Kornimate/medical-research-clean huggingface dataset:
cyclophosphamide in myalgic encephalopathy/ chronic fatigue syndrome (me/cfs)

Conditions: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)

Summary: significant clinical improvements of me/cfs symptoms were observed in two patients with long-standing me/cfs who received adjuvant chemotherapy including cyclophosphamide for breast cancer, also in one me/cfs patient who received chemotherapy including iphosphamide for hodgkin lymphoma. three pilot me/cfs patients were thereafter treated with six intravenous infusions four weeks apart, in two of these with a significant clinical response. the hypothesis is that a subset of me/cfs patients have an activated immune system, and that me/cfs symptoms may be alleviated by treatment with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. the purpose of the present study is to treat me/cfs patients with cyclophosphamide as intravenous pulse infusions four weeks apart, six infusions in total. the effects on me/cfs symptoms and tolerability/side effects during 12 months follow-up will be registered, and additional tests will be performed to objectively register changes in physical ability during follow-up. studies to investigate possible large vessel endothelial dysfunction and skin microvascular dysfunction will be performed before start of intervention and during follow-up.


Eligibility criteria:
inclusion criteria: * patients with me/cfs according to "canadian" criteria (2003) * duration of me/cfs at least 2 years * mild/moderate, moderate, moderate/severe and severe me/cfs may be included * age 18-65 years * signed informed consent exclusion criteria: * patients with fatigue who do not comply by the diagnostic "canadian" criteria (2003) for me/cfs * duration of me/cfs less than 2 years * mild me/cfs * very severe me/cfs (bedridden requiring help for all tasks) * patients where the workup uncovers other pathology as possible cause of symptoms * pregnancy or breast feeding * previous malignant disease (except basal cell carcinoma of skin and cervical carcinoma in situ/dysplasia) * previous long-term systemic treatment with immunosuppressive agents (e.g. azathioprine, ciclosporin, mycophenolate mofetil). except steroid treatment for e.g. obstructive lung disease or autoimmune diseases such as e.g. ulcerative colitis * serious endogenous depression * lack of ability to complete the study including follow-up * reduced renal function (creatinine \> 1.5 x unl) * reduced liver function (bilirubin or transaminases \> 1.5 x unl) * known hypersensitivity to cyclophosphamide or metabolites * reduced bone marrow function * ongoing cystitis or urinary tract obstruction * known hiv positivity, previous hepatitis b or hepatitis c, or reason to suspect other ongoing and clinically relevant infection

Keywords: chronic fatigue syndrome myalgic encephalomyelitis (me) cyclophosphamide immunomodulatory treatment cfs
pharmacokinetics of everolimus in subjects with hepatic insufficiency

Conditions: Hepatic Insufficiency

Summary: this clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.


Eligibility criteria:
inclusion criteria: all subjects: * in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values (except for values related to hepatic insufficiency). hepatic impaired subjects: * a child-pugh classification score clinically determined as class a, class b, or class c. * absolute neutrophil count (anc) \> 1000 cells/mm3 * hemoglobin \> 9 mg/ml * platelet count \> 50,000/mm3 at screening and baseline * serum creatinine ≤ 2.0 x uln * free of significant medical disorders unrelated to the subject's hepatic disorder exclusion criteria: all subjects: * significant illness, including infections, or hospitalization within 4 weeks prior to dosing (hospitalization is allowed for hepatic impaired subjects if related to liver disease). invasive systemic fungal infections need to be fully resolved prior to study entry. * history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). * history of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug (everolimus) or drugs similar to the study drug (other mtor inhibitors, e.g., rapamycin or temsirolimus). * active bleeding during the last 28 days prior to dosing, including variceal bleeding. * except for hepatic impairment, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. * use of tobacco within 7 days prior to dosing or during the study. * consumption of alcohol within 3 days prior to dosing or during the study. * consumption of grapefruits, grapefruit juice, sevilla oranges, starfruit or related foods within 7 days prior to dosing or during the study period. * use of any drugs known to affect cyp3a4 or pgp, including both inhibitors and inducers, within 7 days prior to dosing or during the study. hepatic impaired subjects: * symptoms or history of grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hepatic insufficiency liver disease cirrhosis pharmacokinetics
cancer coaching and remote education for self-empowerment (cares) study

Conditions: Pancreatic Cancer

Summary: this pilot study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * participant must have a pancreatic cancer diagnosis or be a caregiver such as a friend or spouse. * participant must be planning to receive treatment and/or care management at moffitt cancer center. * participant must be able to speak and read english. * participant must be able to provide informed consent. exclusion criteria: * documented or observable psychiatric or neurological disorder that would interfere with study participation such as severe dementia * any participant that does not meet all inclusion criteria will be excluded.

Keywords: pancreas pancreatic cancer caregiver
clinical research on bowel symptoms of patient with pelvic organ prolapse

Conditions: Bowel Symptoms

Summary: to study the prevalence of bowel symptoms in patients with pelvic organ prolapse.


Eligibility criteria:
inclusion criteria: * the patients with stage\>2 pop are recruited.the patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. exclusion criteria: * gestation； * inflammatory bowel disease； * slow transit constipation diagnosed by colonic transit test； * unable to follow up.
effects of anticholinergic or long-acting beta 2 agonist on feno and pulmonary function in sci

Conditions: Spinal Cord Injury

Summary: to determine the acute and chronic effects of a short course of treatment on spinal cord injured (sci) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (salmeterol) on: * fraction of expired no (feno) * selected biomarkers of inflammation in exhaled breath condensates (ebc) * pulmonary function, as measured by pulmonary function tests and body plethysmography


Eligibility criteria:
inclusion criteria: 1. chronic spinal cord injury (\>1 year post-injury) 2. all american spinal injury association (asia) classifications 3. stable tetraplegia (level of injury c3-c8, non-ventilator dependent) 4. age 18-65 years exclusion criteria: 1. smoking, active or history of smoking within last 6 months; 2. active respiratory disease; 3. known history of asthma during lifetime or recent (within 3 months) respiratory infections; 4. use of medications known to affect the respiratory system; 5. use of medications known to alter airway caliber; 6. coronary heart and/or artery disease; 7. hypertension; 8. adrenal insufficiency; 9. pregnancy; 10. severe milk protein allergy; 11. lack of mental capacity to give informed consent; 12. previous allergic reaction or hypersensitivity to salmeterol or tiotropium; 13. individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as: (1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: carteolol; levobunolol; metipranolol; nadolol; penbutolol; pindolol; propranolol; sotalol; timolol); (3) cyp3a4 inhibitors: (e.g, atazanavir; clarithromycin; conivaptan; darunavir; delavirdine; fosamprenavir; imatinib; indinavir; isoniazid; itraconazole; ketoconazole; lopinavir; nefazodone; nelfinavir; nicardipine; posaconazole; quinidine; ritonavir; saquinavir; telithromycin; voriconazole; (4) iobenguane i 123 / sympathomimetics: albuterol; aminophylline; arformoterol; armodafinil; benzphetamine; caffeine; dexmethylphenidate; dextroamphetamine; diethylpropion; dipivefrin; dobutamine; dopamine; doxapram; dyphylline; ephedrine; epinephrine; fenoterol; formoterol; isometheptene; levalbuterol; levonordefrin; lisdexamfetamine; metaproterenol; methamphetamine; methylphenidate; midodrine; modafinil; naphazoline; norepinephrine; oxymetazoline; phendimetrazine; phentermine; phenylephrine; pirbuterol; propylhexedrine; pseudoephedrine; sibutramine; terbutaline; theophylline; xylometazoline.

Keywords: spinal cord injury tetraplegia pulmonary function bronchodilator
a clinical validation study to evaluate the diagnostic accuracy of a cough-based auxiliary diagnosis algorithm for copd

Conditions: COPD; Cough; Algorithm

Summary: cough is one of the most common symptoms in copd patients, and its different characteristics in amplitude, frequency and waveform can be analyzed by intelligent algorithms for the auxiliary diagnosis of copd. the current study is to conduct external clinical validation of copd auxiliary diagnosis algorithm and lung function prediction algorithm, and preliminatively verify the performance of the algorithm, with the ultimate goal of developing a portable and rapid copd auxiliary diagnosis and condition assessment tool that can be used at home.


Eligibility criteria:
inclusion criteria: * patients with stable copd were recruited for this study. inclusion criteria were age ≥40 years and a diagnosis of copd exclusion criteria: * exclusion criteria were acute exacerbations of respiratory symptoms within the past 2 weeks or significant comorbid cardiovascular, neurological, musculoskeletal, immunological, or infectious diseases.
stroke, measurement and rehabilitation

Conditions: Stroke

Summary: the main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (nmes) in post-stroke patients.

post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead to emotional and social problems, reducing quality of life and well-being. the main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (nmes) in post-stroke patients. the clinical trial showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement of physical and social-emotional health which lead to better quality of life and well-being. there was also increased temperature in the treated regions with laser and nmes. therefore, transcranial laser stimulation associated with nmes can be an important therapeutic resource for rehabilitation after stroke.

Eligibility criteria:
inclusion criteria: * female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke. exclusion criteria: * bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.

Keywords: stroke photobiomodulation electrical stimulation
evaluation of the signa excite 3.0 t mri excite for detection and characterization of liver lesions

Conditions: Liver Cancer

Summary: primary objective: 1. to compare the efficacy of 1.5t vs. 3t t1 and t2-weighted mr images sequences for the detection and evaluation of liver lesions.

magnetic resonance imaging is taken with scanners at different magnetic field strength. the current practice at utmdacc is to perform these exams at 1.5 tesla. tesla is the unit of strength of the magnetic field. this study will compare the images taken at the standard 1.5 tesla (t) magnetic field with those at the newer 3.0t magnetic field. you are already scheduled to receive a standard 1.5 t mr of the liver area as requested by your doctor. as part of this study, you will then be asked to return on a separate date to have a similar exam performed with the signal 3.0t excite mr scanner. you will return within a two week period from the date of your first mri examination. the examination will be performed in a machine that looks similar to the 1.5t scanner. it will also take about the same amount of time as the examination at 1.5t. the images taken by both scanners will be evaluated and compared. after you have had the second scan, your participation in this study will be over. if there are new findings identified with the new scan your doctor will be notified. this is an investigational study. the 3.0t scan will be performed free of charge. a total of 20 patients will take part in this study all will be enrolled at utmdacc. this protocol is partially funded by a research grant from general electric medical systems (gems).

Eligibility criteria:
inclusion criteria: 1. patients with a liver lesion larger than 1cm detected by a prior imaging modality. 2. patients have been scheduled and are eligible for an mri of the abdomen or mri of the liver or mri of the kidney examination. exclusion criteria: 1) patients who are unable to cooperate with breath hold.

Keywords: liver cancer magnetic resonance imaging signa excite 3.0t mri scan
zd 1839 in treating patients with glioblastoma multiforme in first relapse

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: biological therapies such as zd 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme. purpose: phase ii trial to study the effectiveness of zd 1839 in treating patients who have glioblastoma multiforme in first relapse.

objectives: * determine the activity of zd 1839 in patients with glioblastoma multiforme in first relapse. * determine the pharmacokinetics and toxicity of this drug in these patients. * assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug. outline: patients receive oral zd 1839 once daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed for at least 6 months. projected accrual: a total of 53 patients will be accrued for this study within 12-18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed glioblastoma multiforme in first relapse patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * more than 12 weeks hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * ast/alt no greater than 2.5 times uln renal: * creatinine less than 1.5 times uln cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other: * no other uncontrolled concurrent illness * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * no prior allergic reactions to compounds of similar chemical or biologic composition to zd 1839 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * ocular inflammation must be fully treated before study entry prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered endocrine therapy: * must be on stable dose of steroids for at least 1 week radiotherapy: * at least 4 weeks since prior radiotherapy and recovered surgery: * at least 1 week since prior surgery other: * no other concurrent investigational agents * no other concurrent anticancer therapy * no concurrent combination antiretroviral therapy for hiv * no concurrent enzyme-inducing anticonvulsant drugs

Keywords: recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
us-guided hydro dissection vs fluoroscopy-guided hydro dissection for adhesive capsulitis

Conditions: Shoulder Pain

Summary: this study aims to evaluate the differences in joint range of motion, visual analog scale (vas) scores, and the shoulder pain and disability index (spadi) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (usg) or fluoroscopy guidance, in addition to a suprascapular nerve block.

adhesive capsulitis is a common condition characterized by painful restriction of both active and passive glenohumeral movement, especially when joint degeneration alone is insufficient to explain the limitation. the condition is more prevalent in women and has a strong correlation with diabetes mellitus and thyroid dysfunction. the prevalence in the general population is approximately 3-5%, but it can reach up to 20% in diabetic patients. the primary goals of treatment are to alleviate pain, improve mobility, shorten symptom duration, and facilitate a return to normal activities. the suprascapular nerve is a major sensory nerve for the posterior and superior aspects of the shoulder and is an accessible target for blockade. conditions in which suprascapular nerve block is used include chronic shoulder pain syndromes such as rheumatoid arthritis, glenohumeral osteoarthritis, post-stroke shoulder pain, motor neuron disease-related shoulder pain, and various rotator cuff disorders. hydrodilatation therapy works by releasing the contracted joint capsule and reducing fibrosis, while corticosteroids exert strong anti-inflammatory effects throughout the shoulder joint. the high-pressure transmission mechanism used in hydrodilatation enhances the distribution of corticosteroids throughout the glenohumeral joint capsule. the procedure involves injecting fluid into the joint cavity under radiological guidance using either ultrasound or fluoroscopy. this study aims to determine whether performing hydrodilatation under ultrasound versus fluoroscopy guidance in addition to suprascapular nerve block leads to differences in joint range of motion, vas scores, and spadi disability index outcomes in patients diagnosed with adhesive capsulitis. assessments will be performed before the procedure, on the day of the procedure, and at the 3rd month

Eligibility criteria:
inclusion criteria: * diagnosis of frozen shoulder disease * vas\>5 exclusion criteria: * other shoulder diseases that may cause shoulder pain (rotator cuff tear, clavicle fracture, etc.) * allergy to local anesthetics * history of shoulder surgery in the last 12 months * pregnancy * coagulopathy or antiplatelet use * the patient has a mental illness that prevents decision-making

Keywords: nerve block fluoroscopy pain management
pivotal study for the cardiac performance system (cps)

Conditions: Cardiovascular Diseases

Summary: this multi-center, observational study evaluates the accuracy of the cardiac performance system (cps), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. the study compares cps measurements to invasive measurements to assess agreement and potential clinical utility.

the study will enroll adults undergoing right heart catheterization as part of their clinical care. a single cps measurement will be performed before the scheduled procedure. data from both cps and catheterization measurements will be analyzed to assess agreement. no investigational treatment or additional follow-up visits are required.

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older * scheduled for clinically indicated right heart catheterization * ability to provide informed consent exclusion criteria: * heart transplant recipients * patients with a left ventricular assist device (lvad) * presence of external devices (e.g., holter monitors) or surgical scars/wounds that interfere with cps measurements * measurement concerns related to data reliability or quality

Keywords: cardiac performance system cps hemodynamic parameters right heart catheterization
monitoring everyday life motor activity in children

Conditions: Neurologic Disorders

Summary: the overall aim of this project is to monitor everyday life activity of children with neurological disorders undergoing rehabilitation using wearable sensors capable of accurate and unobtrusive long-term measurement. specific objectives: 1. to adapt the sensors for the use by children with neurological disorders. the focus lies on the exact positioning and the investigation of the needed amount of imus. 2. to validate the sensor data with collected video recordings and to develop specific algorithms to automatically extract specific movements and to analyze long-term sensor recordings. 3. to perform a cross-sectional study to assess intensity, task-specificity and duration of upper and lower limb activity during rehabilitation. there, we aim to gain objective information about levels and types of activity during rehabilitation in relation to age, gender and disorder. 4. to conduct a responsiveness study to assess whether or not the sensor output is able to highlight changes over time during rehabilitation. therefore, at time point t=0 (shortly after admission to our center), participants are equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum). additionally, a small wearable camera is mounted to the chest. the participants then return to their everyday life for 4 hours (no therapies, measurement period is in the evening). afterwards, the equipment is removed again. to investigate responsiveness, the same protocol is being repeated 4 weeks later (time point t=1).


Eligibility criteria:
inclusion criteria: * various neuro-orthopedic diagnoses. broad inclusion criteria are required to better generalize study results to the patient population of our center. * both walking or in wheelchair, but mobility independent from assisting people * cognitive ability to be able to follow simple verbal instructions. * signed informed consent from legal guardians and also from adolescents aged 15 years or older before study onset.

Keywords: cerebral palsy stroke traumatic brain injury