Kornimate/medical-research-clean huggingface dataset:
the wearing-off phenomenon of ocrelizumab in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. finally, we would like to extend knowledge on wearing-off symptoms in general.

ocrelizumab is a monoclonal antibody very effective for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. ocrelizumab is usually administered intravenous every six months. natalizumab is another type of treatment used for relapsing-remitting multiple sclerosis and is administered every four weeks. often patients report ms-related symptoms just prior to their next infusion such as fatigue, coordination problems or motor problems, the so-called wearing-off phenomenon. the exact etiology of this phenomenon remains unknown. although not studied before, patients do report similar symptoms when using ocrelizumab. furthermore, because of the covid-19 pandemic, some patients receive extended dosing of ocrelizumab based on b-cell count. whether this can increase wearing-off symptoms is unknown. the goal of this research is to study the prevalence of wearing-off symptoms and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab. all patients using ocrelizumab during one year or more that provided written informed consent to participate in the study will be asked to complete three questionnaires before or during their next treatment with ocrelizumab. the questionnaires that will be used are the msis-29, the treatment satisfaction questionnaire and a questionnaire about wearing-off symptoms. exact weight of the participants will be measured. information about age, gender, date of diagnosis, start date of ocrelizumab, clinical and radiological disease activity, edss score, b-cell count and the biomarker neurofilament light will be extracted from the patient files. after two weeks, participants receive two additional digital questionnaires, the msis-29 and a follow-up questionnaire about wearing-off symptoms.

Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis multiple sclerosis * use of ocrelizumab as a treatment for multiple sclerosis for a minimum of one year exclusion criteria: * unable to answer questionnaires in dutch * different infusion protocol during the previous ocrelizumab infusion (e.g. 300 mg of ocrelizumab instead of 600 mg).

Keywords: multiple sclerosis ocrelizumab wearing-off effect neurofilament light extended dosing
international study on covid-19 vaccine to assess immunogenicity, reactogenicity and efficacy (invite)

Conditions: COVID-19

Summary: invite is funded by niaid and is conducted in multiple international sites (approximately 20 sites across 7 countries). this is a study of adults who receive locally available covid-19 vaccines through local vaccination programs. persons will be enrolled within one day (before or after) of receipt of a covid-19 vaccine. the study will enroll participants who receive covid-19 vaccination at local clinics and/or study sites.

this is a multicenter study of covid-19 vaccine immunogenicity and durability, and breakthrough serious acute respiratory syndrome coronavirus-2 (sars-cov-2) infections in people who receive a covid-19 vaccine through their country's national vaccination programs. participants will be enrolled upon signing the informed consent within a day of receipt of a covid-19 vaccine (before or after). the study team will not be administering the vaccine; receipt of vaccine will be provided through each country's vaccine program. blood specimens will be collected to measure the immune response to the vaccine. participants may be asked to contact study staff at any time during the study for evaluation if they develop symptoms consistent with sars-cov-2 infection, at which time they will be counseled about the need for a medical evaluation that may include collection of an upper airway swab for diagnosis (and research) and a blood sample for research. infections will be confirmed by molecular or antigen (ag) testing at the time of symptoms, and swabs will be collected and stored for viral sequencing and analyses.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * ability to provide informed consent. * enrollment within one day (before or after) of receipt of covid-19 vaccine. * willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with sars-cov-2 infection during the study period. * willingness to allow storage of biological samples for research testing as outlined in this protocol. exclusion criteria: * any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness. * inability to comply with study visits.

Keywords: sars-cov-2 infection
a community paramedicine initiative for older adults living in subsidized housing (chap-ems/cp@clinic)

Conditions: Cardiovascular Diseases; Diabetes Mellitus

Summary: older adults living in subsidized housing report poorer health. their age and low income make it harder for them to use community services. many older adults have heart disease and diabetes, which lead to frequent emergency calls and hospital admissions. to decrease the costs of treating heart disease and diabetes through emergency and hospitalization, improved screening and health education is needed. our program will take place in communal areas within housing buildings of older adults and deliver a heart disease, diabetes, and falls risk check-up with health education. this is expected to improve the health of older adults leading to fewer emergency calls and hospital visits.


Eligibility criteria:
inclusion criteria: * 55 years and older * resides in subsidized apartment building exclusion criteria: - none

Keywords: emergency medical services elderly
impact of perioperative intravenous fluid utilization on postoperative outcomes

Conditions: Benign Neoplasm of Intestinal Tract; Primary Malignant Neoplasm of Intestinal Tract; Secondary Malignant Neoplasm of Intestinal Tract

Summary: subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

the purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. the study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. patients, who consent to the study, will be randomized at the time of consent, preoperatively. the primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. approximately 186 patients will participate in the study, 93 in each group. patients will be randomized into one of two groups: the restricted fluid regimen group and the normal fluid administration regimen group. a very specific flow chart for each group will be followed to distinguish the group. a research nurse will collect the data needed for the study on a daily basis. the patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. if for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.

Eligibility criteria:
inclusion criteria: * patients 18 years or older * asa i-iii * ability to provide informed consent * creatinine less than or equal to 1.3 mg/ml) exclusion criteria: patients younger than 18 years old * asa iv or higher * urgent or emergent surgery * mental disease or addictive disorders impairing ability to provide informed consent * renal insufficiency (cr greater than 1.3 mg/ml) * significant language barriers * cirrhosis causing ascites * nyha iii or iv, ef less than 25% * use of intraoperative epidural anesthesia * uncontrolled diabetes * uncontrolled hypertension in the opinion of the enrolling surgeon * etoh consumption greater than 35 drinks weekly * cachexia or absolute neutrophil count of less than 1,200/mm3 * existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3

Keywords: surgery fluid morbidity
psychological skills group for youth of refugee and immigrant backgrounds

Conditions: Stress, Psychological; Acculturation Problem

Summary: there are currently 28 million child refugees worldwide - approximately 1 in every 200 children on earth. to date, nearly one million forcibly displaced child migrants have been resettled in the united states. it is well documented that refugee and immigrant youth, especially forcibly displaced ethnic and cultural minority youth, present with alarmingly high rates of stress-related psychiatric illness (e.g., ptsd, depression, anxiety) and are grossly underserved by current mental health, medical, and social services. previous research found that in a sample of 144 somali refugee children resettled in the united states, only 8% of those who met full clinical criteria for ptsd received any mental health services. through a process of community-based participatory research with refugee and immigrant communities and stake-holders the investigators have developed a multi-tiered psychological and systems intervention for refugee youth and families, trauma systems therapy for refugees (tst-r), that includes community outreach and advocacy, group psychological treatment, office-based psychotherapy, and home-based services. whereas tst-r is one of the only empirically-based behavioral health treatment models for refugee youth, it has only been studied as a full intervention model; financial and staffing resource barriers have limited the wide-spread adoption of the model. this obstacle noted, implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven group treatments) may provide significant benefit while also being easily scalable. implementing time-limited (i.e., 10 week) manual-based group psychological interventions focused on culturally-responsive strategies to support refugee youth with, and at-risk for, ptsd, depression, and anxiety, may be an efficient and cost effective means of (1) reducing psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective social belongingness, and psychological resilience (e.g., ability to thrive in the context of adversity). furthermore, if effective, treatment groups can importantly function as a destigmatizing treatment gateway and triage to other services for youth who require a higher level of care (e.g., individual psychotherapy and medication management).


Eligibility criteria:
inclusion criteria: * age 15-18 years old living in the greater boston area. * of refugee or immigrant background (e.g., youth or a parent arrived to the usa as a refugee or immigrant) * no current plans to move from greater boston area within the next 6 months * conversationally proficient in english language exclusion criteria: * not able to attend group once a week for 10 weeks * medical, cognitive, or other health or psychosocial issue that would prevent consistent and engagement and participation in group.
testosterone for men with insulin treated type 2 diabetes

Conditions: Hypogonadism; Diabetes

Summary: the purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and imt in hypogonadal men with type 2 diabetes treated with insulin.

there is epidemiological data linking low serum testosterone levels in men with the development of diabetes. clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. type 2 diabetes is also associated with changes in arterial stiffness and imt which are known to be linked to the presence of cardiovascular disease. artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. the purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from sustanon 250 im injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.

Eligibility criteria:
inclusion criteria: * males over 40 years old * type 2 diabetes treated with insulin * serum testosterone less than 12nmol/l on 2 consecutive morning samples * symptoms attributable to hypogonadism exclusion criteria: * current or previous breast cancer * current or previous prostate cancer * raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy * severe symptoms of benign prostatic hypertrophy * treatment with testosterone in the three months prior to the trial * investigational drug treatment in the three months prior to the trial
efficacy study of early onset of antipsychotic drug action in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.


Eligibility criteria:
inclusion criteria: * patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill. * patients must have experienced an exacerbation of their illness within the previous 2 weeks. * patients in whom a switch to another antipsychotic medication is acutely indicated. exclusion criteria: * patients who are deemed nonresponsive to risperidone or olanzapine. * patients who have been hospitalized for greater than 2 weeks immediately prior to visit 1. * patients having received olanzapine or risperidone in the past 30 days. * treatment with clozapine within 1 year prior to visit 1. * diagnosis of substance-induced psychosis by diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria within 7 days of visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to visit 1 (or at any time during the study). * a diagnosis of parkinson's disease, dementia-related psychosis, or related disorders.
therapeutic equivalence of osvaren® tablets and osvaren® granules

Conditions: Hyperphosphatemia; Chronic Kidney Disease

Summary: phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. with the new formulation of granules the pill burden of patients is sought to be reduced. this study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.

the study is aimed at demonstrating the therapeutic equivalence of both products, i.e. granules versus tablets. secondary objectives are: comparing both preparations with regard to the number of patients reaching serum phosphate levels \< 1.76 mmol/l and the difference in serum phosphate levels between the first and last visit under each treatment. furthermore, it is the aim of this study to evaluate the safety profile of osvaren® granules in comparison to osvaren® tablets. especially serum calcium, magnesium, and pth are of interest.

Eligibility criteria:
inclusion criteria: * signed written informed consent form is obtained prior to starting the screening visit * male and female patients 18-80 years of age with dialysis dependent renal failure (ckd 5d) * patients have been on 3x/week in-centre renal replacement therapy for at least 2 months on either low-flux or high-flux hd or ol- /hdf * prescribed haemodialysis session duration is ≥ 4 hours * spkt/v ≥ 1.20 according to last in-centre measurement prior the study enrolment * patients have been on osvaren® tablets for at least 12 weeks as sole phosphate binder and the titration phase has been completed according to physician´s discretion * patients are able to take the study medication as prescribed particularly osvaren® stickpacks * patients are willing to stop any calcium, magnesium or vitamin d containing supplements * patients are willing to maintain their typical diet with regards to phosphate uptake for the time of the study * patients are willing to comply with the study protocol exclusion criteria * pregnant women (by blood ß-hcg pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or * patients with a life expectancy shorter than the planned duration of the study or * patients with any acute or chronic severe disease potentially interfering with study outcomes or * patients with pth levels \> 800 ng/l or * patients who participated in an interventional clinical study during the preceding 30 days or * patients suffering from any other, not mentioned condition which could interfere with the patient's ability to comply with the study or * patients who previously participated in the same study are excluded from the study
faslodex observations during regular use by advanced mammacarcinoma patients

Conditions: Breast Cancer

Summary: the purpose of this study is to identify which patients, receiving faslodex within the approved label, benefit most from faslodex treatment.


Eligibility criteria:
inclusion criteria: * postmenopausal * locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (er) and progesterone receptor (pr) status * patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment exclusion criteria: * life threatening metastases

Keywords: advanced breast cancer
crp-apheresis for attenuation of pulmonary, myocardial and/or kidney injury in covid-19

Conditions: Covid19

Summary: the 'capmykco' study is a randomized controlled, open-label, single center proof of concept trial. the aim of this study is to evaluate whether a crp-apheresis in addition to the current standard therapy is intended to mitigate the severity of the disease course of sars-cov-2, especially with regard to tissue injury in the lungs, heart and kidneys and their consequences. crp-apheresis should reduce the necessity and duration of non-invasive/invasive ventilation requirements compared to the control group. the influence of crp-apheresis on the attenuation of pulmonary, myocardial and/or kidney tissue injury as well as the course of the covid-19 disease will also be demonstrated by evaluating various biomarkers, several clinical scoring systems, and the duration of intensive care medical treatment.

the prognostic value of c-reactive protein (crp) in assessing disease progression in covid-19 is well known: the steeper the crp rise in the days after infection and the higher the crp concentration at hospitalization, the worse the prognosis. it is believed that crp concentration not only reflects tissue damage but also causally contributes to the severity of the damage that occurs. crp apheresis effectively limits crp rise, which may lead to improved prognosis. crp apheresis is a therapeutic hemapheresis procedure that selectively removes c-reactive protein from the patient's plasma. other causal therapies for immediate selective reduction of crp in the acute phase of disease are not currently available. in the planned 'capmykco' study, crp-apheresis in addition to current standard covid-19 therapy is expected to mitigate the severity of disease progression, particularly with regard to tissue injury in the lungs, the heart and/or the kidneys and their respective clinical consequences. crp-apheresis treatment in covid-19 patients should reduce the necessity and duration of non-invasive / invasive ventilation compared to the control group. the influence of crp-apheresis on the course of the covid-19 disease will also be demonstrated by evaluating different organ biomarkers and the duration of intensive medical treatment.

Eligibility criteria:
inclusion criteria: * confirmed sars cov-2 infection (pcr-test) * oxygen therapy (maximum 'high-flow' therapy) * crp plasma concentration ≥ 50 mg/l and/or * crp increase ≥ 15 mg/l within 24 h after admission. * completed informed consent and written informed consent. * legal capacity exclusion criteria: * age \< 18 years * pregnancy / lactation period * invasive, mechanical ventilation * extracorporeal membrane oxygenation (ecmo) * participation in other interventional trials * extracorporeal membrane oxygenation (ecmo) support * participation in other interventional trials

Keywords: crp-apheresis covid-19 sars-cov-2
a study of trk-950 in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: the main purpose of this study is to determine the safety and tolerability of trk-950 alone and in combination with nivolumab in patients with advanced solid tumors

this is an open-label phase i study and consists of two parts. in the part 1, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists will receive two dose level of trk-950. in the part 2, patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with nivolumab 240 mg alone administered at 2-week intervals will receive two dose level of trk-950 in combination with nivolumab. the objectives of this study are to determine the safety, tolerability, pharmacokinetic (pk) profile and the incidence of the development of anti-drug antibodies (ada) and neutralizing antibodies (nab) against trk-950.

Eligibility criteria:
inclusion criteria: * part 1: patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. part 2: patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with nivo 240 mg alone administered at 2-week intervals. * patients with life expectancy of at least 3 months after the start of study drug administration * patients aged \>=18 years at the time of consent * patients who are able to provide written consent in person to be a subject of this study * a negative pregnancy test before enrollment (if female of childbearing potential) exclusion criteria: * patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed) * patients who are unwilling or unable to comply with the protocol specified procedures * patients who are positive for human immunodeficiency virus (hiv) antibody * patients who meet any of the following conditions on hepatitis b virus (hbv) and hepatitis c virus (hcv) testing * patients who are positive for hepatitis b surface antigen (hbsag) * patients who are positive for hcv rna

Keywords: nivolumab-eligible solid tumor