Kornimate/medical-research-clean huggingface dataset:
study of flavocoxid (limbrel) versus naproxen in subjects with moderate-severe osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the purpose of the study is to compare the efficacy and safety of flavocoxid (limbrel) with naproxen and placebo in oa of the knee.

to compare the efficacy, safety, quality of life and economic impact of flavocoxid vs naproxen.

Eligibility criteria:
inclusion criteria:major inclusión criteria: 1. adults of either gender, ages 35-85, in general good health 2. diagnosed with oa of the knee, k-l grade 2-3 3. history of positive response to nsaid's or cox-2 inhibitors 4. able and willing to discontinue other medicinal oa therapies for length of the study (subjects may continue low dose aspirin for cardioprotection) 5. females of child bearing potential must use acceptable method of birth control major exclusion criteria: 1. unwilling or unable to read and sign informed consent document 2. pregnant and nursing women 3. history of severe cardiovascular disease including, but not limited to chronic angina, congestive heart failure, uncontrolled hypertension, acute myocardial infarction within past year 4. k-l grade 1 or 4 oa of the target knee 5. chronic bleeding disorder or present use of anticoagulants 6. history of upper g-i bleed in the past 5 years 7. significant renal disease including nephrotic syndrome, proteinuria \>1 gm/24 hrs or serum creatinine \>2.0 8. any arthritic disease that is or has the potential to affect the knees during the course of the study 9. any other condition that might confound evaluation of the target joint including, but not limited to, bursitis, tendonitis or internal derangement in or about the knee, gait disturbances (e.g. mechanical, neurological conditions or disorders of the back), fibromyalgia, polyneuropathies, etc.
efficacy and safety of a new sperm capacitation method

Conditions: Reproductive Issues; Male Infertility; Asthenozoospermia; Oligozoospermia; Teratozoospermia

Summary: prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of hypersperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.


Eligibility criteria:
inclusion criteria: * ability to provide a semen sample via masturbation exclusion criteria: * current diagnosis of a sexually transmitted infection (sti) * previous diagnosis of hepatitis a, b, c, d, or hiv * prior participation in this study * participation in a clinical trial involving an intervention within the last 3 months
adenovirus vaccine pregnancy registry

Conditions: Adenovirus

Summary: the primary purpose of the adenovirus vaccine pregnancy registry is to prospectively collect data concerning: 1. pregnant women exposed to adenovirus type 4 and type 7 vaccine, live, oral, 2. potential confounding factors, and 3. the outcome of these pregnancies. the secondary purpose of the adenovirus vaccine pregnancy registry is to evaluate the frequency of birth defects in prospectively enrolled pregnant women. this registry is also designed to detect any unusual patterns of birth defects.


Eligibility criteria:
inclusion criteria: for women: * u.s. military service member, present or former * confirmed exposure to adenovirus type 4 and type 7 vaccine, live, oral * received adenovirus type 4 and type 7 vaccine, live, oral while pregnant or has an estimated date of conception (doc) within 6 weeks after receiving adenovirus type 4 and type 7 vaccine, live, oral * positive β-hcg test or fetal ultrasound,and * verbal and/or written informed consent obtained from the patient. for live born offspring: * infant born to a woman meeting the above inclusion criteria and enrolled in the registry, followed through one year post delivery, and * verbal and/or written informed consent obtained from the mother of the infant. exclusion criteria: * patients who refuse to provide informed consent (verbal or written) to the institutional review board (irb)-approved informed consent. * females not exposed to adenovirus type 4 and type 7 vaccine, live, oral within the inclusion criteria period. * patients not willing to meet registry study conditions and requirements.

Keywords: adenovirus adenovirus type 4 adenovirus type 7 adenovirus type 4 and type 7 vaccine, live, oral
gallant 22 tesaglitazar vs. placebo

Conditions: Type 2 Diabetes

Summary: this is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. the study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period. the study design of gallant 2 is identical to gallant 22; the blinded study data from gallant 2 will be transferred to the gallant 22 database and will be analyzed together with the data from gallant 22 clinical study.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are \>=18 years of age * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents * drug-naïve (ie, no use of antidiabetic drug\[s\], for at least 24 weeks prior to visit 1). exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
effects of dexmedetomidine on respiratory function and inflammatory responses in patient with sepsis undergoing cleaning focus of infection

Conditions: Organ Protection

Summary: the purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.

sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. it is well accepted that inflammatory reaction is the major cause of lung injury. dexmedetomidine (dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. recently, animal studies have shown that dex plays an anti-inflammatory role, while it is not known whether dex possesses any lung protective functions in patients with sepsis. therefore, the aim of this study is to investigate the efficacy of dex on lung protection in patient with sepsis undergoing cleaning focus of infection.

Eligibility criteria:
inclusion criteria: * the patients with sepsis requiring abdominal cleaning focus of infection * older than 18 years * american society of anesthesiologists (asa) physical status ii-iv. exclusion criteria: * bradycardia * atrioventricular block * allergic to the drugs * a history of respiratory disease * pregnancy or breast-feeding women

Keywords: dexmedetomidine sepsis respiration
lymphedema sensor technology development study

Conditions: Lymphedema Arm; Lymphedema; Cancer

Summary: the goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. the main questions this study aims to answer are: * do these sensors detect lymphedema? * if so, how accurate are these wearable sensors? participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of unilateral lymphedema that affects the upper extremity (ue). * patients previously diagnosed with non-metastatic cancer. * adults 18 years of age and older. exclusion criteria: * patients with history of lymphatic surgery. * patients with implantable devices (e.g., pacemaker, pacemaker/defibrillator, intrathecal pump, joint replacements, etc.) or any other device deemed unsafe by the treating investigator. * patients with an amputation involving the upper extremity. * patients with known allergies to adhesives - including silicone adhesives. * patients with the following comorbidities: diabetes, congestive heart failure, peripheral vascular disease, irradiated upper extremity skin, psoriasis, atopic dermatitis, open wounds/skin breakdown.

Keywords: sensor device lymphedema upper extremity wearable tissue hydration stiffness cancer
infrared imaging in complex regional pain syndrome

Conditions: Complex Regional Pain Syndromes

Summary: this research proposal aims to investigate the potential use of infrared (flir) imaging to monitor the successful achievement of the sympathetic blockade in patients with complex regional pain syndrome (crps).

sympathetic blocks are clinically used to diagnose and treat sympathetically mediated pain. despite the frequent use of these blocks, there remains a need for an objective method to determine the achievement of a sympathetic block in the clinical setting. current clinical practice assess the success of a sympathetic block by observation of clinical signs of sympathetic blockade. these signs include monitoring skin temperature, pulse amplitude, blood oxygen, or any combination of these methods. however, clinical signs of sympathetic blockade often demonstrate an unpredictable or delayed response and can make monitoring difficult. therefore, it is necessary to develop an objective monitoring method that is reliable, rapid response, and not affected by the other confounders. one potential method is the use of thermal camera imaging (flir). such a monitor could increase procedural accuracy and efficiency, thus improving patient care. to plan the prospective treatment options, objective confirmation of successful sympathetic block is essential to differentiate sympathetically mediated pain (smp) versus sympathetically independent pain (sip). in this context, utilization of a monitor with a rapid response and easy clinical applicability, would serve as an objective endpoint for evaluating sympathetic blockade both clinically and for future research. therefore, this research proposal aims to investigate the infrared (flir) thermal camera as an objective method for determining the achievement of sympathetic block in the clinical setting.

Eligibility criteria:
inclusion criteria: * the patient is between 18 and 85 years old * providing crps diagnostic criteria by using budapest clinical criteria \[16\] * the patient has had pain and other symptoms for more than 3 months * not responding to conventional medical treatments and multidisciplinary approach * high nrs detection in pain assessment despite appropriate treatment (nrs = and \> 6/10). * pain is a limitation in the patient's functional capacity despite appropriate treatment. exclusion criteria: * patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (mri, ct). * systemic or local infection * coagulation disorders * history of allergy to contrast material * malignancy * pregnancy * uncontrollable medical and psychiatric condition * the patients diagnosed with dysautonomia, sympathetic dysfunction (such as raynaud disease or buerger disease), sweating disorders (such as acquired idiopathic generalized anhidrosis), and patients on vasoactive drugs, the mechanism of action is directly on the vascular tone.

Keywords: complex regional pain flir sympathetic block
study of efficacy & safety of oral ym087 in subjects with euvolemic or hypervolemic hyponatremia

Conditions: Hyponatremia

Summary: study of efficacy \& safety of oral ym087 in subjects with euvolemic or hypervolemic hyponatremia


Eligibility criteria:
inclusion criteria: * serum sodium 115 to \<130meq/l * plasma osmolarity \<290 mosmol/kg h2o exclusion criteria: * significant renal insufficiency * serum sodium increase of ≥8 meq/l over the baseline day ( hours 0 to 12)

Keywords: hyponatremia hypervolemic euvolemic conivaptan
fecal and oral microbiota between pancreatic cancer and benign/low-grade malignant tumor patients

Conditions: Microbiome; Pancreatic Neoplasms; 16s RRNA

Summary: significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (pca) versus benign or low-grade malignant pancreatic tumors (npca). this study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.

in the past decade, microbiome research has rapidly progressed, revealing the critical roles of fecal and oral microbiota in maintaining internal homeostasis. studies employing 16s rrna and metagenomics have highlighted dysbiosis of the fecal and oral microbiota as closely linked to pca development and progression. however, significant gaps exist in understanding the fecal and oral microbiota in patients with pancreatic cancer (pca) versus benign or low-grade malignant pancreatic tumors (npca). this study aimed to analyze fecal and oral microbiota characteristics, and to establish classifiers to discriminate pca from npca, providing a reference for early clinical identification of malignant tumors.

Eligibility criteria:
inclusion criteria: * patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection * patients volunteer to provide oral and fecal samples exclusion criteria: * current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders * specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days

Keywords: fecal microbiome oral microbiome pancreatic neoplasms 16s rrna
30-second sit-to-stand test for assessing functional capacity in juvenile idiopathic arthritis

Conditions: Juvenile Idiopahtic Arthritis

Summary: juvenile idiopathic arthritis (jia) is a heterogeneous, idiopathic, chronic inflammatory, rheumatic disease that is most common in childhood and is thought to involve immunological mechanisms in its etiopathogenesis. the physiology of children and adolescents is constantly changing due to the development and maturation of their systems. at the same time, the changes that this population shows, especially during the growth spurt and adolescence, can affect their performance in frequently used functional tests such as the 6-minute walk test (6mwt). at the same time, it is emphasized that alternative tests are needed because the evaluation procedures of the 6mwt are not practical enough. the aim of this study is to investigate whether 30 second sit to stand test (30sst) is an alternative tool for assessing functional capacity in patients with jia. h0: 30sst is not an alternative tool for assessing functional capacity in patients with jia. h1: 30sst is an alternative tool for assessing functional capacity in patients with jia. the study will include 81 adolescent patients with oligoarticular/polyarticular jia and 116 healthy adolescent between the ages of 12-18. the 6mwt, 30sst and 10 stair climb test (10sct) will be applied to the cases that meet the inclusion criteria to evaluate their functional capacity. demographic data and test results of the participants will be recorded and evaluated with statistical analysis methods. we believe that alternative tests that can be used to evaluate functional capacity in patients with jia will contribute to the literature as a result of this study.


Eligibility criteria:
inclusion criteria: * being 12-18 years old for both groups * having been diagnosed with jia at least 6 months ago at the istanbul medical faculty pediatric rheumatology clinic for usability and validity group * having a diagnosis of oligoarticular/polyarticular jia for usability and validity group * volunteer to participate in the study for both groups exclusion criteria: * history of trauma or surgery affecting the musculoskeletal system within the last 6 months * having an additional chronic disease affecting the musculoskeletal system for both groups * having vision or hearing problems for both groups * having cognitive impairment at a level where the person cannot understand the commands given for both groups * having vision or hearing problems for both groups * having had a corticosteroid injection into the knee or ankle within the last week for both groups * difference in length in the lower extremities for both groups

Keywords: adolescents juvenile idiopahtic arthritis functional capacity
stress reduction & cvd morbidity and mortality in blacks

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to compare the effects of two stress reduction techniques, transcendental meditation (tm) and progressive muscle relaxation (pmr), on the control of mild hypertension in elderly blacks with hypertension.

background: life expectancy for black americans is about 10 percent less than for whites. the leading cause of excessive mortality in older blacks is cardiovascular disease which may be largely due to disproportionately high rates of hypertension in older blacks. conventional antihypertensive drug therapies are frequently associated with adverse effects on quality-of-life (ql) and low compliance rates, especially in elderly minority populations. the present study is an extension of a pilot study on a comparable sample of 80 black elderly. the previous study, which was the first of its kind, yielded results which indicated that both tm and pmr produced moderate reductions in systolic and diastolic blood pressure, with tm producing the most significant improvements in blood pressure and in quality-of-life. dr. schneider hypothesized from this and related evidence that tm should prove to be an effective therapeutic adjunct to regular pharmacotherapy for mild hypertension in elderly blacks, and should prove even more effective in fostering compliance and in improving overall quality-of-life without any of the unpleasant side effects of anti-hypertensive medications. design narrative: randomized. over an 18-month period, 213 people were screened for inclusion in the study. of these, 127 with initial diastolic blood pressure of 90 to 109 mm hg, systolic blood pressure of 189 mm hg or less, and final baseline blood pressure of 179/104 or less mm hg were randomized to treatment. of the 127 participants, 16 did not complete follow-up blood pressure measurements. thus, 111 subjects completed the study. all subjects were pretested over a four session baseline period on clinic blood pressure, ambulatory blood pressure, cardiovascular and emotional reactivity, and quality-of-life measures. subjects were then randomly assigned, 36 to tm, 37 to pmr, and 38 to lifestyle modification education control and followed monthly with major post-tests at three months and eighteen months on these variables. the primary outcome variables were changes in clinic systolic and diastolic blood pressure values measured blindly. the secondary outcomes were changes in self-monitored home blood pressure and compliance. the study was extended through july, 2007 for an additional 5 years of followup of the cohort.

Eligibility criteria:
inner-city blacks with mild hypertension
efficacy of acyclovir in combination with a glucocorticosteroid on uv-induced herpes labialis

Conditions: Herpes Labialis

Summary: the primary objective was to compare the efficacy of me-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (hsv) lesions experimentally induced after ultra violet radiation (uvr) exposure.

the primary objective was to compare the efficacy of me-609 cream vs placebo cream on the time to healing (loss of hard crust) of delayed classical herpes labialis (hsv) lesions experimentally induced after ultra violet radiation (uvr) exposure. secondary objectives were to compare the time to normal skin, incidence of lesion development (number and type of lesions), maximum lesion size, length of lesion stages, frequency/severity/duration of pain, frequency/severity/duration of tenderness, redness and/or oedema in the uvr exposed area, frequency of virus positive lesions, time to cessation of viral shedding and safety of me-609 cream vs placebo cream.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * a history of reactivation of recurrent herpes labialis with overexposure to sunlight in the last 12 months, or 2 or more cold sore lesions in the last 12 months * generally healthy as determined by medical history and verbal interview * females who were still able to conceive were to have had a negative pregnancy test on enrolment * fritzpatrick skin type category of i to iv exclusion criteria: * previous inclusion in this study * participation in clinical investigational drug studies in the 4-week period prior to enrolment * participation in any herpes uvr reactivation study within the previous 3 months * previous herpes vaccination at any time * occurrence of herpes labialis (end of episode) within one month prior to enrolment * inflammatory, congenital or iatrogenic underlying immunodeficiency disorders * use of topical steroids in or near the face or on the forearms, systemic steroids (within 30 days from enrolment) or anti-inflammatory drugs (within 10 days from enrolment) * women who were pregnant, lactating or breast feeding * women of child bearing potential not using adequate contraception as judged by the investigator * recent history of alcohol or drug abuse which in the opinion of the investigator could interfere with compliance * significant skin disease such as atopic dermatitis or eczema, that would interfere with the assessment of lesions * allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues * administration of any drug commonly associated with photosensitivity (tetracycline, retin a) within one week of uvr exposure * any antiviral therapy within 14 days prior to enrolment * history of allergy or sensitivity to sunscreen * history of herpes keratitis

Keywords: uv-induced herpes labialis time to healing