Kornimate/medical-research-clean huggingface dataset:
veteran affairs osteoarthritis knee study

Conditions: Knee Osteoarthritis

Summary: a clinical study at the dallas veterans affairs, is being proposed to test the efficacy of a novel electrical stimulation platform named the pro-sport ultra® device by avazzia to reduce pain and increase activity level in patients with knee osteoarthritis.

the primary objective of this study is to document the possible short- and long-term decrease in pain as scored by participants on a numeric rating scale (nrs) after use of avazzia pro-sport ultra® device with pulsed microcurrent in patients with osteoarthritis of the knee. patients with a clinical diagnosis of osteoarthritis (oa) of the knee for a minimum of 6 months will be recruited for this study. their oa has not responded/is not responding to treatment and continuing symptoms interfere with normal function. additionally, patients will have a pain score of 3 or greater on the nrs even with pain medication. secondary objectives include changes in: * mobility via a timed up \& go assessment (tug). participants are timed getting up from sitting in a standard armchair, walking approximately 3 meters, turning, walking back to the chair, and sitting down. * patient-relevant outcomes via the knee injury and osteoarthritis outcome score (koos). the koos is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. * brief pain inventory - short form * use of pain medication.

Eligibility criteria:
inclusion criteria: * have a prior diagnosis (dx) of oa of the knee and have had a trial of conservative treatment for a minimum of 6 months without successful results due to continuing symptoms that interfere with normal function * age \>18 - \<70 years old * males/females of all ethnicities * nrs pain score of 3 or greater while on medication * ability to understand the informed consent document before signing it * for female participants, is at least 4 years post-menopausal, has a history of hysterectomy, has had bilateral tubal ligation, or consents to use two forms of birth control. exclusion criteria: * poor diabetic control (a1c\>11 within the last 3 months) * diagnosis of acute sciatica and/or acute vasculitis * diabetic peripheral neuropathy * lower extremity surgery within the last 6 months * knee replacement * uncontrolled mood disorders, such as depression, anxiety * drug or substance abuse within past 90 days * injury that results in a change in pain level due to causes other than osteoarthritis (i.e., a recent fall or accident) * epilepsy * open wounds around knee joint * active litigation, workers compensation * an electrically implanted device such as a pacemaker, neural stimulator, etc. * currently pregnant, nursing, or may become pregnant.

Keywords: electric stimulation microcurrent knee pain knee injury
a pms of jakavi® in patients with steroid-refractory graft-versus-host disease (sr-gvhd) in korea

Conditions: Graft-versus-Host Disease

Summary: this study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of jakavi® (ruxolitinib) in the real-world clinical setting in korean graft-versus-host disease (gvhd) patients

the dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of jakavi®. all participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. this study will enroll patients who are newly starting jakavi® and patients who have been taking jakavi® prior to study participation. considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. mandatory additional safety monitoring will be conducted following the last dose of the treatment for further ae assessments.

Eligibility criteria:
inclusion criteria: 1. patients who diagnosed with gvhd and currently receiving or going to receive jakavi® treatment according to locally approved label 2. patients who are willing to provide written informed consent prior to study enrollment exclusion criteria: 1. patients under 12 years old 2. patients with contraindication according to locally approved label of jakavi® 3. patients who receive or are going to receive any investigational medicine during the observation period.

Keywords: graft-versus-host disease gvhd nis korea ruxolitinib jakavi
hydrocephalus ipad-app based intervention study

Conditions: Hydrocephalus; Hydrocephaly; Hydrocephalus in Children

Summary: this is a pilot study examining the feasibility and efficacy of using apple ipad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. each subject will participate in an initial assessment and baseline mri, followed by 6-weeks of ipad app-based interventions, and finally a follow-up assessment and a follow-up mri.

long term visuospatial and visuomotor functional deficits are common in pediatric patients with surgically treated hydrocephalus. the deficits are often mild/moderate at early school age although the gap may widen as the children grow older, leading to increasing adverse impact on school performance and academic achievement. the proposed study will generate initial pilot data for the usage of ipad application based therapy intervention for the treatment of cognitive deficits common to pediatric hydrocephalus. it will help determine the optimal intensity and duration of training protocol adapted for the study. in addition, the sensitivity of neuroimaging (dti) in response to the therapy will be assessed and validated as a biomarker that reflects the neuroanatomical alterations underpinning the outcome changes. this study will generate the crucial data to support the design of future phase iii clinical trial with the long term goal as changing the current standard of care in order to prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry becomes irreversible. the participants who meet the inclusion criteria and do not opt-out of participation will be called by a study coordinator to ensure eligibility and to schedule the initial assessment date. participation in this study will include 8-10 study visits. these visits include 2 neuropsychological assessments, 2 mri visits, and 6 weekly visits during intervention phase. mri visit can be combined with the neuropsychological assessment visit if possible at both the pre- and post intervention time points.

Eligibility criteria:
inclusion criteria: * children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention * deficits in 2 of more of the following neuropsychological testing categories: visual motor, visual attention, or visual reasoning. exclusion criteria: * shunt revision within the past one year * mri-sensitive programmable shunt or any other mri-sensitive implant * braces or other dental hardware that would interfere with the quality of mri images (participants with braces are only excluded from the mri portion of the study) * intellectual disability: iq \< 70 * deficits in one or none of the three following neuropsychological testing categories: visual motor, visual attention, or visual reasoning * age 18 years or greater * non-english speaking: we will not enroll non-english speaking participants because the ipad applications are not readily available in other languages. all neuropsychological testing materials are also in english.
fatty liver study in patients with type ii diabetes

Conditions: Type II Diabetes; Nonalcoholic Fatty Liver

Summary: the primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

in patients with type 2 diabetes whose glycemic control is not accomplished with metformin alone, there are several options for additional hypoglycemic agent. as per recent national guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, lantus insulin, and dpp4 inhibitors. all three approaches have been proven to help accomplishing goals of therapy for glycemic control (hba1c\ 7.6%) and fatty liver (presence of "bright" liver in abdominal ultrasound). the primary objective of this trial is to measure changes in hepatic lipid content using three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent in a manner approved by the institutional review board (irb) and is willing and able to comply with the trial procedures. 2. adults at least 18 years of age at the time of consent. 3. have type 2 diabetes mellitus. 4. be on a stable medication with metformin (2000 mg/day) for at least 3 months prior to study enrollment. 5. have blood a1c \>7.6% and \< 8.5% within 3 months prior to study enrollment. 6. have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment. 7. stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months. 8. women of childbearing potential must be willing and able to use acceptable forms of birth control while on the study. exclusion criteria: 1. currently taking medication that can affect glucose metabolism other than metformin. 2. history of kidney diseases that, in the opinion of the investigator , would place the subject at increased risk of participation or plasma levels of creatinine \> 1.4 for women and \> 1.5 for men. 3. history of cirrhosis of liver, hepatitis, or other liver diseases that, in the opinion of the investigator, would place the subject at increased risk of participation. 4. current alcohol consumption more than12 to 15 g of alcohol a day, or \>12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits. 5. history of heart failure. 6. concurrent participation on another research study 7. use of an investigational agent in the 30 days prior to signing informed consent. 8. history of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions. 9. females who are pregnant or lactating 10. current diagnosis or history of bladder cancer

Keywords: type ii diabetes nonalcoholic fatty liver
can nava mode reduce mechanical ventilation day in patients with copd ?

Conditions: Obstructive Lung Diseases

Summary: background： neurally adjusted ventilatory assist (nava) mode is a new mode of ventilator, using electronic potential of diaphragm to adjust tidal volume. at the same time, this mode can trigger and cycle-off inspiratory time by high sensitivity of electronic potential of diaphragm, increase patient-ventilator synchrony, reduce sedative drug, improve oxygenation, shorten mechanical ventilation day and reduce the rate of diaphragm atrophy. it can improve survival rate and hospital day of patients. both the animal and human experiment have the effect of lung and diaphragm protection effect： the results of this trial are expected to obtain electronic potential of diaphragm in patients with obstructive pulmonary disease. reviewing the current literature, few related literatures have such data presentation. this trial hopes to evaluate whether the use of nava can reduce mechanical ventilation day by analyzing electronic potential of diaphragm in patients with obstructive pulmonary disease. investigators expect that participants with obstructive pulmonary disease using nava mode will have significantly less mechanical ventilation day than using conventional mode


Eligibility criteria:
inclusion criteria: 1. obstructive pulmonary diseases include chronic obstructive pulmonary disease (copd), asthma (asthma), cystic fibrosis (cystic fibrosis), bronchiectasis (bronchiectasis), bronchiolitis or other diseases that cause airway stenosis, etc. 2. other patients with obstructive pulmonary disease assessed by the clinical team 3. consent signed by the principal or legal representative 4. age \> 20 years old and \< 99 years old exclusion criteria: 1. those who cannot place a nasogastric tube due to medical conditions 2. pregnant women 3. those who have received gas cutting 4. patients with phrenic nerve palsy 5. neuromuscular disease 6. intubation due to cardiac arrest

Keywords: neurally adjusted ventilatory assist ventilator-free days patient-ventilator synchrony diaphragm atrophy chronic obstructive pulmonary disease
helicobacter pylori eradication with different bismuth quadruple therapies

Conditions: Gastric Cancer; Helicobacter Pylori Infection; Bismuth

Summary: this study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in h. pylori first-line eradication. it is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. patients with confirmed h. pylori positive status will be randomized to one of the treatments described above. at week 2and 6 follow-up visits, a urea breath test(ubt) will be performed to confirm eradication.

the study will include three phases: screening, treatment and follow-up.screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. endoscopy and urea breath test will be performed in addition to the baseline routine evaluations.treatment: subjects are randomly assigned to treatment and will be treated for 14 days. a randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 12 and 14.follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. eradication of h. pylori will be confirmed through urea breath test(ubt).

Eligibility criteria:
inclusion criteria: * age between 18\~75,both gender. * patients with upper gastrointestinal symptoms and with documented h.pylori infection. * patients are willing to receive eradication treatment. * women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: * patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with h. pylori. * contraindications to study drugs. * substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. * constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening). * patients were diagnosed with gastroduodenal ulcer and maltlymphoma. * pregnant or lactating women. * underwent upper gastrointestinal surgery. * patients with barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. * evidence of bleeding or iron efficiency anemia.- page 3 of 4 \[draft\] - * a history of malignancy. * drug or alcohol abuse history in the past 1 year. * systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). * patients who has psychological problem or poor compliance. * enrolled in other clinical trials in the past 3 months. * refuse to sign informed consent.
the prevalence of prediabetes in primary care medicine in tunisia

Conditions: Prediabetes

Summary: the study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in tunisia.

tn-prediab is a tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. the study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects. the objectives of the study are: * primary objective: to estimate the overall prevalence of prediabetes among tunisian population * secondary objective: * describe the clinical and epidemiological profile of prediabetic subjects * describe nutritional factors associated with prediabetes a scientific committee validates the scientific writing, a steering committee supervises the clinical operations of the project. collected data are managed by the dacima clinical suite®, the electronic data capture platform which complies with the fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation).

Eligibility criteria:
inclusion criteria: * ambulatory patient consulting in primary care in a public or private structure exclusion criteria: * known diabetes * concomitant medication that may influence blood sugar (corticosteroids, metformin, glp1 analogues, sglt2 inhibitor) * severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure) * severe anemia * pregnancy

Keywords: prediabetes stmgf survey
to evaluate the physical effects of systane(r) lubricant eye drops compared to refresh tears(r) lubricant eye drops

Conditions: Dry Eye

Summary: this is a multi-site, randomized, investigator-masked study to evaluate the physical effects of systane(r) versus refresh tears(r) in subjects with moderate to severe dry eye. it is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.


Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed symptom eligibility question. * a sodium fluorescein corneal staining sum of ≥ 3 in either eye. * a best-corrected visual acuity of 0.6 logmar or better in each eye as assessed using an etdrs chart. exclusion criteria: * a history or evidence of ocular or intraocular surgery in either eye within the past 6 months. * lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study. * a history of intolerance or hypersensitivity to any component of the study medications.

Keywords: systane refresh tears dry eye moderate to severe dry eye
effectiveness and safety of zilucoplan treatment for french patients with myasthenia gravis over 3 months

Conditions: Myasthenia Gravis

Summary: this study called "multicenter retrospective study on the short- and medium-term efficacy and tolerance of zilucoplan therapy in a cohort of french patients with anti-achr myasthenia gravis", is investigating the effects of a new treatment called zilucoplan (generic name: zilbrysq) on patients in france with a condition known as myasthenia gravis. myasthenia gravis is an autoimmune disease that causes muscle weakness that worsens throughout the day with activity and impacts the ability to work and perform daily activities. the study aims to see if zilucoplan can improve muscle strength and quality of life over three months, while also assessing its tolerance and safety by monitoring side effects. researchers hope this treatment will offer significant benefits for people with this challenging condition.


Eligibility criteria:
inclusion criteria: - confirmed diagnosis of myasthenia gravis with anti-achr antibodies in patients treated with zilucoplan exclusion criteria: * none
long-term safety study of mp-513 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of mp-513 (teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 diabetes for 52 weeks administration.


Eligibility criteria:
inclusion criteria: * patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients whose hba1c is between 6.5% - 10.0% * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc) * patients who are accepting treatments of arrhythmias * patients with serious diabetic complications * patients who are habitual excessive alcohol consumption. * patients with severe hepatic disorder or severe renal disorder. * patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance
intranasal diagnostics in food allergy: a feasibility study

Conditions: Food Allergy

Summary: the investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. the data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.


Eligibility criteria:
inclusion criteria: * aged 6 - 17 years old * physician-diagnosis of food allergy on the basis of: * positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; or * history of convincing clinical reaction to the causative food within the last 12 months and positive skin prick test within last 12 months; or * evidence of \>95% likelihood of food allergy (on the basis of serum specific ige or skin prick test (spt) 8mm or above to the causative food allergen within past 12 months * written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. participants aged over 16 years will need to provide their owned informed consent. exclusion criteria: * contraindicated as acutely unwell or current unstable asthma: * acute wheeze in last 72 hours requiring treatment * febrile ≥38.0oc in last 72 hours * recent admission to hospital in last 2 weeks for acute asthma * current medication * use of asthma reliever medication in last 72 hours * recent administration of a medication containing antihistamine within the last 4 days * current oral steroid for asthma exacerbation or course completed within last 2 weeks

Keywords: food allergy diagnosis