Kornimate/medical-research-clean huggingface dataset:
impact of prehabilitation in oncology via exercise- bone marrow transplant

Conditions: Hematopoietic Stem Cell Transplant; Hematologic Diseases; Physical Activity; Prehabilitation

Summary: the purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.

hematopoietic stem cell transplant may have the potential for severe side effects, including functional (reduced aerobic capacity, reduced muscle strength) and psychosocial (e.g. reduced quality of life, increased fatigue) detriments. evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with regard to the above mentioned side-effects. also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. however, no experience exists with regard to prehabilitation exercise in hematopoietic stem cell transplant patients.

Eligibility criteria:
inclusion criteria: * hematological cancer (e.g. acute myeloid leukemia, chronic lymphocytic leukemia, multiple myeloma, non-hodgkin lymphoma, etc.) * hematological cancer in remission * females and males ≥18 years of age * fluent in written and spoken english * must be able to provide and understand informed consent * must have an ecog score of ≤ 2 * scheduled for an inpatient autologous or allogeneic stem cell transplant at penn state cancer institute * ≥ 2 weeks until scheduled transplant * primary attending physician approval exclusion criteria: * hematological cancer not in remission * evidence in the medical record of an absolute contraindication (e.g. heart insufficiency \> nyha iii or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability) for exercise * any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist * uncontrolled hypertension * receiving non-transplant related chemotherapy and/or radiotherapy * not fluent in written and spoken english * active infections, hemorrhages, and cytopenias that could place transplant patients at risk for further adverse events, deemed by the exercise interventionist, physician and/or nurse

Keywords: exercise hematopoietic stem cell transplant physical function quality of life
comparison of gap-score with schwab-score

Conditions: Spinal Fusion; Adjacent Segment Degeneration

Summary: the predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation.

the multilevel spinal fusion is associated with high rate of failure. this results from insufficient adaptation of the fused spine to the proper individual spinal alignment. in the recent years, comprehensive understanding of spinal alignment and definition of several parameters contributed to develop score systems to evaluate the alignment of the multilevel spinal fusion and to predict failure. in the following study the results of multilevel spinal fusion were evaluated retrospectively according to two scoring systems: gap-score und schwab-score. the predictive value of each score system is analyzed by the correlation of the failure rate with its corresponding score value.

Eligibility criteria:
inclusion criteria: * 3 and more fusion levels exclusion criteria: * neuromuscular disease

Keywords: gap-score schwab score proximal junctional failure spinal fusion
safety and feasibility of preoperative and intraoperative image-guided resection of gliomas

Conditions: Brain Tumor Adult

Summary: this study evaluates the use of specialized magnetic resonance imaging (mri) techniques including magnetic resonance (mr) perfusion and 2-hydroxyglutarate (2hg) spectroscopy in the surgical treatment of gliomas. cohort 1 participants will undergo an mr perfusion scan or 2-hg spectroscopy prior to surgery and intra-operatively. cohort 2 participants will only undergo standard of care imaging and tumor acquisition. participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * suspected glioma (grade ii, iii, or iv) * preoperative mr perfusion (enhancing tumors) * preoperative mr 2-hg spectroscopy (nonenhancing tumors)patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care * karnofsky performance status ≥ 60 * life expectancy \> 12 weeks * cohort 1: ability to comply with study and follow-up procedures * cohort 2: ability to comply with study procedures exclusion criteria: * prior diagnosis of intracranial glioma * other malignancy with expected need for systemic therapy within 3 years * inability to have 6000 grays of radiation to the brain * need for urgent palliative intervention for primary disease (e.g., impending herniation) * evidence of bleeding diathesis or coagulopathy * history of intracerebral abscess within 6 months prior to day 0 * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the course of the study * pregnant females * subjects unable to undergo an mri with contrast
trial of a non-pharmacological intervention to prevent delirium among elderly in-patients

Conditions: Delirium

Summary: this study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.

delirium is an acute neuropsychiatric syndrome usually associated with a general medical condition. its prevalence is high among hospitalized elderly patients and is generally underdiagnosed. delirium is associated with prolonged hospitalization, increased mortality, institutionalization, falls, cognitive and functional decline and also with higher economic costs. the etiology of delirium is multifactorial, including excessive sensorial stimulation and disruption of the sleep-wake cycle as triggering factors. the aim of this study is evaluate the effect of earplugs and eyemask for delirium prevention among elderly in-patients of a brazilian university hospital. this will be a partially blinded clinical trial, in wich both control and intervention group will receive information about orientation to time and space every evening, and intervention group will also receive earplugs and eyemask for use during the night. the primary outcome will be the occurrence of delirium.

Eligibility criteria:
inclusion criteria: * in-patients, expected to stay for at least 24 hours. * understand and consent in participating in the study and sign the consent form. * 60 years of age, or older. * visual and auditory acuity sufficient to perform cognitive tests. exclusion criteria: * diagnosis of delirium in the selection visit. * glasgow coma scale less than 15 in the selection visit. * prisma-7 ≤3 patient will be excluded.

Keywords: eyemask earplugs
open-label extension of voxelotor

Conditions: Sickle Cell Disease

Summary: open-label extension study of voxelotor for participants with sickle cell disease who have participated in voxelotor clinical trials.

open-label extension (ole) study of voxelotor for participants with sickle cell disease who have participated in voxelotor clinical trials. up to approximately 600 participants with sickle cell disease (scd), will be enrolled at approximately 70 clinical sites globally. all participants will receive voxelotor once daily, administered orally as tablets, dispersible tablets, or powder for oral suspension formulation. the objective of this ole is to assess the safety of, and scd-related complications of, long-term treatment with voxelotor, in participants who have completed treatment in a global blood therapeutics (gbt)-sponsored voxelotor clinical study.

Eligibility criteria:
inclusion criteria: * male or female participant with scd, who participated and received study drug in a gbt-sponsored voxelotor clinical study. note: participants who discontinued study drug due to an ae, but who remained on study, may be eligible for treatment in this study provided the ae does not pose a risk for treatment with voxelotor. note: participants who discontinued study gbt440-032 as the result of an abnormal transcranial doppler (tcd) flow velocity assessment (≥ 200 cm/sec) are eligible for treatment in this study. - participant has provided written consent/assent (for pediatric participants, both the consent of the participant's legal representative or legal guardian and the participant's assent \[where applicable\] must be obtained). exclusion criteria: * female participant who is breastfeeding or pregnant * participant withdrew consent from a gbt-sponsored voxelotor clinical study * known hypersensitivity to voxelotor or any other components of the study drug * use of st. john's wort, sensitive cytochrome p450 (cyp) 3a4 substrates with a narrow therapeutic index, or moderate or strong cyp3a4 inducers within 30 days of day 1
ctdna in cutaneous squamous cell carcinoma

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: the purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.

the study aims to better understand whether circulating tumor dna, or ctdna, a type of personalized blood test informed by the tumor, can help monitor recurrence and treatment responses in patients with cutaneous squamous cell carcinoma (cscc), especially during and after treatment. blood samples will be collected during regular treatment visits or through mobile phlebotomy visits, and analyzed to study how ctdna levels change over time. participants will be in the study for 2 years. circulating tumor dna consists of small fragments of dna shed into the bloodstream by cancer cells. it may serve as a non-invasive biomarker for detecting and monitoring cscc, offering insights into tumor treatment response and/or progression. ctdna can provide a "liquid biopsy," allowing real-time tracking of tumor dynamics. specifically, the study is researching how ctdna levels change in patients undergoing surgery, immunotherapy, or other standard treatments. the goal is to see if ctdna can serve as a biomarker to better understand treatment response and detect potential progression/ recurrence of the cancer. this study does not involve any experimental drugs or devices. all drugs and treatments administered to participants, including surgery and immunotherapy, are part of standard of care. the ctdna blood test is being used as a research tool and is not currently approved by the u.s. food and drug administration (fda) for monitoring cscc. the study aims to evaluate its potential future use as a reliable biomarker.

Eligibility criteria:
post-operative cohort inclusion criteria: * patients with surgically resectable primary cscc with pni (\>0.1mm caliber nerve) or at least 2 high-risk features defined as size \> 2cm, recurrent cscc, lvi, immunosuppressed, poorly differentiated, and/or invasion \>6mm/beyond subcutaneous fat; * patients with surgically resectable regional metastases not receiving neoadjuvant therapy exclusion criteria: * patients with cutaneous squamous cell carcinoma not amenable to surgical resection * patients receiving or undergoing systemic therapies. neoadjuvant cohort inclusion criteria: * patients with resectable ajcc (8th ed) stage ii, iii or iv(m0) cscc treated with neoadjuvant immunotherapy as part of standard care. exclusion criteria: * patients ineligible for neoadjuvant treatment. definitive immunotherapy cohort inclusion criteria: * patients with unresectable locally advanced or metastatic cscc, ajcc (8th ed) stage ii, iii, or iv), receiving immunotherapy as part of standard of care. exclusion criteria: * patients undergoing systemic therapies outside the standard of care or enrolled in conflicting clinical trials.

Keywords: circulating tumor dna cscc skin cancer biomarker ctdna minimal residual disease (mrd) liquid biopsy advanced skin cancer
impact of treatment with targeted therapies on the generation of car t cells in cll patients

Conditions: CLL; Chronic Lymphocytic Leukemia

Summary: in this biological study, blood samples will be collected from patients with cll treated with targeted agents (ibrutinib and venetoclax) to assess the impact of these treatments on the generation of car t cells in terms of manufacturing efficiency, immunophenotypic characteristics and functional properties.

this is a biological study aimed at analyzing the features of car t cells generated in cll patients treated with ibrutinib or venetoclax. to this purpose, blood samples will be collected from patients with cll before starting therapy with ibrutinib or venetoclax and after 6 and 12 months of treatment. anti-cd19 car t cells will be generated and tested for: (i) viability, expansion and generation efficiency; (ii) phenotypic characteristics, in terms of cd4/cd8 composition, differentiation subset distribution, exhaustion markers and expression of immune checkpoint molecules; (iii) in vitro functional properties, in terms of proliferation ability, cytokines production, cytotoxic activity and killing of target cells. car t cells produced from the same patient at different timepoints will be compared. phenotypic and functional data on car t cells will be also correlated with main cll prognostic factors (e.g. ighv mutational status, fish abnormalities, tp53 mutation status) and outcome variables (response status, duration of response).

Eligibility criteria:
inclusion criteria: * diagnosis of cll/sll meeting the iwcll 2008 criteria; * ≥18 years old; * indication for treatment with targeted therapies (i.e. ibrutinib or venetoclax); * anticipated possibility to collect blood samples at the baseline and at 6- and 12-month timepoints; * signed written informed consent according to ich/eu/gcp and national local laws; * confirmed availability of the laboratory to enroll and to process patient samples. exclusion criteria: * expected treatment duration with targeted drug \< 12 months, according to treating physician; * previously treated with more than 2 lines of cll-directed therapy; * concurrent use of systemic steroids or chronic use of immunosuppressive medications; * active hbv (hbsag+ or hbv dna+) or hcv or hiv infection.
pharmacokinetics of enoxaparin in intensive care patients

Conditions: Venous Thromboembolism

Summary: to evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily. to investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin


Eligibility criteria:
inclusion criteria: * body mass index between 18-30 kg/m2 * critically ill patients requiring intensive care and pharmacological thromboprophylaxis * expected to remain in the icu for at least 72 h * written informed consent obtained from the patient or his/her legal representative. exclusion criteria: * other indications for anticoagulant therapy than thromboprophylaxis * intracranial haemorrhage or central neurosurgical operation within three months prior to the admission * disseminated intravascular coagulation (dic) according to the international society on thrombosis and haemostasis criteria * known heparin induced thrombocytopenia (hit), or hypersensitivity to enoxaparin or heparin * treatment with enoxaparin or any other low-molecular weight heparin (lmwh) or heparin within 24 hours prior to icu admission. if patient has received thromboprophylactic dose of lmwh within 24-72 hours before icu admission inclusion can be done if measured anti-factor xa level is \<0.1 iu/ml at the time of admission * any long-term anticoagulant medication, expect low-dose aspirin * major bleeding within the last week unless definitively treated * blood platelet count \ 1.7 * glomerular filtration rate less than 50 ml/min/1.73 m2 estimated from serum creatinine by applying cockcroft-gault equation or chronic dialysis * hiv, hepatitis b virus, or hepatitis c virus infection * pregnancy
evaluation of kisspeptin glucose-stimulated insulin secretion with oral glucose tolerance test

Conditions: Metabolic Diseases

Summary: the goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

assignment: each study subject will serve as their own control. the order of the visits will be randomized. delivery of interventions: * prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. * during the inpatient study, the subjects will * undergo a 16-hour kisspeptin infusion * undergo an oral glucose tolerance test

Eligibility criteria:
inclusion criteria: history: * over the age of 18, * normal pubertal development * stable weight for previous three months, * normal body mass index (bmi between 18.5-25) * regular menstrual cycles physical examination: • systolic bp \< 140 mm hg, diastolic \< 90 mm hg laboratory studies: (per massachusetts general hospital reference ranges) * normal hemoglobin * hemoglobin a1c \< 6.5% * blood urea nitrogen, creatinine not elevated * aspartate aminotransferase, alanine aminotransferase \< 3x upper limit of normal exclusion criteria: * active illicit drug use, * history of a medication reaction requiring emergency medical care, * difficulty with blood draws. * history of chronic disease, except well controlled thyroid disease, * recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). use of levothyroxine or seasonal allergy medications is acceptable, * history of diabetes in a first degree relative, * use of contraceptive pills, patches or vaginal rings within last 4 weeks. * hyperlipidemia by fasting lipid panel * positive serum pregnancy test (for all women)
sa4503 8-week study in major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to determine the efficacy of sa4503 compared to placebo in the treatment of subjects with major depressive disorder (mdd). secondary, to evaluate the safety of sa4503 compared to placebo in subjects with mdd.

further study details as provided by m's science corporation:

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 65 (inclusive) * diagnosis of mdd according to the diagnostic and statistical manual of mental disorders (dsm)-iv criteria and a shortened mini evaluation * ham-d17 score of \>/= 21 and a severity score of at least 2 for item 1 (depressed mood) at both screening and baseline * current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to screening. exclusion criteria: * subjects who have received fluoxetine within 1 month prior to baseline or any other antidepressant within 2 weeks prior to baseline, or any unlicensed medication within 1 month before screening * subjects who require psychotropic medication other than the study medication * subjects who started psychotherapy within 4 months prior to screening * subjects who currently (i.e., in the month prior to screening) meet dsm-iv criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders * subjects who have a primary diagnosis of anxiety * subjects who regularly use sleeping medication more than 3 times per week * subjects who have major psychiatric or neurologic disorders other than mdd * subjects with depression secondary to stroke, cancer, or other severe medical illness * subjects who have a history of alcohol or substance dependence(within 1 year prior to screening)
safer still (exploratory project 3)

Conditions: Suicide Prevention

Summary: the long-term goal is to decrease suicide and suicidal behaviors in at-risk youth through preventative interventions. investigators propose to develop an interactive intervention ("safer still") to help promote safe storage of firearms during the critical period immediately following high-risk care transitions. the objective of this study is to develop and test the safer still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely.

the objective of this study is to develop and test the safer still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely. exploratory aims of the study are as follows: (1) evaluate parental motivation to change firearm storage behavior as a potential mediator of the three-month intervention effect. investigators hypothesize that higher change scores in the "action" stage of the readiness to change model1 at one month will mediate the intervention effect at three months; (2) identify whether the response to the safer still intervention varies by adolescent history of suicide attempt and parental primary reason for firearm ownership at one and three months; and (3) ascertain common parental reasons for declining to safely store firearms.

Eligibility criteria:
inclusion criteria: * parent or legal guardian of an adolescent aged 12 to 17 years at time of consent * have a child who is receiving psychiatric inpatient, crisis, or emergency treatment at nationwide children's hospital * indicate that at least one firearm is located in or around the residence of the adolescent and is stored unlocked, loaded, or both unlocked and loaded. * only one parent per household is permitted to participate to avoid contamination across the two study conditions. exclusion criteria: * inability to speak/read english * lack access to a digital device (smartphone, ipad, tablet computer, desktop, laptop pc).

Keywords: firearms safety lethal means prevention safe storage of firearms and medication mobile application interactive intervention firearm storage behavior behavioral economics behavioral nudges lethal means restriction medication storage practices