Kornimate/medical-research-clean huggingface dataset:
chlorhexidine versus povidone-iodine antisepsis for reduction of post cesarean section surgical site infection

Conditions: Surgical Site Infection

Summary: there is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.

the aim of this study is to examine the efficacy \&safety of chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.chlorhexidine is a chemical antiseptic. it is effective on both gram-positive and gram-negative bacteria, although it is less effective with some gram-negative bacteria. it has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption. iodine is commonly used as an antiseptic agent clinically. iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. this formulation increases the solubility of iodine and provides a reservoir for sustained release. the most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. this leads to reduced protein synthesis and bacterial cell wall damage.

Eligibility criteria:
inclusion criteria: 1. patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation). 2. body mass index (bmi) between 20-35kg/m2. 3. able to communicate well with the investigator and to comply with the requirements of the entire study. exclusion criteria: 1. rupture of membranes. 2. patients who have history of allergy to chlorhexidine, alcohol and iodophors. 3. documented concomitant infections like: chorioamnionitis, pyelonephritis, urinary tract infection, mastitis.
treatment satisfaction of using omnipod system compared with conventional insulin pump in adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: randomized, two arms, open study in order to evaluate treatment satisfaction of using omnipod system compared with conventional insulin pump in adults with type 1 diabetes. the study will include two consecutive 12 weeks treatment periods. according to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with omnipod system and than 12 weeks with patient's previous insulin pump or vice versa.

a randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of using omnipod system compared with conventional insulin pump in adults with type 1 diabetes. the study will include two consecutive 12 weeks treatment periods. according to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with omnipod system and than 12 weeks with patient's previous insulin pump or vice versa. study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4 telephone visits taking place at 4,8,16 and 20 weeks. in addition, patients will be invited one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor. patients will complete dtsq and comfort \& function questionnaires at weeks 0, 12 and 24, before and at the end of each study arm. on each clinical visits the following parameters will be evaluated: vital signs, hba1c, 4 and 7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related technical problems. the telephone visits will include pump related technical problems solving and ae/sae reporting.

Eligibility criteria:
inclusion criteria: 1. type 1 diabetes diagnosed at least 1 year prior to study entry 2. use of continuous subcutaneous insulin infusion therapy for at least one year 3. age: 18-35 years old 4. hba1c \>8.0 5. at least 4 self blood glucose measurements per day 6. no more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month 7. capable of reading pump screen in english 8. able to understand and sign subject informed consent forms exclusion criteria: 1. any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study. 2. patients participating in other device or drug studies 3. clinical diagnosis of hypoglycaemic unawareness 4. known dermal hypersensitivity to products that contain medical adhesive 5. taking prescription medications that could complicate the management of glycemic control. 6. inability to understand/complete the treatment satisfaction questionnaire

Keywords: treatment satisfaction omnipod insulin pump diabetes
an efficacy and safety study of jaktinib hydrochloride tablets in the treatment of severe novel coronavirus pneumonia

Conditions: Novel COVID-19-Infected Pneumonia

Summary: this study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 eligible patients with severe novel coronavirus pneumonia.


Eligibility criteria:
inclusion criteria: * aged 18 to 80 years old (including threshold), regardless of gender; * there is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week; * hrct is consistent with the manifestation of viral pneumonia (judged by the investigator) * participants who voluntarily sign informed consent. exclusion criteria: * participants who cannot take orally, or are suspected to be allergic to jaktinib hydrochloride, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; * critical pneumonia patients with other organ failure requiring icu monitoring and treatment; * participants who have received the following treatments within the specified time window before randomization: 1. participants have received janus kinase (jak) inhibitor, interleukin 6 (il-6) inhibitor, il-1 inhibitor, tumor necrosis factor (tnf) inhibitor, t cell or b cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid; 2. systematically used cyp 3a4 potent inhibitor or potent inducer in the first five drug half lives at random; * immune deficiency; * participants who have received novel coronavirus vaccine within 1 week before randomization; * prior to randomization, there were the following active and uncontrolled infections: tuberculosis, hiv, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than sars cov-2 that required systemic anti-infection treatment; * renal diseases requiring dialysis treatment; * pregnant and lactating women; * any other participants that were considered unsuitable by the investigator.
azithromycin treatment for the airway microbiome in asthma

Conditions: Asthma Chronic

Summary: the purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.


Eligibility criteria:
inclusion criteria (all participants): 1. age 18 - 55 years 2. able to provide informed consent 3. smoking history \< 10 pack-years inclusion criteria for subjects with poorly controlled asthma 1. methacholine pc20 \ 12% on fev1 after 4 puffs of albuterol 2. currently prescribed ics + laba 3. meet definition for th2-low asthma: peripheral blood eosinophil count \< 300 and exhaled nitric oxide level \< 30 ppb. exclusion criteria (all participants) 1. history of allergy or intolerance to any medications used in this study 2. medication exclusions: 1. current use of medications that prolong qtc interval 2. current use of omalizumab or other ant-ige therapies 3. current use of anti-il 5 therapies 4. current use of anticoagulants 3. prednsione or other oral steroids within past 3 months 4. pregnancy or lactation, or plans to become pregnant 5. other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema) 6. pre-existing liver disease by history 7. smoking within the last 6 months 8. exacerbation of asthma in past 3 months 9. affected by a hearing disorder 10. clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator 11. corrected qt interval \> 450 msec. patients with known cardiac history or prolonged qt interval on a screening ekg are excluded given the small but real potential for macrolide-related side effects

Keywords: asthma azithromycin microbiome sputum
prediction of anterior circulation large vessel occlusion stroke with eeg

Conditions: Anterior Large Vessel Occlusion Stroke

Summary: this study is designed to evaluate the accuracy of saline electrode eeg in the prehospital diagnosis of lvo-a stroke.

this is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of june 1, 2024-december 31, 2025, and record single scalp eeg signals with eyes open at rest in the lying position of the patients using a non-invasive eeg acquisition device, and collect clinical data.

Eligibility criteria:
inclusion criteria: * phase i.1.acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (m1/m2)) confirmed by cta, mra or dsa (diagnosis in accordance with the "chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2023")；2. patient age ≥18 years；3: last normal time to eeg acquisition time ≤ 72 hours；4: signed informed consent. phase ii-iii 1. diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient 2. patient age ≥18 years 3. last normal time to eeg acquisition time ≤ 24 hours 4. signed informed consent exclusion criteria: 1. wounds in the area of electrode cap placement or active infection in the scalp; 2. patients who do not cooperate with the eeg examination.

Keywords: anterior large vessel occlusion stroke electroencephalography prehospital triage
characterizing bilateral hypoglossal nerve stimulation during drug-induced sleep endoscopy

Conditions: OSA - Obstructive Sleep Apnea

Summary: the study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the inspire hypoglossal nerve stimulator.


Eligibility criteria:
inclusion criteria: * adults (≥ 22yrs) willing and capable of providing informed consent * implanted with the inspire hypoglossal nerve stimulator exclusion criteria: * • pregnant women\*
the effect of motivational interviewing based on the com-b model

Conditions: Cervical Cancer

Summary: this research will be conducted to determine the effect of motivational interviewing based on the com-b model on women's cervical cancer health beliefs and participation in screening.

cancer is an important public health problem in terms of mortality and morbidity in the world and in our country, and ranks second among the causes of death. it can reduce the mortality and morbidity rate in cancer with early diagnosis and screening studies. one of the cancers for which early diagnosis and screening studies are carried out in women is cervical cancer, and it is the 4th most frequently diagnosed cancer type that causes death in women. although early diagnosis and screening studies are carried out, women do not participate in enough cervical cancer screenings for different reasons. interventions are needed to increase women's motivation to participate in screening. this research will be conducted to determine the effect of motivational interviewing based on the com-b model on women's cervical cancer health beliefs and participation in screening. the research is planned as a parallel group single-blind randomized controlled experimental study and will be conducted on women between the ages of 30-65 who are registered at altınordu central family health center in ordu province. the population of the research will be women between the ages of 30-65 who are registered at altınordu central family health center, and the sample will be 74 women who meet the research criteria and agree to participate in the research. the data of the research will be collected with the "information form", "cervical cancer and pap smear test health belief model scale", "cervical cancer screening status evaluation form" and "satisfaction evaluation form". a motivational interview program based on the com-b model will be applied to the women in the experimental group for 1 month (1st week face-to-face, 2nd, 3rd and 4th weeks online). no intervention will be applied to the control group during the research process. the analysis of the data will be done in a computer environment by an expert statistician. necessary institutional permissions and ethics committee approval will be obtained for the research.

Eligibility criteria:
inclusion criteria: * registered at altınordu central family health center, * a woman, * between 30-65 years of age, * the one who is married, * have not had a pap smear test in the last 5 years, * has a smart phone * has an internet connection, * open to communication and collaboration, * women who volunteer to participate in the study will be included in the study. exclusion criteria: * who had total hysterectomy surgery, * the pregnant one, * those diagnosed with cervical cancer and * women with a psychiatric diagnosis will be excluded from the study.

Keywords: cervical cancer motivational interviewing early diagnosis and screening health beliefs nursing com-b model
sex hormone binding globulin, testosterone and glycemic control in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: sex hormone-binding globulin(shbg) is a surrogate marker of insulin resistance. this study aims at the characteristic and clinical significance of shbg and testosterone in patients with type 2 diabetes(t2d).

the investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, hba1c, shbg, testosterone, insulin, epo, c-peptide, glucagon, microalbuminuria, glycemic variation via cgm, carotid plaque, ecg and ultrasonic cardiogram in patients with t2d who visited in the department of endocrinology at the nanjing first hospital from january 2015 to aprol 2018. the relationship between levels of shbg, testosterone and glycemic variation/diabetic complications are analysed.

Eligibility criteria:
inclusion criteria: ● patients with t2d and the diagnostic criteria of t2d is according to the world health organization in 1999. exclusion criteria: * patients use systemic steroidal anti-inflammatory drugs. * patients with an acute infection. * patients with acute complication of diabetes.

Keywords: sex hormone-binding globulin
a phase 2b study to evaluate the efficacy and safety profile of pf-06651600 and pf-06700841 in active non-segmental vitiligo subjects

Conditions: Active Non-segmental Vitiligo

Summary: this is a phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. the study will have a maximum duration of approximately 60 weeks. this includes an up to 4 weeks screening period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week follow up period.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18-65 years of age, inclusive, at time of informed consent. * must have moderate to severe active non-segmental vitiligo. exclusion criteria: * history of human immunodeficiency virus (hiv) or positive hiv serology at screening, * infected with hepatitis b or hepatitis c viruses. * have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb)
digital support intervention for pregnant people with opioid use disorders

Conditions: Digital Intervention; Bibliotherapy

Summary: the goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with opioid use disorders through digital technology (e.g. smartphones). the main question it aims to answer is: • what is the feasibility of providing customized digital parenting and recovery supports to pregnant people with opioid use disorders residing in natural communities? o feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; secondary outcome exploratory data will include moud treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the parental sense of competency scale, self-rated abilities for health practices scale, and self-efficacy in infant care scale) through self-report; the intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. participants will complete the following tasks: * schedule an online meeting with the research team to receive more information about the study. once consented to participate, the participant will be randomly assigned to one of the groups. * complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. the surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. the total time to complete the survey after consenting to be in the study will take approximately 40 minutes. the total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.


Eligibility criteria:
inclusion criteria: female, pregnant, greater 13 weeks gestational age * opioid dominant use disorder and primary phenotype * residing in natural home environment * minimum of 18 years of age * able to speak and understand english * able to understand and provide informed consent exclusion criteria: * not pregnant, has active illicit opioid use and not currently in treatment * a violent criminal history * cannot read and communicate in english

Keywords: parentss project opioid use disorders pregnancy postpartum methadone buprenorphine digital technology digital apps
a study evaluating megestrol acetate modulation in hormone receptor positive advanced breast cancer

Conditions: Breast Neoplasm

Summary: this pilot trial evaluates in vivo megestrol acetate (ma) modulation of steroidal receptors in advanced breast cancer.

progesterone receptor (pr) expression has been considered a biomarker of oestrogen receptor-α (erα) activity. this longstanding relationship has been recently challenged and instead of being merely an erα-induced gene target, pr may be a critical determinant of erα activity. the functional significance of this steroid receptor crosstalk is regulation of a gene expression program associated with low tumorigenicity; hence, better disease outcome. genomic alterations in the pr genomic locus seem to be a relatively common mechanism for reduction of pr expression, which may consequently lead to altered erα chromatin binding and target gene expression patterns that increase breast tumorigenicity and confers a poor clinical outcome. this erα-pr crosstalk may be directly influenced by many variables, including the relative receptor levels and the hormonal milieu. er-positive advanced breast cancer is a heterogeneous group of diseases with considerable variability in outcome to a range of treatments. prior response predicts the likelihood of subsequent benefit from another endocrine agent and this should be taken into account in the treatment decision process when assessing whether to prescribe a subsequent endocrine therapy. despite the enormous progress made regarding the elucidation of breast cancer subgroups and their molecular drivers, most information comes from primary tumors. ma lacks cross-resistance and is active after acquired resistance to potent ai. this pilot trial evaluates in vivo ma modulation of steroidal receptors in advanced breast cancer.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer with er and/or pr positive (primary tumor) * metastatic site amenable to biopsy exclusion criteria: * platelet count below 100,000 / mm3 * renal or hepatic impairment * coagulation disorder

Keywords: megestrol acetate steroid, receptors
comparison of efficacy and tolerability of apd treatment with different pd cyclers

Conditions: Renal Failure; End Stage Renal Disease

Summary: the study has been designed in order to investigate the performance and safety of the new silencia pd cycler including the silencia tubing system in comparison to the pd-night and homechoice pd cycler which are both well-established pd cyclers.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/authorised physician * ckd patients being treated with apd for at least 3 months * minimum age of 18 years * body weight ≥ 40 kg * fluid status regularly monitored with body composition monitor (bcm) * patients planned to change to the silencia pd cycler * proper functioning catheter * intraperitoneal pressure (ipp) ≤ 18 cm h2o for the maximum of tavo parameter "permitted patient volume" * ability to understand the nature and requirements of the study exclusion criteria: * patients who have any condition prohibiting the use of bcm, like patients with major amputations (e.g. lower leg) * patients receiving polyglucose containing pd solution * any conditions which could interfere with the patient's ability to comply with the study * patients who suffer from peritonitis/exit site infection during the last 4 weeks * women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period * life expectancy \< 3 months * participation in an interventional clinical study during the preceding 30 days * previous participation in the same study

Keywords: peritoneal dialysis automated peritoneal dialysis (apd) pd cyler renal replacement therapy
evaluate the safety and efficacy of caspofungin acetate as empirical therapy in chinese adults with persistent fever and neutropenia (0991-055)

Conditions: Fungal Infection

Summary: registration study


Eligibility criteria:
inclusion criteria: * patient has had an absolute neutrophil count \ 38.0 degrees centigrade within the last 24 hours prior to study entry * appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage exclusion criteria: * patient has an inadequately managed bacterial infection at the time of enrollment