Kornimate/medical-research-clean huggingface dataset:
end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis in sigmoid and upper rectal cancer

Conditions: End to End Anastomosis; Colorectal Anastomosis; End to Anterior Rectal Wall; Sigmoid Cancer; Upper Rectal Cancer

Summary: the aim of this study is to compare end to end anastomosis with omega suture versus end to anterior rectal wall in colorectal anastomosis as regard post operative anastomotic leakage, bowel function, operative time and intra operative blood loss.

colorectal cancer has been reported to be the 3rd most common and the second most deadly cancer world wide. anterior resection is the gold standard operation for both rectal and recto-sigmoid cancer with considering oncological safety maintenance to be the most important goal which can be achieved by keeping abundant resection margin and ensuring anastomotic safety, despite the technical difficulties of working in a narrow deep pelvis. understanding the characteristics of each anastomotic technique and establishing a stable anastomotic procedure both are pillars in anastomotic leakage prevention. the intersection of the linear staple line and circular staple line in conventional anastomotic way is considered a risk factor for anastomotic leakage by creating stapled corners (called "dog-ears") which considered potentially ischemic and represent the area with high incidence of anastomotic leakage. single stapled technique using ether end to end with omega suture or end to side stapled anastomosis allows avoidance of the formation of this intersection.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years. * both sexes. * recto sigmoidal carcinoma. * upper rectal cancer. exclusion criteria: * patients younger than 18 years * recurrent or non-resectable cancer * complicated cancer (e.g., obstructed or perforated) * previous left-sided colorectal surgery or anorectal surgeries * lower rectal cancer
a study to evaluate the drug levels of mezigdomide in adult participants with renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.


Eligibility criteria:
inclusion criteria * participants must have a body mass index (bmi) of ≥ 18.0 kg/m2 to ≤ 40.0 kg/m2 inclusive at screening. * participants must have a body weight ≥ 50 kg at screening. * participants must be afebrile (febrile is defined as ≥ 38°c or 100.4°f) at screening, check in, and predose. exclusion criteria * participants must not have any history of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide. * participants must not have any history of malignancy of any type other than in situ cervical cancer or surgically excised non-melanomatous skin cancers. * participants with an inability to tolerate oral medication. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: chronic kidney disease end stage renal disease dialysis hemodialysis mezigdomide pharmacokinetics healthy
a patient and provider intervention to address health disparities in lung cancer screening

Conditions: Lung Cancer

Summary: to test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

the proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between african american and whites in lung screening awareness and utilization. guided by nih's health disparities research framework and building on the formative work conducted in the k99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the medstar health system in the r00 phase.

Eligibility criteria:
inclusion criteria: * 50-80 years old; * current cigarette smoker or quit within 15 years; * a 20+ pack-year smoking history; * non-adherent to lung screening (\>13 months); * english-speaking; * scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and * able and willing to provide meaningful consent and complete telephone interviews exclusion criteria: * individuals with a history of lung cancer
observational study on efficacy and safety in patients using novomix® 30 for the treatment of diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate the efficacy on blood glucose control while using novomix® 30 flexpen® under normal clinical practice conditions in korea. a clinical safety profile will be also evaluated.


Eligibility criteria:
inclusion criteria: * any patient with type 1 and type 2 diabetes who are treated with novomix® 30 * patient who signed on informed consent form exclusion criteria: * patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit * patients who were previously enrolled in this study * patients with a hypersensitivity to novomix® 30 or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
new urethral reconstruction in robot-assisted laparoscopic radical resection

Conditions: Prostate Cancer

Summary: the purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection it will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence the main questions it aims to answer are: is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? the researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation. participants will: the intervention group adopted the new reconstruction proposed by our team; end-to-end anastomosis was performed in non-intervention group.

it is one of the most common malignant tumors in urology, and its incidence rate is the second among male malignant tumors in the world. in recent years, with the economic and social development in china, the incidence rate has increased year by year, which seriously threatens the radical resection is the current treatment plan. although radical surgery can prolong the survival time of patients, because of the surgical injury, the incidence of urinary incontinence and sexual function after operation is high, which greatly affects the physiological health, mental health and social function of patients. in order to solve the above problems, professor shi benkang's team of urology department of qilu hospital of shandong university improved the existing urinary tract reconstruction after consulting a large number of related literatures and combining with the new findings of our team's previous anatomical work, which needed to be carried out under da vinci xi surgical system. by continuously suturing the fascia on the surface of levator anal muscle and the posterior dorsal median ridge (mdr) and dirichlet fascia of the lateral tissue, it achieved the purpose of protecting the apical saccular tube bundle (nvb) and maintaining the stability of the length of vascular and nerve lengthening function in the posterior mdr we found that the postoperative urinary incontinence of patients with new reconstruction technique is obviously better than that of anastomosis, which provides a new idea for improving the postoperative urinary incontinence of rarp patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, confirmed by puncture pathology as prostate cancer * the tumor has no extensive distant metastasis, or has reached a resectable state through neoadjuvant chemotherapy and endocrine therapy * willing to accept robot assisted laparoscopic radical prostatectomy exclusion criteria: * tumor metastasis cannot achieve curative effect through surgery * concomitant severe cardiovascular and cerebrovascular complications * merge severe mental and neurological disorders * poor liver and kidney function * refusal to accept robot assisted laparoscopic radical prostatectomy
erlotinib combined with radiotherapy in patients with non-resectable locally advanced non-small cell lung cancer (la-nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (nsclc). however,the optimal chemotherapy regimen is still controversial.the objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using erlotinib and radiotherapy followed by erlotinib consolidation treatment.

patients with non-resectable non-small cell lung cancer will receive thoracic radiation therapy 60-70 gy over 30-35 fractions and concurrent with erlotinib 150mg/day. followed by erlotinib 150 mg/day consolidation treatment.

Eligibility criteria:
inclusion criteria: * histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc) * tumor egfr mutation * presence of measurable disease by recist * stage iiia or iiib, non-resectable * ecog performance status 0-2 * no prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy * patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. exclusion criteria: * carcinoid tumor, small cell carcinoma of lung * patients with any distant metastasis * history of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) * pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women * women and men of childbearing potential who have no willing of employing adequate contraception * tumor egfr wild

Keywords: non-small cell lung cancer egfr-tki erlotinib radiotherapy
comparing effects of fermented and unfermented pulses and gut microbiota

Conditions: Fermented Food; Inflammation

Summary: the goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. the main questions it aims to answer are: 1. how does consuming the fermented foods impact the gut microbiome? 2. does this interaction between the fermented foods and the gut microbiome affect inflammation? participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses. researchers will compare the gut microbiome and inflammation between these two diets.

the rationale for the research is that fermentation of pulses can reduce the concentration of compounds that suppress butyrate producing bacteria and butyrate production. this will in turn boost butyrate production during consumption of these fermented pulses relative to that in unfermented pulses. this in turn will lead to lower inflammation in people consuming fermented pulses. to best study this question the investigators will utilize a cross-over design trial where participants will consume daily meals containing either fermented or unfermented pulses (chickpeas), followed by a washout period and then a period of consuming the other type of pulse. the investigators hypothesize that those consuming the fermented pulses will experience a significant decrease in inflammatory markers driven by increased butyrate production by gut bacteria.

Eligibility criteria:
inclusion criteria: * healthy adults exclusion criteria: * taken antibiotics within the past month * taking any medication for the management of diabetes or obesity * are pregnant * bmi \> 24.9 * allergies to pulses or any other meal components
labor characteristics and outcomes in women with gestational hypertension or preeclampsia who underwent labor induction

Conditions: Gestational Hypertension; Mild Pre-eclampsia

Summary: comparison of labor characteristics and maternal-neonatal outcomes in induced labor between women with gestational hypertension/mild preeclampsia and normotensive controls

the american college of obstetricians and gynecologists (acog) recommends that women with gestational hypertension or preeclampsia without severe features at or beyond 37 weeks of gestation are usually managed by scheduled induction of labor (iol). occasionally, normal pregnant women request elective induction of labor because of a perceived decrease in fetal movements in the presence of normal findings in fetal heart rate monitoring. however, there is limited information available to compare labor induction outcomes between patients with gestational hypertension or mild-preeclampsia and those with normal pregnancies. in addition, no studies have analyzed the characteristics and interventions of labor in hypertensive patients with induction of labor who undergone vaginal birth. therefore, the purpose of this project was to investigate the differences of labor characteristics and maternal-neonatal outcomes with induction of labour (iol) between pregnant women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies, providing clinical references of intrapartum management for women with gestational hypertension or mild pre-eclampsia. our results showed that women with hypertensive pregnancies had higher rates of cesarean delivery due to failed induction compared to normotensive pregnancies. however, no significant differences were observed in induced labor characteristics, intrapartum interventions, and maternal-neonatal complications between women with gestational hypertension or mild pre-eclampsia and those with normotensive pregnancies. parity, bishop score, birth weight, and the hypertensive disorders of pregnancy were independently and significantly associated with an increased risk of cesarean section following induction. consequently, these findings could provide evidence for the intrapartum management of labor induction in women with gestational hypertension or mild pre-eclampsia.

Eligibility criteria:
inclusion criteria: * undergoing an induction of labor at term (37-42 weeks) who gave birth to a live born, non-anomalous singleton in cephalic presentation, as well as women aged 18-35 years old exclusion criteria: * women with pregnancy complications including diabetes mellitus, intrahe-patic cholestasis of pregnancy, placenta previa, placental abruption, oligohydramnios, and polyhydramnios, previous caesarean births, fetal birth weight of ≥4.0 kg, severe preeclampsia, chronic hypertension, prepregnancy hypothyroidism and hyperthyroidism, renal system disease, nutritional deficiency, immune system disease, hematological system diseases, and prepregnancy thrombocytopenia. women were also excluded if clinical data were incomplete.

Keywords: induction of labor gestational hypertension mild pre-eclampsia
traxi panniculus retractor for cesarean delivery

Conditions: Obesity, Morbid; Cesarean Section Complications

Summary: this prospective, open-label, randomized-controlled trial is designed to evaluate the use of the traxi panniculus retractor-- a commercially available class i fda-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

morbidly obese women (bmi \>/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to traxi panniculus retraction or standard of care for panniculus retraction. the primary outcome evaluated will be operating time (incision to closure). other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel. a secondary aim of the study is to evaluate the hypothesis that the traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. to do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer. a tertiary aim of the study is to evaluate the hypothesis that the traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. patient and provider-reported outcomes will be evaluated using surveys.

Eligibility criteria:
inclusion criteria: * pregnant * bmi greater than or equal to 40 kg/m\^2 * undergoing non-emergent cesarean delivery * able and willing to provide written, informed consent * singleton gestation exclusion criteria: * fetal demise * disruption of abdominal skin (infection, rash, abrasion, laceration) * known adhesive allergy
chronic gvhd response measures validation

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to develop and validate endpoint measures that can accurately determine whether patients are responding to treatment for chronic graft-versus-host disease (gvhd). hopefully, this will also lead to being better able to predict which patients will respond to what therapies.


Eligibility criteria:
inclusion criteria: * age 7 years or older * prior first allogeneic stem cell transplant, with any graft source, donor type, and gvhd prophylaxis. * diagnosis of chronic gvhd according to the criteria of the diagnosis and scoring group of the nih consensus conference (patient must have at least one diagnostic manifestation of chronic gvhd or one distinctive manifestation with pathological confirmation of the diagnosis. concurrent acute gvhd manifestations will be allowed as long as at least one classic chronic manifestation is present.) * initiation of a new systemic treatment for chronic gvhd in the past 4 weeks or anticipated within the next 4 weeks. systemic treatment is defined as any medication or intervention that has intended systemic effects, including extracorporeal photopheresis, regardless of prior lines of therapy or prior treatment with the agent(s). if a patient is restarting a treatment to which they were previously exposed, they must have been off of it for at least 4 weeks before restarting. * no evidence of persistent or progressive malignancy at the time of enrollment * evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center up to four subsequent times: at 3 months, 6 months, and 18 months after enrollment and once if another treatment is added for chronic gvhd. * signed, informed consent exclusion criteria: * inability to comply with study procedures * complete resolution of chronic gvhd at the time of enrollment (patient must have some measurable chronic gvhd activity)
validation of a training program for patients with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: this study aims to detect how the web-based program salience affects patients with alcohol-use disorder in terms of craving, cognitive functions and risk of relapse.

in the web-based program salience ("stop alcohol in everyday life - new choices and evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". it has been developed as an add-on therapy to increase the overall outcome. participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. then the patients receive three training sessions with salience each week. after three weeks there is another examination. after these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. after the 90 day period there is a third examination analog to the first and the second one. for the first 25 subjects, the follow-up and t3 will be omitted; for this collective, an interim evaluation will be performed after t2 as a pilot study, followed by optimization of the protocol if necessary. the first 25 subjects will all receive salience; a comparison with standard therapy is not planned for this collective. there will be 2 weeks between t1 and t2 in the pilot study.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 * alcohol use disorder (dsm-5) * inpatient or part inpatient treatment * alcohol abstinence for at least 72 hours and maximum for three weeks * normal or correctable eyesight * sufficient ability to communicate with the investigators, to answer questions in oral and written form * "fully informed consent" * "written informed consent" exclusion criteria: * withdrawal of the declaration of consent * severe internistic, neurological or psychiatric comorbidities * severe withdrawal symptoms (ciwa-r \> 7) * alcohol-intoxication (\> 0 ‰) * pharmacotherapy with psychoactive substances within the last 14 days (except clomethiazole or benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days) * axis 1 disorder according to icd-10 and dsm 5 (except tobacco use disorder and specific phobia within the last 12 months)