Kornimate/medical-research-clean huggingface dataset:
collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders

Conditions: Islet Cell Tumor; Pancreatic Cancer; Pancreatic Disease; Acute Pancreatitis; Chronic Pancreatitis; Hereditary Pancreatitis; Pancreatic Neuroendocrine Carcinoma

Summary: rationale: gathering medical information and collecting and storing samples of blood and tissue to test in the laboratory may help doctors develop better ways to screen people at risk for pancreatic cancer or other pancreatic disorders in the future. purpose: this clinical trial is collecting medical information and tissue samples from patients with pancreatic cancer or other pancreatic disorders.

primary objective: i. to maintain a resource (bank) of biospecimens and data collected from individuals being seen clinically for pancreas conditions to facilitate the discovery and development of (but not limited to) biomarkers of risk (including genomic and proteomic) and early detection as well as novel targeted therapies for pancreatic diseases with a focus on pancreatic cancer. outline: this is an observational study. patients undergo blood, saliva, and previously obtained leftover tissue sample collection on study. patients also complete questionnaires and have their medical records reviewed on study.

Eligibility criteria:
* known or suspected pancreas disease including: * pancreas adenocarcinoma * islet cell cancer * pancreatic cysts * pancreatitis (hereditary, acute, or chronic) * next of kin of deceased participant who did not complete participation before passing away exclusion criteria: * under the age of 18 * unable to provide informed consent * prison inmates

Keywords: recurrent pancreatic cancer stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent islet cell carcinoma pancreatic alpha cell carcinoma pancreatic beta islet cell carcinoma pancreatic delta cell carcinoma pancreatic g-cell carcinoma
vascade antegrade-pvd post-market registry

Conditions: Surgical Wound

Summary: the objective of the registry is to collect procedural outcomes data when the cardiva vascade vascular closure system (vcs) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7f introducer sheaths via an antegrade approach.

due to the growing adoption of antegrade femoral access and the use of vcds to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. the aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the vascade vcs in a way that is consistent with the respect study design and the fda-approved instructions for use (ifu).

Eligibility criteria:
inclusion criteria: * acceptable candidate for post-procedural manual compression * able to ambulate at least 20 feet, with or without assistance exclusion criteria: * active systemic or cutaneous infection or inflammation * ipsilateral femoral arteriotomy with any of the following conditions: a) access within \< or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within \< or = 90 days, use of an intra-vascular closure device (i.e., angioseal) * previous vascular grafts or surgery at the target vessel access site * major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit * extreme morbid obesity (bmi greater than 4 kg/m2) or underweight (bmi less than 20 kg/m2) * femoral arterial diameter \< 6 mm at access site * antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture * length of tissue tract, the distance between the anterior arterial wall and skin, is \< 2.5 cm.

Keywords: vessel closure antegrade access femoral arteriotomy peripheral endovascular interventions
safety and efficacy of lx4211 with metformin in type 2 diabetes patients with inadequate glycemic control on metformin

Conditions: Type 2 Diabetes Mellitus

Summary: this study is intended to assess the effect on hba1c of different dose regimens of lx4211 in combination with metformin in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy.


Eligibility criteria:
inclusion criteria: * adult subjects between the ages of 18 to 75 years, inclusive * confirmed diagnosis of type 2 diabetes mellitus * meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dl * stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks * willing and able to provide written informed consent * willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study exclusion criteria: * history of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes * history of renal disease or clinically significant abnormal kidney function tests * presence of active hepatic disease or clinically significant abnormal liver function tests * subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study day 1 * history of clinically significant cardiac arrhythmias within one year of study day 1 * subjects with congestive heart failure * subjects with uncontrolled stage iii hypertension * triglycerides \>1000 mg/dl at screening * known history of hiv or hepatitis c * history of illicit drug or alcohol abuse with one year of study day 1 * have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study day 1 * use of any other investigational drug within 30 days of study day 1 * prior exposure to lx4211 * use of any medication or herbal supplement for the purpose of weight loss * chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study day 1 * use of corticosteroids within 2 weeks prior to study day 1 * major surgery within 6 months of study day 1 * subjects with any history of severe gastroparesis * inability or difficulty swallowing whole capsules or tablets * women who are pregnant or breast feeding

Keywords: diabetes mellitus
home-based intermittent pneumatic compression therapy for gynecologic cancer

Conditions: Gynecologic Cancer; Lymphedema of Leg

Summary: investigators conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (ipc) device during the maintenance phase of lower extremity lymphedema. this device has a unique mode designed to mimic the manual lymphatic drainage (mld) technique and thereby gently facilitate lymphatic draining of proximal extremities.


Eligibility criteria:
inclusion criteria: * stage 3 chronic unilateral secondary leg lymphedema * aged 20-70 years * underwent 1-2 cycle of treatment of decongestive phase with current inter-limb volume difference of more than 10% * stable limb-volume change (within 10%) during the preceding 3 months * capacity for self-maintenance care for lymphedema (multilayer limb bandaging, compression garments, and mld) exclusion criteria: * bilateral leg lymphedema * current cancer metastasis * ongoing chemotherapy or radiation therapy * acute inflammation * venous thrombosis, or chronic venous insufficiency * systemic etiologies of edema * congestive heart failure * patients taking medication that influenced body fluid or electrolytes
autologous bone marrow-derived stem cell therapy for motor neuron disease

Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Progressive Muscular Atrophy; Progressive Bulbar Palsies

Summary: herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.

a motor neuron disease (mnd) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. they include amyotrophic lateral sclerosis (als), primary lateral sclerosis (pls), progressive muscular atrophy (pma), progressive bulbar palsy (pbp) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.they are neurodegenerative diseases that cause increasing disability and eventually, death. in spite of intensive research, motor neuron diseases (mnds) are still incurable. some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for mnds. in this study, the investigators suggest a protocol for the treatment of mnd by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.

Eligibility criteria:
inclusion criteria: * patients age 24-20 years old * patients with the diagnosis of definite motor neuron disease exclusion criteria: * hiv/hbv/hcv * malignancies * bleeding * pneumonia * renal failure * liver dysfunction * severe anemia (hb \< 8) * bone marrow diseases * pregnancy and lactation * acute medical conditions/infections such as respiratory infections * ventilatory support
levofloxacin triple and bismuth quadruple therapies for rescue treatment of h pylori infection

Conditions: Helicobacter Pylori Infection

Summary: from the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

the h pylori-infected adult patients with failure of standard triple therapy and h pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either eal (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.) or ebtl (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-h pylori therapy.

Eligibility criteria:
inclusion criteria: * positive results of both rapid urease test and histology, * a positive result of urea breath test, * or a positive result of culture. exclusion criteria: * ingestion of antibiotics, bismuth, or proton pump inhibitor（ppi）within the prior 4 weeks, * patients with allergic history to the medications used, * patients with previous gastric surgery, * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), * pregnant women

Keywords: helicobacter pylori eradication rate rescue treatment
palace 2: efficacy and safety study of apremilast to treat active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

psoriatic arthritis (psa) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. the immunopathogenesis of psa, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. apremilast (cc-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (pde4) enzyme inhibition. therefore, apremilast has the potential to be effective in the treatment of psa.

Eligibility criteria:
inclusion criteria: * males or females, aged ≥ 18 years at time of consent. * have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration. * meet the classification criteria for psoriatic arthritis (caspar) psa at time of screening. * must have been inadequately treated by disease-modifying antirheumatic drugs (dmards) * may not have axial involvement alone * concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine * have ≥ 3 swollen and ≥ 3 tender joints. * males \& females must use contraception * stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed. exclusion criteria: * pregnant or breast feeding. * history of allergy to any component of the investigational product. * hepatitis b surface antigen and/or hepatitis c antibody positive at screening. * therapeutic failure on \> 3 agents for psa or \> 1 biologic tumor necrosis factor (tnf) blocker

Keywords: psoriasis arthritis psoriatic arthritis inflammation skin condition inflammatory cells apremilast cc-10004 phosphodiesterase type 4
parents resources for decreasing the incidence of change triggered temper outbursts

Conditions: Child Behavior

Summary: 'predictors' (parents resources for decreasing the incidence of change triggered temper outbursts) aims to evaluate web-based training packages for caregivers of children who show frequent temper outbursts following changes to their routines and plans. the training packages will teach caregivers how to apply strategies that aim to reduce the number of temper outbursts that the children show following changes, as well as making any outbursts they do show less severe (less functionally impairing).

the aims of predictors are: 1. to refine the tools to implement and evaluate a resource-efficient caregiver training program for signalling changes to children with intellectual disabilities or autism spectrum disorders. 2. to pilot the program to test the feasibility of taking it forward into a clinical trial. 3. to conduct a process and economic evaluation of the pilot intervention to provide further data on its suitability for a clinical trial. parents/caregivers of children aged 7-16 years old who frequently show temper outbursts when things change in their routines or plans will keep a web-based diary accessed via smart phone or other device on their child's temper outbursts for a 6 month period (baseline). after 6 months of keeping this diary, parents/caregivers will then access web-based training for approximately 1 month which will include sessions to study once or twice per week as well as exercises to practice in between sessions. after the training is complete parents will be asked to implement the strategies they have learnt in the 6 months that follow. in addition researchers from the university will telephone parents/ caregivers to ask some questions about their child's temper outbursts and on the effects this behaviour has on daily life. parents will be interviewed at three points during the study (before baseline, after baseline, before intervention and after intervention phases). interviews will focus on gathering information of their child's behaviour. focus groups with relevant experienced professionals and parents (not participating in the main part of the study) will guide the training resource development and development and content of the behaviour diary used by parents during the study.

Eligibility criteria:
inclusion criteria: * children aged 7-16 years of age, with temper outbursts triggered by change to routine or plans and their parent(s)/caregiver(s) exclusion criteria: * children who show less than one change triggered temper outburst (temper outbursts following an unexpected change in plan, routine or expectation) per month

Keywords: change triggered temper outbursts parent training autism intellectual disability prader-willi syndrome fragile x syndrome web-based training down syndrome
absorption of corticosteroids in children with juvenile dermatomyositis

Conditions: Vasculitis, Hypersensitivity; Connective Tissue Diseases; Dermatomyositis; Vasculitis

Summary: juvenile dermatomyositis (jdm) is a connective tissue disease that causes skin rash and weak muscles in children. the purpose of this study is to measure the absorption of oral prednisolone and intravenous (iv) methylprednisolone and to determine levels of disease activity indicators in the blood. these levels will be compared to see if there are patterns specific to active and less active jdm.

jdm is a connective tissue disease that is characterized by inflammation of the muscles and the skin. corticosteroids, such as prednisolone and methylprednisolone, can be administered to help control symptoms of the disease, but absorption patterns of these medications in oral and iv forms are unknown. this study will assess absorption of oral prednisolone and iv methylprednisolone, measure levels of two disease activity indicators (von willebrand factor and neopterin), and correlate these values in children with jdm. patients will participate in this study twice within a period of up to a year, once when the patient's disease is active, and again 6 to 12 months later when the disease is less active. each of the two study periods will last two nights and two days. patients will be admitted to the hospital the first night, and a small iv port will be inserted in the patient's arm the first morning to allow for multiple blood draws without additional needle sticks. patients will receive oral prednisolone the first morning and iv methylprednisolone the second morning. baseline blood draws will be performed prior to administration of drug, with 13 additional draws over a 6 hour period following drug administration. following the final blood draw on the second day, the iv port will be removed from the patient's arm and the patient will be discharged from the hospital. blood drawn from patients will be assessed for absorption of the drugs and levels of von willebrand factor and neopterin. patients will undergo the same sequence of events sometime between 6 to 12 months after the first hospitalization, after their vasculitis is judged to be less active.

Eligibility criteria:
inclusion criteria: * juvenile dermatomyositis with evidence of active vasculitis * elevated von willebrand factor antigen prior to study entry * elevated neopterin level prior to study entry exclusion criteria: * severe renal involvement * critically ill or clinically unstable * diseases other than dermatomyositis with vasculitis

Keywords: cardiovascular disease respiratory disease rare diseases vasculitis
corevitas systemic lupus erythematosus (sle) drug safety and effectiveness registry

Conditions: Systemic Lupus Erythematosus

Summary: prospective, observational registry for subjects with sle under the care of a rheumatology provider. longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.

the objective of the registry is to create a cohort of systemic lupus erythematosus (sle) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for sle. data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of sle, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. further, data collected will inform clinical decision making by patients and treating providers. this will be enabled through the standardized data collection including validated patient-reported outcomes (pro) and clinician-reported outcomes (clinro), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.

Eligibility criteria:
inclusion criteria: to be eligible to participate in this registry, an individual must meet all the following criteria: 1. has been diagnosed with sle by a rheumatologist or a qualified rheumatology practitioner. 2. is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment. 3. willing and able to provide informed consent. 4. willing and able to provide personally identifiable information (full legal name, sex at birth, date of birth, and home address zip/postal code at a minimum) if required based on registry location and applicable laws and regulations. 5. in addition, subjects must meet at least one of the following criteria: * new diagnosis of sle (=\<12 months) from registry enrollment, or * initiation of a biologic or immunosuppressant for the treatment of sle at registry enrollment, or * lupus nephritis (ln; class iii-v) diagnosed within 2 years of registry enrollment exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in the registry: 1. is participating in a double-blind clinical trial for a sle drug 2. subjects participating in any non-blinded trial for any indication, with the exception of non-blinded car-t or other cell/gene therapies for the treatment of sle

Keywords: systemic lupus erythematosus sle lupus
a digitally-supported shared decision making approach for coronary artery disease patients during cardiac rehabilitation

Conditions: Cardiac Rehabilitation; Digital Health; Telerehabilitation

Summary: investigating the role of shared-decision making in cardiac rehabilitation

the clinical study is a prospective double-arm, randomized controlled trial to study the user experience of the approach with the supporting applications, and the impact on patients' quality of life, physical activity, perception of rehabilitation and engagement in the decision making process.

Eligibility criteria:
inclusion criteria: * have a history of coronary artery disease with or without intervention (pci/cabg/conservative) * be clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test * recently having started cardiac rehabilitation in jessa hospital hasselt * age ≥18 years * willing and physically able to follow a technology-supported shared decision making program and other study procedures in a three months follow-up period * show evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study * possession of and/or able to use an android based smartphone * possession of internet connectivity * dutch speaking and understanding exclusion criteria: * • orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow a technology-supported shared decision making program * planned interventional procedure or surgery in the next three months * pregnant females * present cardiovascular complaints * participation in other cardiac rehabilitation program trials, focusing on exercise outcome * current or recent participation in other technology-supported programs, even when not directly targeting exercise capacity * any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than three months based on investigators judgement