Kornimate/medical-research-clean huggingface dataset:
substance use risk education (sure) project

Conditions: Alcohol Abuse; Alcohol Drinking

Summary: this project is designed to compare college drinking interventions on outcomes and cost-effectiveness. we plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, alcohol 101plus (an interactive cd-rom program), and alcoholedu (a web-based tutorial). participants will be followed over 12 months to determine changes in alcohol consumption and related problems. we will also explore which participants might respond better to one intervention vs the others.

many college students engage in heavy episodic drinking, a pattern that increases risks of undesired academic, social, health, and legal consequences. fortunately, brief motivational interventions - when administered during face-to-face sessions by a trained counselor - can help students to reduce their heavy drinking and related consequences. however, use of such counselor-administered interventions on college campuses remains infrequent; instead, administrators rely on computerized brief interventions because they can be administered with fewer staff at lower cost. two computer-administered interventions (alcoholedu and alcohol 101 plus) are used by more than 1,000 colleges and universities nationwide, even though these interventions have not been evaluated in controlled studies. despite the magnitude of the college-drinking problem, no data have addressed the differential efficacy (or cost-effectiveness) of the computer-administered versus counselor-administered brief motivational interventions. thus, the primary purpose of the proposed research is to address gaps in the scientific literature by evaluating outcomes of three types of brief motivational interventions: a theoretically-based and empirically-tested counselor-administered intervention and the two most popular computerized interventions. a secondary purpose of the proposed research is to identify predictors of outcomes, and moderators associated with differential intervention response. a tertiary purpose is to assess the cost-effectiveness of three types of brief motivational interventions. the proposed research will be a randomized controlled trial with four treatment conditions and four assessment occasions. we will recruit at-risk student drinkers who have been sanctioned to receive an alcohol education intervention because they violated a residence hall policy. these referred students will be randomized to one of the three interventions, or to a delayed intervention control; and assessed at baseline and again 1, 6, and 12 months later on key drinking and drinking consequences outcomes.

Eligibility criteria:
inclusion criteria: * freshman, sophomore, and junior college students * students sanctioned for an alcohol-related violation on campus exclusion criteria: * year in college: senior

Keywords: alcohol abuse alcohol drinking intervention studies computer-assisted instruction college students
safety and tolerability of lixisenatide in combination with oral anti-diabetic treatment in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: the primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in japan. secondary objective: to assess the effects of lixisenatide in combination with background oral antidiabetic drug (oad) on: * hba1c; * fasting plasma glucose; * body weight.

54 weeks +/-11 days

Eligibility criteria:
inclusion criteria : * patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit * patient treated for at least 3 months prior to screening visit with one of following oads at a stable dose of at least usual maintenance dose as described in the label * a biguanide (metformin hydrochloride); * a thiazolidinedione (tzd) (pioglitazone hydrochloride); * an alpha-glucosidase inhibitor (alpha-gi) (acarbose, voglibose or miglitol); * or a glinide (nateglinide, repaglinide or mitiglinide); * signed written informed consent exclusion criteria: * at screening hba1c \ 9.5%; * at screening: fasting plasma glucose \>250 mg/dl (\>13.9 mmol/l); * use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in i02 (as given in inclusion critieria) within 3 months prior to screening; * type 1 diabetes mellitus; * women of childbearing potential with no effective contraceptive method; * pregnancy or lactation; * laboratory findings at the time of screening: * amylase and/or lipase \>3 times the upper limit of the normal laboratory range (uln); * alt \>3 uln; * any contra-indication to the patient's background oral anti-diabetic treatment; * history of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease; * personal or immediate family history of medullary thyroid cancer (mtc) or genetic conditions that predispose to mtc (eg, multiple endocrine neoplasia syndromes); * any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other glp1 receptor agonist. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
clinical study for the investigation and validation of a therapy procedure for the adjustment of risk factors in patients with coronary heart disease by means of digital therapy control

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Coronary Heart Disease; Ischemic Heart Disease

Summary: this study will test a controlled investigation of the efficacy and effectiveness of iatros digital therapy management for risk factor adjustment in patients with coronary heart disease (chd).

the purpose of this study is to determine the efficacy and effectiveness of iatros digital therapy management for risk factor adjustment in patients with coronary heart disease compared to the medical standard of care. in addition, data will be provided to investigate the functionality of the rule engine in the treatment of chd patients and insights will be gained for the further development of this component of the iatros platform for the digital and intelligent treatment of patients. furthermore, the use of digital everyday products (smartphones) in secondary prevention and therapy management of chd patients will be considered.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * patients diagnosed with ischemic heart disease according to icd i20 to i25 who also have at least one of the following: 1. inpatient stay with acute stemi/nstemi or historic stemi/nstemi; and/or 2. coronary stent implantation, angioplasty or bypass surgery that has taken place. * ownership and use of a smartphone that allows installation and use of "iatros," where "use" requires having the physical and mental ability to use and apply the iatros app. * insured with the cooperating insurances exclusion criteria: * no use of a smartphone * lack of the linguistic, physical and mental abilities necessary to use the iatros app, or to use so-called "apps" on a smartphone or tablet in general. * absolute contraindications: any disease associated with a reduced life expectancy of less than 2 years; any disease/condition that limits participation in the program; pregnant or breast feeding patients; patients with advanced dementia * existing participation and enrollment in an iatros health program. * participation in another clinical trial if participation results in complications with compliance, measures to be performed, bias of results, or status of treatment according to the current standard of care. * comorbidities or the presence of another physical condition that complicates the setting of the clinical target parameters sought in the study (i.e., if, due to the patient's individual situation, a different value would have to be issued as the target value for a clinical parameter to be classified as healthy).

Keywords: ehealth cardiology coronary artery disease
six month study of gentamicin in duchenne muscular dystrophy with stop codons

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to determine the safety of giving intravenous (iv) gentamicin to boys with duchenne muscular dystrophy who have stop codon mutations.

the primary purpose of this second cohort is to see if the iv medication, gentamicin, is safe to give twice a week for six months to boys with duchenne muscular dystrophy (dmd). secondarily, we want to know if gentamicin can help strengthen the muscles of boys with dmd who have a particular type of genetic mutation known as a stop codon. the gentamicin is thought to allow for "read-through" of this type of mutation which would allow for the production of dystrophin, a protein which is lacking in boys with dmd.

Eligibility criteria:
inclusion criteria: * age 5-20 years * duchenne muscular dystrophy documented by written report of stop codon mutation analysis of the dystrophin gene. * subject is capable of cooperating for efficacy and safety testing * absent dystrophin on muscle biopsy * subjects may be untreated, taking prednisone or comparable corticosteroids * subjects taking corticosteroids must be on the same dose for at least 3 months (90 days) prior to the start of the study. exclusion criteria: * known allergy to any aminoglycoside or sulfate compounds * current use of potential nephrotoxic or ototoxic drug * current use of corticosteroids has not been stable for 3 months (90) days * known mutation at nucleotide 1555 in 12s rrna gene of mitochondrial dna (predisposes to aminoglycoside hearing loss and commercially available via athena diagnostics lab). this dna testing (hearing susceptibility test) will be made available through funding from this grant. * inability to hear within the range of 0 to 25 db in any hearing frequency by pure tone audiometry * cystatin c equal to or \> 1.4mg/l * other medical condition that would impede the conduct of study (e.g., congestive heart failure)

Keywords: stop codon mutations
a study of wearable device in essential tremor patients

Conditions: Essential Tremor

Summary: the purpose of this research is to observe the daily loss of benefit from dbs therapy by performing a standardized set of tasks throughout the day while wearing an apple watch to collect movement and other physiological data.


Eligibility criteria:
inclusion criteria: * patients with well-classified essential tremor, who are already receiving regular dbs therapy at mayo clinic for their movement disorder. * ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol. * patient agrees to perform daily tasks in brainrise app and consents to the study collecting video and audio recordings during those tasks. * proficient in the use of a smart phone. exclusion criteria: * cognitive or psychiatric condition rendering a patient unable to cooperate with data collection, or to manage and recharge smart watch and tablet computer devices. * presence of open or healing wounds near monitoring sites (infection risk). * inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Keywords: deep brain stimulation therapy
registry study to observe long-term safety of vamorolone (agamree®) in patients with duchenne muscular dystrophy.

Conditions: Duchenne Muscular Dystrophy

Summary: the goal of this observational study is to follow patients being treated with the fda approved drug agamree® in male patients 2 years of age or older with duchenne's muscular dystrophy for long term safety and quality of life.

this is a multi-center, observational, prospective, longitudinal registry designed to collect data in male patients aged 2 years and older with dmd treated with agamree®. this registry will be conducted in the us, at approximately 25 sites known to treat and follow patients with dmd. the registry plans to enroll approximately 250 male patients aged 2 years and older with dmd. evaluations will include: * growth parameters * body mass index (bmi) * vital signs * physical exam * laboratory (chemistry and hematology) * north star ambulatory assessment (nsaa) * performance of upper limb (pul) * cardiovascular status * fractures * bone density * puberty * quality of life (qol) * adverse events (aes) patients will be followed for approximately 5 years in the registry and will return to the site for yearly follow-up visits (+/- 30 days) for registry assessments. information on standard of care treatment and procedures for management of dmd will also be collected. patients and/or their parents/legal guardians will be asked to complete paper qol questionnaires at enrollment and at each yearly follow-up visit (+/- 30 days).

Eligibility criteria:
inclusion criteria: 1. patient or parent/guardian willing and able to provide written informed consent after the nature of the registry has been explained and before the start of any registry-related procedures. 2. patient and/or parent/guardian are willing and able to complete qol questionnaires. 3. male patients at least 2 years old. 4. confirmed diagnosis of dmd (via genetic testing or muscle biopsy with absent dystrophin staining to antidystrophin antibodies 3, 1, or 2, or dystrophin immunohistochemistry or western blot). 5. currently on treatment with agamree®. exclusion criteria: 1. any contraindication to agamree® or medical condition, which, in the opinion of the investigator, would affect registry participation, performance, or interpretation of registry assessments.

Keywords: duchenne muscular dystrophy neuromuscular agamree®
phase i study to investigate the safety, tolerability, and pharmacokinetics/pharmacodynamics of cj-12406 in healthy male subjects

Conditions: Digestive System Diseases

Summary: study objectives * to evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of cj-12406 in healthy male subjects. * to evaluate the pharmacodynamics of cj-12406 after multiple oral administrations to healthy male subjects. * to evaluate the effect of food on the pharmacokinetic of a single oral dose of cj-12406 in healthy male subjects.


Eligibility criteria:
inclusion criteria: 1. male volunteers in the age between 20 and 45 years old 2. subjects with no history of any significant chronic disease 3. the weight range is not exceed ±20% of ideal weight. ideal weight = \[height -100\]\*0.9 4. judged to be in good health on the basis of their vital sign, ecg, physical exam and routine laboratory data 5. available for the entire study period 6. willing to adhere to protocol requirements and sign a informed consent form 7. multiple escalation study; h. pylori positive, as determined by the urea breath test exclusion criteria: 1. history of clinically significant allergies including drug allergies 2. history of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease 3. symptom of an acute illness within 4 weeks prior to drug administration 4. history of surgery except or gastrointestinal diseases which might significantly change absorption of medicines 5. treatments or symptoms of symptomatic gerd, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration 6. clinical laboratory test values are outside the accepted normal range * ast or alt \>1.25 times to normal range * creatinine clearance \<80 ml/min * 12-lead ecg; pr ≥ 210 msec, qrs ≥ 120 msec, qt ≥ 500 msec, qtcf ≥ 450 msec 7. clinically significant vital signs * hypotension (sbp ≤ 89 mmhg) * hypertension (sbp ≥ 141 mmhg or dbp ≥ 91 mmhg) * tachycardia (≥ 101 beats/min) 8. history of drug and alcohol abuse(alcohol \> 30 g/day) 9. subjects who have ever smoke within 3 months prior to drug administration 10. positive urine screen for drugs and cotinine 11. use of any other medication, including herbal products, within the 2 weeks before dosing 12. special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration 13. donated blood within 60 days prior to dosing 14. participated in a previous clinical trial within 90 days prior to dosing 15. subjects considered as unsuitable based on medical judgement by investigators
a validation/interventional study on stress index in predicting mechanical stress in ards patients

Conditions: Respiratory Distress Syndrome, Adult

Summary: 30% of ards patients ventilated according to nih protocol presents ct scan evidence of hyperinflation. functional analysis of pressure-time curve (stress index=si) has been shown to identify this condition in experimental settings. we tested the hypothesis that the si is an accurate predictor of mechanical stress due to overdistention in ards patients.

the study presents two parts : a preliminary validation study and a clinical study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of ards based on american-european consensus conference criteria exclusion criteria: * \>3 days since ards criteria were met and mechanical ventilation was started * history of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month * pre-existing chronic obstructive pulmonary disease * major chest wall abnormalities * chest tube with persistent air leak * abdominal distension * body mass index \>30 * pregnancy * known intracranial abnormality * enrollment in another interventional study

Keywords: ards pressure/time curve stress index
management of eyelid disorders by ophthalmologists in usual medical practice

Conditions: Palpebral Pathologies; Ocular Surface Disease; Meibomian Gland Dysfunction

Summary: the purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.


Eligibility criteria:
inclusion criteria: * outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation * patients informed of the objectives of the survey and agreeing to participate. * patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.

Keywords: mgd ocular surface pathologies
medtronic terminate af study

Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the cardioblate irf and cryoflex hand held devices for the treatment of non-paroxysmal af.

this is a multi-center, single-arm, prospective, non-randomized, interventional study. a maximum of 160 subjects will be treated at up to 25 centers in the us. the study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. subjects will be followed and assessed after procedure and for 12 months. the purpose of this study is to evaluate the safety and effectiveness of the cardioblate surgical ablation irf and cryoflex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Eligibility criteria:
inclusion criteria: * history of non-paroxysmal af (persistent or longstanding persistent) * concomitant indication for non-emergent open-heart surgery, eg, 1. coronary artery bypass grafting 2. valve repair or replacement * able to take the anticoagulant warfarin or novel oral anticoagulants (noac) exclusion criteria: * wolff-parkinson-white syndrome * nyha class = iv * left ventricular ejection fraction ≤ 30% * need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery * previous af ablation, av-nodal ablation, or surgical maze procedure * contraindication for anticoagulation therapy * left atrial diameter \> 6.0 cm * preoperative need for an intra-aortic balloon pump or intravenous inotropes * renal failure requiring dialysis or hepatic failure * life expectancy of less than 1 year * predicted risk of operative mortality \>10% as assessed by sts risk calculator * pregnancy or desire to be pregnant within 12 months of the study treatment * current diagnosis of active systemic infection * active endocarditis * documented mi 30 days prior to study enrollment * current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias
evaluation of body iron stores in overweight healthy volunteers

Conditions: Healthy Volunteers; Overweight

Summary: normal body iron store value in overweight subjects is currently not described in literature. the comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (dios) could allow to quantify iron overload in this condition. the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to dios patients treated with phlebotomy.

normal body iron store value in overweight subjects is currently not described in literature. the comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (dios) could allow to quantify iron overload in this condition. dios is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. it is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by mri or liver biopsy. some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload. the debate surrounding iron overload in dios is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, mri). at present, phlebotomy is the standard method used to determine body iron stores. using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to dios patients treated with phlebotomy included in another ongoing clinical trial (saignees - clinicaltrials.gov identifier: nct01045525).

Eligibility criteria:
inclusion criteria: * male, * at least 18 years old * bmi \> 25 kg/m2 * serum ferritin level between 100 et 300 µg/l * written informed consent exclusion criteria: * blood donations in the past two years * alcohol consumption more than 30 g/day * inflammatory syndrome (crp \> 10 mg/l) * inflammatory, dysimmunitary or cancerous disease * hepatic cytolysis * transferrin saturation \> 45% * person involved in another clinical trial * person with a measure of legal protection (guardianship) * person who reached the annual limit for compensation provided by biomedical research * hemoglobin \< 13 g/dl * uncontrolled heart failure or coronary insufficiency * abnormal ecg * echocardiographic abnormalities contraindicating phlebotomy * hepatic, renal or respiratory insufficiency * superficial venous network insufficiency

Keywords: ferritins iron overload metabolic syndrome venesection therapy volunteers