Kornimate/medical-research-clean huggingface dataset:
the effect of minocycline and n-acetylcysteine for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: evaluation of the effect of combinatorial treatment of fibromyalgia patients (standard of care + minocycline + n-acetylcysteine (nac) relative to standard of care on subjective pain measurement revised fibromyalgia impact questionnaire (fiqr).


Eligibility criteria:
inclusion criteria * female * age 18 years or older * diagnosis of fibromyalgia for at least 6 months (confirmed by the modified 2010 acr diagnostic criteria for fibromyalgia widespread pain inventory and symptom severity scale) * currently on birth control or unable to become pregnant * willingness to avoid taking opioid and opiate medications during the duration of the study (5-6 months) exclusion criteria * known hypersensitivity to minocycline or tetracycline antibiotics or to n-acetylcysteine * current opioid therapy or planned initiation of opioid therapy * active pregnancy, lactation or plans to become pregnant in the next 6 months * significant hepatic disease as indicated by an ast or alt greater than twice the upper limits of normal or bilirubin greater than twice the upper limits of normal * significant renal disease as indicated by an estimated glomerular filtration rate less than 60 ml/min/1.73m2 at baseline or during the first washout period * history of autoimmune syndromes (systemic lupus erythematosus, myasthenia gravis, rheumatoid arthritis, * history of intracranial hypertension or pseudotumor cerebri * history of ibd (crohns disease, ulcerative colitis), clostridium difficile infection * history of esophagitis, esophageal obstruction, achalasia or esophageal dysmotility * history of gi hemorrhage or known risk factors for gi hemorrhage, such as esophageal varices, peptic ulcer disease, etc. * subjects taking divalent and trivalent cations such as oral iron supplements, certain dietary supplements (multivitamins) that contain manganese or zinc, or antacids that contain aluminum, calcium, or magnesium, which would decrease minocycline absorption * subjects taking anticoagulant medication since minocycline can decrease plasma prothrombin activity * subjects taking isotretinoin * subject taking ergot alkaloids for migraines * subjects taking penicillin antibiotics * subjects taking methoxyflurane containing products * subjects who work outdoors or otherwise have prolonged exposure to uv light and sunlight * lack of access to reliable technology to be able to complete emailed redcap questionnaires * cognitive deficits that may make it difficult to adhere to the medication regimen or provide consistent and timely completion of questionnaires * inability or unwillingness to give informed consent * unwillingness to use two forms of birth control for the entire duration of participation in the study (if capable of becoming pregnant) * unwillingness to complete home pregnancy tests throughout the study (if capable of becoming pregnant) * inability to swallow large pills
a study of lcz696 in subjects with mild and moderate hepatic impairment compared with normal healthy volunteers

Conditions: Hepatic Impairment

Summary: this is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of lcz696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects


Eligibility criteria:
inclusion criteria: * all subjects: * male and female subjects aged 18-75 years. * body weight at least 55 kg with a body mass index between 18-35 kg/m2. * hepatic impairment subjects: * mild or moderate hepatic impairment. exclusion criteria: * all subjects: * clinical manifestations of postural symptomatic hypotension at screening or baseline. * history of hypersensitivity to lcz696 or to drugs of similar classes. * hepatic impairment subjects: * hepatic impairment due to non-liver disease. * treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing. * encephalopathyy stage iii or iv. * primary biliary liver cirrhosis or biliary obstruction. * history of gastro-intestinal bleeding within 3 months prior to screening. * healthy subjects: * any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. * use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hepatic impairment
β2-agonist versus ipratropium bromide associated with β2-agonists in chronic obstructive pulmonary disease exacerbation

Conditions: Acute Exacerbation of Chronic Obstructive Airways Disease

Summary: the effectiveness of β2-agonists in the treatment of exacerbations of copd is already established. the purpose of this study is to compare the effectiveness of the β2-agonists alone in nebulization with the association β2-agonists + ipratropium bromide in the treatment of an acute exacerbation of copd consulting the emergency departement based on the clinical and arterial blood gas.

it is a prospective study and randomized performed in patients admitted to the emergency departement for acute exacerbation of copd. the patients were divided in two groups: group terbutaline/ipratropium bromide; received terbutaline + ipratropium bromide in nebulization and group terbutaline received terbutaline alone in nebulization)

Eligibility criteria:
inclusion criteria: * have known or suspected copd based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph * age over 18 years old. * copd exacerbation: sustained worsening of patient's condition from stable state necessitating change in regular medication within the last two weeks and need for non invasive ventilation with regard to arterialo blood gas abnormalities: paco2 \> 45 mmhg, ph\<7,35 sao2\<90% exclusion criteria: * gcs ≤ 14 * hypersensitivity to anticholinergic * severe acidosis * immediate need for intubation * lack of patient cooperation * serious hemodynamic unstability or systolic blood pressure \< 90 mmhg, heart arrhythmia

Keywords: β2-agonist ipratropium bromide chronic obstructive pulmonary disease exacerbation emergency departement
examining changes in muscle size and body composition between two hypertrophy resistance training programs in males

Conditions: Hypertrophy; Body Weight Changes; Muscle Size

Summary: this study aims to investigate if a less physically and psychologically taxing approach to resistance training can generate equal or greater outcomes when compared to a more physically and psychologically taxing approach.

resistance training is commonly used to improve body composition, gain strength, increase muscle size (i.e., hypertrophy) and prevent muscle atrophy (i.e., muscle wasting). the most optimal mode of building muscle remains unclear, however there are many mechanisms that can be tested to yield optimal results. one variable that can be manipulated when designing a hypertrophy-focused resistance training regimen is intensity (i.e., proximity-to-failure). proximity-to-failure is defined as the number of repetitions remaining in a set of prescribed exercises prior to reaching momentary muscular failure (mmf). mmf is when an individual cannot complete the lowering or concentric phase of a given repetition with a full range-of-motion without deviation from the prescribed form of the exercise. for all lifters, particularly amongst older populations, it can be psychologically demanding to push to mmf, and may increase the risk of delayed onset muscle soreness (doms) and/or injury due to technical breakdown. in contrast, there is some evidence that suggests training to a slightly less intensity (i.e., within 1-4 repetitions in reserve \[rir\]) may result in comparable hypertrophic results with less of a physical and psychological demand on participants. for these reasons, this study looks to investigate if an easier (i.e., less intense) approach to training such as training with repetitions in reserve (rir), warrants similar or better muscle hypertrophy adaptations to mmf.

Eligibility criteria:
inclusion criteria: * biological male * age 18 years or older * enrolled at dalhousie university * minimum 3-months of consistent (at least 2x/week) resistance training experience exclusion criteria: * body fat percentage 25% or greater (obese) * use of performance enhancing drugs that aim to increase rate of muscle growth (i.e., androgenic steroids, anabolic steroids, selective androgen receptive modulators, growth hormone).

Keywords: exercise resistance training
intelligent control approach to anemia management

Conditions: End-Stage Renal Disease

Summary: first clinical evaluation of "smart anemia manager" algorithm.

the purpose of this single-center study is to test whether "smart anemia manager" algorithm improves hemoglobin stability compared to standard anemia management protocol. study site: kidney disease program dialysis facility, university of louisville, louisville, ky.

Eligibility criteria:
inclusion criteria: 1. ages 18 to 80, 2. receiving dialysis treatment, 3. receiving or expected to receive esa treatment, 4. adequacy of dialysis kt/v \>= 1.2, 5. adequate iron stores (ferritin \> 200 ng/ml, tsat \> 20%). exclusion criteria: 1. life expectancy less than 12 months, 2. frequent uncontrolled blood loss, 3. frequent dialyzer clotting, 4. frequent access related problems, 5. active infections, 6. severe cardiac disability, 7. coronary bypass within three months prior to the study 8. documented resistance to esa 9. bone marrow suppression due to hiv, leukemia, or pharmacologic agents.

Keywords: end-stage renal disease chronic hemodialysis
ketamine for treatment resistant mdd

Conditions: Depressive Disorder, Major

Summary: this study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of im/sc ketamine for treatment resistant mdd.

major depression disorder (mdd) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. mdd also significantly increase suicide rate. about a third of the patients with mdd suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. ketamine is a widely used anesthetic. multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. so far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route. in the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored im or sc ketamine for treatment resistant major depression. the investigators intend to explore questions regarding optimal dose, treatment frequency and duration. the investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the neurotrax computerized cognitive battery.

Eligibility criteria:
inclusion criteria: * diagnosed with unipolar/bipolar depression with madrs score\>= 20 * inadequate response to \>= 3 adequate treatment trials \[\>=2 trials in the present episode\] * if on psychopharmacological tx, it should be stable since 4 weeks prior to enrollment * qtc wnl exclusion criteria: * hypersensitivity to ketamine * other major psychiatric diagnosis * high suicidality * unstable physical illness * s/p cva / brain sol * pregnant or breast feeding women * illicit drug/alcohol abuse during last year * history of ketamine abuse
evaluation of the ulthera® system for treatment of the brachia

Conditions: Brachial Ptosis

Summary: this study is an evaluation of the ulthera® system used to treat the upper arms for improvement of brachial ptosis. all enrolled subjects will receive one bilateral upper arm treatment. follow-up visits will occur at 60, 90 and 180 days post-treatment.

this is a prospective, non-randomized, clinical trial treating up to 35 subjects. study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. brachial volume and dermal thickness measurements will be obtained.

Eligibility criteria:
inclusion criteria: * male or female, aged 19 - 55 years. * subject in good health. * subjects who desire lift and tightening of the brachia and improvement in skin laxity. * mild to moderate laxity of the upper arm. * mild to moderate subcutaneous fat of the upper arm. * mild crepiness of the skin of the upper arm. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat in the upper arm. * excessive skin laxity in the upper arm. * significant scarring in areas to be treated. * significant open wounds or lesions in the treatment areas. 7. severe or cystic acne in the treatment areas.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc.
eisenmenger syndrome in the nordic countries

Conditions: Eisenmenger Syndrome

Summary: this is a historical cohort study with retrospective collection of data comprising all nordic patient's diagnosed with eisenmengers syndrome in the period 1977 through 2011. the goal is to determine prognostic factors for mortality and morbidity.

the following variables are obtained from national registries for each individual fulfilling the inclusion criteria: * personal data: gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days * specific cardiac malformation diagnosis * heart-lung transplantation. * social data: highest educational level, marital status, employment status (denmark only) primary endpoints * incidence and prevalence of eisenmenger syndrome * all-cause mortality * all-cause morbidity (hospitalization for any cause) * heart-lung transplantation * advanced treatment * mortality with at * highest educational level * personal income * marital status * job status

Eligibility criteria:
inclusion criteria: * eisenmenger syndrome exclusion criteria: -
mri assisted focal boost with hdr monotherapy for prostate cancer patients

Conditions: Prostate Cancer

Summary: radiation therapy plays an important role in the management of prostate cancer. in recent years it has become evident that higher doses of radiation are required to optimize disease control. the limiting factor of escalating dose to the prostate is the surrounding normal tissue. despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. as such there is growing interest in further dose escalating to the area of primary disease burden.the aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.

this study is a pilot study of 60 patients look at the toxicities, biochemical and patient reported quality of life outcomes of an mr-integrated focal boost using hdr prostate brachytherapy. eligible patients for this study will be determined by pre-brachytherapy mri (dce, t2 weighted and diffusion weighted) imaging, to identify a dominant intraprostatic lesion. the hdr dose prescription is 19 gy to the whole gland ad 22.5 gy to mri visible lesion delivered in one fraction, assuming that dose constraints to critical organs can be met.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of adenocarcinoma of the prostate 2. low and intermediate risk disease defined as t1-t2c, gleason \< 7 and psa \< 20 ng/ml. 3. prostate volume \< 60 cc as determined by us, ct or mri 4. ability to undergo mr imaging 5. provide written informed consent 6. identified mr nodule (pirads 4/5) exclusion criteria: 1. ineligible for mr imaging due to contraindications 2. documented nodal or distant metastases 3. previous pelvic radiotherapy 4. previous trans-urethral resection of prostate, previous prostatectomy or hifu 5. use of androgen deprivation therapy. use of 5-alpha-reductase inhibitors permitted 6. poor baseline urinary function defined as international prostate symptom score (ipss) \>15 7. contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease 8. significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Keywords: hdr monotherapy mri guidance intraprostatic lesion dose paining
exercise program for arteriovenous fistula maturation

Conditions: Arteriovenous Fistula

Summary: arteriovenous fistula (avf) is the recommended vascular access for chronic hemodialysis, as it is associated with less mortality and better patency than arteriovenous graft (avg) or central venous catheter (cvc). unfortunately, avf suffers from a high failure rate, due, in part, to poor venous diameter. the aim of this study is to investigate whether a perioperative handgrip training can improve the diameter of avf in patients with chronic kidney disease (ckd) (stage iv-v).


Eligibility criteria:
inclusion criteria: * patients older than 18 years * with chronic kidney disease (estimated glomerular filtration rate (egfr) \<30 milliliter/minute (ml/min)) * with follow-up at the university hospital of lyon sud * who choose hemodialysis as renal replacement therapy exclusion criteria: * contraindication for arteriovenous fistula (avf) surgery * refusing avf creation * prior vascular access * antecedent of iv substance abuse * active cancer * inability to perform handgrip exercise * physical or mental disability limiting follow-up possibility * inclusion in an other interventional study * no social welfare

Keywords: arteriovenous fistula diameter handgrip program exercise maturation
comparison of the effectiveness of two different surgical therapeutic protocols of peri-implantitis

Conditions: Peri-Implantitis; Peri-Implant Health

Summary: the purpose of the present study is to compare the 1-year clinical, radiographic and microbiological outcomes and patients' satisfaction following surgical treatment of peri-implantitis after applying two different surface modification methods. secondarily, analysis and comparison of the microbiological results of implants diagnosed and treated for peri-implantitis with healthy implants will be performed.


Eligibility criteria:
inclusion criteria: general inclusion criteria: * participants ≥ 18 years and ≤ 80 years of age * non-smokers based on the patients' self-reported smoking status, defined as patients who had never smoked or had quit smoking at least 2 years ago * implants in function for more than 1 year after suprastructure connection inclusion criteria for implants diagnosed with peri-implantitis: * presence of at least one implant diagnosed with peri-implantitis defined as presence of bleeding on probing and/or suppuration, probing pocket depth ≥6 mm and ≥3 mm of detectable bone loss after initial re-modelling * absence of implant mobility * in participants with more than one implant, the implant with the worst clinical condition will be studied. inclusion criteria for implants diagnosed with peri-implant health: * absence of peri-implant signs of inflammation (redness, swelling) * lack of bleeding on probing * absence of bone loss beyond crestal bone level changes resulting from initial remodeling, which should not be ≥2 mm exclusion criteria: * smokers * uncontrolled diabetes mellitus (hba1c \>7) * treatment with bisphosphonates * needing antibiotic prophylaxis * currently pregnant or breast-feeding women * history of systemic administration of antibiotic treatment during the preceding 3 months * systemic conditions that contraindicate treatment * use of medications known to induce gingival hyperplasia

Keywords: peri-implantitis surgical therapy implantoplasty air-abrasive device erythritol powder peri-implant microbiota
pain neuroscience education and exercise

Conditions: Neck Pain

Summary: this study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

this study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain. university students with chronic neck pain were randomly allocated to receive pain neuroscience education and exercise or exercise only and assessed at baseline, after the intervention and at 3 months follow up. outcome variables were pain intensity (primary outcome), disability, fear of movement, catastrophizing, knowledge of pain neurophysiology, pressure pain thresholds and neck and scapular muscle endurance.

Eligibility criteria:
inclusion criteria: * participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale. exclusion criteria: * participants were excluded if they had had physiotherapy for their neck pain in the 6 months previous to the study, if they had rheumatic, nervous, cardiac and/or respiratory pathology that could prevent or make it difficult to do the exercises. exclusion criteria were ascertained by self-report.