Kornimate/medical-research-clean huggingface dataset:
influence of periodontitis and coronary heart disease on galectin-3

Conditions: Periodontal Diseases

Summary: the aim of this study was to analyze the association between serum and salivary galectin-3 levels in patients with periodontitis. furthermore, the objective was to determine if the periodontitis influenced serum and salivary galectin-3 levels

healthy controls (n=38), patients with chd (n=39), periodontitis (n=40), and a combination of periodontitis + chd (n=38) were enrolled in the present study. the analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including endothelin-1 (et-1) and for serum and salivary galectin-3 levels.

Eligibility criteria:
inclusion criteria: * presence of at least 16 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
transfix zenith® transection clinical study

Conditions: Thoracic Aorta; Thoracic Injuries; Blunt Injuries

Summary: the transfix study is a clinical trial approved by us fda to study the safety and effectiveness of the zenith® tx2® low profile endovascular graft for treatment of blunt thoracic aortic injury.


Eligibility criteria:
inclusion criteria: * vessels suitable for endovascular access and stent graft placement * blunt thoracic aortic injury of the descending thoracic aorta * at least 16 years of age * informed consent given by patient or legally authorized representative exclusion criteria: * clinical considerations that would compromise patient safety or study outcomes * unsuitable arterial anatomy

Keywords: blunt thoracic aortic injury transection endovascular graft
read-poaf pilot studies postoperative atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation

Summary: postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a reveal xt internal loop recorder two weeks before the surgery. frequency, burden, and possible risk factors will be described. during the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of af.

background of the study: postoperative atrial fibrillation (poaf) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. not all episodes of af are noticed and detected, especially after discharge. several studies have shown high mortality in poaf patients, suggesting a progression in af frequency. objective of the study: to investigate the real incidence and burden of poaf. afterwards a risk stratification of poaf is made. to identify a structural and electrophysiological substrate for the development of poaf and new onset af during follow up. study design: 140 patients will receive a reveal device. after 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation. study population: all patients undergoing cardiac surgery without a history of af and without a pacemaker will be invited to participate in the study. primary study parameters/outcome of the study: incidence of poaf until 3 months after cabg. secondary study parameters/outcome of the study: incidence of poaf until 12 months after cabg. determine risk factors for early and late poaf. detect pre-operative (unnoticed) episodes of af. determine a substrate for development of af. nature and extent of the burden and risks associated with participation, benefit and group relatedness: there is a small risk of minor complications (hemorrhage and infection of the pocket).the device can be explanted easily if necessary. ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). patient will have to visit the out-hospital clinic twice. the operation will be prolonged by 30 minutes due to mapping.

Eligibility criteria:
inclusion criteria: * undergoing non emergency surgery * sinus rhythm on initial visit exclusion criteria: * history of atrial fibrillation * internal pacemaker

Keywords: postoperative atrial fibrillation internal loop recorder risk factors coronary artery bypass surgery
pharmacodynamic study of two lanthanum carbonate formulations in healthy adults

Conditions: End Stage Renal Disease

Summary: this study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. this study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.


Eligibility criteria:
inclusion criteria * ability to provide informed consent to participate in the study. * healthy volunteers, age 18-55 inclusive. * subject must be willing to comply with applicable contraceptive requirements of the protocol * female subjects must have a negative pregnancy test * ability to chew and or swallow doses of the investigational products as prescribed in the protocol. * ability to fully comply with all study procedures and restrictions, including consumption of all food provided while a resident in the crc. exclusion criteria * current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures. * clinically significant abnormal serum phosphate levels, outside of normal limits. * current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 7 days of first dose of investigational product. * a known history of lactose intolerance or allergy to milk or other foods. * clinically significant or multiple allergies as determined by an investigator. * history of alcohol or other substance abuse within the last 6 months. * a positive screen for alcohol or drugs of abuse. * male subjects who consume more than 21 units of alcohol per week or three units per day. female subjects who consume more than 14 units of alcohol per week or two units per day. * a positive human immunodeficiency virus (hiv) antibody screen, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibody screen. * female subjects who are pregnant (positive pregnancy test), lactating, or less than 90 days post-partum. * subjects that have previously been randomized in this study. * use of tobacco in any form or other nicotine-containing products in any form. ex-users must report that they have stopped using tobacco for at least 60 days prior to receiving the first dose of investigational product. * routine consumption of more than two units of caffeine per day or subjects who experience caffeine withdrawal headaches. * donation of blood or blood products within 60 days prior to receiving the first dose of investigational product. * plasma donation within 28 days prior to the first dose of the investigational product. * use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.

Keywords: end stage renal disease
efficacy of adding early scapular muscles strengthening exercise after rotator cuff repair on scapula kinematics

Conditions: Rotator Cuff Injuries; Rotator Cuff Repair Rehabilition; Supraspinatus Tear

Summary: the study investigates the effect of accelerate rehabilitation protocol(adding scapular strengthen exercises (lower trapezius and serratus anterior) from week 1) after arthroscopic rotator cuff repair on scapular upward rotation during shoulder elevation.

the study will consist of 2 group both groups will participate in an accelerated rehabilitation program starting the first week after surgery till week 12, but they will follow different protocols. accelerated rehabilitation protocol with early strengthening of scapular stabilizer muscle (lt and sa) and gh active range of motion protocol will be starting gradual active rom for gh from week 3 post operative till week 12 and gradual scapular muscles strengthening exercises (serratus anterior, lower trapezius) from day 1 while accelerated rehabilitation protocol with delay strengthening of scapular stabilizer muscles and active gh range of motion protocol will start active rom for gh and scapular activation exercises (protraction, retraction, and depression) from week 6 till week 12. patients will wear the sling for the first 6 weeks or as the physician recommends and remove it only during the session and home program. 7 the outcomes will be measured 3 times, at week 3 as a baseline for assessment, then reassess at weeks 6, and 12

Eligibility criteria:
inclusion criteria: 1. patients after arthroscopic rotator cuff repair. 2. both gender between age 30 to 50 years 3. small and medium supraspinatus tear

Keywords: rotator cuff repair rehabilition, scapular upward rotation, scapular strengthen exercise accelerate rehabilitation protocol
phase out in tinnitus patients

Conditions: Tinnitus

Summary: phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. this technique is based on the theory by choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus. the aim is to determine the efficacy of the phase out treatment in pure tone and narrow band noise tinnitus patients.


Eligibility criteria:
inclusion criteria: * consult ent department uza with tinnitus * pure tone tinnitus or narrow band noise tinnitus * unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise * frequency tinnitus \> 1khz * cochlear origin tinnitus * tinnitus duration 3 months or longer * age 18y or more * patient being able to cooperate * patiënt able to fill in vas * normal mri pontine angle exclusion criteria: * depression: bdi \> 21 * pulsatile tinnitus * pregnancy * epilepsy

Keywords: tinnitus phase out
pharmacokinetics and immunogenicity of the first doses of peg-asparaginase -an alltogether pilot study

Conditions: Acute Lymphoblastic Leukemia

Summary: acute lymphoblastic leukemia (all) is the most common malignant disease in childhood. survival rates exceed 90% in children and 75% in adults (aged 18-45 years). during the induction period asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. in both cases, asparaginase is inactivated. it is well known that truncation of asparaginase treatment due to inactivation reduces survival. to approach understanding asparaginase dynamics and hypersensitivity in all patients it is important to examine the pharmacokinetics of asparaginase. the aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of peg-asparaginase given intravenously on the alltogether protocol.

asp enzyme activity is measurable in plasma, and trough levels above 100 iu/l secure effect. patients, who have their treatment truncated, have inferior outcome. for many years prolonged asp treatment for 30 weeks has been part of most protocols worldwide, but a recent nordic randomized study showed that less asparaginase (8 doses vs 15 doses intramuscularly (im)) results in the same disease-free survival and significant less toxicity in the less intensive treatment arm (6). accordingly, in the current western european protocol (alltogether) less asp is now given. the nordic countries participate in this protocol. unlike in the previous nordic protocol, nopho all2008, in alltogether asp will be initiated early during induction (day 4 compared to day 30) and given intravenously (iv) and not im. in february 2017 it was approved by the nopho board to do more extensive pharmacokinetic studies of im administered peg-asparaginase, as it has not been shown if im or iv is preferably in respect to minimizing the incidence of hypersensitivity. most study groups in the world use iv administration, thus nopho has a unique chance to illuminate inactivation after im administration, also in adult patients. other groups have not published this. for \>50% of the patients in alltogether, the induction therapy has been reduced from 4 drugs to 3 drugs. this emphasizes the importance of optimal treatment from the beginning. therapeutic drug monitoring (tdm) will identify patients without activity in order to change asp preparation. additional sampling close after the first dose of peg-asp is expected to identify these patients earlier, providing an opportunity to optimize their treatment for better disease-free survival. the aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first dose of peg-asp given iv on the alltogether protocol.

Eligibility criteria:
inclusion criteria: * treated for acute lymphoblastic leukemia (all) on the all2gether pilot protocol exclusion criteria: * none
premanifest huntington's disease: creatine safety & tolerability extension study

Conditions: Huntington's Disease

Summary: the purpose of this clinical trial is to extend the pre-crest study (protocol # (nct00592995) to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for huntington's disease (hd) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.

extensive evidence exists that neurodegeneration begins many years before hd can be diagnosed clinically. therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. cellular energy depletion is present early in hd and can be ameliorated by creatine, which helps regenerate cellular atp. preclinical evidence for creatine's potential neuroprotective effects in animal models of hd has been well-documented. before the clinical efficacy of creatine can be tested in premanifest hd, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of hd should also be confirmed. this extension trial will continue to follow eligible individuals who completed the precrest study on open-label creatine (up to 30 grams daily) for long term safety and tolerability. additional biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.

Eligibility criteria:
inclusion criteria: * individuals who have completed the pre-crest study. * individuals capable of providing independent informed consent and complying with trial procedures. exclusion criteria: -clinical evidence of unstable medical or psychiatric illness in the investigator's judgment. additional eligibility criteria apply.

Keywords: premanifest at-risk huntington's disease hd
randomized trial comparing embryoscope with embryoscope+.

Conditions: Infertility

Summary: the purpose of the study is to compare the current embryoscope time-lapse system being used in ivf which has become standard of care to the new model embryoscope to demonstrate that the embryoscope+ is as safe and reliable as the embryoscope.

this is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (ivf). the subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo ivf at the center where this study is being performed. the subjects will have undergone the usual informed consent procedure at the center. subjects will undergo ovarian stimulation, oocyte retrieval, ivf, and intra cytoplasmic sperm injection (icsi) procedure following the center's usual procedures. at the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: standard embryoscope time-lapse system versus embryoscope+. the best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated. "best grade" embryos will be transferred regardless of embryoscope use. the standard embryoscope as well as the embryoscope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. subjects will not be provided with the time- lapse images. endpoints will be day 3 and day 5/6 embryo development, implantation and pregnancy rate. the study is approximately 2 months, the estimated time it takes a physician to perform one ivf-art treatment cycle. if embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

Eligibility criteria:
inclusion criteria: * 40 years of age or younger (maternal) * 65 years of age or younger (paternal) * fresh or frozen (including donor) sperm can be used * fresh oocytes only (including donor) * frozen embryos from this study can be included in the outcome portion of this study. * single or double blastocyst transfer only exclusion criteria: * 3 or more previous failed cycles * sperm obtained by testicular biopsy * co-culture patients

Keywords: infertility embryo develpoment ivf icsi embryoscope
predictors of response to fenofibrate

Conditions: Hypertriglyceridemia; Insulin Resistance

Summary: fenofibrate is one of the best options for treating hypertriglyceridemia. in the majority of patients, fenofibrate lowers triglycerides (tg) by 24-55% and improves hdl- and ldl-cholesterol. however, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. genetic and environmental factors may explain the high variability in response. although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. if successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.


Eligibility criteria:
inclusion criteria: * 19 years old or over dyslipidemic patients designated to receive fenofibrate by their attending physician. * all patients will be seen at the uab diabetes and endocrine clinic or cardiology clinic. * women who are unable to have children because of surgery or other medical reason or are using an effective form of birth control before the study begins and agree to continue to use an effective form of birth control for 6 months after taking the study drug. exclusion criteria: * under 19 and/or not a dyslipidemic patient or dyslipidemic but with a medical condition (e.g., liver or kidney disease) that warrants contraindication of fenofibrate. * women who are pregnant, nursing and women who, unless they are unable to have children because of surgery or other medical reason, have not been using an effective form of birth control before the study begins and/or are unwilling to use an effective form of birth control for 6 months after taking the study drug will be excluded from the study.

Keywords: hypertriglyceridemia triglycerides hdl insulin resistance
dose of spinal manipulation for chronic low back pain

Conditions: Low Back Pain

Summary: this study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. the study will also determine the effectiveness of spinal manipulation.


Eligibility criteria:
inclusion criteria: * current episode of low back pain * mechanical origin * threshold low back pain level exclusion criteria: * contraindications to spinal manipulation or massage * complicating conditions that could confound clinical outcome * prophylactic use of prescription medication * health-related litigation, claims, or disability compensation

Keywords: low back pain chronic manipulation chiropractic massage
effect of normatec pump for relief of leg edema

Conditions: Edema; Heart Failure; Pulmonary Hypertension

Summary: the investigators hypothesize that leg edema will decrease rapidly when using the normatec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing bnp secretion. both mechanisms may promote excess fluid removal by the kidneys.


Eligibility criteria:
inclusion criteria: * hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ace-i or arbs, digoxin). * documentation of right heart failure by echo or other modality (ct, mri, right heart catheterization) and hemodynamic data from echo is required and an elevated pulmonary artery pressure (\> 35 mmhg) is expected in such cases. exclusion criteria: * patients in sepsis, * hemodynamically unstable, * during an acute attack of pulmonary edema, * with renal failure (creatinine \> 2 mg%), * with dvt, * psychiatric or noncompliant patients, and * patients who will not sign the informed consent form will be excluded from the study.

Keywords: edema heart failure pulmonary hypertension edema in legs