Kornimate/medical-research-clean huggingface dataset:
effect of pulsed electromagnetic field stimulation on localized pediatric osteomyelitis

Conditions: Osteomyelitis

Summary: this study will be applied to evaluate effect of pulsed electromagnetic field on pediatric localized osteomyelitis.

twenty (11 girls, 9 boys) patients will participate in this study. their ages ranged from 5 to 16 years. they will randomly divide into two groups. group a ( study group) will receive pulsed electromagnetic field in addition to medical treatment three times per week for two months , group b(control group ) will receive medical treatment only.

Eligibility criteria:
inclusion criteria: 1. all patients suffering from localized osteomyelitis in one or both lower limbs 2. all patients will be assessed by a physician before starting the study procedures. exclusion criteria: 1. patients with immune disorders . 2. patients who suffer from any systemic diseases that may interfere with the objectives of the study.

Keywords: osteomyelitis pulsed electromagnetic field
virtual care to improve heart failure outcomes (vital-hf)

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction


Eligibility criteria:
inclusion criteria: * age \>18 years of age * diagnosis of hf and lvef \<40% on most recent imaging assessment within 1 year prior to screening. any validated method for assessing lvef may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. for participants with an lvef reported qualitatively (e.g., moderate lv dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an lvef \<40%. participants with a new diagnosis of hfref may be enrolled. the enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset hfref. * access to a smartphone including through a family member of caregiver * fluent in written and spoken english exclusion criteria: * optimized or nearly-optimized on evidence-based medical therapies for hfref as determined by local investigator. * current pregnancy * chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine * egfr of \<20 ml/min/1.73m2 or ongoing chronic dialysis at screening * prior heart transplant * current or planned left ventricular assist device * currently receiving hospice care * chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel * terminal illness other than hf with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
use of racotumomab in patients with pediatric tumors expressing n-glycolylated gangliosides

Conditions: Neuroblastoma; Ewing's Sarcoma; Wilm's Tumor; Retinoblastoma; Glioma

Summary: this study will be carried out in children with diagnosis of cancer with tumors known to express n-glycolylated gangliosides. the disease must be resistant to conventional therapy. the acute toxicity and immune response will be evaluated. the expression of n-glycolylated gangliosides in tumors has previously been investigated in the tumor sample bank at this hospital. the expression of n-glycolyl gm3 was shown in neuroblastoma, ewing's sarcoma, wilm's tumor and retinoblastoma. gliomas and the aforementioned tumor types have a very bad prognosis when conventional treatment is ineffective. new therapeutic strategies have thus been examined, and several immunotherapeutic approaches, including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently being assessed. racotumomab is an anti-idiotype antibody capable of inducing anti-n-glycolyl gm3 antibodies in patients with melanoma, breast cancer and lung cancer. dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range. the 1 mg dose level was selected for the ensuing clinical studies. this clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg, owing to the difference in body surface between an adult (1.73 sq. m in average) and the candidate population for this study (0.55 to 0.7 sq. m).


Eligibility criteria:
inclusion criteria: * children (both genders) of between 1 and 10 years old at the time of accrual. * diagnosis of neuroblastoma (progression after first line treatment), glioma (progressing disease or metastatic disease, without curative treatment options), ewing's sarcoma (progressive metastatic disease to first line treatment or progressive disease to second line treatment), wilm's tumor (metastatic relapse after treatment), or retinoblastoma (progressing disease or metastatic relapse during or after first line treatment). * previous cancer treatment finished 30 days before accrual. * lansky performance status over 50. exclusion criteria: * history of encephalopathy, convulsions, asthma or severe allergy. * infectious disease grade 3 or 4 according to ctcae version 3. * hepatic, kidney or cardiac insufficiency. * marrow insufficiency after self-transplantation of hematopoietic stem cells. * weight inferior to 12 kg at the time of accrual. * concomitant cancer treatment. * inability to comply with study procedures.
icu doulas providing psychological support

Conditions: Illness, Critical; Anxiety; Depression; Post Traumatic Stress Disorder; Cognitive Impairment

Summary: many patients who survive critical illness suffer from symptoms of anxiety, depression, or post-traumatic stress disorder (ptsd) after leaving the intensive care unit (icu). memories of frightening and delusional experiences in the icu appear to be the strongest potentially modifiable risk factor. research on the formation of fear and associated memories shows that if mitigating information about a traumatic event is introduced during the time between memory formation and its recall, the emotional experience of the memory can be modified in a positive manner. this means that in order to prevent mental health problems in critical illness survivors, psychological support needs to take place in parallel with medical treatment in the icu. the researchers hypothesize that early psychological support for the critically ill can decrease mental health morbidity in critical illness survivors. however, providing consistent psychological support intervention is a challenge for busy icu clinicians. it is not feasible to hire behavioral medicine trained psychologists to become permanent icu staff nationwide. doulas, trained lay health care providers who provide emotional support to women in labor, have been identified as reliable yet affordable alternative. given common elements of their services and our intervention, doulas are in an ideal position to administer early psychological support. the objective of this project is to refine and test a behavioral intervention to be administered in parallel with medical treatment in the icu. this will be accomplished by training doulas in providing standardized psychological support intervention and refining the intervention based on stakeholder feedback


Eligibility criteria:
inclusion criteria: * adults (age \>18) admitted to the icu requiring intubation or vasopressors and expected to stay \>48 hours. exclusion criteria: * history of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy; * patients on comfort care; * patients not expected to survive the hospital stay * non-english speaking, deaf or mute * prisoners
prevail global study

Conditions: Coronary Artery Disease

Summary: the purpose of the study is to evaluate the clinical safety and efficacy of the prevail dcb.

the prevail global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (isr cohort) in a randomized controlled study of the prevail drug-coated balloon, and subjects undergoing percutaneous coronary intervention of the prevail drug-coated balloon for de novo lesions in small vessel disease (dnsv cohort) in a single arm prospectively enrolled study. in the isr cohort this will be accomplished by randomizing subjects to either a prevail dcb arm or an agent dcb arm to compare results of the treatment of isr with coronary lesions previously treated with des or bms in native coronary arteries. in the dnsv cohort this will be accomplished through collection of data to compare results of the prevail dcb to a des historical control in subjects undergoing pci for de novo lesions in small vessel disease. subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. the enrollment period is anticipated to be approximately 12 months. subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * negative pregnancy test * stable or unstable angina, positive functional test, or stable nstemi * life expectancy \>1 year * willing and able to cooperate with study procedures and required follow up evaluations exclusion criteria: * known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated * history of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative * platelet count \ 700,000 cells/mm³, or a white blood cell (wbc) count \< 3,000 cells/mm³ * renal insufficiency (or failure) * acute mi * previous pci of the target vessel within 6 months prior to the procedure * planned pci of any vessel within 30 days post-index procedure and/or planned pci of the target vessel within 12 months post-procedure * history of a stroke or transient ischemic attack (tia) * active peptic ulcer or upper gastrointestinal (gi) bleeding * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * documented left ventricular ejection fraction (lvef) \<30% * planned surgery that would cause interruption in recommended dapt duration per current guidelines * currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, ivus or other coronary artery imaging procedures

Keywords: isr dnsv
the effectiveness of tibial nerve mobilization in patients with tarsal tunnel syndrome

Conditions: Nerve Compression Syndromes; Neuropathic Pain

Summary: this randomized, clinical, single-blinded, controlledstudywasinitiallyplannedtoinclude 35 patients diagnosed with tarsal tunnel who applied to kütahya health sciences university, evliya çelebi training and research hospital, physical medicine and rehabilitation outpatient clinic.patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (emg) in the last 6 months were included in the study. the patients were randomized into two groups using the computer-assisted randomization method. tibial nerve mobilization and foot-ankle range of motion exercises will be given to the study group, and only foot-ankle joint range of motion exercises will be given to the control group. all the patients were evaluated with the visual analog scale (vas), foot functional index (ffi), neuropathic pain questionnairen (npq) and tibial nerve ultrasonography before the intervention and at the fourth week of intervention.


Eligibility criteria:
inclusion criteria: * patients aged 20-55 years who were diagnosed with tarsal tunnel syndrome by electromyography (emg) in the last 6 months were included in the study. exclusion criteria: * have a systemic inflammatory disease * presence of a cognitive disorder, receiving psychotherapy or any psychiatric treatment, disease affecting the central nervous system * being illiterate * having hearing, vision problems * history of foot and ankle surgery * any pathology that may cause pain in the foot joint diagnosed on physical examination * inadequate function of any extremity that would prevent exercise * the presence of a balance disorder or a disease that can disrupt the balance * diagnosis of advanced cardiac or lung disease for which exercise would be contraindicated
chemotherapy in treating patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

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 aminocamptothecin in treating patients with stage iii or stage iv non-small cell lung cancer.

objectives: i. determine whether aminocamptothecin colloidal dispersion (ac/cd) administered as a 120 hour weekly infusion is an effective treatment for advanced non-small cell lung cancer. ii. observe any toxicities associated with this treatment in this patient population. outline: patients receive a 120 hour continuous infusion of aminocamptothecin colloidal dispersion (ac/cd) once a week for 2 weeks, followed by 1 week of rest. patients are assessed after every 2 courses of therapy. treatment with aminocamptothecin continues indefinitely if there is tumor shrinkage or stable disease and no significant toxicity is experienced. patients are followed every 3 months. projected accrual: a total of 19-36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed measurable stage iiib or iv non-small cell lung cancer no brain metastases patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: wbc at least 3500/mm3 granulocyte count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl sgot and sgpt no greater than 2.5 times upper limit of normal (uln) alkaline phosphatase no greater than 2.5 times uln renal: creatinine no greater than 1.5 mg/dl creatinine clearance at least 60 ml/min calcium and electrolytes normal other: no other malignancy within past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix not pregnant or nursing no active infections or other serious medical conditions prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: at least 2 weeks since prior radiotherapy no prior radiotherapy to site(s) of measurable disease surgery: at least 3 weeks since any prior surgery

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
controlled trial of brexpiprazole for the treatment of co-occurring schizophrenia and substance use disorder

Conditions: Schizophrenia; Schizoaffective Disorder; Substance Use Disorders

Summary: the proposed study is a 4-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). thirty-nine participants will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). the study will be conducted at 4 sites in the us. the investigators expect to enroll 80 subjects across 3 sites. umass medical school, worcester ma is the lead site. sub-sites include massachusetts general hospital (mgh) and the university of north carolina at chapel hill (unc).

study objectives the primary objectives of the study include: 1. examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the timeline follow-back (tlfb) assessment; 2. examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (vas). the secondary objectives are to examine the effect of brexpiprazole treatment on: 1. the dollar amount spent on substances in the past week; 2. the psychiatric symptoms as measured by various clinical rating scales 3. quality of life

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old 2. meets the dsm-5 criteria for diagnoses of schizophrenia or schizoaffective disorder and substance use disorder (alcohol, cocaine, heroin, or cannabis) based on the mini international neuropsychiatric interview for the dsm-5 (mini 7.0) 3. uses substance on at least 4 of the past 30 days prior to randomization with at least one use in the week prior to randomization for one of substances (cocaine, heroin, cannabis or alcohol) assessed by the tlfb interview 4. stable dose of antipsychotic agent for at least one month 5. well established compliance with outpatient medications 6. female subjects of child-bearing potential are required to practice appropriate birth control methods during the study. exclusion criteria: 1. psychiatrically unstable 2. currently meets dsm-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis 3. significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases 4. history of a seizure disorder 5. pregnancy or breastfeeding 6. currently on aripiprazole or cariprazine 7. currently on medications to treat substance use (disulfiram, naltrexone, acamprosate, methadone, buprenorphine, varenicline or buproprion)

Keywords: schizophrenia schizoaffective disorder substance use disorders alcohol use disorder cannabis use disorder cocaine use disorder heroin use disorder
immune monitoring protocol in men with prostate cancer enrolled in a clinical trial of sipuleucel-t

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the immune response induced by sipuleucel-t (provenge®).

subjects will receive sipuleucel-t, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. for this study, cellular and humoral immune responses will be assessed. no additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age * subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-t (including a dendreon-sponsored clinical trial or registry, or an iit) * subjects have not yet undergone leukapheresis for their first dose of sipuleucel-t * subjects must understand and sign an informed consent form prior to their first leukapheresis exclusion criteria: •none
rituximab, methotrexate, procarbazine and vincristine followed by high-dose chemotherapy with autologous stem-cell rescue in newly-diagnosed primary cns lymphoma

Conditions: CNS Lymphoma; CNS Brain Cancer; Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to determine the safety of this new treatment offered in this study. pcnsl can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. some patients younger than age 60 also develop these side effects.


Eligibility criteria:
inclusion criteria: * all patients must have non-hodgkin's lymphoma involving the brain, as demonstrated by ct or mri and histologic confirmation by one of the following: a positive csf cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers. a biopsy of the vitreous or uvea demonstrating non-hodgkin's lymphoma. brain biopsy. * patients must be hiv-1 negative. * patient must have left ventricular ejection fraction ≥ 50%. * patients must have no evidence of systemic lymphoma. this must be demonstrated by a ct scan of the chest, abdomen and pelvis prior to registration. * patients must have adequate bone marrow function (defined as peripheral leucocyte count \>3000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \ 50cc/min/1.73m2). * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. * patients must be between 18 and 72 years-old. * patients must sign an informed consent. exclusion criteria: * prior cranial irradiation * other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ. * pre-existing immunodeficiency such as renal transplant recipient. * prior treatment with chemotherapy for cns lymphoma.
clinico-biological collection of autoimmune, dysimmune or auto-inflammatory dermatological diseases

Conditions: Autoimmune Bullous Dermatosis; Dysimmune Dermatological Diseases; Auto-inflammatory Dermatological Diseases; Skin Diseases

Summary: the aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. this collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

autoimmune diseases include around a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (fai²r: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). the common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. in addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. consequently, and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Eligibility criteria:
inclusion criteria: skin damage of documented or probable autoimmune, dysimmune or autoinflammatory origin. the patients included may be adults or children, and will be: * patients with autoimmune bullous dermatoses (pemphigus, pemphigoid and others), * patients with systemic autoimmune diseases associated with skin damage (lupus, scleroderma, dermatomyositis for example), * patients with cutaneous lupus * patients with dysimmune skin diseases (psoriasis, eczema) * patients with immuno-induced dermatological disorders or drug dermatitis * patients receiving, or likely to receive, new, innovative therapies (new molecule on the market, checkpoint inhibitors, gene therapy, cell therapy, etc.). patients with dermatological damage whose autoimmune, dysimmune or auto-inflammatory origin is suspected exclusion criteria: * patients under protective supervision (guardianship, curators) * patients under 6 years old * pregnant or breastfeeding woman

Keywords: auto-inflammatory dermatological diseases cutaneous lupus scleroderma dermatomyositis psoriasis eczema new therapies