Kornimate/medical-research-clean huggingface dataset:
zoledronic acid as adjuvant therapy in neovascular age-related macular degeneration (z-amd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: a pilot study of zoledronic acid as adjuvant therapy to standard anti-vascular endothelial growth factor (anti-vegf) treatment for neovascular age-related macular degeneration (amd).

this is a one-year, randomized, controlled pilot study. a total of 40 treatment-naïve namd patients will be allocated 1:1 to receive an intravenous infusion of either zoledronic acid (za) 5 mg or placebo at baseline and after 26 weeks as adjuvant therapy to intravitreal anti-vegf injections in accordance with a treat and extend algorithm; bevacizumab is the first-line treatment, and refractory eyes are converted to aflibercept. the participants will be recruited among patients admitted to the department of ophthalmology at oslo university hospital (ouh). the department is the largest provider of retinal care in norway and serves a local community of almost one million people, which makes it well-suited for recruitment. administration of za or placebo will take place at pilestredet park specialist centre, an endocrinology clinic in oslo with particular interest in treatment of osteoporosis. the clinical trial unit at ouh will monitor the study.

Eligibility criteria:
inclusion criteria: 1. active, treatment-naïve neovascular amd in the study eye, intraretinal or subretinal fluid involving the fovea centre on optical coherence tomography (oct), and evidence of choroidal neovascularization on fluorescein angiography (fa) and/or oct angiography (oct-a). 2. age ≥50 years 3. best-corrected visual acuity (bcva) between 0.1 and 1.0 logmar 4. menopausal for at least one year 5. only one eye per patient will be recruited for the study. if both eyes are eligible for the study, the eye with the wors best-corrected visual acuity (bcva) will be selected as the study eye. 6. subjects must give written informed consent before any study related procedures are performed exclusion criteria: 1. lesions comprising more than 50% blood or fibrosis involving the fovea centre 2. polypoidal choroidal vasculopathy (pcv) - indocyanine green (icg) angiography is performed at the discretion of the investigator on clinical suspicion of pcv 3. presence of other ocular disease causing concurrent vision loss 4. presence of ocular disease making intravitreal treatment contraindicated (e.g. current ocular or periocular infection, active uveitis or uncontrolled glaucoma/intraocular pressure ≥ 25 mmhg) 5. systemic anti-vascular endothelial growth factor (anti-vegf) or bisphosphonate treatment within one year preceding the initial study treatment 6. confirmed or suspected active malignancy 7. other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol 8. known or suspected hypersensitivity to any of the trial products 9. hypocalcemia (total ca \< 2.15 mmol/l) 10. renal impairment (estimated clcr \< 35 ml/min).

Keywords: zoledronic acid anti-vegf anti-vascular endothelial growth factor adjuvant therapy amd
biomarkers in tissue samples from patients with acute promyelocytic leukemia

Conditions: Leukemia

Summary: rationale: studying samples fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia.

objectives: * demonstrate that s100a10 is expressed on apl cells and that levels of s100a10 correspond to the amount of fibrinolytic activity. * evaluate the impact of atra on s100a10 level and fibrinolytic activity in vitro. * evaluate the impact of s100a10 knockdown on fibrinolytic activity. * correlate in vitro findings in cell culture to primary patient samples both pre- and post-atra therapy. outline: this is a multicenter study. previously collected samples are analyzed via flow cytometry and western blot analysis. cell surface levels of s100a10 and annexin a2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin a2 and s100a10 in acute promyelocytic leukemia cells.

Eligibility criteria:
disease characteristics: * diagnosis of acute promyelocytic leukemia * available cryopreserved cells from diagnosis or cryopreserved cells from remission (germline) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute promyelocytic leukemia (m3) childhood acute promyelocytic leukemia (m3) adult acute myeloid leukemia in remission untreated adult acute myeloid leukemia childhood acute myeloid leukemia in remission untreated childhood acute myeloid leukemia and other myeloid malignancies
effects of buprenorphine and naloxone in opiate addicts - 4

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the behavioral and physiological effects of buprenorphine and naloxone, both alone and in combination.


Eligibility criteria:
please contact site for information.

Keywords: opiate dependence
mobile-enhanced group cbt for adolescents at risk severe mood disorders

Conditions: Adolescents; Mood Disorders

Summary: although cognitive-behavioral therapy (cbt) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (smd; i.e., bipolar i/ii disorder and recurrent or unremitting major depression), a significant limitation to the cbt's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. this study examines whether a mobile application-enhanced cbt can improve participant adherence and treatment acceptance for adolescents at high risk for smd.


Eligibility criteria:
inclusion criteria: 1. meet dsm-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder 2. be 13-17 years old 3. english speaking and able to complete written questionnaires 4. ability to attend pre-determined group session time(s) 5. access to a smartphone to engage with the study app 6. medication usage is acceptable, but not required exclusion criteria: 1. regular use or current abuse of a psychoactive drug 2. evidence of behavioral problems that are thought to interfere with group treatment 3. suicidality that requires more intensive treatment 4. meeting dsm 5 criteria for bipolar i or ii disorder, a psychotic disorder, or significant psychiatric symptoms (e.g., self-injurious behavior) that require more intensive treatment 5. concurrent participation in cognitive-behavioral therapy 6. inability to travel to study sessions and assessments

Keywords: cognitive behavioral therapy (cbt) mobile health (mhealth) group treatment
risk perception of periodontal disease

Conditions: Periodontal Diseases

Summary: this study aimed at understanding the impact of educational pamphlet on risk perception of periodontal disease using a randomised clinical trial model among patients in a nigerian outpatient dental clinic

this study aimed at understanding the impact of educational pamphlet on risk perception of periodontal disease using a randomised clinical trial model among patients in a nigerian outpatient dental clinic. the outcome will help activate a success oriented periodontal disease prevention model

Eligibility criteria:
inclusion criteria: * consenting dental patients exclusion criteria: * non consenting dental patients
project to update the study of congenital haemophilia in spain

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this study is conducted in europe. the aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (a and b) in spain.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. (study-related activities are any procedure related to recording of data according to the protocol) * male patients of any age diagnosed with congenital haemophilia a or b who visited their htc at least once during the period of january 2013 to december 2013 exclusion criteria: * previous participation in this study * female patients * acquired haemophilia
evaluation of the targeted screening of type 2 diabetes by capillary blood glucose

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is the chronic disease with the most important development in france, and particularly in the saint-etienne area due to his specific population. different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality. the current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose. the objective of the sainté diabete network is to optimize the screening of diabetics, their follow-up and their treatments. using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.


Eligibility criteria:
inclusion criteria: * man or woman * 45 years or older * signed informed consent exclusion criteria: * fasting glucose performed in the last 2 years * diabetes history * not living in saint-etienne

Keywords: diabetes, capillary blood glucose, self-administered questionnaire
mechanistic study of inspiratory training in childhood asthma (mica)

Conditions: Asthma in Children; Obesity; Pediatric Obesity; Pediatric Asthma

Summary: this is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, sham-controlled trial of inspiratory training (it). the primary outcome is to describe the contributions of inspiratory muscle dysfunction (imd) and small airway dysfunction (sad) to obesity-related versus non-obesity-related asthma. the study will involve training (it) for 8 weeks at three intensity levels (sham, low and high). target dose: 150 inspirations three times weekly. the population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (bmi 5th to 84th cdc percentile) or obese habitus (≥95th percentile bmi and less than 170% of the 95th cdc percentile). participants will be involved for 10 weeks. the investigators will use analysis of covariance (ancova) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (naepp step 2 vs ≥3), and atopy status

cross-sectional analytic study of pulmonary mechanics comparing lean and obese children with asthma followed by a randomized, sham-controlled 3-arm intervention trial of inspiratory training on small airway dysfunction and inspiratory muscle function. the central objective of the mica (mechanistic study of inspiratory training in childhood asthma) study is to assess key respiratory mechanisms in 6-17 year olds with symptomatic asthma (with and without obesity) in response to it. our central hypothesis is that obesity promotes dyspnea and worse asthma control via inspiratory muscle fatigue/dysfunction (imd) and small airway dysfunction (sad), and that it will improve inspiratory muscle function and small airway measures. the sample size calculations and main analyses for the it trial are designed as a traditional parallel arm intervention trial (any dose it vs. sham control) with visits 1-2 serving as the baseline evaluation and the main it endpoints being collected at the 8-week visit. in depth phenotyping involving measures of respiratory mechanics and muscle functioning and a rct involving inspiratory training will address these objectives.

Eligibility criteria:
inclusion criteria: * 6-17 years of age * documented clinician-diagnosed asthma * currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease) * either obese (≥95th percentile bmi and less than 170% of the 95th cdc percentile) or have a normal bmi (bmi 5th to 84th cdc percentile) exclusion criteria: * act (asthma control test) score \<17 * ever intubated for asthma * fev1 \< 50% of predicted at enrollment * currently pregnant * legal guardian unable to consent in english or spanish * any major chronic illness that, in the opinion of the pi, would interfere with participation * younger than 6 years of age
comparative evaluation of corneal staining with balafilcon a lenses and two multi-purpose solutions

Conditions: Myopia; Hyperopia; Astigmatism

Summary: a new multi-purpose solution (mps)was clinically evaluated against opti-free replenish mps at specific time points over the course of four days. the study was conducted with purevision lenses.


Eligibility criteria:
inclusion criteria: * were at least 18 years old; * were experienced contact lens wearers; * were correctable to at least 20/40 or better in both eyes with contact lenses; * were in good general health, with healthy eyes (other than requiring vision correction); * had not worn lenses for at least 12 hours before each baseline visit; * had a corneal staining score no greater than grade 1 in either eye at time of enrollment; * had previously used an mps or hydrogen peroxide solution successfully. exclusion criteria: * had a confirmed diagnosis of sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition; * required concurrent ocular medication or have used ocular medication within 24 hours of entering the study; * had a known sensitivity or intolerance to any mps, study products or ingredient(s); * were currently participating in any other clinical study; * had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
the effect of vitamin d replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin d deficient asthmatic children

Conditions: Asthma; Vitamin D Deficiency

Summary: research title: the effect of vitamin d replacement on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in vitamin d deficient asthmatic children. introduction: vitamin d seems to play a role in allergic and asthmatic reactions as an immunomodulator. asthma disease involves inflammatory process in the lower respiratory tract and airway hyperreactivity. aim: to assess the effect of vitamin d replacement on airway reactivity, and allergy and inflammatory mediators in exhaled breath condensate in vitamin d deficient asthmatic children. design: double blind placebo control prospective study comparing the effect of vitamin d replacement and placebo on airway reactivity, allergy and inflammatory mediators in exhaled breath condensate in asthmatic pediatric population with vitamin d deficiency. participant selection: the study group will consist of pediatric patients (age 6-18 years) followed and treated at the pediatric pulmonary unit at the investigators hospital. patients with mild-moderate asthma with low or insufficient vitamin d levels that are currently not receiving anti-inflammatory treatment will be recruited. sample size: 60 participants in the two groups (30 receiving vitamin d and 30 receiving placebo). intervention: vitamin d (14000 units) or placebo will be provided in a similar appearance preparation once weekly for 6 weeks between visit two and three. three visits will be conducted. each subject will undergo evaluation including a respiratory questionnaire (visit 1), methacholine challenge test with determination of pc20 (visit 1 or 2 and visit 3), exhaled nitric oxide (eno) (visit 2, 3), and exhaled breath condensate (ebc) (visit 2,3). venous blood will be analyzed for complete blood count + eosinophils (visit 1, 3), ige levels (visit 1, 3), and vitamin d levels (visit 1, 3). prick skin test for inhaled allergens will be performed (visit 2, 3). primary end point: airway reactivity as assessed by methacholine challenge test. secondary outcome parameters: all other parameters are the secondary end points.


Eligibility criteria:
inclusion criteria: * 6-18 years * mild-moderate asthma * no anti inflammatory treatment over the past 2 weeks exclusion criteria: * any chronic lung disease * febrile illness in last 2 weeks * fev1 \< 65% in study day * bronchodilators over the past 24 hours prior to each study * participation in any other clinical studies over the past 4 weeks

Keywords: asthma vitamin d airway reactivity metacholine challenge test
diagnosis and treatment of cad in severe pad after lower extremity revascularization

Conditions: Peripheral Artery Disease; Coronary Artery Disease

Summary: peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the veteran population. in patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. the goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.

this study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (ct) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. therefore, this study will provide the opportunity for veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.

Eligibility criteria:
inclusion criteria: * male or female 50 to 85 * severe intermittent claudication with abi \< 0.6 or monophasic waveform if non-compressible and tbi \< 0.6 * chronic limb threatening ischemia (clti) with pain at rest (rutherford category 4) with abi \< 0.5 or tbi \< 0.6 * clti with minor tissue loss (rutherford category 5) with abi \< 0.5 or tbi \< 0.6 * completed lower extremity revascularization and enrolled within 45 days * the patient or legal representative will provide informed written consent * the patient has a life expectancy of at least 1 year exclusion criteria: * major tissue loss of the ischemic limb (rutherford category 6) * uncompensated congestive heart failure (nyha class iv) * myocardial infarction or stroke within the past 90 days * prior coronary artery bypass graft (cabg) revascularization surgery * prior percutaneous coronary intervention (pci) with angioplasty or stenting * presence of a pacemaker * congestive heart failure with ejection fraction \< 30% * elevated liver function tests more than twice the upper limit of normal * severe chronic renal disease (glomerular filtration rate, gfr \< 30) or on hemodialysis * pregnancy, human immunodeficiency virus, or organ transplant recipients * current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease) * any condition the review panel determines would make the patient unsuitable for participation in the study
encalm: a study of enx-102 as a monotherapy treatment in patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the encalm trial is designed to evaluate the efficacy and safety of enx-102 in patients diagnosed with generalized anxiety disorder (gad)


Eligibility criteria:
key inclusion criteria: * male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at screening * diagnosed with gad according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), confirmed by a mini-international neuropsychiatric interview (mini) version 7.0.2 * experiencing clinically significant generalized anxiety in need of treatment as measured by hamilton anxiety rating scale (ham-a) screening and day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by ham-a items 1 and 2, respectively, with score each ≥2 at screening and day 1 key exclusion criteria: * clinically predominant psychiatric diagnosis other than gad as confirmed by the mini * any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication * reports moderately severe to severe symptoms of depression * ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to day 1, including thc and cbd, and unwillingness to refrain from their use for the entire duration of the trial * recent suicidal ideation or behavior * current or recent moderate to severe substance use disorder as assessed by the mini * clinically significant abnormal findings in safety assessments * has significant progressive disorders or unstable medical conditions * unable to comply with the requirements of the study or, in the opinion of the investigator or sponsor, is unsuitable for the study
study on the effects of botulinum toxin type a on back muscle in chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to analyse the changes in back muscle size and strength following use of dysport®, and to establish whether there is any association between pain reduction and change in strength, in patients suffering from chronic low back pain.


Eligibility criteria:
inclusion criteria: * suffering from muscular low back pain (between l-1 and s-1 level). * symptoms of more than six months duration. * no benefit from previous treatments. * patient must present with bilaterally more than 2 active trigger points (trps) in the region of the low back musculature. * ct scan or mri examination of the lumbar spine was performed within the past year. * absence of significant pathology, such as bone fracture, nerve damage or severe psychiatric condition. exclusion criteria: * constant or persistent severe pain due to nerve root compression or fibromyalgia. * the patient has received surgery on the spine. * other musculoskeletal disabilities e.g. myasthenia gravis, or disorders of the neuromuscular junction. * any serious pathology, such as cancer, systemic inflammatory disease, vertebral fractures, neurological signs, spinal infection. * epidural injection of local anaesthetics and steroids within 12 weeks proceeding inclusion. * trigger point injection of local anaesthetics and steroid within 8 weeks proceeding inclusion. * pain associated with urinary tract infections, or gynaecological disorders. * bleeding disturbances or currently using coumarin derivatives.

Keywords: chronic muscular