Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of trichuris suis ova (tso) as compared to placebo in autism spectrum disorder

Conditions: Autism

Summary: this is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of tso treatment and 16 weeks of placebo.


Eligibility criteria:
inclusion criteria: * male or female patients, 5 to 17 years of age * patients must fulfill dsm-v diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the autism diagnosis observation schedule - second edition (ados-2) * written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. in accordance with institutional review board (irb) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. * patients are able and willing to swallow study medication suspension. exclusion criteria: * known diagnosis of syndromal form of autism (e.g. rett syndrome, childhood disintegrative disorder, fragile x syndrome, etc.) * patients who cannot discontinue anti-psychotic medication * patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening * female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control. * patients who have received helminthic treatment

Keywords: t. suis ova trichuris suis ova autism spectrum disorder asd
effects of chewing gum against postoperative ileus

Conditions: Postoperative Ileus

Summary: the purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy.

postoperative ileus is common after surgery. one non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. however, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer. this study was conducted as a phase-iii trial. patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. the treatment group received chewing gum postoperatively and standard care. controls received glucose solution and standard care. participants were included on the day of admission, which was the day prior to surgery. randomization to the two groups (1:1) was done when patients returned from the intensive care unit (icu) to the ward. this procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. with a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.comparisons between the groups were analyzed with non-parametric tests; the mann whitney u test and chi 2 test. controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. the chewing gum used was chiczatm, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). patients started to chew after they returned from the icu the day after surgery. chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). during each four-hour period, patients chewed two pieces of gum for 30 minutes each. chewing gum was used during the whole hospital stay. the time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data.

Eligibility criteria:
inclusion criteria: * diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy. * understand and speak swedish * no diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function * no ongoing treatment for mental disease * no ongoing abuse of alcohol or other drugs * no previously known allergies to the content of chewing gum exclusion criteria: * additional surgery after primary surgery. * no radical curative surgery * previous abdominal surgery.
evaluation of intravascular monitoring of partial pressure of oxygen for neonatal intensive care patients -3

Conditions: Catheters, Indwelling; Preterm Birth; Compromised Health

Summary: the study is a non-blinded trial with one single intervention in sick newborn infants. the neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. the catheter will be connected to the neosense monitor/measuring unit. blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). oxygen tension data from the neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. this data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. the blood gas samples will be analysed according to clinical and laboratory routine. the infants will remain in the study as long as the neosense measuring system is used


Eligibility criteria:
inclusion criteria: sick newborn infants where the clinical routine indicates use of an umbilical catheter. at least one of the criteria below should be fulfilled: * the infant needs invasive measurement of blood pressure. * the infant needs repetitive sampling of blood. * the infant needs prolonged infusion(s) \&gt; 2 days. * the infant needs infusion of vessel irritating and potentially vessel harming solutions. * the infant is born extremely preterm (before 28+0 weeks gestational age). * a newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% fraction of inspired oxygen (fio2)). * the infant is undergoing therapeutic hypothermia following asphyxia \&#34;oxygen deficiency at birth\&#34;). * the infant has a severe infection/sepsis. also: • signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required). exclusion criteria: * gastroschisis * omphalocele * peritonitis * necrotizing enterocolitis * omphalitis * the infant has a severe infection/sepsis * expected mri investigation within the 7 first days after birth * the infants birth weight is below 750 g * the infant is born before week 25+0 * local vascular compromise in lower limbs or buttocks area, or portal venous hypertension

Keywords: neonatal arterial oxygen tension oxygen therapy
a study of skb264 in combination with pembrolizumab versus pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the aim of the study is to evaluate the efficacy and safety of skb264 in combination with pembrolizumab as firstline treatment for patients with pd-l1-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

this is a randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of skb264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for pd-l1 positive patients with locally advanced or metastatic non-small cell lung cancer.

Eligibility criteria:
inclusion criteria:key inclusion criteria: 1. histologically or cytologically confirmed nsclc that is locally advanced (stage ⅲb/ⅲc) or metastatic (stage iv) nsclc that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy. 2. no prior systemic anti-cancer therapy for locally advanced or metastatic disease. 3. participants whose tumours are pd-l1 tps ≥ 1%. 4. at least one measurable lesion per recist v1.1. 5. eastern cooperative oncology group (ecog) performance status of 0 to 1 with no worsening within 7 days prior to randomization. 6. a life expectancy of at least 12 weeks. 7. adequate organ and bone marrow function. exclusion criteria:key exclusion criteria: 1. active second malignancy. 2. uncontrolled or clinical significant cardiovascular disease. 3. history of noninfectious pneumonitis/interstitial lung disease (ild) that required steroids or has current pneumonitis/ild. 4. active infection requiring systemic therapy within 2 weeks of randomization. 5. active hepatitis b or hepatitis c virus infection. 6. human immunodeficiency virus (hiv) positive or history of acquired immunodeficiency syndrome (aids); known active syphilis infection. 7. known allergy to skb264 or pembrolizumab or any of its components. 8. prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy): 1. immune checkpoint inhibitors (e.g., anti-pd-1/l1 antibody, anti-ctla-4 antibody, etc.), checkpoint agonists (e.g., icos, cd40, cd137, gitr, ox40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy; 2. therapy targeting trop2. 3. any drug therapy that targets topoisomerase i, including antibody-drug conjugates (adcs). 9. major surgery within 4 weeks prior to randomization or expected major surgery during the study. 10. pregnant or lactating women.
a study of bevacizumab versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received previous chemotherapy

Conditions: Non-Small Cell Lung Cancer

Summary: this randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) or placebo on day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. after progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.


Eligibility criteria:
inclusion criteria: * locally advanced (stage iiib not amenable for combined modality treatment), metastatic (stage iv) or recurrent non-squamous non-small cell lung cancer * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate hematological, renal and liver function exclusion criteria: * prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (stage iiib, iv or recurrent disease) * mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component * evidence of tumor invading major blood vessels on imaging * central nervous system (cns) metastases, even if previously treated * history of hemoptysis in the 3 months prior to enrollment * history or evidence of inherited bleeding diathesis or coagulopathy * uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy * clinically significant cardiovascular or vascular disease * malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent
telephone use for care of persons with diabetes mellitus.

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine whether phone use contributes to diabetes control.

studies reinforce the need to test innovative care that can serve more patients, since education is a key element for the accession to the treatment of diabetes. recently, an innovative, feasible and low cost presented in the literature is the use of telephone support as an intervention strategy this study aims to evaluate the implementation of a telephone support for self-monitoring of people with diabetes mellitus treated in ribeirão preto.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * age * ability to listen and answer questions exclusion criteria: * often present less than 75% participation in the proposed activities

Keywords: nursing care diabetes mellitus phone support chronic care model
icg fluorescence imaging in open fracture trauma patients

Conditions: Trauma Injury

Summary: this is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured by indocyanine green (icg) fluorescence imaging, and complications, in an effort to develop icg fluorescence imaging as a diagnostic tool to quantitatively guide operative debridement.

this is a prospective observational study that will evaluate the association between bone and tissue perfusion, as measured using indocyanine green (icg) fluorescence imaging, and complications. this will be used to develop icg fluorescence imaging as a diagnostic tool to objectively and quantitatively guide operative debridement. the study population includes all open fracture patients regardless of race, ethnicity, or sex/gender. primary outcome measure is all-cause re-operation and secondary outcome measure is surgical site infection. all patients will be followed for a total of 12 months.

Eligibility criteria:
inclusion criteria: 1. patients 18 years of age or older. 2. open extremity fracture. 3. planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. open fracture wound management that includes formal surgical debridement within 72 hours of their injury. 5. will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. provision of informed consent. exclusion criteria: 1. inability of patient to provide informed consent 2. fracture of the hand. 3. iodine allergy. 4. received previous surgical debridement or management of their fracture at a non-participating hospital or clinic. 5. open fracture managed outside of the participating orthopaedic service. 6. chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 7. burns at the fracture site.

Keywords: immunofluorescence orthopaedic trauma open fracture
selfit: internet-based treatment for adjustment problems after an accident

Conditions: Adjustment Impairment; Accident; Adjustment Disorders; Mental Disorder

Summary: in this study, people who suffer from adjustment problems after having experienced an accident will be randomized to one of two study groups. the first group receives access to the internet-based self-help intervention immediately. the second group is a waiting control group that receives access to the program 12 weeks later. in both conditions additional care or treatment is allowed. the aim of the study is to investigate the efficacy and cost-effectiveness of an internet-based self-help intervention for people with adjustment problems after an accident compared to a waiting list. there are 6 assessments, which all take place online: baseline, two between-measurements (after 4 and 8 weeks), post assessment (after 12 weeks) and two follow-up assessments (after 3 and 6 months). all participants from both groups are asked to fill out all assessments.


Eligibility criteria:
inclusion criteria: all participants must... * be at least 18 years old * give a declaration of consent to participate in the study * have access to the internet * understand and master the german language to the degree that they understand the contents and instructions of the study * exceed the cut-off value for at least a mild psychological burden on the depression-anxiety stress scale (dass- 21) * be able to specify an emergency address in the event of an acute crisis * have experienced and can specify an accident during a period of two weeks to two years prior to participation in the current study that lead to the conditions described above. exclusion criteria: excluded are persons who... * show severe depressive symptoms (beck depression inventory \[bdi-ii\] \> 29) * show suicidal tendencies (bdi-ii suicide item \> 1) * have a known diagnosis of psychotic or bipolar disorder.
salmeterol effect on exercise performance

Conditions: Healthy

Summary: the purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * age 18-40 * physically active \>5 hours a week * maximum oxygen uptake classified as high or very high exclusion criteria: * active smoker currently or within the past 5 years * regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women) * chronic or acute illness deemed by the responsible study physician to affect the test parameters * deviation from the study protocol * lean mass index \>21 kg/m² * pregnancy * smoker * blood donation during the past 3 months

Keywords: beta2-adrenergic stimulation skeletal muscle hypertrophy
study of the efficacy and safety of ly2940094 in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg) once-daily (qd) dose of ly2940094 for 8 weeks in participants with mdd.


Eligibility criteria:
inclusion criteria: * have a diagnosis of mdd without psychotic features as defined in the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) * have clinically significant depressive symptoms defined by a grid hamilton depression rating scale 17 (hamd17) total score ≥20 at screening * body mass index (bmi) between 18 and 35 kilogram per square meter (kg/m²) exclusion criteria: * have a current or previous diagnosis of bipolar i or ii disorder, mdd with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder * currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode * had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening * have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety
voriconazole for secondary prophylaxis of invasive fungal infections in patients with allogeneic stem cell transplants

Conditions: Prophylaxis Of Invasive Fungal Infections

Summary: to prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants


Eligibility criteria:
inclusion criteria: * patients with proven or probable ifi in previous 12 months receiving an allogenic stem cell transplant for any haematological disease exclusion criteria: * pregnant or lactating women * severe disease other tham the underlying condition * active, symptomatic uncontrolled invasive fungal infection * any evidence of active fungal disease as defined by msg-eortc criteria * concomitant use of voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy * other medical conditions, including hiv positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Keywords: invasive fungal infection, allogenic stem cell transplant, prophylaxis, leukemia, voriconazole
the effect of frailty to perioperative complications in the elderly

Conditions: Fragility; Intraoperative Hypotension; Perioperative Complication

Summary: with the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. however, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care. frailty is a condition in which patients are impaired at physical reserve and homeostatic control. frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. frail patients are at higher risk of perioperative complications and longer hospital stay. however, there has been no standard criteria or tool to evaluate frailty in the elderly. neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.


Eligibility criteria:
inclusion criteria: * age≥65 years * elective major non-cardiac surgery * general anesthesia * american society of anesthesiologists(asa) grade i,ii,iii * study protocol fully understood by the patients, written consent obtained exclusion criteria: * emergency surgery * in active state of infection or inflammation * chronic kidney disease(ckd) stage 5 * having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis) * having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder) * study protocol not fully understood, no written consent obtained

Keywords: frailty intraoperative hypotension perioperative complication elderly