Kornimate/medical-research-clean huggingface dataset:
randomized evaluation of default access to palliative services

Conditions: COPD; ESRD; Dementia

Summary: this is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. the investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. to test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within ascension health, the largest non-profit health system in the u.s.

the redaps trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (ipcs) and to test the incremental effectiveness and costs of a simple, scalable method to increase ipcs utilization among properly selected patients. the redaps trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from ipcs. to achieve these goals, the investigators will conduct a clinical trial at 11 ascension health hospitals using the same electronic health record. participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services. then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart. during the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services. by the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months. the redaps trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.

Eligibility criteria:
inclusion criteria: 1. age 65 years or older 2. current hospitalization of at least 3 calendar days (modified itt) 3. diagnosis of one or more of the following: * end-stage renal disease (esrd) on dialysis * chronic obstructive pulmonary disease (copd) with home oxygen dependence or 2 or more hospitalizations in the past 12 months * dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months exclusion criteria: 1. patients younger than 65 years old will not receive the intervention

Keywords: palliative care pragmatic trial
quetiapine augmentation in severe obsessive compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of ssri/clomipramine for the treatment of ocd in adult subjects.


Eligibility criteria:
inclusion criteria: * signed informed consent, men and women aged ³18 to £65 years with diagnosis of ocd, at least 12 weeks of treatment with ssri or clomipramine exclusion criteria: * substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses

Keywords: obsessive compulsive disorder (ocd)
virus interactions in the respiratory tract; a cohort study with children

Conditions: Respiratory Tract Infections; Coinfection

Summary: rationale: prevention of virus induced acute respiratory infection (ari) is a public health priority. as different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. such interactions can have implications for the effects of vaccination on non-target diseases. in this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children. objective: to quantify the strength and direction of interactions between important respiratory virus infections in young children. study design: this is a prospective observational cohort study. study population: children between 6 weeks and 4 years of age residing in the utrecht area of the netherlands. main study parameters/endpoints: frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. detection will be based on pcr testing for a panel of common respiratory viruses. from these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis. nature and extend of the burden and risks associated with participation, benefit and group relatedness: this study is observational in nature. there will be no direct benefit to research participants. the study includes biological sampling. the results of the tests done on these samples may not contribute to improving the participant's health. minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.


Eligibility criteria:
inclusion criteria: * age between 6 weeks and 4 years and * 1) have older siblings or 2) attend daycare. and * live within 30 minutes drive from umcu (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored exclusion criteria: * recurrent respiratory tract infections and are treated with antibiotic prophylaxis or * known immunodeficiency or * chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) or * congenital anomalies of the airways * parents/guardians have insufficient comprehension of dutch language (all study communication and questionnaires are in dutch language)

Keywords: child viral interference
psychological impact of covid-19 quarantine and worsening of cardiovascular risk in the french general population

Conditions: COVID-19; Anxiety; Depression; Stress

Summary: in response to the covid-19 outbreak, the french government put in place home quarantine of the general population in order to limit the transmission of the virus. it is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.

in response to the covid-19 outbreak, the french government put in place home quarantine of the general population in order to limit the transmission of the virus. it is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk. a prospective epidemiological observational cohort study will be carried out (in french general population aged 50 to 89 years) with data collection by telephone interviews (in agreement with the context of quarantine). the telephone interviews will be carried out during quarantine (v1), in the month following the end of quarantine (v2) and then, at 6 (v3) and 12 (v4) months. at baseline, the questionnaire will focus on socio-demographic and contextual characteristics related to the covid-19 outbreak, medical history, cardiovascular risk factors and treatments, anxiety and depression scales. next (after the quarantine), the questionnaire will focus on the evolution of cardiovascular risk factors and the occurrence of acute cardiovascular events, the evolution of treatments and post-traumatic stress, anxiety or depression scales. the assessment of risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors of the worsening of cardiovascular risk will be based on mixed logistic regression.

Eligibility criteria:
inclusion criteria: * all participants of the monalisa survey residing in south-western france (toulouse area). exclusion criteria: * opposition to participate in this new survey * pregnancy or breastfeeding * subject under guardianship, curatorship or safeguard of justice * lack of health insurance coverage

Keywords: quarantine psychological impact cardiovascular disease general population
simulated clinical use testing on safe'n'sound 1ml stalked passive delivery system with add-on extended finger flanges

Conditions: Needle Stick

Summary: a simulated clinical use testing the save'n'sound 1ml staked passive delivery system with add-on extended finger flanges

this study aims to evaluate the safety of the use of the safe'n'sound 1ml staked passive delivery system cone version with add-on eff in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.

Eligibility criteria:
inclusion criteria: the evaluator must be: * minimum of age 18 * able to understand and provide signed consent for the study * willing to comply with the study protocol, including being willing to answer questions and complete questionnaires * have no concerns about the ability to perform the simulated injections * with no financial interest in the sponsor (nemera) or the cro (namsa) exclusion criteria: * if in the opinion of cro, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
standard bupivacaine vs liposomal bupivacaine in colorectal patients

Conditions: Opioid Use; Pain, Postoperative; Colectomy; Colorectal Surgery

Summary: the transversus abdominis plane (tap) block can be used to reduce pain in patients who get abdominal surgery. tap blocks are given with a local anesthetic. the purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

pain control is a factor that is central to the surgical patient's postoperative experience. opioid pain medications are a mainstay of postoperative pain management. however, these have several adverse effects. multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (eras) protocols. the transversus abdominis plane (tap) block is one intervention that contributes to this regimen. traditionally, tap blocks are performed with local anesthetics such as bupivacaine. more recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively). in this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * undergoing elective colectomy by surgeons of fairfax colon and rectal surgery exclusion criteria: * allergic to local anesthetics * unable to provide consent * pregnant * on opioids at home chronically (patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study) * undergoing emergent operations * undergoing loop ileostomy reversal * undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Keywords: bupivacaine exparel tap block opioids narcotics eras
dotr/dota algorithm guidance for refractory solid tumors

Conditions: Solid Tumor; Individuation

Summary: this study is an open, single center clinical study targeting solid tumor patients who have exhausted or cannot tolerate standard treatment regimens. the main purpose of this study is to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on dotr/dota results for solid tumor patients who have exhausted or cannot tolerate standard treatment regimens.

both oncotarget(darwinoncotargettm (dota)), which identifies high-affinity inhibitors of individual master regulator (mr) proteins, and oncotreat(darwinoncotreattm (dotr)), which identifies drugs that invert the transcriptional activity of hyperconnected mr modules, produced highly significant 30-day disease control rates (68% and 91%, respectively).

Eligibility criteria:
inclusion criteria: 1. the subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form; 2. patients aged ≥ 18 years old; 3. solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens; 4. according to the recist solid tumor efficacy evaluation criteria, there should be at least one measurable lesion; 5. ecog ps score 0-4 (3-4 score only for patients caused by tumor); 6. the expected survival period is not less than 12 weeks; 7. women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug; 8. the subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; 9. if the main organs function normally, they meet the following standards: the blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using g-csf or other hematopoietic stimulating factors): hb ≥ 90g/l; anc ≥ 1.5 × 109/l; plt ≥ 90 × 109/l;biochemical examination must meet the following standards: tbil ≤ 1 × uln; alt, ast ≤ 1.5 × uln; alp ≤ 2.5 × uln; bun and cr ≤ 1.5 × uln; color doppler echocardiography: left ventricular ejection fraction (lvef) ≥ 50%. exclusion criteria: 1. severe heart disease or discomfort that cannot be treated; 2. those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate; 3. pregnant or lactating female patients; 4. participating in other clinical trials at the same time; 5. researchers believe that individuals are not suitable for enrollment.
corneal uptake of riboflavin eye drops

Conditions: Keratoconus

Summary: the overall objective of this study is to optimise the corneal cross-linking standard protocol in terms of a more economical use of the resource "medical personnel" and in terms of increased patient participation. if it can be shown that the riboflavin necessary for corneal cross-linking does not necessarily have to be applied directly on the cornea (as currently performed by the nurses), but can also be applied in the inferior fornix (as it would be performed by patients in the context of self-application), then it would be conceivable to transfer this task from medical staff to the patients.

this national single-centre, experimental, randomized and controlled trial will comprise two parallel arms. the intervention to be studied will be an alternative application of riboflavin drops in the inferior fornix. as comparator serves a conventional riboflavin drop application directly on the center of the cornea. our research hypothesis is that the application of riboflavin drops in the inferior fornix is not inferior to the corneal application with respect to the resulting riboflavin concentrations in the anterior chamber; which represents a sufficient corneal impregnation with riboflavin. this study is randomized but not blinded. recruitment is anticipated to start in september 2019 and is scheduled to last 1-2 months. we will enroll 12 patients in each trial arm.

Eligibility criteria:
inclusion criteria: * healthy clinical staff members of the dept. of ophthalmology at the lucerne cantonal hospital will be evaluated for study inclusion. * signed written informed consent form exclusion criteria: * aged \< 18 years * any ocular or systemic diseases with ocular side effects * medication with potential ocular side effects * epilepsia, due to the flickering light of the fluorophotometer used to measure anterior chamber riboflavin concentration

Keywords: cross-linking, riboflavin, fluorophotometry, fluorotrontm master
rectosigmoid resection vs seromuscular tumor shaving in ovarian cancer surgery

Conditions: Epithelial Ovarian Cancer; Rectosigmoid Cancer Metastatic

Summary: ovarian cancer is the most common cause of death in gynecological cancer. approximately 75% of epithelial ovarian cancers are detected at an advanced stage. metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. metastasis mostly occurs in the peritoneum, omentum, and intestines. the rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood. treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: r0). the residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction. in the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. in seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. there are advantages and disadvantages of each method in terms of morbidity. although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. the investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.


Eligibility criteria:
inclusion criteria: * epithelial ovarian cancer * negative colonoscopy ( no mucosal involvement) * intraoperative confirmed serosal or seromuscular rectosigmoid infiltration * ecog \<3 * asa \<3 exclusion criteria: * nonepithelial ovarian cancers * rectosigmoid mucosal infiltration * total or subtotal colectomy necessitating large bowel infiltrations * ecog \>2 * asa \>2

Keywords: epithelial ovarian cancer rectosigmoid resection seromuscular tumor shaving recurrence
safety and tolerability of buprenorphine/naloxone film strips

Conditions: Opioid-Related Disorders

Summary: this study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

buprenorphine and naloxone soluble film was developed as an alternative dosage form to suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. the soluble film dosage is expected to provide the following enhancements and potential advantages over the current suboxone (buprenorphine and naloxone) product: * mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * improvement in subject convenience and compliance by ensuring rapid disintegration. * protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. this provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * provision of a unit dose product format for hospital and institutional use. * decreased product damage during shipping as compared to suboxone tablets.

Eligibility criteria:
inclusion criteria: subjects must: * be 18-to-65 years of age, inclusive. * have a diagnosis of opioid dependence by medical history according to dsm-iv-tr criteria. * be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of suboxone for at least 30 days. * if female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include: exclusion criteria: subjects must not: * have participated in an experimental drug or device study within the last 30 days. * if female, be breast feeding or lactating. * have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study. * have a clinically significant abnormal finding (in the opinion of the investigator) on oral cavity exam (e.g., active mouth ulcers). * have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.

Keywords: opioid dependence
bay1436032 in patients with mutant idh1(midh1) advanced acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: to determine the maximum tolerated and / or recommended phase ii dose of oral mutant idh1 (midh1) inhibitor bay1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with midh1-r132x advanced acute myeloid leukemia (aml)


Eligibility criteria:
inclusion criteria: * patients with advanced aml that harbors idh1 mutation * patients are relapsed from or refractory to at least 1 previous line of therapy * good kidney and liver function * male or female patients * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal exclusion criteria: * previously treated with any prior midh1 targeted therapy * extramedullary disease only * history of clinically significant or active cardiac disease * active clinically significant infection * unresolved chronic toxicity of previous aml treatment * taking known strong cytochrome p450 (cyp) 2c8 inducers or inhibitors * pregnancy or breast-feeding

Keywords: phase 1 midh1 idh1 mutation midh1 inhibitor