Kornimate/medical-research-clean huggingface dataset:
a study to investigate the bronchodilatory effect of nva237 in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was intended to assess how well inhaled nva237 opens up the airways of patients with mild, moderate or severe copd over a 24 hour period after a 14 day treatment period.


Eligibility criteria:
inclusion criteria: * male or female aged greater than 40 years with copd current or ex-smokers exclusion criteria: * cardiac (heart) disorders, history of asthma, requiring oxygen therapy. other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd bronchodilator
3-month trial observation of a1c change

Conditions: Type 2 Diabetes

Summary: the incidence of type 2 diabetes in long term care facilities has been approximated at 25% with barriers to treatment including untimely access to a specialist and improper/poor adherence to insulin regimes. this 3 month trial will investigate the efficacy of improving overall glycemic control by using an internet blood glucose reporting system to facilitate bi-weekly consultations between long term care facility patients with type 2 diabetes and an endocrinologist.

purpose: this project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin a1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities. hypothesis: our hypothesis is bi-weekly reporting will result in a reduction in a1c after 3 months. justification: elevated a1c values increase risk of health complications for people with type 2 diabetes. objectives: improved type 2 diabetes management for patients in long term care facilities. research methods: patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. consent will be done in person with any questions answered. strips and blood glucose meters will be provided. blood glucose values and testing frequency will be recorded using the internet reporting system heath-e-connect. hba1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist. statistical analysis: hbalc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention

Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus patients at point grey private hospital * trained in self-blood glucose monitoring * willingness to test blood glucose levels a minimum of 3 times daily * willingness to be trained on ibgms exclusion criteria: * patients with medical conditions that may affect their study participation or results will be excluded. * patients currently being treated with steroid medication * patients that have impaired liver function

Keywords: diabetes a1c internet long term care
the use of a prebiotic to promote a healthy gut microbiome in pediatric stem cell transplant recipients

Conditions: Microbial Colonization

Summary: this study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.

children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. they will start taking the product seven days before transplant starts until 14 days after transplant. stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. they will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. from 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). no product (inulin or placebo) will be given during this time frame. the study period ends 100 days after transplant.

Eligibility criteria:
inclusion criteria: 1. age 2-18 years 2. allogeneic stem cell transplant 3. myeloablative therapy 4. inpatient at lurie children's hospital exclusion criteria: 1. previous hematopoietic stem cell transplant 2. autologous stem cell transplant 3. reduced intensity conditioning used for transplant 4. history of ulcerative colitis, crohn's disease, irritable bowel syndrome, celiac disease 5. history of type 1 or type 2 diabetes mellitus 6. previous abdominal surgery necessitating the use of an ostomy 7. g-tube dependence 8. nasal gastric/oral gastric tube dependence prior to starting the conditioning process 9. graft vs host disease prior to enrollment at any site 10. children under 2 years of age - literature shows that the microbiome is still developing in children under two years of age, and this development may skew results

Keywords: microbiome prebiotic
study of epidural steroid injection (esi) versus minimally invasive lumbar decompression (mild®) in patients with symptomatic lumbar central canal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: this is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with mild® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.


Eligibility criteria:
inclusion criteria: * symptomatic lumbar spinal stenosis (lss) primarily caused by dorsal element hypertrophy. * prior failure of conservative therapy and odi score \>20%. * radiologic evidence of lss (l3-l5), ligamentum flavum \>2.5mm, confirmed by pre-op mri and/or ct. * central canal cross sectional area ≤ 100 square mm. * anterior listhesis ≤ 5.0mm. * able to walk at least 10 feet unaided before being limited by pain. * available to complete 26 weeks of follow-up. * a signed informed consent form is obtained from the patient. * adults at least 18 years of age. exclusion criteria: * prior surgery at intended treatment level. * history of recent spinal fractures with concurrent pain symptoms. * disabling back or leg pain from causes other than lss (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.) * significant / symptomatic disc protrusion or osteophyte formation. * excessive / symptomatic facet hypertrophy. * bleeding disorders and/or current use of anti-coagulants. * use of asa and/or nsaid within 5 days of treatment. * pregnant and/or breastfeeding. * epidural steroids previously administered (not esi naive) * wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe copd. * dementia and/or inability to give informed consent. * inability of the patient to lie prone for any reason with anesthesia support (e.g. copd, obesity, etc.). * on workman's compensation or considering litigation associated with back pain.

Keywords: spinal stenosis lumbar spinal stenosis laminotomy laminectomy spine surgery
cognitive stimulation in elderly individuals at risk to develop dementia (allena-mente).

Conditions: Mild Cognitive Impairment; Healthy Subjects With Family History for Dementia

Summary: the allena-mente study is a randomized, controlled, single-blind trial assessing the efficacy of cognitive stimulation (cs) compared to an active control group, participating to sanitary education lessons (ac). this non-pharmacological intervention is delivered to mild cognitive impairment (mci) and cognitively healthy individuals with first-degree relative with dementia (ndfam).

the experimental protocol was set up with a pilot study on healthy elderly individuals. data from this pilot study will be excluded from the statistical analysis. sample size: a priori power analysis was performed to evaluate the sample size required for the study. mci and ndfam were considered separately for sample size calculation. for power calculation a two-tailed test was used and a significance level (α) and test power (1-β) were set at 0.05 and 0.8/0.9, respectively. randomization: the individuals belonging to mci and ndfam subgroup were randomly assigned to cs or ac group. the randomization was performed by a statistician blind to participants characteristics using the random allocation software. allocation ratio was set at 1:1, stratification was performed for birth cohort (≤1937 and ≥1938), education level (years of education ≤5 years and \>5 years). participants provided written informed consent before study participation.

Eligibility criteria:
inclusion criteria: * positive diagnosis for mild cognitive impairment (mci) according to petersen's criteria; * cognitively healthy elderly individuals, having at least one first-degree relative affected by dementia (alzheimer's disease, pre-senile and senile dementia, vascular dementia) (ndfam). exclusion criteria: * (major physical illness) compromission of motor performance of lower and upper limbs * medical conditions leading to clinical instability; * therapies that reduce cognitive and communicative abilities and consciousness; * perceptual disorders (sight, hearing) * language disorders * education level lower than 3 years * psychiatric and behavioral disorders * addiction to drugs or alcohol

Keywords: mild cognitive impairment cognitive stimulation aging elderly randomized controlled trial
allogeneic stem cell transplantation for children with cml

Conditions: Chronic Myeloid Leukemia

Summary: in children and adolescents with chronic myeloid leukaemia (cml) stem cell transplantation (sct) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors (tki). this trial aims to evaluate the use of a reduced intensity conditioning regimen (ric), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related mortality and toxic late effects. strict post-transplant monitoring and reintroduction of tki as well as donor lymphocyte infusions (dli) in case of relevant residual disease are part of the protocol.

chronic myeloid leukaemia (cml) is a rare disease in children with an incidence of 3-5% of all paediatric leukaemias. since the introduction of tyrosinkinase inhibitors (tki) stem cell transplantation (sct) is no longer the first choice treatment for patients with early phase cml. however life-long treatment with tki may not be feasable in several cases due to side effects such as growth retardation, non-compliance and resistance. this protocol evaluates the feasibility of sct following a reduced intensity conditioning regimen (ric) consisting of fludarabine, melphalan, thiotepa and thymoglobuline (atg). matched siblings and matched unrelated donors are permitted for stem cell donation. in case of unrelated donors tissue typing has to be done by high resolution molecular typing. donors with 10/10 or 9/10 identical allels in the human leukocyte antigen (hla) system are accepted. preferred stem cell source is bone marrow but peripheral blood stem cells and umbilical cord blood are also allowed. graft-versus-host-disease (gvhd)-prophylaxis is achieved with cyclosporine a and mycophenolate mofetil. monitoring of the breakpoint cluster region - abelson (bcr/abl) rearrangement is performed monthly in the first year after sct. in case of bcr/abl positivity tki are given in the first year after sct. followed by donor lymphocyte infusions (dli) later on if bcr/abl positivity persists.

Eligibility criteria:
inclusion criteria: * children and adolescents with bcr/abl positive cml in chronic phase, who are eligible for allogeneic stem cell transplantation, irrespective of the previous treatment strategy * availability of a hla matched sibling donor (msd), a matched family donor, a matched unrelated donor or a matched unrelated cord blood (md) * informed consent exclusion criteria: * unavailability of msd or md * patients in accelerated phase or blast crisis * pregnancy * previous autologous or allogeneic sct * no informed consent

Keywords: stem cell transplantation pediatrics
a prospectivetrial comparing thunderbeat to the ligasure energy device during laparoscopic colon surgery

Conditions: Colon Cancer

Summary: prospective randomized controlled study, at colon and rectal surgery, wmc/nyph. subjects undergoing laparoscopic left colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: group 1 - thunderbeat group 2 - ligasure population

prospective randomized controlled study, at colon and rectal surgery, wmc/nyph. subjects undergoing laparoscopic left colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: group 1 - thunderbeat group 2 - ligasure population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary study procedures: this project will consist only of prospective data collection. no interventions will be done for research purpose. data will be collected prospectively on: -patients (before, during and after surgery) -the thunderbeat and ligasure instruments data will be collected on data collection sheets and entered in a password protected database primary outcomes/definitions- overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.

Eligibility criteria:
inclusion criteria: * patients that will be undergoing a left laparoscopic colon resection * older than 18 years old * asa 1 to 3 * elective surgeries * patients who willingly provide informed consent exclusion criteria: * morbidly obese patients (bmi \>35) * patients with acute diverticulitis * patients with multiple previous abdominal surgeries * patients on anticoagulants * patients who can not, tolerate a major surgery * patients for whom electrosurgery is contraindicated * patients who are pregnant * patient with ibds
cognitive rehabilitation for post-covid-19 cognitive impairment

Conditions: Cognitive Impairment

Summary: this pilot randomized controlled trial is to investigate the feasibility and efficacy of cognitive rehabilitation for patients with post-covid-19 cognitive impairment. additionally, the study will obtain preliminary data, using rsfmri, regarding the potential underlying connectivity networks, mediating the effect of cr on cognitive improvements.


Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * have a confirmed sars-cov-2 infection (positive pcr or are serum antibody positive \[against spike protein if unvaccinated or n-capsid peptide if vaccinated\]) * speak english * have objective mild to moderate cognitive impairment, which will be defined as impairment in executive function (a z-score \>1.5 standard deviations below the normative mean) and in at least one other cognitive domain * endorse comfort and familiarity with technology. exclusion criteria: * no method of contact * major neurocognitive disorder, as defined by a score \<17 on the montreal cognitive assessment (moca) * history of pre-covid-19 neurologic disease (e.g., stroke) * history of severe head injury (as defined by loss of consciousness \>30 minutes) * ongoing substance use disorder (mini international neuropsychiatric interview version 7.0.2 \[mini\] or alcohol use disorders test-consumption \[audit-c\] \>8) * unstable medical, neurologic, or psychiatric conditions precluding participation in research activities, and * contraindication for mri (e.g., metallic/electronic implants). * not involved in cognitive rehabilitation/training or daily meditative practices during study enrollment
study to evaluate the feasibility of [18f]florbetapir pet for assessment in ms patients

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the feasibility of \[18f\]florbetapir positron emission tomography (pet) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.

the underlying goal of this study is to assess the feasibility of \[18f\]florbetapir as an imaging tool to detect demyelination in the brain of ms research participants and compare to similarly aged healthy subjects.

Eligibility criteria:
eligibility criteria (for all subjects): * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations * willingness to comply with study procedures * willingness to provide written informed consent * age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent * subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until pet testing is completed * for females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of \[18f\]florbetapir pet injection inclusion criteria (healthy volunteers): * no history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician. inclusion criteria (ms subjects): * have a diagnosis of relapsing remitting ms according to the 2010 macdonald criteria * have at least 10 demyelinating lesion on brain mri with the following characteristics: * hypointense on t2 weighted images with flair exclusion criteria (for all subjects): * the subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness * the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than rrms), immunodeficiency, pulmonary, or other disorder or disease. * women who are pregnant or actively breastfeeding * the subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) * the subject has participated in another clinical study within the previous 30 days * renal impairment with a creatine clearance \<80ml/minute at screening (creatine clearance estimated by cockcroft-gault equation) * the subject is scheduled to have a major surgery or procedure during the time of the study.

Keywords: multiple sclerosis
the effect of exercise by mechanical hippotherapy device on postural stability and balance in stroke

Conditions: Stroke; Gait, Hemiplegic; Balance, Postural

Summary: stroke,one of the leading cause of death, is caused by ischemia or hemorrhage. it results in neurological deficits such as hemiplegia. hemiplegia show disability characterized loss of motor, sensory and cognitive function. reduced postural control and balance stability results gait disturbances such as asymmetric weight bearing, risk of falling and imbalances. it also shows increased energy expenditure, decreased independence on quality of life and limited mobility. physical therapy can be effective method for solving these problems. hippotherapy, also known as horseback riding therapy, is a form of physical therapy strategy that uses equine movement. the concept of hippotherapy is to use a horse as a therapeutic tool, and it is based on similarities in gait between the human and horse. the horse's gait provides patients having motor disabilities with rhythmic and repetitive movements similar to human walking, thereby giving them training opportunities to improve posture, balance, and strength. even though it has many effect on solving these problems, hippotherapy centers are not enough. due to climate and environmental situations, hippotherapy devices were improved and had similar effects on patients with stroke. in literature, these device mostly used on cerebral palsy, but investigator wants to use hippotherapy device on patient with hemiplegia. for these reasons, the effects of exercises by mechanical hippotherapy device on postural control and balance will be investigated.

investigator will randomly allocate 30 patients with hemiplegia to two groups; control group (n=15), experimental group(n=15).the control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks, while the experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks. assessment procedure will be held at the beginning and 4th week of study. assessment procedure will be held at the beginning and 4th week of study. all subjects will be assessed by berg balance scale and biodex primarily while timed up and go test, sf-36, functional reach test, functional independence measurement(fim), trunk impairment scale (tis), trunk control test (tct), motricity index, fugl-meyer will be held secondarily.

Eligibility criteria:
inclusion criteria: * mini mental test score more than 24 * ability to stand and sit independently * ability to follow and understand verbal instructions. exclusion criteria: * musculoskeletal problems * neurologic deficits such as unilateral neglect, hemianopsia, and apraxia

Keywords: stroke, hippotherapy, balance, postural control, gait
a 3-month study to assess the safety and effectiveness of ons-5010 in subjects with neovascular age-related macular degeneration (amd)

Conditions: Neovascular Age-related Macular Degeneration; Age-Related Macular Degeneration; Wet Macular Degeneration

Summary: multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ons-5010.


Eligibility criteria:
inclusion criteria: * active primary subfoveal choroidal neovascularization lesions secondary to age-related macular degeneration (amd) in the study eye * best corrected visual acuity of 35-75 letters read (20/32 to 20/200 snellen equivalent) * study eye must: * have active leakage on fluorescein angiogram involving the fovea * have edema involving the fovea * be free of scarring, fibrosis, or atrophy involving the central foveal zone exclusion criteria: * previous subfoveal focal laser photocoagulation in the study eye * laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization * any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year * active intraocular inflammation (grade trace or above) in the study eye * current vitreous hemorrhage in the study eye * polypoidal choroidal vasculopathy (pcv) in the study eye * history of idiopathic or autoimmune-associated uveitis in either eye * infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmhg despite treatment with anti-glaucoma medication) * premenopausal women not using adequate contraception * current treatment for active systemic infection * known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment