Kornimate/medical-research-clean huggingface dataset:
a study of nivolumab in participants with metastatic or unresectable bladder cancer

Conditions: Various Advanced Cancer

Summary: the purpose the study is to measure the effect of nivolumab (bms-936558) in reducing tumor size in subjects with metastatic or unresectable bladder cancer.


Eligibility criteria:
inclusion criteria: * evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis * measurable disease by ct or mri * progression or recurrence after treatment * i) with at least 1 platinum-containing chemotherapy regimen for metastatic or surgically unresectable locally advanced urothelial cancer, or * ii) within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer * subject that have received more than 2 prior lines of chemotherapy must not have liver metastases * tumor tissues (archived or new biopsy) must be provided for biomarker analysis * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * subjects with active cancer that has spread to the central nervous system * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured * subject with active, known or suspected autoimmune disease * subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration * prior treatment with an anti-pd-1,anti-pd-l1,anti-pd-l2,anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4) antibody, anti-cd137 or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways exclusion laboratory criteria: * positive test for hepatitis b virus surface antigen (hbv s ag) or hepatitis c virus ribonucleic acid (hcv antibody) indicating acute or chronic infection * known history of testing positive for human immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) other protocol-defined inclusion/exclusion criteria apply
does continued use of clopidogrel into surgery cause increased perioperative bleeding?

Conditions: Clopidogrel

Summary: patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. all patients resume clopidogrel after surgery. the investigators track the development of bleeding complications that may develop within 90 days of the surgery. patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. there is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.

a medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. the records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.

Eligibility criteria:
inclusion criteria: * taking clopidogrel * undergoing general surgery * cleared by both cardiologist and surgery for randomized arm exclusion criteria: * previous history of bleeding complications/bleeding disposition * no capacity to consent

Keywords: clopidogrel general surgery
clinical characterization of an investigational soft silicone hydrogel contact lens

Conditions: Refractive Errors

Summary: the primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

participants will attend a screening visit, a dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the dispense visit.

Eligibility criteria:
inclusion criteria: * understand and sign an informed consent that has been approved by an institutional review board. * successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. * willing to stop wearing habitual contact lenses for the duration of study participation. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any condition that contraindicates contact lens wear, as determined by the investigator. * any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the investigator. * history of refractive surgery or plan to have refractive surgery during the study. * current or history of dry eye in either eye that, in the opinion of the investigator, would preclude contact lens wear. * habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear. * monovision or multifocal contact lens wear. * other protocol-defined exclusion criteria may apply.

Keywords: vision contact lenses
non-invasive brain stimulation and delirium

Conditions: Mental Disorders; Delirium

Summary: the purpose of this study is to examine whether non-invasive brain stimulation can be used to improve cognitive deficits in patients with delirium.

data from subject's epic medical record will be abstracted for use in research analysis - the following elements will be reviewed: information regarding diagnosis, age, gender, ethnicity/race, medication they are receiving as well as their past medical history, and doss score. the study team member will also discuss patient's mental status with their treating clinician before approaching him/her. the treating clinician will be consulted and must agree that it is appropriate for the delirious patient to be approached for enrollment. beforehand, a clinician on the research team (dr. gen shinozaki) will evaluate the subjects ability to sign consent, and thus, whether they can be approached for enrollment. when subject is identified, consent team will approach to obtain consent (and assent when applicable), email address and research demographic information. if consented, subject undergo a short cam-icu assessment of delirium indication - the cam-icu is a delirium screening tool and is not done for screening individuals out of the study, a cognitive function evaluation (moca), clinical dementia rating (cdr), and a longer delirium evaluation (drs-r-98) conducted by a study team member. next, study personnel will obtain buccal swab samples and will assist with saliva samples. trained medical staff will perform the blood draw for the blood collection sample, approximately 5-10 ml of blood per sample will be collected. if consented, subject will be asked to wear non-invasive eeg device (with two standard, clinical leads) on their head at the time of initial evaluation and up to two times daily during their hospital stay. what subjects will be asked to do/what happens in the study (in sequential order) if they meet inclusion criteria and consent, they will be asked to wear non-invasive eeg device (with two standard, clinical leads) on their head with eeg monitor capability up to three times daily while they are in the hospital. one session of non-invasive brain stimulation will be administered. study personnel will again obtain buccal swab samples and will assist with saliva samples. trained research team members will perform the blood draw for the blood collection sample, approximately 5-10 ml of blood per sample will be collected.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis consistent with enrollment (positive for delirium) exclusion criteria: * history of recurrent seizures or epilepsy * any other neurological or psychiatric diagnosis outside the diagnosis for which the participant is enrolled. * active substance use disorder in the past 6 months other than tobacco use disorder. * pacemaker * coronary stent * defibrillator * neurostimulation * claustrophobia * uncontrolled high blood pressure * atrial fibrillation * significant heart disease * hemodynamic instability * kidney disease * pregnant, trying to become pregnant, or breast feeding
the immediate effect of mobilisation with movement in amateur futsal athletes with chronic ankle instability

Conditions: Ankle Injuries and Disorders

Summary: chronic ankle instability (cai) is an increasingly prevalent condition among futsal athletes. mobilization with movement (mwm) is a conservative rehabilitation strategy commonly used in this condition. even so, the effects of two mwm dorsiflexion techniques on sports performance are not known. the aim is to analyze the immediate effect of two mwm techniques on the dorsiflexion range of motion, the dynamic balance and the performance variables in futsal athletes with cai. also, to analyze the impact of performing them in a different order.


Eligibility criteria:
inclusion criteria: 1. a history of at least one significative ankle sprain: * initial sprain must have occurred at least 12 months prior to study enrolment; * was associated with inflammatory symptoms; * created at least one interrupted day of desired physical activity; * the most recent injury must have occurred more than 3 months prior to study enrolment. 2. a history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability": * participants should report at least two episodes of "giving way" in the 12 months prior to study enrolment, to account for the seasonal nature of futsal; * recurrent sprain was defined as two or more sprains to the same ankle. 3. self-reported ankle instability should be confirmed with the ankle instability instrument: answer "yes" to at least 5 yes/no questions. exclusion criteria: 1. a history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either lower extremity. 2. a history of bilateral ankle sprain. 3. a history of a fracture in either lower extremity requiring realignment. 4. acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (i.e., sprains, fractures), resulting in at least one interrupted day of desired physical activity. 5. have conditions for which manual therapy is generally contraindicated (such as the presence of a tumour, fracture, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, or severe vascular disease). 6. receiving concurrent physiotherapy treatment in the last 3 months. 7. inability to read portuguese.
18f-fdg pet/ct for igg4-related disease

Conditions: Autoimmune Disease

Summary: this is an open-label study to investigate the diagnostic performance of 18f-fdg pet/ct (positron emission tomography/computed tomography) in evaluation of patients with igg4-related disease. a single dose of 18f-fdg will be intravenously injected into patients with igg4-related disease before and after treatment.

immunoglobulin g4-related disease (igg4-rd) is a recently defined emerging clinical entity characterized by tissue infiltration by igg4-positive plasma cells, tissue fibrosclerosis and elevated serum igg4 concentration. the most important feature of igg4-rd is chronic inflammation with multiple organ involvement. however, some organ involvements are difficult to find by ultrasound, ct or mri. 18f-fdg pet/ct is a sensitive imaging tool for inflammation. in this study, pet/ct were performed in patients with igg4-rd both before and after glucocorticoid treatment by a single dose of 18f-fdg. visual and semiquantitative method will be employed to assess the pet/ct images. the pet/ct image data will be used to establish a diagnostic model as well as assessment criteria for response evaluation of igg4-rd treatments.

Eligibility criteria:
inclusion criteria: * males and females * age 18-75 years old with informed consent * patients with igg4-rd: 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum igg4 (\>1.35 g/l) or with histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and igg4+ plasma cells on immunohistology when performed); 3. exclusion of other diseases. exclusion criteria: * females planning to bear a child recently or with childbearing potential; * inability to complete the examination; * concurrent severe and/or uncontrolled and/or unstable diseases; * currently under treatment using glucocorticoids.

Keywords: igg4-related disease igg4-rd 18f-fdg pet/ct
a study to evaluate 611 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Sinusitis; Nasal Polyps; Polyps

Summary: this study will evaluate the effect and safety of 611 in patients with chronic rhinosinusitis with nasal polyps (crswnp).

the main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (mfns) in reducing endoscopic nasal polyp score (nps) and nasal congestion/obstruction score (ncs) severity in eligible patients with crswnp whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (incs) therapy in comparison to placebo.

Eligibility criteria:
inclusion criteria: 1. female and male patients aged ≥18 and ≤ 75 years at the time of screening. 2. bilateral crswnp. 3. bilateral nps of ≥5 with a minimum score of 2 in each nasal cavity 4. nasal congestion score of \> 2 at screening and a weekly average severity of \> 1 at time of randomization. 5. patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with scs anytime within the past 2 years; and/or had a medical contraindication/intolerance to scs; and/or received nasal polyp surgery 6 months before signing the icf. exclusion criteria: 1. patients with other nasal diseases or symptoms. 2. patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening. 3. patients who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. 4. history of cancer. 5. known or suspected history of immunosuppression. 6. known with allergic or intolerant to mometasone furoate spray or 611/placebo.
genesearch™ breast lymph node (bln) assay post approval study

Conditions: Breast Cancer

Summary: this post-approval study is designed to determine the performance of the fda-approved genesearch™ bln assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more extensive histological evaluation when the assay is being used by clinicians to make surgical decisions on complete axillary dissections (alnd).

the primary objective of this clinical study is to gather data to estimate the positive predictive concordance (ppc) between the genesearch™ bln assay and histology as routinely practiced, i.e., routine h\&e histology of sentinel lymph node(s) (sln) and, when available, routine histology of non-sentinel axillary lymph nodes (aln). this study will provide information on the assay that will augment the performance data gained in pre-market validation studies. in addition, with the assay being used for alnd decision-making, the metastatic status of the non-sentinel axillary nodes can be taken into account in the performance measures, i.e., if the patient's sentinel or non-sentinel nodes are histologically positive, the patient will be considered positive for the primary comparison to the assay results.

Eligibility criteria:
inclusion criteria: * pre-operatively established diagnosis of invasive carcinoma of the breast * scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients * patients for whom the genesearch™ bln assay will be used intra-operatively to make a decision for an axillary lymph node dissection * 18 years of age or older * female or male * willing and able to give informed consent to participate in the study exclusion criteria: * previous diagnosis of lymphoma * subjects participating in other research studies that would interfere with their full participation in this study * patients and/or conditions with 'interfering substances' as listed in the ifu. * patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen

Keywords: breastcancer sentinel lymph nodes metastasis
umbilical cord blood use for admission blood tests of very low birth weight preterm neonates: a multi-center randomized clinical trial

Conditions: Anemia

Summary: the goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.


Eligibility criteria:
inclusion criteria: * birth weight less than 1200g or gestational age less than 30 weeks born at participating medical centers exclusion criteria: * no specific exclusion criteria
risk prevention program and therapeutic patient education program of patients with uncontrolled epilepsy

Conditions: Epilepsy

Summary: pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("recognize and manage risks") integrated into usual therapeutic patient education (tpe) versus "control" group (usual consultations with the neurologist and usual tpe). 37 subjects per group will be included in this study.

the study will be proposed to patients with uncontrolled epilepsy (n=74) aged 18 to 40. the investigators will evaluate 3 months after the last therapeutic patient session, the impact of the epilepsy-related risk prevention system on the self-management of epilepsy ("safety management" score of the epilepsy self management scale (esms). this scale has 5 dimensions (5 sub-scores): treatment management, information management, safety management, seizure management and lifestyle management. each clinical investigation team works in collaboration with a clinical psychologist for psychological assessment interviews. the implementation of such a plan should enable patient to acquire so-called safety skills aimed at protecting his life, reducing risky behavior and increasing medication compliance.

Eligibility criteria:
inclusion criteria: * patient between 18 and 40 years old * patient with poorly controlled epilepsy (persistence of seizures evolving for more than a year despite proper treatment). * patient agreeing to participate in a therapeutic education program (tpe) exclusion criteria: * epileptic patient who has already benefited from a tpe epilepsy program * patients with major cognitive impairment * patient deprived of liberty by court or administrative decision, subject to a legal protection measure (guardianship or curatorship) * pregnant or breast-feeding women * failure to obtain written informed consent after a reflection period * patient who for geographical, social or psychological reasons could not participate in the research * any situation that, in the opinion of the investigator, could present risks to the patient and to the research * participation in another therapeutic research * subjects not covered by public health insurance

Keywords: epilepsy therapeutic patient education
a study of physiologic changes in a telemetry unit

Conditions: Acute Illness Requiring to Hospital Telemetry Admission

Summary: the purpose of this study is to determine the physiological changes associated with health deterioration, as well as different types, doses, and routes of administration of medications and fluids in acutely ill patients.


Eligibility criteria:
inclusion criteria: mayo clinic patients who: * admitted to telemetry unit * with acute illness * received any type of medication via any route of administration (oral, sublingual, intranasal, inhalational, intramuscular, intravenous, subcutaneous, transdermal) * received any amount of any type of intravenous fluids * cognitively and/or physically be able to sign consent exclusion criteria: - none
virtual reality behavioral activation: an intervention for major depressive disorder

Conditions: Major Depressive Disorder; MDD; Depression

Summary: the primary purpose of this study is to test the safety and feasibility of virtual reality (vr) technology in the use of behavioral activation (ba) as a treatment for major depressive disorder (mdd). the secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for vr delivered ba.

this is a treatment development trial. participants will be randomly assigned to ba in vr, ba in real-life, or a waitlist control group. the former two groups will follow a ba protocol developed for primary care settings over a four-week treatment period. this study is taking place over zoom, due to covid-19.

Eligibility criteria:
inclusion criteria: * patient must meet dsm v criteria for mdd * patient must be at least 18 years of age * patient must be english speaking exclusion criteria: * substance use disorders in past year * any psychosis or bipolar i disorder * any seizure in the last 6 months or untreated epilepsy * current nonsuicidal self-injury or parasuicidal behavior * current suicidal urges and intent

Keywords: virtual reality behavioral activation depression