Kornimate/medical-research-clean huggingface dataset:
carmustine in treating adults with recurrent supratentorial low-grade glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

objectives: * determine the antitumor activity of gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma. * assess the toxicity of this therapy in these patients. outline: patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma). patients receive up to 8 gliadel wafers (containing carmustine) implanted in the resected tumor cavity. patients are followed every 2 months. projected accrual: this study will accrue a maximum of 68 patients within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed recurrent primary low grade glioma including: * fibrillary astrocytoma * oligodendroglioma * mixed glioma * evidence of measurable enhancing or non-enhancing cns neoplasm on mri patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * hematocrit greater than 29% * absolute neutrophil count greater than 1500/mm\^3 * platelet count greater than 125,000/mm\^3 hepatic: * sgot less than 1.5 times upper limit of normal (uln) * bilirubin less than 1.5 times uln renal: * creatinine less than 1.5 mg/dl * bun less than 25 mg/dl other: * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 4 weeks since prior chemotherapy unless disease progression endocrine therapy: * concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study) * no concurrent immunosuppressive agents radiotherapy: * at least 4 weeks since prior radiotherapy unless disease progression surgery: * not specified other: * no other concurrent medication that may interfere with study

Keywords: recurrent adult brain tumor adult brain stem glioma adult mixed glioma adult anaplastic astrocytoma adult pilocytic astrocytoma adult oligodendroglioma
a clinical trial to evaluate the immunogenicity of the nonavalent vaccine against human papillomavirus in men infected by hiv who have sex with men. gesida 10017

Conditions: HIV Infections

Summary: phase iv, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the hpv9v vaccine in men with hiv infection (hiv +) who have sex with men (msm)

the investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with hiv infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the hpv genotypes included in the vaccine from baseline to month 7 and 24.

Eligibility criteria:
inclusion criteria: * patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment. * understand the purpose of the study and be available to perform the visits stipulated in the protocol. * be ≥18 years and \<of 36 years. * patient with chronic infection with hiv-1. * viral hiv load \ 200 cells / ul for at least the last six months. * transgender men or women who have had insertive or receptive anal sex with other men exclusion criteria: * previous history of anal cancer. * have previously received any vaccine against hpv.
catch healthy smiles:an elementary school oral health intervention trial

Conditions: Caries,Dental

Summary: the purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, catch healthy smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (k-2) children serving low-income, ethnically-diverse children,to determine the impact of catch healthy smiles on child behavioral, psychosocial, and environmental outcomes beginning in k through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.


Eligibility criteria:
inclusion criteria: for schools: * greater than 75% of the children enrolled in the dree/reduced school lunch program. * enrolling children in grade k in the 2021-2022 school year. * agree to implement the catch healthy smiles program and agreed to participate in the measurements for parent and child to participate in the measures: * ability of the parent to speak and read in english or spanish at the 4th grade level, * child enrolled in the participating school in grade k in the 2021-2022 school year * child ability to participate in the regular activities at the school exclusion criteria: -no congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
investigations into iscu myopathy or iron sulfur scaffold u protein myopathy

Conditions: Myopathy

Summary: background: - a mutation in a gene known as iscu was found to be the cause of a rare myopathy that affects the muscles. researchers collected clinical samples from people with this myopathy. more research is being done to develop a therapy for this disease. researchers are asking for permission to study the samples already collected. objectives: - to allow researchers to use clinical samples collected to study new treatments for iscu myopathy. eligibility: - people with iscu myopathy who have provided clinical samples for study. design: * participants will allow researchers to study clinical samples already collected. blood, urine, muscle, and cell samples may be used. medical records and photographs may also be studied. * treatment will not be provided as part of this study.

in 2008, nih investigators collaborated to find a mutation in the human gene, iscu, which is the official human gene name for a gene involved in assembly of iron sulfur clusters, and is abbreviated from iron sulfur cluster assembly protein, u, which was identified as the cause of a rare myopathy that affected about 25 patients in sweden. this protocol is intended to allow for the collection and analysis of clinical specimens and medical information from several research subjects who previously participated in studies that led to identification of the disease gene.

Eligibility criteria:
* inclusion criteria: * subjects will be eligible for this study if they have iscu myopathy or carry a mutation in iscu. no exclusions will be made based on gender or, ethnicity and adults will be the only patients included.

Keywords: metabolism muscle mutation iscu myopathy myopathy
vestibular rehabilitation exercises vs. general fitness training on dizziness, balance confidence, and mobility in individuals with bilateral vestibular hypofunction

Conditions: Vestibular Disorder

Summary: the goal of this clinical trial is to compare the effectiveness of vestibular rehabilitation exercises (vre) and general fitness training (gft) in adults diagnosed with vestibular disorders. the main questions it aims to answer are: does vre lead to better improvements in gaze stabilization, balance, and gait than gft? does gft lead to more improvements in overall fitness than vre? participants will be randomly assigned to either the vre or gft group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. researchers will compare the improvements in the two groups to see which intervention is more effective.


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 - 60 years. * diagnosis of a vestibular disorder confirmed by a healthcare professional. * able to walk unassisted for at least 10 meters. * able to understand and comply with the procedures of this study. * willing to provide informed consent. exclusion criteria: * severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise. * neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder. * history of orthopedic surgery within the past 6 months. * currently participating in another interventional clinical trial. * pregnant or breastfeeding women.
relaxation response training for the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the relative effectiveness of relaxation response (rr) training for the treatment of rheumatoid arthritis (ra). the study will compare rr training to rr training with cognitive behavioral therapy and to a standard ra education program.

rr training is a part of most multi-component psychosocial therapies for ra. rr training may decrease perceived psychosocial stress and autonomic tone, which in turn diminishes pain and the anticipatory anxiety associated with pain. rr training involves learning relaxation techniques which include diaphragmatic breathing, progressive skeletal muscle relaxation, and the induction of a state of focused attention on a chosen word, phrase, or image. in clinical practice, rr training is generally administered as one component of ra therapy. in this study, the effectiveness of rr training will be evaluated when rr training is administered alone and in combination with a cognitive behavioral therapy program. the cognitive behavior techniques include problem solving, relabeling, enhanced awareness of pain behaviors, and attention refocusing. the effectiveness of rr training will be evaluated in comparison to standard ra education that includes topics such as the nature of ra disease, medical therapies, physical activities, nutrition, and pain mechanisms. after a baseline assessment of health beliefs, ra severity, social support, and psychological distress, patients will be randomized to one of three study arms. patients in arm a will complete six individualized weekly rr training sessions. patients will receive a 20-minute audiotape to guide them through the exercise; they are asked to practice 5 to 7 times per week. patients in arm b will learn cognitive behavioral and rr techniques during eight weekly sessions. patients in arm c will receive standard ra education. after the initial training, all patients will be followed up with monthly telephone conversations for 4 months. patients will have follow-up study visits at months 6 and 12. follow-up study visits include a medical interview, physical exam, and blood tests.

Eligibility criteria:
inclusion criteria * ra as defined by the american college of rheumatology * english literacy and fluency exclusion criteria * major medical condition or illness which limits life expectancy or results in severe symptoms or functional disability (duke severity of illness score \> 0.85) * fibromyalgia * received or currently receiving psychosocial treatment for ra * unavailability for month 12 follow-up

Keywords: treatment pain relaxation response cognitive behavioral therapy
behavioral indicators of pain representation

Conditions: Non-specific Chronic Low Back Pain; Healthy Volunteer

Summary: the goal of this observational study is to compare the postural response to the mental simulation of everyday situations identified as painful in participants with non-specific low back pain and healthy volunteers. the main questions it aims to answer are : do participants with low-back pain show reduced variability in center of pressure displacements compared with non-painful participants when faced with mental simulation of everyday situations identified as painful? is the postural response correlated with the level of kinesiophobia? participants will be faced to pictures of everyday situations identified as painful while several physiological measurements (posturography, electromyography, heart rate) are being recorded.


Eligibility criteria:
inclusion criteria: * age between 18 and 55 * non-specific chronic low back pain for the concerned group exclusion criteria: * low back pain for 0 to 3 months * unable to stand 1 minute without technical aid * neurological, motor or cognitive know impairment * bmi \> 30

Keywords: kinesiophobia low back pain posturography
genetic influences on statin blood concentrations in african americans

Conditions: Hyperlipidemia; Hypercholesterolemia; Dyslipidemia

Summary: this study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in african-american patients.


Eligibility criteria:
inclusion criteria: * african-american patients taking a statin metabolized by cyp3a (e.g., atorvastatin, simvastatin, or lovastatin) exclusion criteria: * age less than 18 years
development of a patient reported outcome measure for advanced ovarian cancer patients receiving surgical and chemotherapy treatment

Conditions: Ovarian Cancer; Surgery; Chemotherapy; Patient Reported Outcome Measure

Summary: development of a patient reported outcome measure (prom) for ovarian cancer patients receiving combined surgery and radiotherapy

the study will be conducted in four stages: stage i - item generation approximately 20 interviews will be conducted with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. the interviews will be audio recorded and transcribed verbatim. the qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. interviews will be conducted either in person or virtually depending on national social distancing guidance at the time. interviews will be audio recorded using a dictaphone which encrypts files in real time. stage ii - cognitive interviewing following the initial interviews, approximately 7 participants will undergo cognitive interviews to ensure that all items are clear and easily understood. interviews will be audio recorded using a dictaphone which encrypts files in real time. stage iii - item reduction and refinement of the draft prom a draft prom and the eortc qlq-c30 (a validated measure of health related quality of life for cancer patients in clinical trials) will be administered to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. approximately 50 patients will be asked to repeat the draft prom approximately one week later to assess test-retest reliability. hierarchical item reduction and rasch analysis will be used to determine which items should be included in the final prom. stage iv- pilot testing the final prom will be pilot tested with approximately 10 patients at the christie site to assess its acceptability

Eligibility criteria:
inclusion criteria: * patients who are receiving combined surgery and chemotherapy for advanced ovarian cancer * aged over 18 (no upper age limit) * ability to understand and communicate in the english language * able to provide written informed consent exclusion criteria: * patients who are not receiving combined surgery and chemotherapy for advanced ovarian cancer * unable to understand and communicate in the english language * aged under 18 * unable to provide written informed consent * patients who are not able to complete informed consent or the study questionnaires
effects of sulfur thermal water inhalation on airway oxidative stress in copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the chronic obstructive pulmonary disease (copd) is a chronic inflammatory disease of the airways characterized by fixed airflow obstruction, with important systemic co-morbidities. the obstruction is usually progressive and irreversible despite chronic therapy. cigarette smoking is the major cause of this disease. copd is an important cause of morbidity and mortality worldwide. numerous studies have shown that oxidative stress plays a key role in the pathogenesis of copd. in particular, the active metabolites of oxygen such as superoxide anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative processes at the cellular level. these molecules can alter the extracellular matrix remodeling, cell respiration, cell proliferation, cellular repair and the immune response in the lung. all these events are key elements in the pathogenesis of copd. currently available treatments for copd (i.e. long-acting bronchodilators and inhaled corticosteroids) have not demonstrated a significant in vivo antioxidant effect. the thermal inhalation treatments are a therapeutic strategy used since many years in an empirical way in patients with copd. indeed, the evidence of effectiveness of spa treatment in patients with copd are very limited. the aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable copd patients.


Eligibility criteria:
inclusion criteria: * forty stable moderate to severe copd patients (global initiative for chronic obstructive lung disease (gold) stage 2 and 3), according to international guidelines. * fev1/fvc ratio post-bronchodilator \<70% * 30% \< fev1 \< 80% exclusion criteria: * atopy * asthma * concomitant lung diseases (e.g. lung cancer) * acute infections of the respiratory tree in the previous 3 months including copd exacerbation.

Keywords: copd thermal water oxidative stress inflammation
safety, tolerability and preliminary efficacy of ibi363 in subjects with advanced solid tumors or lymphoma

Conditions: Solid Tumors or Lymphoma

Summary: this study is an open-label, multicenter, phase ia/ib study. the study will evaluate the safety, tolerability and preliminary efficacy of ibi363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (mtd) or maximum administered dose (mad), and thus determine the recommended phase 2 dose (rp2d).

this study is an open-label, multicenter, phase ia/ib study. the study will evaluate the safety, tolerability and preliminary efficacy of ibi363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (mtd) or maximum administered dose (mad), and thus determine the recommended phase 2 dose (rp2d). the phase ia part consists of the dose escalation and pd marker exploration part. the phase ib part consists of the dose expansion part.

Eligibility criteria:
inclusion criteria: 1. male or female subjects, ≥ 18 years 2. histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors or lymphomas 3. subjects who progressed or are intolerant to existing standard therapy or subjects without standard therapy note: subjects may have received and failed prior therapy with a pd-1/pd-l1 inhibitor and be considered eligible for this trial. 4. subjects with at least one measurable lesion according to recist v1.1 for solid tumor or lugano 2014 for lymphoma 5. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 6. expected survival time ≥ 3 months. exclusion criteria: 1. subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 2. subjects with active thrombosis, or a history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the investigator to be stable. 3. active uncontrolled bleeding or a known bleeding diathesis. 4. subjects with massive pleural effusion or massive ascites.
comparison of web- versus classroom-based basic ultrasound and extended focused assessment with sonography for trauma (efast) training in two european hospitals

Conditions: Learning

Summary: study objective: training physicians in new skills via classroom-based teaching has inherent costs and time constraints. we sought to evaluate whether web-based didactics result in similar knowledge improvement and retention of basic ultrasound principles and the efast (extended focused assessment with sonography for trauma) compared with the traditional method. methods: physicians from two german emergency departments were randomized into a classroom group with traditional lectures and a web group that watched narrated lectures online. all participants completed a pre- and post-test, and a second post-test eight weeks later. both groups underwent hands-on training after the first post-test. a control group completed the two initial tests without didactic intervention.


Eligibility criteria:
inclusion criteria: * physicians currently practicing in a german emergency department * age ≥ 18 years exclusion criteria: * inability to participate in all aspects of the study prior to study begin * control group: subjects who did not complete the pre-test

Keywords: ultrasound education blended learning distance education trauma ultrasound fast
real-world comparative effectiveness of dabigatran versus vitamin k antagonist

Conditions: Atrial Fibrillation

Summary: to obtain a better understanding on the comparative effectiveness of dabigatran versus vitamin k antagonist (vka) for stroke prevention in patients with non-valvular atrial fibrillation (nvaf) in a real-life setting.


Eligibility criteria:
inclusion criteria: * non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with icd-9 427.31 (international classification of disease, ninth revision, clinical modification) as the diagnosis code at any time in the patient's data history prior to inclusion * patients will be required to have 180 days of enrollment for the assessment of baseline characteristics * cha2ds2-vasc (diabetes mellitus; s2: prior stroke or tia or thromboembolism; v: vascular disease; a: age 65-74 years; sc: sex category ) score ≥2 during the 180 days prior to index dabigatran use baseline period exclusion criteria: * patients \<18 years of age * patients with valvular atrial fibrillation * pregnancy * malignant cancers * transient cause of atrial fibrillation * patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis) * patients with major surgery defined as hip or knee replacement * prescriptions of oral anticoagulants (oacs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date * prescription of more than one oac on the index date * patient with any of the events defined in the composite endpoint

Keywords: non-valvular atrial fibrillation (nvaf) prevention stroke
vascular endothelial growth factor-b (vegf-b) blockade with the monoclonal antibody csl346 in subjects with diabetic kidney disease

Conditions: Diabetic Kidney Disease (DKD)

Summary: this phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (pk), of repeat doses of csl346 in subjects with diabetic kidney disease (dkd) and albuminuria receiving standard of care treatment.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes mellitus (t2dm) * urinary acr ≥ 150 mg/g * egfr \> 20 ml/min/1.73m2 * glycosylated hba1c \< 12% exclusion criteria: * current diagnosis of type 1 diabetes mellitus * history of acute kidney injury or chronic dialysis/renal transplant * uncontrolled hypertension or class iii / iv heart failure * left ventricular ejection fraction \< 50% by echocardiogram * troponin-i \> the upper reference limit * b-type natriuretic peptide \> 200 pg/ml * alt \> 2x the upper limit of normal