Kornimate/medical-research-clean huggingface dataset:
clinical research on the application of single-channel uterine fibroid morcellation system in laparoscopic myomectomy

Conditions: Leiomyoma, Uterine

Summary: research purpose the purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal. research design this study is a single-center, randomized, single-blind, 1:1 controlled trial. intervention measures study participants were randomly assigned in a 1:1 ratio into two groups. experimental group: conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids. control group: conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids. observation indicators primary observation indicator: time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity). secondary observation indicators: success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.


Eligibility criteria:
inclusion criteria: patients with uterine fibroids who meet the surgical indications. patients aged 18 and above but below 45, who strongly request to preserve the uterus. patients planning to undergo laparoscopic myomectomy. those who understand the purpose, procedures, potential risks of this trial, voluntarily participate in this study, and sign the informed consent form. exclusion criteria: patients who cannot tolerate laparoscopic surgery due to their overall physical condition. patients with multiple fibroids have at least 4 fibroids, with the largest diameter of a single fibroid being equal to or greater than 10cm. patients who require surgical procedures other than laparoscopic myomectomy (excluding pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and superficial intraperitoneal lesions resection/electrocoagulation). preoperatively considering the possibility of uterine fibroid malignancy. patients with preoperative unclear diagnosis, requiring differentiation from ovarian tumors. previously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with severe pelvic or abdominal adhesions. presence of untreated infectious sexual diseases, including but not limited to vaginitis, cervical inflammatory diseases, and pelvic inflammatory diseases. patients who cannot understand the research protocol, cannot cooperate with the research and follow-up, and any other patients that researchers deem unsuitable for participation in this study.
first line comparative study of en3348 (mcc) vs bcg in nmibc

Conditions: Bladder Cancer

Summary: the purpose of this study is to compare the safety and efficacy of en3348 (mcc) versus bcg as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.


Eligibility criteria:
inclusion criteria: * histologically confirmed urothelial carcinoma of the bladder (high grade ta or t1 papillary lesions, cis) * histologically confirmed diagnosis within 42 days of study treatment * life expectancy of greater than 5 years * ecog performance status of 2 or less * absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment exclusion criteria: * current or previous history of muscle invasive bladder tumors (\>t2) * current or previous history of lymph node and/or distant metastases from bladder cancer * current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder * current systemic cancer therapy * previous immunotherapy for bladder cancer * previous intravesical chemotherapy treatment * contraindication to use bcg of known tolerance to bcg * history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage t1 prostate cancer, carcinoma in situ of the cervix, colon polyps) * patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)

Keywords: non-muscle invasive bladder cancer superficial bladder cancer
osna versus ultrastaging to detect sentinel lymph node metastasis in endometrial cancer

Conditions: Endometrial Cancer

Summary: patients enrolled in the study will be randomized before surgery: in one study arm, the search for lymph node metastases in surgically removed sentinel lymph nodes will occur using the ultrastaging method (standard), while in the other arm it will be conducted using the osna method.

this is a non-inferiority randomized trial with the incidence of patients with metastatic sln as primary endpoint. based on recent literature, incidence of patients with metastatic sln detected by ultrastaging has an average value of 11%. assuming a -4% as the maximum allowable difference in detection rate to declare non-inferiority, a power of 80% and a significance level of 2.5% (one-side) a sample size of 1922 (961 per arm) is needed. two interim analyses are planned, one after the first 640 and the second after 1280 patients. at the first interim analysis null hypothesis (inferiority of osna with respect to ultrastaging) will be rejected at a significance level \<0.00010 otherwise the study will go on and at the second analysis the null hypothesis will be rejected at a significance level of 0.0059. the final analysis will use 0.0189 as significance threshold. the o'brien fleming alpha spending function was used to define these values. the primary endpoint is defined as the proportion of patients with positive sln over the total of randomized patients. this proportion will be reported together with the 95% confidence interval to better identify the range of inferential values. incidence of isolated tumor cells, micro- and macro-metastasis will be calculated. number of copies of ck19 mrna to define volume of metastases will be adapted from previous reports. to describe the sample, quantitative variables will be summarized using median and interquartile range while categorical items will be reported as absolute counts and percentages. patients will be described according the arm they were randomized to. a first analysis will be performed on an intent-to-treat basis, considering all randomized patients. a secondary analysis will be performed on the per-protocol population.

Eligibility criteria:
inclusion criteria: * histologically confirmed endometrial cancer * apparent (pre-operative) figo stage i-ii * radical surgery * attempt of sln mapping exclusion criteria: * uterine sarcoma (including endometrial stromal sarcoma) * fertility sparing surgery * dedifferentiated histology * undifferentiated histology * neoadjuvant therapy * previous surgery to pelvic lymph nodes * lymph nodes with short axis \>15 mm at pre-operative imaging

Keywords: endometrial cancer osna sentinel lymph node ultrastaging
cgb-400 for the reduction of facial redness and bumps and blemishes

Conditions: Rosacea

Summary: open-label multicenter study using cgb-400 gel to reduce facial redness, bumps, and blemishes.

this is a open-label multicenter study to evaluate the ability of cgb-400 gel to reduce facial redness and bumps/blemishes typically associated with rosacea. approximately 25 subjects will be enrolled. subjects will receive study treatment for 12 weeks and attend a total of 5 study visits (i.e., bl, w2, w4, w8, w12).

Eligibility criteria:
inclusion criteria: 1. outpatient, male or female of any race, 18 years of age or older. female subjects of childbearing potential must have a negative upt at baseline and practice a reliable method of contraception throughout the study. 2. facial redness associated with rosacea with or without bumps or blemishes. 3. facial redness (iga-r) score of 2 or 3 (i.e., mild or moderate). 4. iga score of 2 or 3 (i.e., mild or moderate). 5. absence of any skin conditions that could interfere with the visual erythema assessments. 6. willing to forego any other topical or non-topical treatment on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer). 7. willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study. 8. sign the irb-approved icf (which includes hipaa) prior to any study-related procedures being performed. exclusion criteria: 1. known hypersensitivity or previous allergic reaction to any constituent of the investigational products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.). 2. any transient flushing syndrome. 3. history of basal cell carcinoma within 6 months of visit 1. 4. history or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.). 5. diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at baseline. 6. blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist. 7. uncontrolled systemic disease. 8. foreseen unprotected and intense/excessive uv exposure during the course of the study. 9. use of any of the following concomitant medications/procedures: * cosmetic and/or otc products for redness reduction and/or skin clearing * topical medications for rosacea * systemic antibiotics or corticosteroids * topical antibiotics, corticosteroids, or antiparasitic agents * intense/excessive ultraviolet (uv) radiation * phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion 10. exposure to any other investigational drug/device within 30 days prior to study entry.
glycemic and blood pressure control in type 2 diabetes, in a primary care unit: a staged management strategy

Conditions: Diabetes Mellitus; Arterial Hypertension

Summary: the aim of this study is to to analyze if it is possible to reach the goals of hba1c \<7.0% and blood pressure \<= 130/80 mm hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the brazilian national health system. it is an open label, observational study, with a duration of 4-6 years. patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. they will be followed on a monthly basis by a team of physicians and nurses. glucose, a1c, blood pressure will be the outcomes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (who) exclusion criteria: * terminal disease (renal, cancer, heart failure)

Keywords: diabetes mellitus arterial hypertension treatment primary care
diagnostic and prognostic value of lung microbiota in early lung infection after lung transplantation

Conditions: Pneumonia

Summary: the present study is a prospective case-control study. patients were enrolled post lung transplantation and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. pulmonary infection was used as the primary study endpoint. to describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period.

lung infection is a common and serious problem in the perioperative period of lung transplantation, and early diagnosis of lung infection is important, while traditional culture methods are time-consuming and have low positivity rates. pathogenic detection by macro-genomic sequencing (mngs) may be useful for early and rapid diagnosis of post-operative infections, and the simultaneous detection of lower respiratory tract microbiota may also be useful for early diagnosis of infections. however, the use of lung microbiota in the perioperative period of lung transplantation in the setting of pulmonary infections is still at an exploratory stage. the present study is a prospective case-control study. patients in the micu after lung transplantation were enrolled, and alveolar lavage fluid was obtained within 48 hours of the patient's surgery, divided into aliquots, and subjected to macrogenomic sequencing, routine microbiological testing and cytokine testing. patients were divided into pulmonary infection and non-pulmonary infection groups based on whether they had a co-infection at the time of sampling. pulmonary infection was used as the primary study endpoint. to describe and compare the characteristics of the lung microbiota in the two groups and to determine whether variation in the lung microbiota could predict the development of lung infection and prognosis in patients in the early post-transplant period. to explore the diagnostic thresholds of common lung pathogens by macrogenomic sequencing in patients with co-infections in the early post-transplant period

Eligibility criteria:
inclusion criteria: * patients admitted to the icu for lung transplantation; consent for bronchoscopy; informed consent signed by the patient or their representative. exclusion criteria: * patients admitted to icu for other serious illnesses; patients more than 48 hours after lung transplantation; patients predicted to die within 48 hours; participation in other clinical studies; failure to sign an informed consent form.
the treatment of acne vulgaris with radiofrequency device

Conditions: Acne Vulgaris

Summary: radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild to moderate acne patients faces. the aim of the study is to check whether rf heating of subcutaneous and dermis will improve acne in needed patients.


Eligibility criteria:
inclusion criteria: * mild-moderate acne * age over 18 * otherwise healthy exclusion criteria: * age under 18 * pregnancy * systemic acne treatment in the last month * local acne treatment in the last month

Keywords: acne radiofrequency
combination chemotherapy in treating patients with hiv-related non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients with hiv-related non-hodgkin's lymphoma that has relapsed or has not responded to chemotherapy.

objectives: i. evaluate the response rate and duration of response to etoposide, mitoxantrone, and prednimustine in patients with relapsed hiv-associated non-hodgkin's lymphoma (nhl). ii. evaluate the response rate and duration of response to cyclophosphamide, doxorubicin, and etoposide in patients with refractory hiv-associated nhl. iii. assess the toxic effects of these regimens in these patients. outline: patients with relapsed non-hodgkin's lymphoma (nhl) receive oral etoposide and prednimustine on days 1-5 and intravenous mitoxantrone on day 1 every 3 weeks. patients with refractory nhl receive cyclophosphamide, doxorubicin, and etoposide as a continuous infusion over 4 days every 4 weeks. all patients receive concomitant antiretroviral therapy with zidovudine or didanosine. g-csf is given for hematologic support as indicated. all patients are evaluated for response after 2 courses of chemotherapy. patients with a complete response (cr) receive 2 additional courses. patients with a stable or partial response receive 2 additional courses and are re-evaluated; those with a cr receive 2 more courses, while those with a stable or partial response are treated off study at the physician's discretion. patients with progressive disease are removed from study. projected accrual: 15-20 patients will be treated on each regimen.

Eligibility criteria:
disease characteristics: histologically proven non-hodgkin's lymphoma at first presentation no documented cns involvement (i.e., primary cns or meningeal lymphoma) positive serologic test for hiv antibodies required no opportunistic infection unless effectively treated disease relapsed, refractory, or unresponsive to first-line chemotherapy no more than 1 prior combination chemotherapy regimen chemotherapy consisted of cyclophosphamide, doxorubicin, vincristine, and prednisone (chop) or a chop-like regimen, acvbp, or other similar regimen patient characteristics: age: 18 and over performance status: ecog 0-3 life expectancy: at least 1 month hematopoietic: not specified hepatic: bilirubin less than 5 times normal or transaminases less than 5 times normal renal: creatinine less than 2 mg/dl prior concurrent therapy: see disease characteristics

Keywords: aids-related peripheral/systemic lymphoma
a study of the clinical activity and safety of jnj-64041809, a live attenuated listeria monocytogenes immunotherapy, in combination with apalutamide versus apalutamide in subjects with metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasms, Castration-Resistant

Summary: the purpose of this study is to evaluate if the anti-tumor activity of jnj-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate * metastatic disease as documented by technetium-99m (99mtc) bone scan or metastatic lesions by computed tomography (ct) or magnetic resonance imaging (mri) scans * surgically or medically castrated, with testosterone levels of less than (\<)50 nanogram per deciliter (ng/dl) * castration-resistant prostate cancer documented by time to prostate-specific antigen (psa) increase during continuous treatment with androgen deprivation therapy (adt) or radiographic progression of soft tissues or radiographic progression of bone according to pcwg3 exclusion criteria: * predominately small cell or neuroendocrine carcinoma of the prostate * known brain metastases (even if treated) or untreated epidural spread * prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer * treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (\>=)28 days prior to randomization
assessing the efficacy of artemisinin combination therapies for treatment of uncomplicated malaria infection in children

Conditions: P. Falciparum Malaria

Summary: following the rapid development of significant drug resistance to both chloroquine and sulfadoxine-pyrimethamine (the first line therapy in tanzania from 2001 -2006), artemether- lumefantrine (coartem or al) was adopted as first line therapy in tanzania in 2006. now that this drug has been widely used for some time, the investigators propose to conduct an antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if this drug remains efficacious, or if significant resistance has emerged, in which case a new antimalarial strategy will need to be contemplated. the investigators hypothesize that the efficacy of artemether-lumefantrine remains high, and that the other artemisinin combination therapies will be equally efficacious. children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated with either artemether + lumefantrine (coartem) or dihydroartemisinin-piperaquine (duo-cotecxin or artekin). clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.


Eligibility criteria:
inclusion criteria: 1. age 6-59 months 2. axillary temperature ≥ 37.5º c or history of fever in the past 48 hours 3. weight ≥ 5.0 kg 4. slide-confirmed infection with p. falciparum, with parasitemia 2,000-200,000 asexual forms per μl 5. live within the boundaries of the officially recognized catchment area of miono health center. 6. caregiver agrees to all blood draws and return visits. exclusion criteria: 1. general danger signs or symptoms of severe malaria 2. signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (national center for health statistics \[nchs\]/world health organization \[who\] normalized reference values) 3. slide confirmed infection with any other plasmodium spp. besides falciparum or mixed plasmodium infection 4. severe anemia, defined as hb \< 5 g/dl 5. known hypersensitivity to any of the drugs being tested 6. presence of febrile conditions caused by diseases other than malaria 7. serious or chronic medical condition (heart failure, sickle cell disease). 8. plan to travel or leave the area within the next 3 months. 9. have been treated for malaria in the 2 weeks prior to enrollment.

Keywords: malaria treatment artemisinin combination therapy tanzania p. falciparum malaria in children age 6-59 months