Kornimate/medical-research-clean huggingface dataset:
international prospective study on adherence to treatment in patients with active systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the treatment of systemic lupus erythematosus (sle) may change in the future due to the availability of new biological treatments, especially monoclonal antibodies in patients with active disease. however, one of the main causes of treatment failure in sle is the lack of treatment adherence since "drugs don't work in patients who don't take them." hydroxychloroquine (hcq-plaquenil) has a long terminal elimination half- life, and investigators have demonstrated that patients who do not take hcq for a long time have undetectable or very-low blood hcq concentrations (\< 200 ng/ml). the rate of severe non-adherence was 7% in a cohort of 203 patients and was even higher in patients with active disease: 8 out of 35 (23%) in patients with a sledai ≥6 and 6 out of 20 (30%) in patients with a sledai ≥12. investigators will evaluate the importance of non-adherence to the treatment in a large population of sle patients with active disease. this will be done with blood hcq monitoring in a translational multicentric prospective study.

this international multicentric prospective study is an observational study that will include consecutive sle patients treated with hcq and with sle flare (defined by the selena-sledai flare composite). the study will only require the sampling of 1 vial of whole blood for the dosage of hcq (that would be centralized and performed in pitie-salpetriere hospital at the completion of the study). the patients and the physicians will also have adherence self-questionnaires to complete, and the physicians will complete a patient data sheet. the end points are adherence of the treatment in the whole group, and subgroups, adherence according to the severity of sle, and the relationship between patient's questionnaires, physician evaluation of adherence and blood hcq dosage. if investigators confirm their previous data, this study might demonstrate that a significant proportion of patient candidates for treatment escalation are in fact nonadherent to the treatment. it might further demonstrate the interest of hcq concentrations monitoring, both in "real life" and in therapeutic study in sle as it may avoid unnecessary, expensive or even hazardous regimen escalation.

Eligibility criteria:
inclusion criteria : * history of meeting 4 american college of rheumatology (acr) criteria for systemic lupus erythematosus including a positive test for antinuclear antibodies, * sle flare defined by the selena-sledai flare composite * treatment with hcq for at least 2 months with a daily dosage \> or equal to 200 mg/day. exclusion criteria : * patients who are not able to take their medications (notably patients with repeated vomiting and patients who are not allowed to take oral medications)

Keywords: adherence compliance systemic lupus erythematosus hydroxychloroquine blood monitoring flares
inion otps biodegradable fixation system for the ankle

Conditions: Surgery

Summary: the purpose of the investigation is to compare post-operative fracture and wound healing using inion otps biodegradable fixation system implants versus conventional metal implants.


Eligibility criteria:
inclusion criteria: * distal fibular fracture including either instabile/dislocated weber class b or any weber class c fracture or bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture or trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured * fresh/acute fracture * aged between 18 and 60 years exclusion criteria: * contraindication for the inion otps biodegradable fixation system:active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed * multiple trauma * previous ankle fracture * pregnancy * bone malignancy * any clinically significant condition based on investigators judgement * high-load bearing applications
the effect of informing relatives of patients with short messages

Conditions: Cardiovascular Surgery; Anxiety; Short Message

Summary: surgical intervention is a planned or unplanned procedure performed to eliminate the existing or subsequent abnormal conditions in the individual's body, to reduce the effects of these conditions, or to remove the abnormal structures from the individual's body to eliminate the existing distress. while surgical interventions also cause anxiety in patients, it is known that they also cause significant anxiety in patients' relatives.this study was planned as a randomized controlled experimental study in order to examine the effect of this information on the anxiety level of the relatives of the patients by informing the relatives of the patients about the operation process with a short message during cardiovascular surgery. in data collection; introductory information form for the patient and patient relatives, a short message follow-up form, state and trait anxiety inventory will be used during the surgical intervention. the sample of the study will be the relatives of the patients who are willing to participate in the study. considering the change in the state anxiety scale scores between the experimental and control groups in the study of baydemir s. (2019), it is calculated that there is a large effect size difference. based on this finding, in order to test a large effect size (d=0.8) difference in anxiety scale scores of patient relatives between our experimental and control groups with 5% margin of error and 95% power, a total of 84 relatives of patients, 42 from each group, were included in the study. needed was calculated. h0: informing by text message has no effect on the anxiety of patient relatives. h1: informing by text message has an effect on the anxiety of patient relatives.


Eligibility criteria:
inclusion criteria: * 18 years and over, * to know turkish, * being literate * having mental adequacy, * willingness to participate in the research, * having an active mobile line, * ability to use a telephone * being in the hospital before, during and after the operation exclusion criteria: * be under the age of 18, * not knowing turkish, * being illiterate * lack of mental adequacy, * lack of active mobile line, * inability to use the phone * absence from the hospital before, during and after the operation

Keywords: cardiovascular surgery anxiety relatives of the patient short message
bevonescein to highlight nerves in patients undergoing head & neck surgery

Conditions: Parotid Neoplasm; Thyroid Neoplasms; Head and Neck Neoplasms; Surgery; Nerve Injury; Imaging

Summary: bevonescein to highlight nerves in patients undergoing head \& neck surgery

this study will evaluate the safety, tolerability, and efficacy of bevonescein (alm-488) administered as an intravenous (iv) infusion to patients undergoing head \& neck surgery. the study will also characterize the pharmacokinetics of bevonescein (alm-488) in this subject population and determine the dose of bevonescein (alm-488) needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. the study will also evaluate the effect of timing of bevonescein (alm-488) administration, relative to surgery, on fluorescence characteristics.

Eligibility criteria:
inclusion criteria: 1. a neoplasm located in the head and neck. 2. primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection. 3. can understand and is willing to sign a written informed consent document. 4. ≥18 years of age. 5. life expectancy of at least 6 months. 6. normal liver and kidney functions. 7. if of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. the subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence. 8. plans to undergo head and neck surgery. exclusion criteria: 1. prior radiation or chemotherapy for any prior head and neck neoplasm. 2. open surgery in the ipsilateral head and neck within 1 year. 3. abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year. 4. current evidence of renal disease. 5. pregnant or breastfeeding. 6. unresolved acute toxicity from prior anti-cancer therapy. 7. history of fluorescein allergy. 8. any other criteria deemed by the principal investigator that may prevent the patient from successfully completing the trial.

Keywords: nerve fluorescence surgery imaging real-time intraoperative highlighting
containment measures and eating disorders

Conditions: Eating Disorders; COVID 19

Summary: since march 17, 2020, the french government has implemented national containment measures due to the covid-19 epidemic. quarantine is an unpleasant experience : separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms. in addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ed). finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ed.

investigators will recruit 40 patients with eating disorders. all patients were initially assessed in the daily hospital of the endocrinology, diabetes, nutrition department (montpellier university hospital) from january to march 2020. all participants will performed a phone interview to assess eating disorder symptoms, caracteristicus of containment, 1 month after the beginning of the containment, and 1 month after the end of the containment.

Eligibility criteria:
inclusion criteria: * adult women * surferring from ed * assessed in the ed daily hospital (uh of montpellier) from january to march 2020 exclusion criteria: * minors * refusal to participate
a study of ly2523355 in participants with breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of the study is to evaluate the anti-tumor activity of ly2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.


Eligibility criteria:
inclusion criteria: * have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent. * have measurable disease defined by response evaluation criteria in solid tumors (recist) 1.1 guidelines. * have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens. * have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting. * have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment. * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale. * have adequate organ function. exclusion criteria: * have common terminology criteria for adverse events (ctcae) grade 2 or greater (moderate or worse) peripheral neuropathy * have a second primary malignancy. * have symptomatic, untreated, or uncontrolled central nervous system metastases. * have received autologous stem cell transplant following high-dose chemotherapy. * have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study. * have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (hiv) or viral hepatitis. * have previously received ly2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen. * have a history of radiation therapy involving more than 25 percent of the bone marrow. * have a fridericia corrected qt (qtcf) interval of \>470 milliseconds (msec) on screening electrocardiogram (ecg). * have qrs widening of \>120 msec on screening ecg. * cannot change or stop taking a strong cytochrome p450 3a4 (cyp3a4) inhibitor or cyp3a4 inducer per the ixabepilone label. * have hypersensitivity to drugs formulated with cremophor® el per the ixabepilone label.

Keywords: locally recurrent breast cancer
comparison of f-18 fdg and c-11 acetate pet in multiple myeloma

Conditions: Multiple Myeloma

Summary: investigators are doing this study to determine which of four imaging techniques: fludeoxyglucose positron emission tomography (18 fdg pet) computerized tomography (ct), 18 fdg pet magnetic resonance imaging (mri), c-11 acetate pet ct, and c-11 acetate pet mri) is the best test for finding sites of active myeloma disease.

participants who are clinically scheduled to undergo f-18 fdg pet/ct myeloma evaluation will also undergo f-18 fdg pet/mri, and c-11 acetate pet ct/mri. on day 1 of study, participants will undergo f-18 fdg pet/ct-mri. f-18 fdg radiopharmaceutical is infused intravenously, followed by a 60 minute waiting uptake phase. after 60 minutes, participant will undergo pet/ct imaging for 30 minutes. at 90 minutes, participant will undergo pet/mri imaging for 30 minutes. on day 2 of study, participants will undergo c-11 pet/ct-mri. c-11 radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. after 10 minutes, participant will undergo pet/ct imaging for 30 minutes, followed by a 60 minute pause with the participant at rest. at the end of 60 minute pause, the participant is given the second c-11 acetate infusion, followed by a 10 minute waiting uptake phase. after 10 minutes, participant will undergo pet/mri imaging for 30 minutes. on day 3, study team member makes a phone call to participant for follow up.

Eligibility criteria:
inclusion criteria: * patients being staged for multiple myeloma as follows: new diagnosis, high risk smoldering multiple myeloma, relapsed as defined by investigator * patients who have undergone standard of care workup * 300 pounds or less * can provide informed consent * scheduled for a clinically indicated f-18 fdg pet scan * english speaking exclusion criteria: * pregnant, breast feeding * concurrent active non-multiple myeloma malignancy * contraindication to pet mri * previous type i or type ii diabetes mellitus or a fasting blood glucose \>150 mg/dl

Keywords: positron emission tomography (pet) computerized tomography (ct) magnetic resonance imaging (mri) fludeoxyglucose (f-18 fdg) c-11 acetate
avatrombopag for the treatment of thrombocytopenia after donor hematopoietic stem cell transplant

Conditions: Platelet Disorder

Summary: this phase ii trial studies the side effects and how well avatrombopag works for the treatment of thrombocytopenia after donor hematopoietic stem cell transplant. thrombocytopenia is defined as abnormally low level of platelets in the blood. avatrombopag is a small molecule thrombopoietin receptor agonist which stimulates thrombopoietin receptor leading to increase production of platelets.

primary objective: i. to determine the safety and efficacy of avatrombopag for the treatment of thrombocytopenia after allogenic hematopoietic stem cell transplantation. secondary objective: i. to identify predictors of response to avatrombopag. outline: patients receive avatrombopag orally (po) once daily (qd) for up to 1 year in the absence of disease progression or unacceptable toxicity. avatrombopag will be titrated weekly until platelet count of greater than or equal to 60,000/ul is achieved and persists for 7 consecutive days, and the patient remains free from platelet transfusion. after completion of study treatment, patients are followed up weekly for 4 weeks and then monthly up to 1 year.

Eligibility criteria:
inclusion criteria: * failure to engraft platelets by day 30 (d30) after hematopoietic cell transplantation (hct) defined as: platelet count less than 20,000/ul and patient is still dependent on platelet transfusion support * patient must be able to start treatment with avatrombopag within 30-60 days following transplant * able to provide written informed consent from patient or legal representative exclusion criteria: * serious uncontrolled infections * steroid refractory graft versus host disease (gvhd) * patients with thrombotic microangiopathy * pregnant or lactating women * creatinine clearance \< 30 ml/min * active thromboembolism requiring anticoagulation * unable to understand the investigational nature of the study or provide informed consent * evidence of disease relapse by flow cytometry of chimerisms * concomitant use of other thrombopoietin receptor agonists (tpo-ra) medication during the treatment phase of the study or two weeks prior to enrollment
feasibility of a resistance exercise and dietary protein intervention in elderly people in practice (promuscle 65pk)

Conditions: Sarcopenia

Summary: the purpose of this pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting.


Eligibility criteria:
inclusion criteria: * in home assisted (also informal care) elderly individuals, that experience loss of muscle strength * able to understand and perform the study procedures exclusion criteria: * type i or type ii diabetes (fasted blood glucose level ≥7,0 mmol) or hypertension, unless well regulated by medication * diagnosed cancer or chronic obstructive pulmonary disease (copd) * severe heart failure * renal insufficiency (egfr \<60 ml/min/1.73 m2) * newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress on scar tissue) * allergic or sensitive for milk proteins

Keywords: older adults dietary protein resistance exercise feasibility study physical functioning real-life setting
(study: vertex iis) does ivacaftor alter wild type cftr-open probability in the sweat gland secretory coil?

Conditions: Cystic Fibrosis

Summary: clinical studies of lumacaftor + ivacaftor (combo therapy) produced better fev1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results. to help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of cftr (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil. the investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in wt (wild-type, i.e. normal) cftr open probability by measuring cftr-dependent sweating (c-sweat) in subjects with wt cftr.

cystic fibrosis (cf) is a genetic disease caused by malfunctioning of a protein called cftr. cf affects various organs including the sweat glands and the lungs. an fda approved drug called ivacaftor helps some people with cf, and laboratory tests show that it produces further improvement when combined with an investigational drug called lumacaftor. however, results from clinical tests of the two drugs used together gave mixed results: lung function improved but sweat gland function did not improve. this study will measure cftr-dependent sweat rate to test the hypothesis that cftr in the normal sweat glands might be functioning at peak efficiency, and so can't be improved further with ivacaftor, thus accounting for the apparent discrepancy between lung function and sweat gland results. cftr-dependent sweat rate is important to understanding cf because it is a very accurate measure of cftr function.

Eligibility criteria:
inclusion criteria: * healthy adults without a cystic fibrosis (cf) mutation * carriers with a known cf mutation exclusion criteria: 1. documented liver disease 2. participants should not be taking: * medicines that are strong cyp3a (cytochrome p450, family 3, subfamily a) inducers, such as: * the antibiotics rifampin and rifabutin; * seizure medications (phenobarbital, carbamazepine, or phenytoin); and * the herbal supplement st. john's wort, substantially decreases exposure of ivacaftor and may diminish effectiveness.
from structural to functional characteristics of the lumbar multifidus in low back pain

Conditions: Low Back Pain; Chronic Low Back Pain

Summary: to delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.


Eligibility criteria:
inclusion criteria for chronic low back pain group: * non-specific low back pain, during 3 or more months, without radicular leg pain * modified low back pain disability questionnaire \> 20% * indication for mri of the lumbar spine * no contra-indications for mri * informed consent to participate inclusion criteria for healthy control group: * no history of low back pain needing medical treatment or resulting in limited activity level * any low back pain in the previous 3 months * informed consent to participate exclusion criteria for all subjects: * pregnancy * previous trauma or surgery to spine, abdomen or pelvis * structural deformity (e.g. scoliosis) * neurological/neuromuscular/systemic disease * inability to lie prone for 20 minutes