Kornimate/medical-research-clean huggingface dataset:
a study of hr+/her2- metastatic breast cancer patients treated with palbociclib together with an aromatase inhibitor from 2017 to 2023 in denmark.

Conditions: Breast Cancer

Summary: the purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer. the study will consider participants who: * have advanced or metastatic breast cancer that is spread to other parts of the body. * have hr+/her2- (hormone receptor positive\* / human epidermal growth factor receptor 2 negative\*\*) breast cancer types. * hormone receptor positive (hr+): are cells that have a group of proteins that bind to a specific hormone. for example, some breast cancer cells have receptors for the hormones estrogen or progesterone. these cells are hormone receptor positive, and they need estrogen or progesterone to grow. this can affect how the cancer is treated. knowing if the cancer is hormone receptor positive may help plan treatment. * human epidermal growth factor receptor 2 negative (her2-): cells that have a small amount or none of a protein called her2 on their surface. in normal cells, her2 helps control cell growth. cancer cells that are her2 negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of her2 on their surface. checking to see if a cancer is her2 negative may help plan treatment. * have started treatment in the period between january 2017 and december 2021. the study will describe the treatment effect for different patient groups in terms of age and comorbidities. comorbidity is the condition of having two or more diseases at the same time. the data is collected by the danish breast cancer group in the period between 2017 to 2023.


Eligibility criteria:
inclusion criteria: * patients with breast cancer (icd-10: c50) * a diagnosis of hr+/her2- locally advanced or metastatic breast cancer * endocrine sensitive, endocrine resistant, or de novo mbc patient * inclusion date: date of relapse/stage iv disease/progression leading to initiation of palbociclib+ai exclusion criteria: * there are no exclusion criteria for this study

Keywords: metastatic breast cancer (mbc) icd10: c50 advanced breast cancer hr+/her2- hormone receptor positive / human epidermal growth factor receptor 2 negative endocrine sensitive endocrine resistant de novo mbc denmark danish breast cancer group (dbcg) palbociclib aromatase inhibitor (ai) real-world evidence (rwe) non-interventional study (nis) age comorbidities first-line treatment charlson comorbidity index (cci)
the efficacy of the administration of fibrinogen in liver transplantation

Conditions: Intraoperative Bleeding

Summary: objective: * to evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / l compared with placebo, reflecting a reduction in the number of rbc units transfused during the procedure. * to determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure. * to determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.

methods: a multicenter, randomized, double-blind, placebo-controlled study. one hundred thirty two patients (132) will randomly be assigned to: treatment group, fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / l to obtain a value of 2.9 g / l. placebo group, to whom the same dose volume of saline will be administered. determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. a standard protocol for intraoperative management will be applied. blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. patients will be followed for one year after transplantation.

Eligibility criteria:
inclusion criteria: * patients candidates for liver transplantation * patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / l. exclusion criteria: * patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / l. * known history of thromboembolic events in 30 days * known or suspected pregnancy * previous randomization in this trial * known or suspected allergy to trial products or related products * known presence of congenital bleeding disorder. patients treated with aspirin, warfarin * the following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, budd-chiari syndrome * heart beating donors and living donor * patient reluctant to participate in the trial

Keywords: liver surgery hemostasis coagulation fibrinogen
remotely monitored and coached cardiac rehabilitation northern sweden

Conditions: Heart Defects, Congenital

Summary: supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (cr) programs. despite the proven effectiveness, uptake and adherence to supervised exercise-based cr (excr) remains suboptimal (approximately 50%), especially in rural and remote areas of sweden. the main reasons for low participation rate in centre-based excr are different accessibility barriers i.e. long distances, transportation problems or employment commitments. in this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached excr using the remote-cr system compared to home-based excr based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. our hypothesis is that remotely monitored and coached excr will improve exercise capacity to a greater extent than home-based excr without monitoring and coaching (usual care).


Eligibility criteria:
inclusion criteria: * scheduled appointment with physiotherapist for follow-up after cardiac event: ----myocardial infarction (mi) * per cutaneous coronary intervention (pci) due to mi or angina pectoris * open heart surgery due to coronary artery disease or valvar disease * living in the catchment area of heart centre, university hospital of umeå. exclusion criteria: * clinically unstable * postoperative infection * comorbidity affecting ability to participate in excr
development and validation of the automated evaluation of gastrointestinal symptoms (aegis) platform

Conditions: Abdominal Pain; Deglutition Disorders; Fecal Incontinence; Nausea; Diarrhea; Constipation; Gastroesophageal Reflux

Summary: through a four-year grant awarded to the university of california at los angeles in 2009, dr. brennan spiegel served as a principal investigator (pi) for a project to develop and initially validate a bank of items to assess gastrointestinal (gi) symptoms for the national institutes of health's (nih's) patient reported outcomes measurement information system (promis). by the end of the grant period in july 2013, the project team had successfully developed and initially validated eight scales measuring the most common gi symptoms. afterwards, dr. spiegel's promis team joined forces with the ucla computing technology research laboratory (ctrl) and the university of michigan center for healthcare communication research to develop the automated evaluation of gastrointestinal symptoms (aegis) algorithm which is delivered via my gi health, an open--source internet based patient-provider portal (p3) designed to enhance the delivery of gi health care (www.mygihealth.org). through my gi health and aegis, patients are able to complete promis gi symptom measures and provide additional information about their gi symptoms and histories from computers, tablets or smart phones without the constraints of physical locale. this information is condensed into a gi promis scores report and initial gi history that patients' providers can review prior to or concurrent with seeing the patient. the report, which can be incorporated into the electronic health record (ehr), helps busy clinicians to quickly understand the patient's complaints, document their symptoms and gi history, and leaves more time for conversation with the patient. beyond focusing their interaction, my gi health also supports both the clinician and patient with an individualized "educational prescription" which guides the patient through a library of multi-media educational materials on gi symptoms, conditions, and treatments also contained within the website. the prescription is initially created by the website based on each patient's unique gi promis "fingerprint", and can be modified by the provider based on their interaction with the patient. the clinician and patient can also access the promis-tailored education in the exam room to jointly review pertinent materials, including animations of normal and abnormal gi functions, further reinforcing the patients' educational experiences around the promis symptoms. the aim of this current study is to validate the use of gi promis in clinical practice by conducting a pragmatic clinical trial (pct) comparing delivery of gi promis on a novel e--platform vs. usual care.


Eligibility criteria:
inclusion criteria: * presenting to the gastrointestinal clinic for evaluation. * able to read and write english. * has basic computing skills. exclusion criteria: * having been seen and evaluated in the gastrointestinal clinic within the last 8 months.
influenza vaccine in lung transplant patients - seroprotection

Conditions: Influenza

Summary: this a sub-study of a 5-year study designed to investigate how antibody and t cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals. this study is designed to investigate two different definitions of influenza vaccine seroprotection at mid-season in lung transplant patients.

given the significant risk of morbidity and mortality, it is critical and highly recommended that lung transplant patients receive annual influenza immunizations that confer protection throughout the influenza season. previous studies have demonstrated that transplant recipients and nonimmunocompromised populations display similar rates of seroprotection between 3 and 5 weeks after influenza vaccination, despite the transplant population achieving generally lower antibody concentrations. two studies show influenza vaccine antibody persistence at reasonable rates at 1 year, but not 2 years, after immunization. however, there are no studies comparing seroprotection rates 6 months after vaccination, reflecting adequate coverage throughout the entire influenza season. seroprotection has traditionally been defined as an antibody concentration of at least 40 hemagglutination units (hau) after vaccination, which is the criterion for influenza vaccine licensure. this concentration of antibody provides protection from infection at a rate of about 50% in typically healthy individuals. protection from infection improves with higher antibody concentrations. for this study, a hau of at least 160 was selected as a more conservative definition of seroprotection, where protection may reach up to 95%. the hypothesis is that seroprotection, defined as 40 hau or greater, will persist up to 6 months at high rates in lung transplant patients and that these rates will be comparable to the rates in healthy individuals. as a secondary outcome, seroprotection rates are compared when 160 hau or greater was used to define seroprotection. influenza vaccine responses in lung transplant patients and healthy control subjects without lung disease will be compared over the course of the 2008 to 2009 influenza season. serum collected from participants before immunization, 2 to 4 weeks after immunization (postimmunization), and 6 months after immunization. \[this substudy that was originally registered to nct00205270 and subsequently registered to its own nct number for the purpose of clarity in linked results\]

Eligibility criteria:
inclusion criteria: * receiving care post-lung transplant at university of wisconsin hospital * healthy adult exclusion criteria: * allergy to eggs * moderate to severe febrile illness * active treatment for acute rejection * received season's influenza vaccine prior to enrollment

Keywords: post-lung transplant healthy
marigold study: a study of ro4917523 versus placebo as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy

Conditions: Major Depressive Disorder

Summary: this randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of ro4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. anticipated time on study treatment is 6 weeks with a 3-week follow-up.


Eligibility criteria:
inclusion criteria: * adult patient, 18 to 70 years of age at time of informed consent * major depressive disorder without psychotic features as defined by dsm-iv-tr criteria * inadequate response to ongoing antidepressant treatment, as defined by protocol * body mass index (bmi) 18 to 38 kg/m2 inclusive exclusion criteria: * currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol * previously received ro4917523 * history of failure, or utilization during the current episode of electroconvulsive therapy (ect) or repetitive transcranial magnetic stimulation (rtms) * history of use at any time of vagus nerve stimulation (vns) or deep brain stimulation (dbs) * current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes) * pregnant or lactating women
excimer laser, serum markers & psoriasis

Conditions: Psoriasis

Summary: the overall aims for this study are to determine whether uvb excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment. the investigators hypothesize that treatment of psoriasis with uvb delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. the investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.

subjects will undergo excimer treatment twice a week until they reach a pasi 75 improvement, or until they reach the maximum of 20 total treatments. a blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. chromameter assessment, photographs, pasi and pga (physician global assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.

Eligibility criteria:
inclusion criteria: * age 18 years and older * male or female with diagnosis of psoriasis * psoriasis involvement of 5-15% bsa * has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks * has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks * fitzpatrick skin types i-vi exclusion criteria: * active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria) * any suspicion that the psoriasis is of the photosensitive variant. * any medical condition that could be aggravated or may cause extreme discomfort during the study period.

Keywords: excimer laser uvb psoriasis
comparison of the variability of hepatic load quantification in iron and fat estimated by mri at 1.5 and 3 tesla

Conditions: Iron Hepatic Overload; Fat Hepatic Overload

Summary: the study proposes to compare the results of two examinations at 1.5 and 3 tesla obtained on the same day on a series of 80 patients.

quantification of hepatic iron by mri is validated at 1.5 tesla on a small number of subjects with some discrepancies between the two most used techniques (liver to muscle ratio or calculation of the decay rate of the t2 \* signal). since the initial publications at 1.5 tesla, new technical innovations have emerged which can allow better quantification. recently, the investigators have applied these innovations to rennes and have validated (surfer study) the possibility of making a quantification of iron and fat on two 3 tesla devices with good results in a single apnea acquisition. but it is not uncommon to have, in a structure, different magnetic field devices, and it is important to ensure that the results are transposable. it is also crucial for multicentre or cohort studies to ensure consistency. it is therefore proposed to compare the results of two examinations at 1.5 and 3 tesla obtained on the same day on a series of 80 patients.

Eligibility criteria:
inclusion criteria: * adult 18 years of age or older; * having an mri indication of iron and fat quantification; * benefiting from social security; * having given a free, informed and written consent. exclusion criteria: related to mri * implantable cardiac pacemaker or defibrillator; * non-mri cardiac valve compatible; * clips, stents, coils, etc ... no mri compatible; * cochlear implants; * neuronal or peripheral stimulator; * foreign bodies metallic intra orbital or encephalic, foreign body close to the eyes, wound by metallic lash (war, ball); * endoprostheses placed for less than 4 weeks and osteosynthesis materials placed less than 6 weeks old; * claustrophobia; * pumps, tattoos, permanent make-up, intrauterine device, patches; * metallic, magnetic, non-removable material and close to the analysis field. other criteria * unstable hemodynamic status, acute respiratory failure, general precarious condition or a need for continuous monitoring incompatible with mri constraints; * persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty. * known pregnancy, breastfeeding.

Keywords: liver iron liver steatosis mri
gastroesophageal reflux during lma in control ventilation (lma, laryngeal mask airway)

Conditions: Gastroesophageal Reflux

Summary: laryngeal mask airway is seldom used for control ventilation in america, while it is popular in china. the question is whether the incidence of gastroesophageal reflux in control ventilation is really higher than in spontaneous ventilation. so the investigators combine the third generation laryngeal mask and catheter-based digitrapper ph-z monitor system to evaluate the exact incidence of gastroesophageal reflux in these two groups.

patients scheduled for lma ventilation are divided into two groups randomly, control ventilation group and spontaneous ventilation group. after the third generation laryngeal mask is inserted, catheter-based digitrapper ph-z monitor system is applied to measure the exact incidence of gastroesophageal reflux in these two groups.

Eligibility criteria:
inclusion criteria: * patients for lower extremity operations; * patients for urological operations; * patients for gynecological operations. exclusion criteria: * gastroesophageal reflux disease; * body mass index more than 30.

Keywords: gastroesophageal reflux laryngeal mask airway control ventilation spontaneous ventilation
experimentation of sensorized pseudoelastic orthoses produced by additive manufacturing

Conditions: Acquired Brain Injury

Summary: the proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury. the primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury. the effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. the tolerability and acceptability of the device will also be checked.


Eligibility criteria:
inclusion criteria: 1. quadriplegia or acquired hemiplegia. 2. age 6-20 years. 3. dystonic, dyskinetic, spastic. 4. chronic phase patients (\> 1 year post event). 5. spastic syndrome with ashworth score (as) for the limb of interest\> 1. 6. collaborative. exclusion criteria: 1. fixed limitations of the joint. 2. joint pain. 3. skin allergies. 4. behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
a study of ak104+lenvatinib in combination with transarterial chemoembolization (tace) versus tace in participants with incurable/non-metastatic hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: a study to evaluate cadonilimab (ak104) + lenvatinib in combination with transarterial chemoembolization (tace) versus tace in participants with incurable/non-metastatic hepatocellular carcinoma


Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by histology/cytology，or meet the clinical diagnostic criteria of the american association for the study of liver diseases (aasld) 2. no evidence of metastasis 3. not amenable to curative surgery or transplantation or curative ablation but amenable to tace 4. child pugh score class a 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 at enrollment 6. measurable disease by recist 1.1 7. adequate organ function exclusion criteria: 1. history of liver transplantation 2. history of hepatic encephalopathy 3. uncontrolled arterial hypertension 4. deep venous thrombosis within 3 months before first treatment 5. bleeding events within the last 6 months 6. co-infection with hbv and hcv
efficacy of a mindfulness program to reduce stress and burnout in professionals of medicine and nursing (minduudd)

Conditions: Stress; Burnout Syndrome

Summary: the objective is to check whether a training program in mindfulness and self-pity based on a 4-session intervention (abbreviated program) is as effective as the standard 8-session mbsr program in reducing work stress and burnout in tutors and residents of medicine and family and community nursing. it is a controlled clinical trial, randomized by cluster, of three parallel arms, multicentric. six teaching units (ratio 1: 1: 1) will be randomized to one of the three study groups: 1) experimental group-8 (eg8); 2) experimental group-4 (eg4); 3) control group (cg). at least 132 subjects will participate, 44 in the eg8, 44 in the eg4 and 44 in the cg. the interventions will be based on the mbsr (mindfulness based stress reduction) program, to which some of the practices of the msc (mindful self-compassion) program will be added. the eg8 intervention will be carried out during 8 weekly sessions of 2.5 hours, while the eg4 intervention will be of 4 sessions of 2.5 hours. the participants will have to practice at home for 30 minutes / day in the eg8 and 15 minutes / day in the eg4. in the 3 groups the questionnaires ffmq (mindfulness), scs (self-pity), ordinal scale (0-10) and questionnaire psq (perceived stress) and mbi (burnout) will be passed. empathy will also be measured, through the eemj, anxiety and depression disorders (eadg) and self-perceived health status.


Eligibility criteria:
inclusion criteria: * health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active. exclusion criteria: * that you have previously done a training course or workshop in mindfulness of at least 4 weeks. * that during the field work they are in a situation of prolonged or long-term sick leave. * have mental disorders that discourage the intervention. * that they do not give their informed consent to participate