparum to receive sp alone, sp with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.

treatment of p. falciparum malaria with sulfadoxine-pyrimethamine (sp) is followed by a sharp rise in the density of gametocytes. drug-induced release could enhance transmission of resistant parasites and would argue against the use of sp, especially for intermittent preventive treatment (ipt). we did a randomized trial to determine the effect of treatment with sp on gametocyte carriage. the trial is a three-arm open-label randomized trial. we randomized asymptomatic carriers of p.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. the trial was conducted during the dry (low malaria transmission) season in four rural villages in the gambia. adults and children aged over 6 months who had asexual p.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of sp, or sp plus a single dose of artesunate (sp+as), or placebo. the primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.

Eligibility criteria:
inclusion criteria: * p.falciparum parasitaemia above 20/ul * resident in one of the four study villages exclusion criteria: * fever * any other sign of clinical malaria * pregnancy * weight \<5kg * history of hypersensitivity to any of the study drugs * treatment with any of the study drugs in the last 4 weeks

Keywords: malaria gametocytes asymptomatic carriers
a trial of hrs-5041-103 to evaluate the safety, tolerability, pharmacokinetics and efficacy of hrs-5041 in subjects with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: to evaluate the safety, tolerability, pharmacokinetics and efficacy of 5041-103 in subjects with metastatic castration-resistant prostate cancer.


Eligibility criteria:
iinclusion criteria 1. ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. adequate bone marrow and other vital organ functions 3. adequate liver function tests 4. metastatic castration-resistant prostate cancer exclusion criteria 1. plan to receive any other anti-tumor therapy during the study. 2. receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study. 3. uncontrolled hypertension (systolic blood pressure \[sbp\] \> 150 mmhg and/or diastolic blood pressure \[dbp\] \> 100 mmhg with regular anti-hypertension therapy). 4. factors that may affect the oral administration of the ip (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (gi) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of ip. 5. known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.). 6. active heart disease within 6 months prior to the first dosing of this study. 7. medical history of other malignant tumor within 5 years prior to dosing. 8. positive hepatitis b virus (hbsag), hepatitis b core antibody (hbcab), hepatitis c virus (hcv-ab), or syphilis or severe infections which need treatment.
long-term impact of infection with novel coronavirus (covid-19)

Conditions: COVID

Summary: liinc is a study of volunteers who were previously infected with sars-cov-2 (also known as novel coronavirus or covid-19) who have recovered from acute infection. the study is designed to provide a specimen bank of samples with carefully characterized clinical data. liinc specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in covid-19, with a focus on understanding variability in the long-term immune response between individuals.

liinc is an observational, prospective study of individuals previously infected with sars-cov-2 who have recovered from acute illness. the overall objective of the study is to investigate the clinical consequences of sars-cov-2 infection. these include the pre-existence and development of medical conditions, measures of immune activation and inflammation, changes in immunologic function, and variability in host responses. there will be a specific focus on demographic differences including age, gender, and race. enrolled volunteers are seen at san francisco general hospital at baseline, monthly for 3 months and then every 3 months for up to 2 years. visits include a detailed interview, saliva collection, and a blood draw. baseline visits take approximately 90 minutes, and follow up visits take approximately 20-40 minutes. no personal identifiers are used for specimen bank samples.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent, and 2. age \>/= 18 years, and 3. a history of sars-cov-2 infection, as evidenced by: 1. available laboratory documentation of sars-cov-2 rna positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or 2. reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for sars-cov-2 or covid-19 infection, 4. and a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier. exclusion criteria: 1. self-reported or documented chronic anemia with hemoglobin \< 9 g/dl. anemia during a preceding acute illness will not be exclusionary. 2. serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. 3. active drug or alcohol use or dependence that, in the opinion of the principal investigator, would interfere with adherence to study requirements or to give informed consent.

Keywords: covid-19 coronavirus sars-cov-2 long covid post-acute sequelae of sars-cov-2
phase iii clinical trial of npb-01 in patients with bullous pemphigoid unresponsive to corticosteroids

Conditions: Bullous Pemphigoid

Summary: patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive npb-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days or placebo(physiological saline). subsequently, efficacy of npb-01 for therapy of bullous pemphigoid will be evaluated the score using pemphigus disease area index (pdai) and pemphigoid activity score involving skin lesion area and number of new blisters. as a safety endpoint, the safety of npb-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.


Eligibility criteria:
inclusion criteria: 1. patients with corticosteroids over 0.4mg/kg/day(prednisolone) at informed consent. 2. patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent. 3. patients who the score using pemphigus disease area index(pdai) is score10 and more before study medication received. 4. patients who the score using pemphigus disease area index(pdai) is not improve before study medication received. 5. patients with twenty years old at informed consent. 6. patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication . exclusion criteria: 1. patients treated with plasmapheresis at 28 days before informed consent. 2. patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent. 3. patients treated with intravenous immunoglobulin at 56 days before informed consent. 4. patients who receive or adjust in increments immunosuppressants at 14 days before informed consent. 5. patients with malignancy or a history of this disease. 6. patients with history of shock for npb-01. 7. patients with history of hypersensitivity for npb-01. 8. patients with iga deficiency. 9. patients with impaired liver function. 10. patients with impaired renal function. 11. patients with cerebro- or cardiovascular disorders. 12. patients with high risk of thromboembolism. 13. patients with hemolytic/hemorrhagic anemia. 14. patients with decreased cardiac function. 15. patients with decreased platelet.

Keywords: ivig in pemphigoid patients with bullous pemphigoid unresponsive to corticosteroids