Kornimate/medical-research-clean huggingface dataset:
venous sinus stenting for idiopathic intracranial hypertension refractory to medical therapy

Conditions: Idiopathic Intracranial Hypertension (IIH)

Summary: idiopathic intracranial hypertension (iih) is a disease that affects mainly young people, and is associated with headache and loss of vision. the medical and surgical management of iih is problematic and many patients are not treated effectively. some cases of iih are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with iih after the narrow veins of the brain were treated with a stent. our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe iih refractory to medical management.


Eligibility criteria:
inclusion criteria 1. age \> 18 years 2. established diagnosis of idiopathic intracranial hypertension according to the criteria of the 2004 international classification of headache disorders (table 3). 3. visual field loss: one of criteria a, b or c must be fulfilled. a. severe visual function loss, defined as grades 4 and 5 on the humphrey visual field analyzer sita standard 24-2 test grading scale (table 4) at initial presentation. b. moderate visual function loss, defined as grade 3 on the humphrey visual field analyzer sita standard 24-2 test grading scale (table 4) at presentation and failure of treatment with acetazolamide (diamox) given at efficient dose (2g/d or maximum tolerated dose) or topiramate (topamax) given at efficient dose (maximum 150mg daily). failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance. c. mild visual function loss, defined as grades 0,1 or 2 on the humphrey visual field analyzer sita standard 24-2 test grading scale (table 4) at presentation and a worsening to moderate or greater visual function loss, defined as grades 3-5, after 1 month of treatment and/or medication intolerance. 4. magnetic resonance venography (mrv) or computed tomography venography (ctv) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. at least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter. 5. signed informed consent obtained from the patient.
efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: pipf-016 (ascend) is a randomized, double-blind, placebo controlled, phase 3 study of the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis. the study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%fvc) in patients with idiopathic pulmonary fibrosis (ipf), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with ipf.


Eligibility criteria:
select inclusion criteria: 1. diagnosis of idiopathic pulmonary fibrosis (ipf), consistent with the ats 2011 guidelines, of 6-48 months' duration 2. age 40 to 80 at randomization 3. percent forced vital capacity (%fvc) ≥50% and ≤90% at screening 4. percent carbon monoxide diffusing capacity (%dlco) ≥30% and ≤90% at screening select exclusion criteria: 1. forced expiratory volume in one second (fev1)/fvc ratio \<0.8 after administration of bronchodilator at screening 2. expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the united states, on a lung transplant waiting list at randomization 3. known explanation for interstitial lung disease 4. history of asthma or chronic obstructive pulmonary disease 5. active infection 6. ongoing ipf treatments including investigational therapy, immunosuppressants, and cytokine modulating agents 7. history of unstable or deteriorating cardiac or pulmonary disease (other than ipf) within the previous 6 months

Keywords: pirfenidone ascend ipf fvc
corneal endothelium cell loss after cataract extraction in patients taking tamsulosin

Conditions: Cataract

Summary: the purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking tamsulosin.

cataract surgery in patients taking tamsulosin is regarded as more challenging for the surgeon because intraoperative floppy iris syndrome (ifis) might occur. however, the question is whether this has any practical implication for the outcomes of surgery. in this study we investigate whether cornea is damage during surgery on tamsulosin patient. in an observational study 30 cataract patients taking tamsulosin is compared to 30 patients not taking tamsulosin, but otherwise similar. number of patients is based on power calculation. cornea is examined by specular microscopy.

Eligibility criteria:
inclusion criteria: * cataract needing surgery exclusion criteria: * glaucoma * corneal scarring * diabetes * uveitis

Keywords: cataract surgery tamsulosin endothelium cell
protein supplement and exercise training for the treatment of sarcopenia risk in older adults

Conditions: Sarcopenia

Summary: to explore the effectiveness of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive home care and are at risk of sarcopenia.

the aim of this study is to investigate the effectiveness of consuming a whey-based protein ons enriched with leucine and vitamin d, in conjunction with an online resistance-based exercise programme, versus the effectiveness of an online exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of sarcopenia and who require supportive home care. the primary outcome will be functional and nutritional status measured using the timed get up and go (tug) test and the full form of the mini-nutritional assessment (mna-ff). the secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and quality of life. the groups will be as follows: (i) whey protein ons enriched with leucine and vitamin d plus an online exercise programme or (ii) an online exercise programme alone. the exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the ucd zoom platform. the exercise programme will include strength movements that are intended to build muscle mass and improve physical function. the exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks). the ons is a high protein, leucine and vitamin d enriched drink. participants randomised to the ons group will be asked to consume the drink twice a day for 12 weeks.

Eligibility criteria:
inclusion criteria: * older adults (70+ years) * requiring supportive homecare * at risk of sarcopenia exclusion criteria: * cognitive impairment * severe kidney disease (glomerular filtration rate \< 30 ml/min) * moderate to severe liver disease (child-pugh class b or c) * psychiatric disorder * receiving treatment or palliative care for cancer * receiving enteral or parenteral nutrition * hypersensitivity to any component of ons * taking ons * allergic to dairy products * regularly undertaking resistance (strength) training * advised by gp not to undertake physical activity

Keywords: older adults home care community-dwelling sarcopenia oral nutritional supplement resistance exercise
bone-biomarkers of spinal cord injury patients

Conditions: Spinal Cord Injuries; Bone Resorption; Osteoporosis

Summary: patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. recently, various treatment drugs for osteoporosis have been developed. in particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. however, there are a few research concerning sclerostin of spinal cord injuries patients. therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.


Eligibility criteria:
inclusion criteria: * spinal cord injury patients * functional ambulatory category index of 3 or less exclusion criteria: * history of using bone absorption medication within the effective period

Keywords: sclerostin osteoporosis spinal cord injury unloading
pharmacokinetic, efficacy, and safety study of octafibrin compared to haemocomplettan/riastap

Conditions: Congenital Fibrinogen Deficiency; Afibrinogenemia

Summary: the purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of octafibrin compared to haemocomplettan® p/riastaptm in patients with congenital fibrinogen deficiency


Eligibility criteria:
inclusion criteria: * age ≥ 12 years. * documented congenital fibrinogen deficiency (afibrinogenemia). exclusion criteria: * life expectancy \> 6 month. * bleeding disorder other than congenital fibrinogen deficiency. * presence or history of hypersensitivity to study medication. * presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment. * presence or history of arterial thrombosis with 1 year prior to enrollment. * hypersensitivity to human plasma products. * acute bleeding. * pregnant or currently breast-feeding women. * suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available). * blood or plasma donation in the 3 months prior to enrollment. * human immunodeficiency virus (hiv) positive with a viral load \> 200 particles/µl or \> 400000 copies/ml. * end-stage liver disease. * history of oesophageal varicose bleeding.
a plant-based whole-foods meal delivery service for patients with multiple myeloma undergoing autologous hematopoietic cell transplant

Conditions: Multiple Myeloma

Summary: this clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. an autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. a plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. in this pilot study, study investigators will explore the feasibility of this approach.

outline: patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. patients undergo blood and stool sample collection on study.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent prior to initiation of any study procedures * planned first autologous stem cell transplantation for multiple myeloma * planned outpatient treatment for the duration of transplantation (if admitted, the investigators will request that caregivers bring the meals/snacks to the hospital as they might with other food prepared at home) * access to a refrigerator * ability to reheat foods * able to consume an oral diet at enrollment * able to communicate clearly regarding aspects of the study: e.g. give feedback on logistics and meals, in order to maximize the operational data the investigators can gather in this pilot study * at least 18 years of age exclusion criteria: * major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team * planned inpatient transplantation
trial on three eating disorders group treatment

Conditions: Eating Disorders

Summary: this trial aims at comparing three group treatments designed for eating disorders: a cognitive-dissonance, a mindfulness and a person-centered based programs. women with eating disorders will be recruited and randomized to one of the three programs. participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. this trial aims to compare the programs to analyze the specific dimensions upon which each program acts. the investigators therefore made hypotheses according to the programs' theory: participants in the cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. participants in the mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. participants in the person-centered based program should report a greater increase in congruence than other participants.


Eligibility criteria:
inclusion criteria: * eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder) or other specified feeding or eating disorder (subthreshold of anorexia, bulimia or binge eating disorder) according to diagnostic statistical manual 5 * to have no regular treatment (no more than one session per month) during the 8 weeks of the program * participants with a body mass index under 17.5 could be include in the study if they had a medical monitoring in another structure exclusion criteria: * a psychotic disorder * a bipolar disorder * a mental retardation * to not read or speak french fluently
relaxation therapy for pain, fatigue and vital signs in post-operation with head and neck cancer

Conditions: Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers

Summary: this study aimed to investigate the effects of progressive muscle relaxation (pmr) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.


Eligibility criteria:
inclusion criteria: - head and neck cancer, need for surgery. (1) clear consciousness; (2) \>= 20 years; (3) no history of surgery for head and neck cancer, regardless of cancer staging, tracheostomy tubing, degree of primary tumor resection, neck dissection, modified radical neck dissection, resection of cervical nerve root branches, and flap reconstruction (including free flap and transposition flap); (4) plan to undergo surgery; (5) willingness to participate in this study and provide informed consent; (6) physically capable of participation the study, as determined by the physician in charge; (7) ability to communicate in mandarin or taiwanese, with no reading, listening, or writing disability, and complete the questionnaire alone or with the assistance of the researchers. exclusion criteria: - head and neck cancer, not for surgery. (1) use of hypnotics or record of a sleep disorder within 3 months prior to admission; (2) difficulty hearing, external auditory canal trauma, or hearing impairment; (3) diagnosis of a psychotic disorder or cognitive impairment; (4) experience practicing jacobson's pmr.

Keywords: progressive muscle relaxation head and neck cancer
study comparing etanercept in combination with methotrexate in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: to compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis. * currently receiving an optimal dose of oral methotrexate (mtx)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis. * active rheumatoid arthritis at the time of screening. exclusion criteria: * previous or current treatment with etanercept, other tumor necrosis factor-alpha (tnf) inhibitors, or other biologic agents. * concurrent treatment with any disease-modifying anti-rheumatoid drugs (dmard), other than mtx within 28 days before baseline. * concurrent treatment with more than 1 non-steroid anti-inflammatory drug (nsaid) at baseline.

Keywords: active rheumatoid arthritis
phase 0 biodistribution of novel imaging for resectable pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this clinical trial is to study an experimental drug called ptp-01 that is being used as an imaging agent to diagnosis pancreatic cancer. currently, pancreatic cancer is diagnosed using ct or mri scans which miss small pancreatic cancers, particularly early stage disease. researchers at the university of virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. these researchers have also developed ptp-01, an experimental drug that may be used with spect imaging to detect pancreatic cancer cells in humans.


Eligibility criteria:
inclusion criteria: * subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (pdac) * subject must have adequate renal function * ecog performance status of 0-2 * women of child-bearing age and men must agree to use contraception prior to and during the study exclusion criteria: * subjects receiving any other investigational agents * significant history of uncontrolled cardiac disease or central nervous system (cns) disease * pregnant or breastfeeding women

Keywords: pancreatic resection
phase 3 study evaluating safety and efficacy of otx-tp in subjects with oag or oht

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the objective of the study is to evaluate evaluate the safety and iop lowering efficacy of otx-tp, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension

this was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (pv) controlled study conducted to evaluate the safety and iop-lowering efficacy of otx-tp, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. a total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either otx-tp or pv to evaluate the safety and efficacy of otx-tp.

Eligibility criteria:
inclusion criteria: * documented diagnosis of ocular hypertension with an open angle of schaffer grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession * iop is currently controlled as assessed by the investigator exclusion criteria: * punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge * a history of an inadequate response or no response to topical prostaglandin * known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
concurrent treatment for patients with cervical radiculopathy

Conditions: Spinal Nerve Root Disorder Nos

Summary: this study evaluates the effectiveness of two treatment interventions in patients with cervical radiculopathy. one group will receive a concurrent approach using traction and neuromobilizations. the other group will receive the sequential approach of traction and neuromobilizations

physical therapists routinely use cervical traction and manual therapy in patients with cervical radiculopathy. the standard of care is a sequential approach in which the patients receive interventions successively. this study will provide the standard of care approach for one group while the other group receives the concurrent approach in which the patient will have neuromobilizations while they are receiving mechanical traction. both groups will also receive exercise and manual therapy to the cervical and thoracic spine.

Eligibility criteria:
inclusion criteria: * participants that test positive on at least 3 out of 4 special tests. * participants will score at least 10 on the neck disability index * participants will score at least 2 on the numeric pain rating scale exclusion criteria: * do not test positive on at least 3 of 4 special tests. * signs of cervical trauma * cervical myelopathy * active pregnancy * medical red flags (fracture, tumor, long term steroid use, rheumatoid arthritis, and osteoporosis) * evidence of vascular compromise * cervical spine surgery * recent injections in the past six weeks

Keywords: cervical radiculopathy neck pain neuromobilizations
efficacy of melatonin in patients with severe sepsis or septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: objectives. to establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock. specifically: 1. to evaluate the survival to 28 days of mechanical assisted ventilation, days with vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution towards the failure of other organs. 2. to evaluate, waiting for reduction under the influence of the treatment with melatonin, : 1. clinical - analytical parameters of sepsis; 2. levels of cytokines; 3. oxidative and nitrosative stress; 4. acute-phase proteins (app), specially of the itih4; 5. immune response; 6. endocrine response. methodology. patients will be randomized in two groups, n = 55 in each group: 1) treatment with melatonin 30mg/12 hours 28 days; 2) placebo. determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase activity; d) interleukins-1,2,4,5, 6, 7,8,10,12,13, ifn-γ; tnf-α and gm-csf; e) acute-phase proteins: pcr, haptoglobin, apo a-i, α1-gpa and itih4; f) lymphocytes t, b, nk, t cd4, and t cd8, and immunoglobulins; g) cortisol, aldosterone, acth, adh, insulin, glucagon and 25-hydroxyvitamin d3. data will be analyzed following a prospectively define plan and by intention-to-treat (itt) analysis.

this study will be done in the hospital clinico lozano blesa (zaragoza, spain), promoted by the health science aragon institute and its principal investigator is f. agustín garcía gil (surgical service). it will start in april-may 2013 and will finish 12 months later approximately. the study sponsor is i+cs (aragon institute of health sciences).

Eligibility criteria:
inclusion criteria: * patients (males and females) over 18 years who meet the diagnostic criteria for severe sepsis or septic shock secondary to community-acquired pneumonia or hospital and or intra-abdominal infection exclusion criteria: * patient with more than 24 hours from the first documentation of organ dysfunction

Keywords: sepsis