Kornimate/medical-research-clean huggingface dataset:
skills for change: nutrition education program for emirati adults with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the "skills for change" diabetes nutrition education program was a one-year, community-based conducted in ambulatory health care services health centers in al ain. the project involved nutrition education to improve blood glucose control, diet and physical activity levels of emirati adults with type 2 diabetes.

despite the high prevalence of diabetes and its complications in the uae, very few diabetes education intervention studies have been conducted in a representative population in the country. the skills for change program was a one-year, community-based, cluster randomized study involving emirati adults with type 2 diabetes. we implemented a behavioral lifestyle intervention to improve glycemic control, food choices, and physical activity levels and to decrease sedentarity. the project was culturally adapted to emirati adults with type 2 diabetes and was driven by theoretical principles of behavior change and education to enhance intervention effectiveness.

Eligibility criteria:
inclusion criteria: * united arab emirates national * type 2 diabetes * adults: male and female * age: 20-70 years * attending one of the 7 health centers in al ain managed by the ambulatory healthcare services. exclusion criteria: * type 1 diabetes * age \>70 years * medical conditions that prevent active participation in the program, based on recommendation of the attending physicians * participating in other nutrition intervention programs

Keywords: emirati adults united arab emirates lifestyle intervention type 2 diabetes
neural mechanisms of mindfulness-based cognitive therapy (mbct) for posttraumatic stress disorder (ptsd)

Conditions: Post Traumatic Stress Disorder

Summary: this study will examine the effects of psychotherapy as treatment for ptsd, and specifically how brain activity and brain connectivity is affected by mindfulness based cognitive therapy (mbct) and an active mind-body comparison comparison therapy.

this research will see how brain activity and brain connectivity is affected by mindfulness based cognitive therapy (mbct) and an active comparison therapy called muscle relaxation therapy (mrt). participants that qualify to be in this study will be randomly assigned to receive 8 weeks of group therapy in either mbct or mrt treatments. prior to receiving therapy participants will: complete baseline assessments related to their ptsd; fill out surveys; have an functional magnetic resonance imaging (fmri); and provide saliva samples. these assessments will be repeated after the therapy is over. overall study participation should last approximately 10-12 weeks. due to covid precautions, treatments shifted from in-person to remotely-delivered ("zoom" video-conferencing) modality.

Eligibility criteria:
inclusion criteria: * meets current diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for ptsd (with or without major depressive disorder) or subsyndromal ptsd (has qualifying trauma, has intrusive and avoidant symptoms, and at least one negativity and one arousal symptom, and significant impairment); type of trauma shall be interpersonal violence, combat, and/or sexual assault, etc. exclusion criteria: * dissociative ptsd * delayed-onset ptsd * magnetic resonance imaging (mri) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.) * serious medical or neurologic conditions (e.g. stroke, seizures) * suicide risk * psychosis * life history of schizophrenia * life history of bipolar disorder * current substance dependence * other factors that preclude safe and meaningful participation in the study, at discretion of the pi and study team

Keywords: mindfulness-based cognitive therapy muscle relaxation fmri group psychotherapy
safety and efficacy study in subjects with seborrheic dermatitis

Conditions: Seborrheic Dermatitis

Summary: the purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.


Eligibility criteria:
inclusion criteria: * investigator assessment of seborrheic dermatitis. * additional criteria as identified in the protocol. exclusion criteria: * history of or ongoing psoriasis of the scalp. * history of or ongoing atopic dermatitis of the scalp. * additional criteria as identified in the protocol.
graft patency in beating heart vs. conventional cabg using cardiac ct

Conditions: Coronary Artery Disease Amenable to Bypass Graft Surgery

Summary: the purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac ct scanning to evaluate the bypass grafts.

the issue of whether to perform conventional cabg or off-pump cabg continues to be the subject of debate. controversy remains regarding the appropriateness of applying opcab to all patients as opposed to selected sub-populations. the main strategy of cabg is to obtain complete revascularization with the least morbidity and highest long-term patency rates. current medical literature is conflicted regarding graft patency rates in opcab vs. conventional cabg. data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. cardiac computed tomography (ct) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. this study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump cabg using cardiac ct scanning. the study hypothesis is that graft patency rates will be equivalent between the two techniques.

Eligibility criteria:
inclusion criteria: * surgery indicated * patient is hemodynamically stable * isolated coronary artery surgery (no valve) * no contraindications to cardiopulmonary bypass * no previous surgery (not redo cabg) exclusion criteria: * critically ill patient with hemodynamic instability. * concomitant cardiac procedures. * inability to provide written informed consent. * prior severe reaction to contrast dye : * life-threatening anaphylactoid reactions * cardiac dysrhythmias and arrest * cardiovascular and pulmonary collapse * elevated serum creatinine (\>150 mmol/l). * contraindications to cardiopulmonary bypass. * age \< 18 years .

Keywords: coronary artery disease coronary artery bypass graft surgery off-pump cabg cardiac ct bypass graft ct angiography
pharmacological effect of lysozyme for chronic obstructive pulmonary disease and asthma with sputum symptom

Conditions: Chronic Obstructive Pulmonary Disease; Asthma

Summary: the aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in chronic obstructive pulmonary disease (copd) and/or asthma.


Eligibility criteria:
inclusion criteria: for copd: * over 20 years of age and below 85 years of age * smoking history * brinkman index 200 or more * diagnosis of copd * forced expiratory volume in 1 second (fev1) of \<80% of the predicted value * ratio of fev1 to forced vital capacity (fvc) of \<70% * symptom of expectorated sputum for asthma * over 20 years of age and below 85 years of age * scored between 20 to 24 by act (asthma control test) * symptom of expectorated sputum * diagnosed partly controlled by global initiative for asthma exclusion criteria: * egg allergy * domiciliary oxygen therapy * pneumonia or pulmonary tuberculosis * patients with severe cardiovascular disorder, severe kidney disorder, severe hepatic disorder, severe hematological disorder * cancer

Keywords: copd asthma lysozyme hydrochloride
efficacy and tolerability of lanreotide (autogel 120 mg) in patients with acromegaly

Conditions: Acromegaly

Summary: the purpose of the protocol, is to evaluate if lanreotide autogel 120 mg is effective in the control of growth hormone (gh) secretion in patients with active acromegaly.


Eligibility criteria:
inclusion criteria: * documented diagnosis of active acromegaly, defined by serum gh levels above 5 µg/l, absence of reduction of serum gh levels below 1µg/l after oral glucose tolerance test (ogtt) and abnormal igf-1 values exclusion criteria: * patients who have undergone pituitary surgery less than 3 months before selection * patients previously treated with radiotherapy * patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
swallowing exercises for nasopharyngeal cancer after radiation therapy

Conditions: Nasopharyngeal Cancer; Dysphagia

Summary: this study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise programs for patients with npc after radiation therapy. this study also compares two different swallowing exercise: effortful swallow and mendelsohn's maneuver, to see which one can bring more benefits to patients after a certain period of exercise training. three assessment tools are selected to evaluate the study result: mann assessment of swallowing ability (masa), videofluoroscopic swallowing study (vfss), and chinese version swallowing quality-of-life questionnaire (cswal-qol). the hypothesis of this study is that the effortful swallowing exercise would have better treatment efficacy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with npc * completed radiation therapy at least 1 year * mild to moderate swallowing disorder defined by videofluorography * able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions exclusion criteria: * feeding tube insitu * received pharyngeal surgery * tracheostomy tube insitu * patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing * severe swallowing disorder or aspirate defined by videofluorography * other malignances, neurovascular disease, demyelinating disease * cancer relapse or metastases

Keywords: radiation speech-language pathology
mri in bpd subjects

Conditions: Bronchopulmonary Dysplasia

Summary: the investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call bpd (bronchopulmonary dysplasia)

this is an observational case study involving up to three mri visits. the first mri will be complete after the infant's clinical initial evaluation. the second image will be obtained approximately 1 month later and the third mri will be complete prior to discharge. infants will be imaged at various ages, based up their initial evaluation. the investigators will collect urine and obtain clinically collected remnant blood around time of mri, tracheal/endotracheal aspirate at time of the mri when available and bal samples as clinically available. mri findings will be correlated with laboratory findings and outcomes from the medical record, and a research database will be built for the data. the investigators will also obtain a one-time mri visit in non-bpd nicu patients to acquire data related to normal vasculature and pulmonary alveolar development. sub-study 1: inpatient polysomnography patients with the same inclusion/exclusion criteria as reported below will be approached for a brief inpatient polysomnogram. the population will include patients with and without bpd. the polysomnography (psg) will be performed in the nicu within 1 week from the mri that is obtained prior to discharge.

Eligibility criteria:
inclusion criteria: * any term age nicu patient exclusion criteria: * - ecmo, * evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia, * suspected muscular dystrophy or neurologic disorder that may affect lung development. * significant genetic or chromosomal abnormalities that may affect lung development * evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold). * standard mri exclusion criteria as set forth by the cchmc department of radiology. this includes any contraindications from tracheostomy tubes that are not mr compatible.
an active surveillance program for cases of medullary thyroid carcinoma (mtc)

Conditions: Diabetes; Diabetes Mellitus, Type 2; Medullary Thyroid Carcinoma; Weight Management

Summary: this study is conducted in the united states of america (usa). the aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (mtc) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other glp-1 receptor agonists into the us market.

this active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting glp-1 ras and the development of mtc in the united states population. given the very low incidence of mtc in the general population, the expected rate of exposure to long-acting glp-1 ras, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of mtc other than ret proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between mtc and products in the long-acting glp-1 ras class. given the uncertainty of the association of mtc in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting glp-1 ra was thought to provide evidence of an association, if one exists. if such an association is identified, a case-control study will be initiated to quantify the association. the mtc registry is a food and drug administration (fda) post-marketing requirement for long-acting glp-1 ra products. because of the rarity of mtc and in order to minimize inconvenience to patients, physicians, and state cancer registries, fda encouraged sponsors of long-acting glp-1 ras to work collaboratively to conduct this registry. consequently, the mtc registry consortium has been formed for this purpose. the mtc registry consortium refers to the sponsors with approved long-acting glp-1 ras who have a contractual agreement to participate in the mtc registry. this active surveillance program for cases of mtc will be conducted with assistance from the north american association of central cancer registries (naaccr). naaccr is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in north america interested in improving the quality and use of cancer registry data. all of the central cancer registries in the u.s. and canada are members of naaccr, including those that participate in seer.

Eligibility criteria:
inclusion criteria: * a record of medullary thyroid carcinoma (mtc) identified from state/regional population-based cancer registries * at least 18 years or older. there are no other inclusion or exclusion criteria.

Keywords: glp1 glucagon like peptide liraglutide exenatide extended release dulaglutide semaglutide semaglutide tablets
a dose-response study of tranexamic acid in total hip arthroplasty

Conditions: Arthropathy of Hip

Summary: a single preoperative dose of tranexamic acid (txa) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. numerous regimens have been tested, ranging from 10mg/kg up to 3g. however the optimal dose to administer is unknown.

this dose-response study is a randomized double blind study with five groups of 30 patients each. patients will be randomized to placebo, tranexamic acid (txa) 300 mg, tranexamic acid (txa) 500 mg, tranexamic acid (txa) 1000 mg or tranexamic acid (txa) 3000 mg. in addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (txa) plasma concentration as a predictor of intra and postoperative d-dimer values.

Eligibility criteria:
inclusion criteria: * patient requiring primary hip arthroplasty (less than 3 months) * informed consent from the patient or their legally authorized representative * affiliation to french social security healthcare system exclusion criteria: * hip fracture of less than 3 months * bilateral hip arthroplasty or anterior approach to hip arthroplasty * haemorrhagic surgery in the previous 2 weeks * contraindication to tranexamic acid * contraindication to apixaban * chronic use of anticoagulant * pregnancy * previous participation to this study

Keywords: tranexamic acid (txa) arthroplasty hip exacyl
a second open-label extension of a double-blind, parallel, phase iv study to assess the efficacy and safety of adjunctive lovaza® (formerly known as omacor®) therapy in hypertriglyceridemic subjects treated with antara™

Conditions: Hypertriglyceridemia

Summary: this was a 24-month, open-label extension study that followed an 8-week double-blind study (study lov111859/om5) and an 8-week, open-label extension study (lov111860/om5x). study lov111859/om5 was conducted to evaluate whether combination therapy with lovaza (omega-3-acid ethyl esters) and antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. this second extension of 24 months was to assess the continued efficacy of adjunctive lovaza (omega-3-acid ethyl esters) \[formerly known as omacor\] therapy in hypertriglyceridemic subjects treated with antara (fenofibrate) in lowering serum triglyceride (tg) levels.

three studies comprise this program. study lov111859/om5 (double-blind study) was followed by two open label extensions - lov111860/om5x (1st open label extension - 8 weeks) and lov111821/om5xx (2nd open label extension - 24 months). studies lov111859/om5 and lov111860/om5x are outlined in nct00246636.

Eligibility criteria:
subjects were men and women who had successfully completed the previous open-label extension study (lov111860/om5x) and had met all inclusion and exclusion criteria for the original double-blind study (lov111859/om5) and throughout lov111860/om5x, or who had a renewed waiver of a previously approved protocol deviation. eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind lov111859/om5 protocol. subjects were men and women who had successfully completed the previous open-label extension study (lov111860/om5x) and had met all inclusion and exclusion criteria for the original double-blind study (lov111859/om5) and throughout lov111860/om5x, or who had a renewed waiver of a previously approved protocol deviation. the main eligibility criteria for lov111859/om5 were, * 18 to79 years of age (inclusive) at screening * fasting serum tg levels ≥500 mg/dl and \<1300 mg/dl * bmi ≥ 25 kg/m2 and ≤43 kg/m2. subjects enrolled directly from the end of lov111860/om5x into lov111821/om5xx.

Keywords: omega-3-acid ethyl esters very high triglycerides lovaza fenofibrate
the effect of start back screening tool

Conditions: Low Back Pain

Summary: the aim of this study is to examine the effectiveness of start back tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between start back tool test and kinesophobia.

low back pain (lbp) is a common disorder that affects about 80% of adults at least once in a period of their life. 10% of low back pain becomes chronic and can affect the quality of life negatively and lead to disability. the start-back-tool was developed to identify people with poor prognosis, such as difficulty returning to work, loss of work force, disability. it has been reported that it would be beneficial to categorize patients according to their risk levels with this tool and plan treatment in primary care treatment centers. being able to identify patients with a high probability of becoming chronic in the early period is very important to reduce or prevent disability that may occur. the aim of this study is to examine the effectiveness of start back tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between start back tool test and kinesophobia.

Eligibility criteria:
inclusion criteria: * above 18 years old * low back pain for less than 3 months * sign the written informed consent. * being able to read and write exclusion criteria: * inflammatory rheumatologic disease * having a history of lumbar surgery * back pain for more than 3 months

Keywords: start back secreening tool low back pain
access bnp clinical enrollment study

Conditions: Heart Failure

Summary: the goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * adult greater than or equal to 22 years old, any gender, race, ethnicity * presenting with clinical suspicion of new onset heart failure or worsening symptoms suggestive of decompensated or exacerbated heart failure * ability to fulfill study data collection requirements (including responding to questions for the nyha evaluation) exclusion criteria: * individuals less than 22 years old * impairment in individual's capacity to give informed consent * dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma). * on dialysis * on nesiritide infusion * subject clinical/medical history access is not available to sponsor, delegates, and fda or other regulatory agencies upon request. * active participation in a clinical study that may interfere with participation in this study (e.g., investigational drug study) * reason(s) determined by the principal investigator that would place the individual at increased risk or preclude the individual from fully complying with or completing the study.
study of the pharmacokinetics and safety of voriconazole in children 2 to less than 15 years old who are at high risk for systemic fungal infection

Conditions: Aspergillosis, Aspergilloma

Summary: in this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. we give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. meanwhile, we draw a little bit of blood at certain times to measure the drug in it.


Eligibility criteria:
inclusion criteria: * male or female from 2 to \<15 years of age. * require treatment for the prevention of systemic fungal infection. * expected to develop neutropenia (anc \<500 cells/ul) lasting more than 10 days following chemotherapy. * anticipated to live for more than 3 months. exclusion criteria: * evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia. * documented bacterial or viral infection not responding to appropriate treatment. * hypersensitivity to or severe intolerance of azole antifungal agents. * receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Keywords: open-label pharmacokinetics intravenous to oral switch safety voriconazole immunocompromise children high risk for systemic fungal infection