Kornimate/medical-research-clean huggingface dataset:
an investigational scan (me-4fdg pet/ct) for the detection of sodium-glucose transport for early diagnosis of lung cancer

Conditions: Lung Adenocarcinoma

Summary: the phase i/ii trial assess the safety and efficacy of a new positron emission tomography (pet) test for early diagnosis of lung cancer. this study uses pet and me-4fdg new glucose tracer (alpha-methyl-4-deoxy-4-\[(18)f\]fluoro-d-glucopyranoside) designed specifically to determine glucose update into cells in the body. pet is a non-invasive imaging method used to detect cancer in patient. me4fdg is a radioactive glucose tracer used in pet to locate cells in the body taking up glucose by sglt2. slgt2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. this study may help researcher determine how effective pet with me4fdg tracer works in detecting lung cancer.

primary objective: i. assess the safety and efficacy of alpha-methyl-4-deoxy-4-\[(18)f\]fluoro-d-glucopyranoside (me-4fdg) for early diagnosis of lung cancer. secondary objective: i. evaluate the correlation of me-4fdg positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(sglt2). outline: patients receive me-4fdg tracer intravenously (iv) and then undergo pet/ct over 15 minutes. after completion of study , patients are followed up at 7 days.

Eligibility criteria:
inclusion criteria: * age \> 18 years * lung nodule \>= 1 cm visualized by ct imaging * cancer arm: pathologically confirmed lung adenocarcinoma. for patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. for patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy * benign arm: lung nodules considered to be clinically benign, according to the guidelines for management of incidental pulmonary nodules from the fleischner society. will consider "benign" the nodules with a lung-rads score of 1-3 exclusion criteria: * pregnancy * diagnosis of diabetes * current treatment with sglt2 inhibitors or metformin
long-term risk, clinical management and healthcare resource utilization of stable cad in post mi patients

Conditions: Stable Coronary Artery Disease (CAD), Myocardial Infarction

Summary: this study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-mi, including a description of patient characteristics, current treatment patterns, rate of major cv events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

tigris is a multinational, multi-centre, observational, prospective, longitudinal cohort study which will include stable cad patients with history of mi 1-3 years ago and high risk of developing atherothrombotic events in a real world setting. the follow-up period is 3 years. patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Eligibility criteria:
inclusion criteria: - stable cad patients aged 50 years or older with documented history of presumed spontaneous mi with their most recent mi occurring 1 to 3 years prior to enrollment and have at least 1 of the following risk factors: age ≥ 65 years; diabetes mellitus requiring medication; documented history of a second prior presumed spontaneous mi (\>1 year ago); documented history of angiographic evidence of multivessel coronary artery disease; chronic renal dysfunction. exclusion criteria: * presence of serious co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year) * current participation in a blinded randomized clinical trial. * presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient * patients receiving treatment of ticagrelor beyond 12 months, or off label use of ticagrelor.

Keywords: coronary artery disease, myocardial infarction
post-hospital intervention for veterans with comorbid bipolar and substance use disorders

Conditions: Bipolar Disorder; Substance Use Disorders

Summary: this trial aims to evaluate the effectiveness of a novel intervention for veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

this randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in veterans with comorbid bipolar disorder and substance use disorders (bp-sud) following a psychiatric hospitalization. participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to va treatment as usual. veterans with bp-sud will be recruited from the providence vamc inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.

Eligibility criteria:
inclusion criteria: * diagnosis of a mood disorder * diagnosis of a substance use disorder (drug and/or alcohol) * taking at least one psychiatric medication exclusion criteria: * unable to speak and read english * younger than age 18

Keywords: bipolar disorder substance use disorders treatment adherence veterans psychosocial intervention
the prone to supine breast mri trial

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether a supine mri obtained immediately after a standard diagnostic prone mri exam, without a second injection of gadolinium (gd) contrast material, would be of sufficient quality to allow the radiologist to define the tumor edges ("segment" the tumor) so that a 3-d image of the tumor can be generated to form a bcl.

the purpose of this study is to find out whether additional mri images taken with patients in a different position after completing a standard mri are of sufficient quality to allow a radiologist to identify the edges of the tumor. these additional mri images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.the information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * female gender. * histologic diagnosis of invasive breast cancer or ductal carcinoma in situ * tumor size at least 1 cm in diameter as visualized on mammogram or us. * a diagnostic breast mri is considered to be clinically indicated. * ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. exclusion criteria: * absolute contraindication to mri, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes. * severe claustrophobia. * contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (egfr \< 30 ml/min/1.73m2). * history of median sternotomy. * pregnancy. patient attestation that they are not pregnant will be acceptable. * patients who have received neoadjuvant chemotherapy.

Keywords: breast cancer locator
natural course and therapeutic effect of chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: the goal of this observational study is to establish a prospective cohort of chronic pancreatitis (cp) patients to provide evidence-based guidance for clinical practice and comprehensively optimize diagnostic and treatment strategies. the study aims to collect detailed demographic information, clinical data, medical imaging, biological samples, and follow-up information from cp patients.

chronic pancreatitis (cp) is clinically characterized by abdominal pain and pancreatic dysfunction, including diabetes and steatorrhea, which significantly impact patients' quality of life and life expectancy. globally, the annual incidence of cp is 9.62 per 100,000 individuals, with a mortality rate of 0.09 per 100,000 and a prevalence ranging from 13.5 to 560 per 100,000. in china, the prevalence of cp has also been increasing annually, currently reaching 13.52 per 100,000 individuals. in most countries worldwide, the incidence and prevalence of cp are generally on the rise, leading to an increasing healthcare burden. due to the endocrine and exocrine functions of the pancreas, cp presents with highly variable clinical symptoms, diverse complications, and a risk of malignant transformation. therefore, establishing a standardized, large-scale, long-term follow-up prospective cohort for cp is crucial for a more comprehensive understanding of its clinical characteristics and for providing high-quality evidence-based medical guidance for clinical practice.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic pancreatitis. exclusion criteria: * patients who refuse to sign informed consent.
the effect of mindfulness training before primary total joint arthroplasty on sleep quality

Conditions: Sleep Disturbance; Arthropathy

Summary: the primary purpose of this study is the determine whether a 15 minute mindfulness meditation (mm) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (tja) results in any improvement in pittsburg sleep quality index (psqi) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively.

the primary purpose of this study is the determine whether a 15 minute mindfulness meditation (mm) administered at the preoperative appointment prior to primary unilateral total joint arthroplasty (tja) results in any improvement in pittsburg sleep quality index (psqi) score, a validated metric for sleep quality, at 2, 6 or 12 weeks post-operatively. we hypothesize that patients in the mm cohort will have lower psqi scores, indicating higher sleep quality, at both post-operative time points. secondary aims include characterizing differences between cohorts in visual analog scale (vas) for pain, epworth sleepiness scale (ess) scores, patient reported outcome measurement information system - sleep disturbance - short form, and knee injury and osteoarthritis outcome scores (koos) at 2, 6 and 12 weeks following tja.

Eligibility criteria:
inclusion criteria: * patients undergoing primary unilateral total joint arthroplasty at colorado joint replacement * between the ages of 18 and 90 years old will be included in the study. exclusion criteria: * simultaneous total joint arthroplasty * uni-compartmental knee arthroplasty * revision surgery for infection, fracture or other indication. * history of drug or alcohol abuse * patients who are unable to present at a standard pre-operative appointment within 4 weeks prior to scheduled surgery will also be excluded, as the mm intervention would not be possible to administer.
the use of stromal vascular fraction for knee arthrosis

Conditions: Knee Arthrosis

Summary: a trial to investigate the safety and efficacy of svf for the treatment of knee arthrosis. patients will undergo a single liposuction to obtain the svf. the svf will then be isolated and frozen in our laboratory. the svf will then be injected up to 2 times into the fat pad of the patient's knee.

stromal vascular fraction (svf) from adipose tissue is increasingly being used in the clinic for a variety of conditions (skin disorders, joint pain, etc.). svf is a collective term for cells that can be obtained from liposuction fat. these cells can be separated from the fat by mechanical processing of the liposuction fat combined with an additional centrifugation. despite the fact that enough svf can be isolated after such a liposuction for multiple treatments (\>3), our research group has found a way to safely freeze svf without significant loss of svf cells. in this way, a patient would only have to undergo one liposuction and associated anesthesia to be able to obtain multiple svf treatments.

Eligibility criteria:
inclusion criteria: * legal capacity * osteochondral lesions * inflammatory complaints * (peri)tendinitis or tendinopathies and ligamentous injuries * impingement complaints * arthrofibrosis * anterior knee pain
magnesium oxide in treating hot flashes in menopausal women with cancer

Conditions: Breast Cancer; Cancer Survivor; Hot Flashes; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: magnesium oxide may help relieve hot flashes in women with cancer. purpose: this phase ii trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

objectives: primary * to determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer. secondary * to evaluate the effect of magnesium oxide on overall quality of life. * to evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses. outline: patients receive oral magnesium oxide once daily in weeks 2-5. patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5. patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment. after completion of study treatment, patients are followed up for at least 30 days.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * history of breast cancer (currently without malignant disease) * no history of breast cancer but wishes to avoid estrogen due to a perceived increased risk of breast cancer * must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) for ≥ 1 month before study entry * has undergone treatment for cancer (patients other than breast cancer survivors are eligible) patient characteristics: * eastern cooperative oncology group (ecog) performance status 0-2 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * creatinine clearance ≥ 30 ml/min * no hypersensitivity to magnesium oxide * no medical or other condition(s) that, in the opinion of the investigator/sub-investigator, may compromise the objectives of the study prior concurrent therapy: * see disease characteristics * more than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, progestational agents, or gabapentin * more than 28 days since prior and no other concurrent investigational drugs * concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient has been on a constant dose for \> 4 weeks and is not expected to stop the medication during the study period

Keywords: cancer survivor hot flashes breast cancer unspecified adult solid tumor, protocol specific
b7-family score in urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: immunotherapy has been found to confer substantial survival benefits to the patients with higher mutation burdens, which become the first biomarker approved by fda in urothelial carcinoma (uc). nevertheless, among the patients with high mutation burdens, some still remained refractory to immunotherapy. the b7 family molecules have long been perceived as vital determinant of immune response and may define dominant molecular subsets associated with immunotherapeutic response. simultaneously, our previous study (eur j cancer. 2022,171:133-142) unveiled the potential of b7-h4 as a candidate biomarker to refine the predictive capability of tumor mutation burden (tmb) in immunotherapeutic efficacy based on its significant correlation with tmb in mibc. we hypothesized that the integration of b7 family molecules with tmb could better identify patients with better response to checkpoint blockade. in this retrospective study, a total of 1,084 uc patients from 5 independent cohorts were enrolled. we established the b7 family score (bfs) by the expression patterns of three b7 family members: pd-l1 (cd274), b7-h3 (cd276) and b7-h4 (vtcn1) based on protein and transcriptomic level respectively. we further investigated the correlation of bfs with genomic features and therapeutic response in uc. in addition, we integrated the bfs with tumor mutation burden (tmb) to better stratify the clinical benefit from pd-l1 blockade and platinum-based chemotherapy.

on the basis of established findings in the prognostic and functional properties of the three b7 family members, i.e., pd-l1, b7-h3, and b7-h4, we employed the imvigor210 cohort as the discovery cohort to establish the concept of b7 family score (bfs). to maximize the prognostic value of the system, we introduced the r package survmisc (0.5.5) in the imvigor210 cohort to determine the best cut-off value of mrna expression level of the b7 family members (i.e. cd274, cd276, and vtcn1) by calculating the minimum log-rank p value accordingly.

Eligibility criteria:
inclusion criteria: * patients with muscle-invasive bladder cancer receiving radical cystectomy have been included in this study. exclusion criteria: * patients with non-muscle invasive bladder cancer were not eligible in this study.
to assess the effectiveness of structured occupational therapy (ot) interventions on patients with sud in inpatient department (ipd) settings, focusing on improvements in cognitive, physical, and functional domains

Conditions: Substance Abuse Disorder

Summary: ot emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. this work assesses the impact of a 12 session structured ot intervention program for patients with sud in ipd. benefitting from checklists like the montreal cognitive assessment (moca), the barthel index, the lawton-brody iadls scale, it substantiates attaining enhancements in expressive cognitive functions, adls, and iadls to understand how selected ot intervention modalities can enhance functional capabilities.


Eligibility criteria:
inclusion criteria: * substance abused disorder * admitted in rehabilitation center exclusion criteria: * severe cognitive impairment * physical disability
acceptability and feasibility of a stress prevention program based on meditation and acceptance and commitment therapy for staff at a cancer center

Conditions: Employees at a Hospital

Summary: the maeva program seems to meet the challenges of implementing meditation for cancer care workers. as part of our quality of life and working conditions initiative, the investigator decided to offer it to staff at our cancer center. the maeva program is delivered in a closed format: participants commit to following, as far as possible, the three sessions of the program - one session per week for 3 weeks. during the sessions, it will be proposed to train meditative practices and three different themes will be addressed (one theme per session): meditation, acceptance and commitment to values. before and after the program, participants will complete a quality of life evaluation, a perceived stress scale, and a questionnaire to assess psychological flexibility. at the end of the program, each participant will be asked to complete a satisfaction questionnaire and a semi-directive interview, by videoconference, or by telephone in the event of digital impossibility with voice recording, to enable a qualitative analysis.


Eligibility criteria:
inclusion criteria: * participant of legal age * willingness to participate in the program - voluntary registration * commitment to attend all 3 program sessions * schedule compatible with participation in the 3 program sessions * participant has understood, signed and dated the consent form * participant affiliated to the social security system exclusion criteria: * no desire to participate in the program - non-registration * previous participation in maeva program * no commitment to participate in the 3 program sessions * agenda incompatible with the 3 program sessions

Keywords: maeva program quality of life mindfulness workplace caregivers
relationships between olst, gmfm and pedobarographic values in cp

Conditions: Cerebral Palsy

Summary: the primary aim of this study was to investigate the relationship between the one leg-standing test (olst) and the gross motor function measurement (gmfm) and stance phase stability during gait in unilateral cerebral palsy (ucp). the secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait. the investigator's hypotheses are (1) olst has relationship between t2-t1 in children with ucp; (2) olst has relationship between gmfm d and e. eighteen children with ucp and ten typically developing children (tdc) participated in the study. all participants and their legal guardians signed an informed consent form before participating. firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the olst. after analysis, only the ucp group was evaluated with the gmfm. the tdc group was used for comparison of pedobarographic stance phase stability (t2-t1) and olst values.


Eligibility criteria:
inclusion criteria (for experimental group): * diagnosed unilateral cerebral palsy * be able to stand on the affected leg for 0 to 30 seconds exclusion criteria: * children with ucp who had botulinum toxin-a injections to the lower limbs in the previous six months * lower limb surgeries * mental disorders

Keywords: cerebral palsy, gait, gross motor function measurement, stability, foot pressure