Kornimate/medical-research-clean huggingface dataset:
teva asthma predictive analytics study

Conditions: Asthma

Summary: this trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with teva digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices. enrolled participants will complete questionnaires along with other study specific procedures. additionally, in-person and phone visits will be performed.


Eligibility criteria:
inclusion criteria: * a history of severe persistent asthma as defined by european respiratory society (ers) and american thoracic society (ers/ats) criteria which includes the presence of poor asthma control on high dose inhaled corticosteroid (ics) and a long-acting beta-agonist (cs/laba) or the need for high dose ics/laba to maintain asthma control or oral steroids for maintenance therapy for more than 50% of the prior year. * presence of current biologic use or planned initiation of biologics following study enrollment * patients will be categorized on the basis of asthma control (asthma control test (act)\< 19 will be considered poor asthma control). the study will cap the patients with good asthma control at 30% and will no longer enroll those patients once the strata have been fully enrolled. * willingness to switch maintenance inhalers to airduo® digihaler™ and to use proair® digihaler™ for rescue therapy. use of nebulized albuterol will be discouraged but not prohibited. * can read and communicate in english and is familiar with and is willing to use his/her own smart device and download and use the study application * ability to provide informed consent. * the patient must be willing and able to comply with study requirements and restrictions exclusion criteria: * clinically important pulmonary disease other than asthma including chronic obstructive pulmonary disease (copd), bronchiectasis, pulmonary fibrosis, cystic fibrosis, or other lung disease * any disorder that is either not stable or could in the opinion of the investigator affect the ability of the subject to safely participate in the study or could adversely affect study results. * history of human immunodeficiency virus or other immunodeficiency syndrome * malignancy other than skin cancer that has occurred within the past year and that will impact survival thus limit participation in the clinical trial * history of chronic alcohol abuse or drug use * any life-threatening diseases that will impact the patient's ability to complete the 12-month study period

Keywords: adults severe persistent airduo digihaler proair digihaler
samatasvir (idx719) in combinations with simeprevir and/or tmc647055/ritonavir with or without ribavirin for 12 weeks in participants with chronic hepatitis c infection (mk-1894-005)

Conditions: Chronic Hepatitis C Virus

Summary: parts a and b of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (rbv) for 12 weeks in treatment-naïve, genotype (gt) 1b, 4 and 6 hepatitic c virus (hcv)-infected participants. part c of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, tmc647055 and ritonavir (rtv) when administered in combination with or without rbv for 12 weeks in treatment-naïve or interferon/rbv-treatment relapsed, gt 1a and 1b hcv-infected participants.

part a of this study is randomized and double-blind. parts b and c are randomized and open-label.

Eligibility criteria:
inclusion criteria: * must have genotype 1a, 1b, 4 or 6 hcv infection. * documented clinical history compatible with chronic hepatitis c * hcv treatment-naïve or interferon/rbv-treatment relapsed (part c) * must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs. exclusion criteria: * female participants who are pregnant or breastfeeding. * body mass index (bmi) \> 36 kg/m2. * co-infected with hepatitis b virus or human immunodeficiency virus (hiv). * history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc. * history or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency. * has one or more known primary or secondary causes of liver disease, other than hepatitis c * history of, or active, acute or chronic, liver or biliary injury due to drugs, toxins, non-hcv viral hepatitis, gallstones or other etiologies * donated blood or had significant blood loss 30 days prior to dosing

Keywords: hcv hepatitis c chronic hepatitis c antiviral
pethidine analgesia and neonatal hearing screening test

Conditions: Hearing Loss; Newborn Complication

Summary: neonatal hearing screening may fail due to some perinatal and neonatal factors. it is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. there is still widespread concern about the use of opoid analgesics to relieve pain during labor. the aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.

the study group consisted of patients receiving 50 mg intramuscular (i.m) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. newborns were evaluated by otoacoustic emission (oae) test. the oae test was performed before the patients were discharged. perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.

Eligibility criteria:
inclusion criteria: * term singleton pregnancy, * gave birth at 37-41 weeks of gestation, * without chronic internal disease, * pregnant women were included in the study. exclusion criteria: * newborn hospitalized in intensive care, * congenital / chromosomal anomaly, * congenital cmv infection, * facial / ear deformities, * family with hearing problems, * those with hyperbilirunemia, * tested at \<12 hours after birth, * maternal infection, * diabetes mellitus, recurrent abortion, * smoking, * plesanta previa, * prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and * newborns who were at risk of asphyxia hypoxia were excluded from the study.

Keywords: newborn hearing screening otoacoustic emissions pethidine false positive
intravenous acetaminophen for craniotomy patients

Conditions: Craniotomy

Summary: adding intraoperative iv acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. opioids exacerbate symptoms of nausea and vomiting. reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * weigh at least 50 kg (110.23 lbs) * undergoing open, elective intracranial procedure for * tumor resection * aneurysm clipping * revascularization * have an asa (american society of anesthesiologists) physical status of 1, 2, 3, or 4 * able to provide written informed consent exclusion criteria: * significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation * unable to communicate symptoms * current daily opioid use (\>40 mg morphine equivalent) * tramadol use * treated with mao (monoamine oxidase inhibitors) inhibitors within 10 days of surgery * treated with any amount of acetaminophen within 8 hours of anesthesia for surgery * allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines * pregnancy * impaired liver function * participation in interventional clinical study within the last 30 days * known or suspected history of alcohol or drug abuse * surgery for resection of acoustic neuroma * transphenoidal tumor resection

Keywords: craniotomy tumor resection aneurysm revascularization opioid nausea vomiting acetaminophen
risk reduction program for women having high risk of breast cancer

Conditions: Cancer Screening; Early Detection of Cancer; Breast Cancer; Preventive Health Care; Health Behavior

Summary: an intervention program involving education, guidance, counseling, case management and surveillance based on the health belief model will be implemented on women with high risk of breast cancer. the impact of the breast cancer risk reduction program on participation in breast cancer screenings, health beliefs (health motivation, sensitivity, fear of breast cancer) and behaviors (physical activity, nutrition, health responsibility, genetic counseling) will be evaluated in the study.

in women with family history of breast cancer, cancer risk increases at least twice as compared to the population of the same age. the aim of this study is to evaluate the impact of the intervention program based on the health belief model involving education, guidance, counseling, case management and surveillance, on participation in breast cancer screenings, health beliefs and behaviors in women with high risk of breast cancer. this study protocol describes a randomized controlled trial with parallel group design. first degree biological relatives (mother, daughter, sister) of breast cancer patients who are diagnosed with breast cancer at or under the age of 50 and who apply to the oncology department will be randomly assigned to the intervention and control group. the content of the breast cancer risk reduction program created for the intervention group was planned according to the health belief model (hbm) theoretical framework. the interventions based on hbm were carried out according to the omaha nursing interventions categories used in the field of public health nursing (training, guidance, counseling, case management and surveillance). breast cancer risk reduction program (bircarrepro) is a 12-week program that includes six interviews. the first intervention in this group will begin with a 60-minute face-to-face individual training. after the first face-to-face interview, phone calls will be made in the second, third, sixth, ninth, and twelfth weeks. pre-tests and post-tests will be completed by the participants via electronic questionnaires. follow-up questionnaires will be applied by repeating the post-test at the 24th week. in the control group, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being the first degree biological relative of a primary breast cancer patient diagnosed at or before the age of 50 * aged 25 or older * no mammography and/or mri in the last 18 months * being literate exclusion criteria: * having been diagnosed with breast cancer (first degree relative) * being pregnant or breastfeeding
nebulized beclometasone dipropionate improves nasal patency in children with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to examine in children with persistent ar the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.


Eligibility criteria:
inclusion criteria: * children 6-16 years of age with a history of ar in the previous year * t5ss: ≥5 in the last week before enrollment exclusion criteria: * asthma symptoms * acute upper respiratory infections * anatomic nasal defects (ie, septum deviation), or nasal polyps * use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.
mortality score in elderly patients with colon cancer

Conditions: Mortality; Surgery; Colon Cancer

Summary: cr-possum is one of the most used surgical scores to predict mortality after colorectal surgery. its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. the primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. the secondary objective is to analyze its efficacy compared to cr-possum.

patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an italian hospital were retrospectively selected. mecc score \[mortality in elderly patients with colon cancer\] was calculated summing up the scores relating to: arterial saturation of o2, systolic blood pressure, heart rate, wbcs, albumin, creatinine. once cr-possum was calculated, the two scores were compared.

Eligibility criteria:
inclusion criteria: * patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches exclusion criteria: * surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies

Keywords: colon cancer surgery mortality elderly scoring system
flex first registry research protocol

Conditions: Arteriovenous Fistula; Arteriovenous Graft; Fistula; Arterial Occlusive Diseases

Summary: prospective, observational study evaluating the clinical use and outcomes of the flex vessel prep (vp) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

prospective, observational study evaluating the clinical use and outcomes of the flex vessel prep (vp) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the institution's standard practice and at 1-, 6-, and 12-months following treatment.

Eligibility criteria:
inclusion criteria: 1. subject is ≥18 years of age. 2. subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the kdoqi guidelines for av access dysfunction: * elevated venous pressure during hemodialysis, * abnormal physical findings, and * unexplained decrease in delivered dialysis dose. 3. subject has a reasonable expectation of remaining on hemodialysis for ≥12 months. 4. subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form. 5. subject understands the study and is willing and able to comply with the follow-up requirements. exclusion criteria: 1. subject has a known or suspected systemic infection. 2. subject has a known or suspected infection of the hemodialysis graft. 3. subject has an untreatable allergy to radiographic contrast material. 4. in the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.
rituximab and abvd for hodgkin's patients

Conditions: Lymphoma

Summary: primary objective: - to determine the feasibility, toxicity, and efficacy of rituximab with standard dose abvd combination chemotherapy. abvd combination chemotherapy consists of adriamycin, bleomycin, vinblastine and dtic.

before treatment starts, patients will have a physical exam. bone marrow samples will be taken. blood samples (4 to 8 tablespoons) will be taken before and during the study. a chest x-ray, ct scans of the abdomen and pelvis, and a gallium scan will be done if necessary. patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. abvd will be injected over 3 hours every other week for a total of 12 treatments. on the cycles where both rituximab and abvd are given, rituximab will be given on day 1, and abvd will be given on day 2. response to therapy will be determined after 3 months and at the end of therapy (6 months). at the end, patients may receive radiation therapy to areas of large masses. all treatments can be given in an outpatient setting. scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. if tumors do not shrink after 3 months of therapy, patients will be offered a different treatment. this is an investigational study. although abvd is considered the standard treatment for patients with hodgkin's disease, the combination of abvd with rituximab is considered investigational. all drugs involved in this study are commercially available and are approved by the fda. up to 85 patients will take part in this study. all will be enrolled at m. d. anderson. this protocol is partially funded by a research grant from genentech.

Eligibility criteria:
inclusion criteria: 1. hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage ii bulky, iii and iv who are eligible for abvd. 2. must have histologically proven diagnosis of hodgkin's disease (nodular sclerosis or mixed cellularity). 3. must have bidimensionally measurable disease. 4. must sign a consent form. 5. must be older than 16 years of age. 6. must have adequate bone marrow reserve (anc \> 1,000/microl, platelet \> 100,000/microl 7. left ventricular ejection fraction (lvef) \>/= 50% by multigated acquisition (muga) scan or echocardiogram. 8. serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl exclusion criteria: 1. hiv positive. 2. pregnant women and women of child bearing age who are not practicing adequate contraception. 3. prior chemotherapy. 4. severe pulmonary disease including chronic obstructive pulmonary disease (copd) and asthma.

Keywords: hodgkin's disease lymphoma rituximab rituxan adriamycin doxorubicin rubex bleomycin bleomycin sulfate blenoxane blm dacarbazine dtic dtic-dome vincristine vinblastine vinblastine sulfate abvd abvd chemotherapy treatment
obstetric comorbidity index in postpartum hemorrhage

Conditions: Cesarean Section Complications; Postpartum Hemorrhage; Morbidity;Perinatal

Summary: the objective of this study is to examine the predictive capability of the obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery.

the prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. there has been development of the obstetric comorbidity index (obcmi) by bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. the score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. for instance, both the charlson/romano comorbidity index or the elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality. the obstetric comorbidity index has undergone thorough examination and validation across multiple nations. these findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance. however, within the context of thailand, investigations concerning the obstetric comorbidity index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. therefore, this study aims to elucidate the correlation between the obstetric comorbidity index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest university hospital, in thailand. predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period.

Eligibility criteria:
inclusion criteria: the patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (icd-10 coding o72.1) exclusion criteria: * cesarean delivery at less than 24 weeks of gestation * a patient chart that does not contain primary outcome data eg. absence of anesthetic record * blood loss less than 1,000 ml in the first 24 hours postpartum

Keywords: cesarean section postpartum hemorrhage maternal morbidity obstetrics comorbidity index
lymph node mapping via flourescent dye in colon cancer

Conditions: Colon Carcinoma; Lymph Node Metastases

Summary: the aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. the visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative. the draining lymph nodes will be visualized using the fluorescent dye indocyanine green. the aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. the visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative. the draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. preoperatively the participants will receive an indocyanine green(icg) injection at four points around the tumour endoscopically. the icg marking will take place one to five days prior to surgery. in the draining lymph nodes of the specific region the icg will accumulate and thus visible via fluorescence-camera during the surgery. intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. a standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. the fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative. the aim ist not the visualization of the sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.

Eligibility criteria:
inclusion criteria: * histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon. exclusion criteria: * not wanting to participate * other carcinoma then adenocarcinoma * endoscopic marking not possible

Keywords: indocyanine green lymphatic mapping fluorescence