Kornimate/medical-research-clean huggingface dataset:
promoting adherence to improve effectiveness of cardiovascular disease therapies

Conditions: Diabetes Mellitus; Cardiovascular Disease

Summary: the purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (cvd) and diabetes.

the frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. the proposed patient study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.

Eligibility criteria:
inclusion criteria: * aged 40 years or older as of time of randomization. * flagged in kp's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization * at least one dispensing of an acei, arb, or statin from a kaiser permanente (kp) outpatient pharmacy during the baseline year. * suboptimal adherence ((mpr\<0.9) to either statins or acei/arbs during the baseline year * continuous membership in kp for the 12 months prior to randomization. * qualified for an intervention call at the time of randomization. exclusion criteria: * evidence in the electronic medical record (emr) of allergy or intolerance to statins or ace inhibitors/arbs * medical conditions that would contraindicate use of statins or acei/arbs * absence of either a phone number or mailing address in the emr * for kaiser permanente hawaii, clinics whose patients tend to fill prescriptions primarily at non-kp pharmacies * on kaiser permanente's "do not contact" list or in other research studies that could add undue burden

Keywords: diabetes cardiovascular disease randomized clinical trial medication adherence health information technology adult telephone calls ivr
an eight-week study evaluating the efficacy and tolerability of two doses of ssr149415 in outpatients with generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the objective is to evaluate the efficacy and safety of two doses of ssr149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder


Eligibility criteria:
inclusion criteria: * diagnosis of generalized anxiety disorder, as defined by diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria and confirmed by the semi-structured mini international neuropsychiatric interview (mini) general anxiety disorder (gad) plus module. exclusion criteria: * total score of less than 22 on the (hamilton anxiety rating scale)ham-a. * montgomery-asberg depression rating scale (madrs) total score greater than 17. * patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, antidepressants including monoamine oxidase inhibitors (maois) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: anti-anxiety agents antidepressive agents controlled clinical trial
a dose ranging trial of 4 doses of indacaterol delivered via the twisthaler® device in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: this study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the twisthaler® device.


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure (which include any adjustment to their current copd treatment) * cooperative outpatients with a diagnosis of copd (moderate to severe as classified by the global initiative for obstructive lung disease (gold) guidelines, 2006) and: * smoking history of at least 10 pack years * post-bronchodilator forced expiratory volume in one second (fev1) \< 80% and ≥30% of the predicted normal value. * post-bronchodilator fev1/forced vital capacity (fvc) \< 70% exclusion criteria: * pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception. * patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to visit 1 or between visit 1 and visit 2. * patients with a history of asthma. * patients with an acute respiratory tract infection within 4 weeks prior to visit 1, will be not allowed to enter the study. * other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: qmf indacaterol twisthaler® device
fish and marine fatty acids, genetic signatures of diet adaptation, and long-term weight changes

Conditions: Obesity

Summary: the investigators tested whether genetic variants near fads cluster, which were recently identified to be signatures of adaptation to fish- and n-3 pufas-rich diet, interacted with these dietary factors on long-term change of body mass index (bmi).


Eligibility criteria:
inclusion criteria: * 11,323 women of european ancestry. * informed consent was obtained from all participants. the dna extraction methods, quality control measures, * snps genotyping and imputation data are available . * both cases and controls with genotyping data are available based on gwass exclusion criteria: * participants without genetic data
efficacy and safety of biphasic insulin aspart 30 flexpen® in insulin naive subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (oha).


Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin naive diabetes * current treatment with oha, secondary failure * body mass index (bmi) below 40 kg/m2 * hba1c over 8.5% * willing and able to start with insulin therapy and to perform self-blood glucose monitoring exclusion criteria: * history of drug or alcohol abuse * receipt of the investigational drug within the last month prior to this trial * known or suspected allergy to trial products or related products * severe uncontrolled hypertension * any disease or condition, which the investigator feels, would interfere with the trial
electromagnetic tracking to measure tremor

Conditions: Tremor

Summary: deep brain stimulation (dbs) is an effective treatment option for individuals with debilitating tremors that do not respond to medical therapy. however, severe tremors, particularly those that develop after central nervous system insult or from multiple sclerosis, can be comprised of several underlying components that represent dysfunction within distinct brain circuits. some of these dysfunctional brain circuits can be successfully treated with dbs while others respond poorly dbs therapy. for severe tremors, it can be very difficult to discriminate between the underlying components of a patient movement disorder and is exclusively dependent upon clinical expertise. even with extensive clinical experience, it is difficult to reliably predict the results of dbs therapy for patients suffering from severe, debilitating tremor. in an attempt to gain more knowledge, an electromagnetic tracking system will be used which can precisely measure the position of a patient's upper extremity in space during routine neurologic examination. the goal is to use this tool to quantitatively identify various components of severe tremor, which can be discriminated based on oscillatory frequency and regularity of tremor amplitude. the purpose of this research study is to better understand the nature of complex, severe tremors by carefully measuring movement of the upper extremities with sensors during simple tasks. the goal is to break down complicated tremors into their components and then determine which components will respond to deep brain stimulation.

as a participant in the research study small sensors that are connected to wires will be affixed to points on your hand, wrist, elbow and/or shoulder. these sensors are painless and otherwise noninvasive. they will be used to measure the precise location of the hand and arm in space during the neurologic examination. this exam will test the tremors during short, simple tasks using the hand and arm. this information will be stored along with your name and medical record number for analysis after your testing is complete. the sensors that are used to measure movements are connected to thin, flexible wires that will be attached with adhesive tape. the motion sensors use a magnet that produces a weak electromagnetic field. this electromagnetic field poses no direct harm, but could potentially interfere with medical devices such as cardiac pacemakers or deep brain stimulators if placed very close to the electromagnetic emitter.

Eligibility criteria:
inclusion criteria: * adults * individuals who have undergone or are scheduled to undergo deep brain stimulation (dbs) placement exclusion criteria: * individuals who have not had or are not scheduled for deep brain stimulation (dbs) placement
verification of the root form classification of impacted lower third molars

Conditions: Impacted Lower Third Molars Roots

Summary: a clinical study will be conducted to verify the reliability of the root form classification of impacted lower third molars that was put by abu-mostafa n (2023) the root forms of partially or fully impacted lower third molars will be classified pre-operatively based on panoramic radiograph, then clinically after extraction, and the identified root classifications will be compared.

according to abu-mostafa n, the roots of impacted lower third molars are classified into two types: fused roots and separated roots. both have different forms: fused roots forms: straight, curved distal, curved mesial, and s-shaped. separated roots forms: straight, both roots are curved distal, both roots are curved mesial, joined roots, one root is straight and one is curved, and more than two roots. a panoramic radiograph will be taken before extraction, then the roots will be classified by two oral biologist and oral and maxillofacial surgeon individually. after surgical extraction of the third molar, the roots will be examined clinically and classified according to the same classification. the two pre-extraction radiographic classifications will be compared together, and then they will be compared with the clinical classification to check if there is a discrepancy. the surgical extraction procedure: local anesthesia will be achieved by inferior alveolar nerve block and buccal infiltration using lidocaine 2% with epinephrine 1:100,000. a flap with a distobuccal releasing incision will be done. the bone reduction will be performed by a low-speed surgical handpiece under irrigation with normal saline. root separation is done of required for the third molars with separated root forms. the tooth will be luxated by straight elevators and then extracted. the evaluation results will be categorized to: * agreement: the two pre-extraction radiographic evaluations and the clinical evaluations are similar * discrepancy 1: one pre-extraction radiographic evaluation and the clinical evaluations are similar, but the other radiographic evaluation differs. * discrepancy 2: the two pre-extraction radiographic evaluations are similar, but the clinical evaluation differs. * disagreement: the three evaluations are different the results will be analyzed regarding frequencies and association of each category with root forms

Eligibility criteria:
inclusion criteria: patients with impacted lower third molars who visit riyadh elm university" hospital and have lower third molars which are diagnosed clinically and radiographically as partially or fully impacted. the roots of these third molars have to be fully formed. exclusion criteria: incomplete apex formation and root resorption

Keywords: impacted lower third olars roots morphology root forms
fluency® plus in the treatment of peripheral artery disease

Conditions: Vascular Diseases, Peripheral

Summary: this is a retrospective, multi-center study to assess the safety and performance by proactively reviewing pre-existing medical records and imaging of patients who had previous placement of fluency® plus vascular stent graft in iliac artery vessel(s) between january 2010 and march 2020.

the purpose of this study is to retrospectively collect and analyze data on the fluency® plus vascular stent graft to summarize and describe real-world experience, and long-term data regarding its safety and efficacy and to compare these findings with published data on stent-treatment in iliac artery disease. the present study aims to collect clinical data about fluency® treatment of atherosclerotic disease (stenosis, occlusion, dissection) as well as to explore safety and effectiveness data for off-label use in additional indications in the iliac segment that have been described in the scientific literature (vessel rupture, aneurysm).

Eligibility criteria:
inclusion criteria: * the fluency® plus vascular stent graft implantation procedure was for the purpose of lesions in the iliac arteries. * the fluency® plus vascular stent graft was placed between january 2010 and march 2020. * male or female ≥ 18 years old at the time of implantation. * the subject provides written informed consent. the subject may be enrolled without informed consent for anonymous data collection if the responsible ethics committee has waived the requirement due to the retrospective study design, and written documentation about this decision is provided to the investigator and the sponsor. exclusion criteria: * the fluency® plus vascular stent graft was implanted in an anatomic location other than iliac arteries. * absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the fluency® plus vascular stent graft. * subjects without any existing follow-up information after hospital discharge (this criterion does not apply to subjects who deceased during implantation/prior to discharge). * the subject was identified with a medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, or confound the data interpretation.

Keywords: iliac artery disease vascular stent graft
erector spinae plane block for peri-operative pain management in pediatric open pyeloplasty cases

Conditions: Anesthesia and Analgesia; Pediatrics; Urologic Surgical Procedures

Summary: regional anesthesia decreases the need for intravenous analgesia in the peri-operative period. erector spinae plane (esp) and transversus abdominus plane (tap) blocks are two common regional anesthesia techniques shown to be effective in open abdominal surgeries. we aim to compare effectiveness of esp block with tap block for peri-operative analgesia in pediatric open pyeloplasty patients with a flank incision.

regional anesthesia for effective post-operative pain management is a part of the pediatric enhanced recovery after surgery (eras) protocol. epidural anesthesia is the gold standard for analgesia for open abdominal surgeries, however difficulties in application and possible complications deter clinicians from utilizing this method. safe and effective alternatives to epidural anesthesia has been a critical and popular focus of clinical research in recent years. transversus abdominus plane (tap) block is an alternative technique shown to be effective in pediatric open abdominal surgeries. erector spinae plane (esp) block was described as an effective block for multi-dermatome pain after thoracic surgery. it is emerging as a safe and easy-to-perform alternative to epidural anesthesia for pelvic, abdominal and thoracic surgery. during an open pyeloplasty, the flank incision goes through the transversus abdominus plane, where the local anesthetic is injected for tap block. this may weaken the analgesic effect of the block. in the esp block, local anesthetic diffuses cranio-caudally through the fascia of erector spinae muscles and the flank incision does not disturb this plane. we aim to compare the effectiveness of esp block with tap block in open pyeloplasty patients.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist class i, ii or iii * patients scheduled for elective open pyeloplasty surgery exclusion criteria: * local anesthetic allergy or other contraindication to local anesthetic use * coagulation disorders * history of chronic pain * patient/family refusal * history of scoliosis, spinae bifida, abdominal wall defect * past surgical procedures with abdominal wall incision * plan to extend the flank incision for additional surgical intervention

Keywords: esp block tap block pyeloplasty erector spina plane block transversus abdominus plane block flank incision post-op analgesia peri-op analgesia
developing and validating the simple measure of attitudes and risk-taking after acl reconstruction (smart-acl) scale

Conditions: ACL Surgery; ACL Injuries; ACL Reconstruction

Summary: psychological factors play a critical role in recovery following anterior cruciate ligament (acl) reconstruction. while tools such as the acl - return to sport after injury (acl-rsi) focus on psychological readiness, emphasizing fear, hesitation, and apprehension, the opposite spectrum-overconfidence and risk-taking behaviors-remains underexplored. these behaviors can lead to premature return to high-risk activities and an increased likelihood of re-injury. to address this gap, we propose the development and validation of the smart-acl scale: a simple measure of attitudes and risk-taking after acl reconstruction. this scale will assess key factors such as patients' willingness to engage in high-impact activities, their adherence to medical guidance, and their perceived readiness to resume sports despite potential physical or psychological limitations. the smart-acl scale will complement existing tools like the acl-rsi by focusing on overconfidence and risk-taking, offering clinicians a more balanced perspective on psychological recovery. validation of the scale will involve testing its validity, reliability and clinical utility to ensure accurate identification of at-risk individuals. by providing actionable insights, the smart-acl scale will help enhance post-operative care, promote safer return-to-play decisions, and optimize long-term outcomes through a comprehensive assessment of psychological and behavioral factors.


Eligibility criteria:
inclusion criteria: * patients who have had an acl reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) * patient included in the sport medicine follow-up protocole * patients who have provided informed consent. exclusion criteria: * participants who are not included in the return-to-sport process

Keywords: postoperative care return to sport risk-taking anterior cruciate ligament injuries
outcomes on abdominal versus vaginal morcellation at time of hysterectomy

Conditions: Abnormal Uterine Bleeding; Uterine Bleeding; Fibroid Uterus; Surgery

Summary: the purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (am) versus vaginal (vm) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.

the purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (am) versus vaginal (vm) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial. objectives: 1. to evaluate differences in total operating time between subjects undergoing am compared to vm. 2. to evaluate differences in morcellation time between am and vm. 3. to evaluate differences in the amount of total narcotic use during hospital admission between am and vm through morphine milligram equivalents (mme). 4. to evaluate differences in the patient's subjective pain assessment via visual analogue scale (vas) before surgery, at 2-weeks, and at 6 week post-operative visits in both am and vm groups. 5. to evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between am and vm groups. 6. to evaluate differences in body image survey (bis) scores at enrollment and 6-week postoperative visit between the am group compared to vm group. 7. to evaluate differences in overall quality of life (qol) scores at enrollment and 6-week postoperative visit between the am group compared to vm group. 8. to evaluate differences in quality of recovery (qor) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between am and vm group.

Eligibility criteria:
inclusion criteria: * all benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy * adnexectomy, cystectomy, tubal procedures at time of hysterectomy * age \>18 years old * uterus \>12 weeks, or \>250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment * english and spanish speaking exclusion criteria: * pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation * planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy) * appendectomy for endometriosis is not excluded * no chronic pain disorders requiring medical management (endometriosis can be included) * planned abdominal hysterectomy or vaginal hysterectomy candidates * conversion to laparotomy or inability to complete morcellation * contraindications to laparoscopy

Keywords: hysterectomy abnormal uterine bleeding morcellation abdominal vaginal surgery laparoscopic laparoscopy total hysterectomy pelvic pain endometriosis