Kornimate/medical-research-clean huggingface dataset:
clinical and genomic factors for prognosis of aids primary effusion lymphoma

Conditions: AIDS-Related Primary Effusion Lymphoma

Summary: this research trial studies clinical factors and gene expression analysis for prognosis in tissue samples from patients with acquired immune deficiency syndrome (aids)-related primary effusion lymphoma. gathering health information over time and studying samples of tissue from patients in the laboratory may help doctors learn about the prognosis of patients with aids-related primary effusion lymphoma.

primary objectives: i. identify baseline clinical characteristics and treatment strategies in patients with aids-associated primary effusion lymphoma (pel) that correlate with long-term survival (\>= 2 years). (primary clinical objective) ii. identify differentially expressed genes in pel that are associated with long-term survival (\>= 2 years). (primary genomic objective) outline: medical chart review is performed and patient information is collected regarding human immunodeficiency virus human immunodeficiency virus (hiv)/aids medical history, staging of aids related malignancy, and type of treatment. previously collected tissue samples are analyzed via ribonucleic acid (rna) sequencing and microarray.

Eligibility criteria:
inclusion criteria: * patients diagnosed with primary effusion lymphoma (hiv seropositive or negative) on or after january 1, 1998 on whom survival status at 2 years post pel diagnosis is available * participants may be enrolled to either or both the clinical or genomic portions of the study * the minimum data required to be able to include a subject for analysis of clinical prognostic factors are: * hiv status, and for hiv subjects include cluster of differentiation (cd)4 count, hiv viral load closest to time of diagnosis * age at pel diagnosis * gender * stage at diagnosis * treatment of pel * response to treatment * survival status at 2 years * pathology slides (or paraffin block) for central review * the minimum data required to be able to include a subject for analysis of genomic prognostic factors are: * availability of a pathologic specimen of pel that will be submitted for genomic analysis * survival status at 2 years exclusion criteria: * patients who do not fulfill the criteria as listed above are ineligible
efficacy and safety of oral cep-701 for the treatment of patients with advanced multiple myeloma

Conditions: Myeloma

Summary: an open-label study of the efficacy and safety of oral cep-701 for the treatment of patients with advanced multiple myeloma.

an open-label study of the efficacy and safety of oral cep-701 for the treatment of patients with advanced multiple myeloma.

Eligibility criteria:
inclusion criteria: patients are included in the study if all of the following criteria are met: * histological and cytological confirmation of stage ii or iii multiple myeloma. * relapsed or primary refractory multiple myeloma, after 1 or more courses of standard therapy, and progressive disease. * ecog performance status of 0-1. * measurable disease as defined by serum m protein of more than 1.0 gm/dl, serum light chain of more than 200 mg/dl, or bence-jones proteinuria of more than 200mg/24 hours. * at least 18 years of age. * normal marrow function: anc\>1.0x10 9/l, platelets\>50x10 9/l an exception is allowed if myelosuppression or thrombocytopenia is secondary to bone marrow plasmacytosis. growth factor support is allowed. * normal organ function: bilirubin \<1.5xuln, ast and alt\<2xuln, serum creatinine \<2.0 mg/dl. * contraceptive measures during participation as appropriate. * willing to be able to comply with study procedures and restrictions. * signed written informed consent. exclusion criteria: patients are excluded from participating in this study if 1 or more of the following criteria are met: * nonsecretory disease or plasma cell leukemia (defined as \>2000 circulating plasma cells/ul). * more than 4 prior courses if anticancer therapy (bisphosphonates are not considered anticancer therapy for this criterion) * chemotherapy or radiotherapy within 4 weeks prior to enrollment * unresolved adverse events or uncontrolled illness that would be likely to interfere with the objectives of the study. * treatment with an investigational drug within 4 weeks of first day of study treatment * history of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free more than 5 years). * treatment with potent cyp3a4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (hiv), protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment. * currently receiving warfarin. * clinical diagnosis of active gastrointestinal ulceration of melena or hematemesis in the previous 4 weeks. * hypersensitivity to cep701 or any component of cep701. * intolerance of dexamethasone. * requirement for hiv protease inhibitor treatment.
a danish pragmatic randomized trial of nutritional supplements in heart failure

Conditions: Heart Failure

Summary: heart failure is a common and serious condition. despite rapid advancements in heart failure treatment, the prognosis remains severe. smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme q10 and selenium-may reduce the risk of complications associated with heart failure. the danutrio-hf trial will investigate whether these supplements can make a difference for individuals with heart failure. the study will assign approximately 4,044 patients from across denmark to either coenzyme q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.

this investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. the trial plans to randomize approximately 4,044 participants in an event-driven design. participants will be identified through the danish administrative health registries, which will also serve as the primary source for data collection. contact with potential participants will be made via the mandatory danish electronic letter system. no scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants. a substudy involving up to 600 participants will assess the effects of coenzyme q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. this group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.

Eligibility criteria:
inclusion criteria: * individuals aged ≥ 18 years. * registered with a heart failure diagnosis (icd-10: i50) as a primary discharge diagnosis in the danish national patient registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after hf diagnosis. * informed consent form has been signed and dated. exclusion criteria: * use of vitamin k-antagonist * registered with a cancer diagnosis (c00-c97 not c44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in the danish national patient registry.

Keywords: heart failure coenzyme q10 selenium randomized controlled trial registry echocardiography pragmatic factorial 2x2 cardiovascular nutritional supplements
a study to investigate the feasibility and respiratory effects of stimulating two functional targets (neural and/or muscular) for the treatment of obstructive sleep apnea

Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder

Summary: this proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. acute placement and data collection will be conducted while performing a drug induced sleep endoscopy (dise) where the goal will be to quantify changes in airflow with stimulation. data will also be collected during a one- or two-night polysomnography (psg) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. where feasible, osa severity data will be collected, as measured via the apnea/hypopnea index (ahi) with stimulation versus without stimulation as a secondary objective. both data collections will be done when stimulating the hypoglossal nerve (hgn) or genioglossus muscle (gg) and a second functional target (ansa cervicalis - ac) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.


Eligibility criteria:
inclusion criteria: a subject must meet all of the following inclusion criteria to be eligible for inclusion in this study: * age above 18 years not under guardianship, under curatorship or under judicial protection. * body mass index (bmi) \< 35 kg/m2. * osa (15 \< ahi \< 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues. * subject must be eligible for a diagnostic dise or surgical procedure (acute study measures only). * written informed consent obtained from the subject prior to performing any study specific procedure. * willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial. exclusion criteria: subjects meeting any of the following criteria will be excluded from participation in this study: * major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned. * significant comorbidities that contraindicate surgery or general anesthesia/dise * significant tongue weakness * any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/dise in the judgment of the investigator. * prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems: * airway cancer surgery or radiation, * mandible or maxilla surgery in the previous 3 years (not counting dental treatments), * other upper airway surgery to remove obstructions related to osa in the previous 3 months (e.g., uvulopalatopharyngoplasty (uppp), tonsillectomy, nasal airway surgery), * prior hypoglossal nerve stimulation device implantation. * currently pregnant, or breastfeeding during the study period

Keywords: sleep apnea device
outcome assessment in patients treated with hyperbaric oxygen using oxyvu tissue oxygenation monitoring system

Conditions: Wounds

Summary: the objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

the purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (hbot) and to evaluate wound healing progression during hbot using a new hyperspectral imaging technology (oxyvu).

Eligibility criteria:
inclusion criteria: * 18 - 85 years of age * patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections) * compromised flap or grafts. exclusion criteria: * patients with poor cardiac output (ef \< 20%) * patients with severe obstructive pulmonary disease who don't qualify for hbot * patients with untreated asthma who don't qualify for hbot * patients utilizing supplemental oxygen and those on ventilators * patients on life support medications (pressors)

Keywords: hyperspectral imaging tissue oxygenation wounds wound healing prevention hyperbaric
effectiveness of rubber dam isolation versus cotton roll isolation on bonded fissure sealant retention

Conditions: Dental Caries in Children; Dental Caries on Pit and Fissure Surface; Dental Leakage

Summary: the purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.


Eligibility criteria:
inclusion criteria: * teeth having a clinical indication of sealing with bonded resin pit and fissure sealants * patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures exclusion criteria: * patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces. * patients with systemic diseases.
effects of exercise on cardiac fat in women with obesity: a pilot study

Conditions: Obesity

Summary: excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. the aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

excessive cardiac fat accumulation have been recognized to be associate to increased cardiac and metabolic risk. more effective treatments are needed to induce changes in cardiac fat content, body composition, and cardiac fat metabolic activity that result in a reduction in cardiovascular risk in overweight and obese population. despite this need, little is known about which mode, frequency, and duration of exercise will allow for greater reductions in cardiac fat, improvements in body composition, restoration of a healthy cardiac fat metabolic activity, and improvement on cardiovascular risk markers. the aim of this study the effects of exercise in cardiac fat content, cardiac function, physical fitness, and metabolic activity in obesity.

Eligibility criteria:
inclusion criteria: * bmi 30-39.99 * white/caucasian exclusion criteria: * known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded. * pregnant females. * any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study. * participants that exercise more than three times per week or strength train more than twice per week. * individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded. * cigarette smoking (current or those who quit within the previous 6 months * hypertension * diabetics * mri exclusion criteria must be observed: must complete a safety checklist that is designed to identify metal in your body that could pose a hazard during scanning. some forms of metal are acceptable (e.g., dental fillings after 1970). tattoos are generally not exclusionary, unless they have been inked with metallic dyes. all metal must be removed from your body. all female subjects, prior to scanning, are required to complete a pregnancy test. must not be claustrophobic or have a history of claustrophobia
biomarker development in lgmd2i

Conditions: Muscular Dystrophies; Limb Girdle Muscular Dystrophy

Summary: the overall goal of this natural history study is to define the key lgmd2i phenotypes as measured by standard clinical outcome assessments (coas), and to validate a muscle biomarker for lgmd2i to support therapeutic development.

limb girdle muscular dystrophy (lgmd) 2i is an autosomal recessive form of lgmd that is due to missense mutations in the fukutin-related protein (fkrp) gene. patients develop progressive proximal muscle weakness that leads to loss of ambulation. patients will also commonly develop a cardiomyopathy and respiratory compromise. there are promising new therapies that have been developed and as a result therapeutic trials are approaching. the rationale for this study is to define appropriate coas for lgmd2i, which will facilitate therapeutic development and ensure properly powered clinical trials. in addition, measurement of dystroglycan in muscles represents a potential muscle biomarker that could be used in early phase clinical trials as a measure of target engagement. the clinical utility of changes in dystroglycan has not been validated in human samples.

Eligibility criteria:
inclusion criteria: * age between 10-65 at enrollment * clinically affected (defined as weakness on bedside evaluation in either a limb-girdle pattern, or in a distal extremity) * a genetically confirmed mutation in fkrp (lgmd2i) * willing and able to give informed consent and follow all procedures and requirements exclusion criteria: * any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator. * history of a bleeding disorder, platelet count \<50,000, current use of an anticoagulant. * positive pregnancy test * a 10-meter walk time of \<4 seconds

Keywords: lgmd fkrp clinical research ml bio solutions limb girdle muscular dystrophy limb girdle muscular dystrophy type r9 (lgmd r9) lgmd2i
the acute burn resuscitation multicenter prospective observational trial

Conditions: Burns; Shock

Summary: this is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in north america. primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. all aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.

this is a prospective observational study with no intervention. study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation. detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay. at completion of the study we intend to make the following comparisons: 1. subjects that received crystalloids only compared to subjects that received crystalloids plus albumin. 2. subjects that had albumin started "early" (\ 12 hours post burn). 3. characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ≥ 20% tbsa burns * admitted to the burn center ≤ 12 post injury exclusion criteria: * significant associated trauma * high voltage (≥ 1000 volts) electrical burns * surgery anticipated within 48 hours from injury * fresh frozen plasma (ffp) anticipated to be given at any time ≤ 48 hours from injury * hypertonic saline (hts) anticipated to be given at any time ≤ 48 hours from injury * hydroxyethyl starch (hes) anticipated to be given at any time ≤ 48 hours from injury * high dose vitamin c infusion is anticipated to be given at any time ≤ 48 hours from injury * death occurs or comfort measures are instituted within ≤ 48 hours from injury

Keywords: albumin resuscitation burns shock fluid creep
a pilot study of the low glycaemic index diet in adults with epilepsy

Conditions: Epilepsy

Summary: many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (kd) and to some degree also the modified atkins diet (mad) seems difficult for many adults. the lgi diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (kd and mad), but has been little studied in adults. this is a randomised study of immediate versus deferred lgi diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to lgi will be followed by the opportunity for the control group to undertake 12 weeks of the lgi diet.


Eligibility criteria:
inclusion criteria: * adults (\>18 years) * epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy. * at least 1 seizure per week. * bmi \>18 exclusion criteria: * unable to give informed consent * unable to comply with diet * surgery for epilepsy or vns within the last 12 months * non-epileptic seizures * pregnant or planning pregnancy * significant renal impairment * history of renal stones
caudal block versus local wound infiltration for inguinal procedures

Conditions: Anesthesia, Caudal

Summary: single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

inguinal procedures in children are surgical frequently performed in an outpatient setting. this study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.a number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours . caudal anaesthesia was performed after induction of anaesthesia. in patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis. parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. if parents agreed to participate, written informed consent was obtained. pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * no return of questionnaire * parents do not understand language

Keywords: caudal block wound infiltration postoperative pain outpatient surgery