Kornimate/medical-research-clean huggingface dataset:
pilot study of a self-help intervention for depression in patients with a chronic disease

Conditions: Depression; Diabetes Mellitus Type 2; Coronary Heart Disease

Summary: a feasibility pilot trial of the self-help, "cognitive behavioural therapy" based "living life to the full" materials for use by patients with diabetes type 2 and / or coronary heart disease.

depressed mood is common in patients with chronic disease and physical disability. it adversely affects quality of life, adherence to treatment and clinical outcome. depression is expensive to the person, their family, employers and society. recent developments in the uk general practitioners' contract mean that patients with two chronic diseases (coronary heart disease- chd and diabetes - dm) are routinely screened for depression using a simple screening tool. we propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way. this rct is the second phase of a 2 phase mixed methods study examining the feasibility of a full rct. the first involved focus group with patients and health practitioners.

Eligibility criteria:
inclusion criteria: * have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease. * be aged 35 or over. * be attending a participating primary care practice. * have a depression severity scale rating indicating moderate to moderately severe depression, such as:prime-md-phq9 of 10-21; hads-d of 8-15;bdi-2 of 23-44 exclusion criteria: * unable to provide informed consent to participate * already receiving psychological treatment for their depression * have commenced treatment with an ssri within the past 8 weeks * likely to have difficulty communicating by telephone * likely to have difficulty completing the forms and questionnaires * have a serious physical disorder * have a serious mental disorder * express significant suicidal thoughts (phq9 or bdi-2 question 9 scoring \>1) * took part in an earlier related focus group

Keywords: depression diabetes coronary heart disease cbt cognitive behavioural therapy
randomized phase ii trial on safety and neutralizing activity of cl184 and rabies vaccine versus human rabies immune globulin (hrig) and rabies vaccine in children and adolescents

Conditions: Rabies

Summary: the aim of this study is to evaluate the safety of the monoclonal antibody cocktail cl184 in combination with rabies vaccine compared with human rabies immune globulin (hrig) in combination with rabies vaccine in healthy children and adolescents.


Eligibility criteria:
inclusion criteria: * subjects free of obvious health-problems or with stable conditions * male or female subject aged ≥5 to ≤18 years * subject is living, studying, or working close to the study referral site * parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form exclusion criteria: * prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin) * acute infection or disease within the last 2 weeks * history and/or family history of clinically significant immunodeficiency or auto-immune disease * any history of known or suspected anaphylaxis or hypersensitivity reaction * planned immunization with live vaccines during the next 3 months * chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Keywords: rabies post-exposure prophylaxis monoclonal antibody
traditional vs orthodontic extraction of impacted teeth related to the inferior alveolar nerve

Conditions: Inferior Alveolar Nerve Injuries

Summary: the aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. the main question it aims to answer is: -does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction? participants will: * undergo either traditional or orthodontic extraction * be monitored for postoperative paresthesia. researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.

the extraction of an impacted mandibular third molar is one of the most frequently performed procedures by oral and maxillofacial surgeons. the close anatomical relationship between the root of an impacted mandibular third molar and the inferior alveolar nerve may result in inferior alveolar nerve damage. the incidence of inferior alveolar nerve injury during the removal of an impacted mandibular third molar ranges from 0.35% to 8.4%. in addition to radiographic analysis, various surgical techniques, such as coronectomy, have been proposed to reduce the incidence of inferior alveolar nerve injury. the orthodontic extraction technique is an orthodontically supported surgical approach that reduces the risk of neurological complications that may occur in inferior alveolar nerve and facilitates the surgical removal of impacted mandibular third molars close to the mandibular canal, even if they are associated with cystic lesions. the purpose of this study is to examine the effect of orthodontic extraction applied to minimize inferior alveolar nerve damage during the extraction of deeply impacted mandibular third molar teeth on postoperative nerve injury. for this purpose, the postoperative paresthesia findings of patients who underwent orthodontic extraction will be compared with those of those who underwent traditional extraction.

Eligibility criteria:
inclusion criteria: * presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc. * mandibular impacted wisdom teeth close to the inferior alveolar nerve exclusion criteria: * mandibular impacted wisdom tooth not close to inferior alveolar nerve * wisdom tooth whose apexification has not yet been completed * suspicion of a malignant pathological lesion * pathological lesion associated with inferior alveolar nerve * presence of an acute infection

Keywords: mandibular nerve injuries, impacted teeth, tooth extraction
prenatal antibiotics and breast milk / neonatal iga

Conditions: Prenatal Exposure Delayed Effects; Antibiotic Prophylaxis; Dysbiosis; Neonatal Infection; Breast Milk; Noxious Influence, Affecting Fetus

Summary: in this biological study, the investigators will evaluate the levels of breast milk iga, neonatal fecal iga, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation

in a human cohort of women and their neonates, the investigators aim to evaluate the absolute amount of iga in maternal breast milk and in neonatal feces in the presence (n=41 mother/infant pairs) or in the absence (n=41 mother/infant pairs) of exposure to prenatal abx during the last period of pregnancy. moreover, the investigators aim to evaluate, both in maternal breast milk and in neonatal feces, the composition of microbiota, and the proportion and composition of the iga-coated and not-iga- coated fractions of microbiota, by means of fluorescence-activated cell sorting (facs) coupled with 16s rrna sequencing of bacteria. finally, the investigators will measure the concentration of the chemokine ccl28 on maternal serum and breast milk, as a soluble marker of activity of the entero-mammary pathway that is known to drive the migration of iga producing plasma- cells from maternal mesenteric lymph nodes to the mammary gland. all the analysis will be performed in mother-infant dyads with exclusive breastfeeding. breast milk/serum/feces collection and analysis will be repeated at the following timepoints: 1. during the first week of neonatal life 2. at 1 month of life 3. at 3 months of life 4. at 8-12 months of life (or at the time of breastfeeding interruption), after the introduction of solid food in the infant's diet.

Eligibility criteria:
inclusion criteria: * expression of written informed consent * an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group) * the intention to breastfeed their neonates as long as possible during the first year of life exclusion criteria: * absence of written informed consent * the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding) * a maternal antibiotic treatment shorter than 7 days * the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases) * a delivery at a gestational age \< 34 weeks * the administration of antibiotics to neonates after birth, within the first week of life.

Keywords: iga prenatal antibiotics breast milk feces neonatal immune system
exploratory study on the effects of early rosuvastatin treatment in patients with acute ischemic stroke

Conditions: Ischemic

Summary: this is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

this is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

Eligibility criteria:
inclusion criteria: 1. 45 to 75 years old patients; 2. stroke involving the vascular territory of the middle cerebral artery (mca) as judged by clinical and mri evidences; 3. time from symptom onset to take the study assigned medication is within 24 hours; 4. statin naïve or discontinued at least 3 month before stroke onset; 5. first ever stroke or mild sequelae (with modified rankin score 0-1) before the index event; 6. moderate neurological deficit with baseline nihss scoring from 4-20; 7. mri scans （t1w1、t2w2、t2flair、dwi、swi）accomplished from 12 to 48 hours after the onset; 8. consent form signed. exclusion criteria: - any of the following is regarded as a criterion for exclusion from the study: 1. stroke involving the vascular territory of the vertebrobasilar artery as judged by clinical and mri evidences; 2. hemorrhagic transformation or intracranial hemorrhage on baseline mri. mri performed between 12-48 hours after the onset, if mri provides evidences which met with the exclusion criteria, the patients will be excluded from the study; 3. any circumstances under which mri scans can't be performed; 4. evidences suggesting cardiogenic stroke such as atrial fibrillation, acute coronary syndrome, patent foramen ovale , etc; 5. comatose with nihss 1a\>1; 6. medical or psychiatric conditions such as severe hepatic or renal dysfunction, heart failure, malignancy, major depression, dementia, alcohol or drug abuse; 7. suitable for rt-plasminogen activator thrombolysis treatment; 8. receiving medication with possible neuroprotective functions after stroke onset; 9. currently take steroids therapy; 10. diagnosed with malignancy within 5 years; 11. patients with myopathy or serum creatine kinase \> 3 times the upper limit of normal not caused by myocardial injury; 12. severe renal function damage (egfr\<30); 13. concurrent use ciclosporin; 14. a history of hypersensitivity of statins and other severe complication; 15. child-bearing women ; 16. patients who are or may be pregnant; 17. other conditions under which patients not pertinent to attend the study as judged by the investigators.

Keywords: acute ischemic stroke
neuromodulation and mindfulness patients with aud

Conditions: Alcohol Dependence

Summary: our primary objective is to integrate tvns and mindfulness meditation within a structured mindfulness-based relapse prevention (mbrp) program for detoxified alcohol-dependent patients (ad). we aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. in this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of aud. measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. our second objective is to examine the causal role of frontal midline theta oscillations (fmθ) in mbrp and cognitive control. to achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (clam-tacs) to selectively modulate fmθ oscillations during mbrp meditation exercises in aud patients (2).


Eligibility criteria:
inclusion criteria: * alcohol dependence (icd-10) * abstinence between 3 days and 12 months exclusion criteria: * current (last 12 months) substance use disorder/dependence * neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis) * current severe major depressive disorder, manic episode or schizophreniform disorder * intake of anticonvulsive or high-potency antipsychotic medication
umbilical or peripheral catheter insertion for preterm infants on admission to the nicu

Conditions: Hypothermia, Newborn; Preterm Birth Complication; Neonatal Hypothermia

Summary: preterm infants are at risk of hypothermia following delivery and in the first few hours of life. hypothermia in extremely low birth weight infants' is an independent risk factor for death. these infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission. the investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the nicu, instead of umbilical catheters (uvc and/or uac), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

hypothermia is an independent risk factor for death in preterm newborns.(1) despite measures to improve temperature in preterm newborns in the delivery room (dr), hypothermia on admission to the neonatal intensive care unit (nicu) at nmh is common. in a cohort of infants \< 32 weeks' gestation born at nmh in 2019, 54% of infants had a rectal temperature \< 36.5 oc on admission to the nicu.(2) many preterm infants have procedures performed soon after admission to the nicu; in 2019, 98% of infants born before 29 weeks' gestation at nmh had an umbilical venous catheter inserted. this may/often involve(s) prolonged periods of handling and potential exposure to cold. the investigators prospectively studied a cohort of 26 infants \< 32 weeks who had invasive procedures within 3 hours of birth performed in the nicu at nmh between november 2018 and june 2019. almost three-quarters \[19/26 (73%)\] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. only 3 (11%) infants maintained a normal temperature throughout the procedure. perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature \< 36.0oc before and 11 (42%) after the procedure. the median duration of procedure was 53 (37, 73) minutes.(3) the investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the nicu, instead of umbilical catheters (uvc and/or uac), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

Eligibility criteria:
inclusion criteria: * inborn infants admitted to the nicu with; * gestational age \< 29 weeks (up to 28+6 weeks) or * birth weight \< 1250g. exclusion criteria: * end of life (palliative) care * large abdominal wall defects * imperforate anus.
effectiveness of holmium and thulium lasers with ureteroscopy for urinary lithiasis

Conditions: Renal Stone; Ureteral Stone

Summary: holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while thulium is brand new. the latter has been released in july 2020 in europe, and only in-vitro studies have been published. the aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both holmium and thulium lasers. the costs and complications will also be studied.


Eligibility criteria:
inclusion criteria: * renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography * treatment with rigid or flexible ureteroscopy * laser lithotripsy during the procedure * bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics) exclusion criteria: * non-use of laser for stone lithotripsy * pregnant women * under 18 years old * refusal to give informed consent * urinary malformation
concurrent vs sequential adjuvant treatments in early breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most common form of cancer among women. for patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.

breast cancer is the most common form of cancer among women in north america, europe and latin america. because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (ct) are also candidates for endocrine therapy (et). the optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet. in patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.

Eligibility criteria:
inclusion criteria: * women with histological diagnosis of invasive breast cancer completely removed by surgery, any t, any n. * postmenopausal status defined by at least one of the following conditions: 1. aged ≥ 60 2. aged 45-59 and satisfying one or more of the following criteria: * amenorrhea for ≥12 months and intact uterus; * amenorrhea for \<12 months and follicle-stimulating hormone (fsh) within the postmenopausal range, including: * pts with hysterectomy * pts who have received hormone replacement therapy (hrt) * pts with chemotherapy-induced amenorrhea 3. bilateral oophorectomy at any age \>18 years. * primary tumor positive for estrogen receptors (er) and/or progesteron receptors (pgr) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay). * patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (ai) * indication for adjuvant chemotherapy- patients with her-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule. * signed informed consent. exclusion criteria: * hrt currently assumed or during the month before randomization * recurrent or metastatic disease * her-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible * concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy * patients who have received tamoxifen as part of any breast cancer prevention trial * previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied * concomitant severe disease which would place the patient at unusual risk * concurrent treatment with experimental drugs * patients treated with systemic investigational drugs within the past 30 days

Keywords: sequential administration chemiotherapy early breast cancer breast cancer aromatase inhibitor adjuvant post menopausal
scoring system in predicting perforated duodenal ulcer morbidity and mortality in bpkihs

Conditions: Perforated Duodenal Ulcer

Summary: different scoring systems were developed for risk prediction and adjustment of morbidity from perforated duodenal ulcer. however, these scoring systems are not routinely used in perforated duodenal ulcer patient in everyday clinical practice. identification of patient with a high risk of adverse outcomes following surgery is important for clinical decision-making which can assist in risk stratification and triage e.g. timing and extent of pre-operative respiratory and circulatory stabilization, postoperative admission to a high dependency unit (hdu), the level and extent of monitoring, and inclusion in specific perioperative care protocols. few studies assessed and compared the accuracy indices of pulp with boey and asa in predicting post ppu repair 30-day morbidity further, the efficacy must be verified in individual settings like ours. so we wish to assess its efficacy in bpkihs-a tertiary referral center of eastern nepal.

perforated peptic ulcer disease (ppu) is an important indication for emergency surgery, complicating 2%-10% of peptic ulcer disease. in the context of modern peptic ulcer therapy, the incidence of ppu has been declining over the past two decades, but mortality has not followed a commensurate decline, in spite of advances in operative strategy and perioperative care. omental patch repair of duodenal ulcer perforation is both simpler than and as effective as definitive ulcer surgery in the emergency situation. however,mortality due to ulcer perforation treated by simple closure and/or other methods is still around 10%. factors reported to affect mortality in duodenal ulcer perforations in other series are old age, co-morbidity, preoperative hypotension, large size of the perforation, delay in presentation, and, delay in operation . several scoring systems have been proposed for the predictions of 30-day morbidity and mortality of perforated peptic ulcer (ppu) in order to risk stratify patients subject to their anticipated complications, and accordingly direct the required attention to high-risk patients. scoring systems most commonly used include asa (american society of anesthesiologists), boey and peptic ulcer perforation score (pulp). each comprises 3-11 demographic, clinical and biochemical variables that consider only pre-operative, or include pre/intra -operative and laboratory findings. clinical scoring systems need good diagnostic accuracy in order to risk stratify patients correctly.

Eligibility criteria:
inclusion criteria: * all patient with perforated duodenal ulcer managed surgically exclusion criteria: * perforated other organs eg: gastric ulcer or intestinal perforation incomplete data available in database

Keywords: pulp boey asa perforated duodenal ulcer risk score