Kornimate/medical-research-clean huggingface dataset:
my diabetes, my community

Conditions: Type 2 Diabetes

Summary: older adults with diabetes are a highly vulnerable population that suffers the highest rates of cardiovascular and microvascular complications as well as adverse drug events such as hypoglycemia. investigators will conduct a 12-month pragmatic clinical trial evaluating the impact of scalable interventions that are designed to support personalized goal setting and self-care through remote delivery of clinical and socioeconomic risk assessment, telephonic care management, and community resource linkage. this highly personalized approach to diabetes care has to potential to improve quality of life of this high-risk population while avoiding adverse drug events.

to address the needs of older patients with diabetes, multiple organizations have called for a personalized approach to setting risk factor goals and self-care plans. the american geriatrics society (ags) and the american diabetes association (ada) have published recommendations urging individualized glycemic goals (hemoglobin a1c (a1c) \<7.5%, \<8.0%, or \<8.5%) for three strata of older patients (healthy, complex, very complex). the guidelines also acknowledge the importance of addressing socioeconomic risks that are barriers to self-care management such as cost-related non-adherence and food insecurity. despite widespread agreement by experts, the clinical impact of this highly personalized approach to diabetes care for older adults has been rarely studied in controlled trials. interventions designed to personalize diabetes care must overcome multiple challenges to implementation including the brief clinical encounter, lack of patient engagement between encounters, and lack of systems to leverage community-based self-care resources. investigators propose to address these knowledge and care gaps by studying the integration of two evidence-based interventions designed to engage patients and enhance self-care:. managing diabetes to gain opportunities for a more active life (my diabetes goal) and communityrx. the my diabetes goal intervention is designed to engage older patients in personalized goal setting and chronic disease management.

Eligibility criteria:
inclusion criteria: 1. history of type 2 diabetes 2. seen in clinic within past year 3. a1c\>7.5% 4. community dwelling 5. access to personal email address or internet access 6. speaks and reads english 7. resides in the target geographic region (zip codes) exclusion criteria: 1. unable to consent to study for themselves 2. prior participation in crxcaregiver, crxhunger, or my diabetes goal trials
tooth borne versus temporary anchorage devices (tad) based intrusion systems for the correction of anterior deep overbite

Conditions: Deep Overbite

Summary: compare the tooth borne versus fixed orthodontic intrusive system (tads) for the correction of anterior deep overbite

this study determined which method was more compliant, efficacy and comfortable. it was performed to evaluate intrusion of upper incisors with applying tooth borne system as connecticut intrusion arch (cia) and temporary anchorage devices (tads) \[miniscrew\] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. it also evaluated oral hygiene and pain sensation in the two groups during the study period.

Eligibility criteria:
inclusion criteria: 1. class i or class ii malocclusion with minimal crowding. 2. 70% to 100% overbite. 3. high lip line with gingival display on smiling and super-eruption of maxillary incisors. 4. all patients had permanent dentition with average to vertical growth pattern and curve of spee of 4mm or less. exclusion criteria: 1. having missing teeth on the anterior maxillary area. 2. any history of trauma or root canal treatment. 3. previous orthodontic treatment. 4. low lip line duing social smile. 5. having any hormonal disorder or syndromes.

Keywords: anterior deep bite intrusive arch miniscrews
active bodysuits for adult degenerative scoliosis

Conditions: Scoliosis

Summary: adult degenerative (de novo) scoliosis (ads) is a condition of the ageing population caused by degenerative changes without pre-existing spinal deformity. pain is the most frequent problem, especially low back pain and radicular pain, and seriously affects the daily activities and health of ads patients. the current treatment for ads is not well defined. the main intervention for ads treatment is surgical, but surgery is clearly not appropriate for every patient. active bodysuits will be designed based on body alignment and pain management using special design components and incorporating active posture training from a biofeedback system. back pain is often localized along the convexity of the curve, and passive support to the areas of pain, most likely in the lower trunk, hip and lower extremities, should be provided.

the potential materials that can provide support are 3d printable rigid materials, semirigid foam padding, velcro tape and stretchable wide waistbands. the 3d printable materials can be very versatile in terms of properties and can be further finished with an epoxy resin or thermoplastics. different compositions and structures of knitted fabrics will be used in different areas of the proposed bodysuits to provide a close fit, high breathability and effective pain management due to extra support. the fastening system includes a magnetic zipper and pulley system that can be adjusted by pulling on knobs. the pulley system contains a microadjustable dial, super-strong lightweight lacing, and low friction lacing guides.

Eligibility criteria:
inclusion criteria: * adults diagnosed with degenerative scoliosis * cobb's angle greater than 25 degrees * chronic lower back pain * limited mobility due to degenerative scoliosis exclusion criteria: * substantial cardiac, pulmonary, renal or metabolic disease * neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, parkinson's disease, post-polio syndrome, charcot marie tooth disease) * spine tumor, infection or connective tissue disorder * cognitively impaired or unable/unwilling to comply with follow-up * past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine

Keywords: active bodysuits
avalus european registry - an observational study to evaluate safety and efficacy in a real world population

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: this is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the avalus valve. this prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the avalus pericardial bioprosthesis.

the study is a prospective, observational, single-arm, multi-center registry. the patients must undergoing bioprosthetic aortic valve replacement with the avalus valve. this prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the avalus pericardial bioprosthesis. the goal of this project is to evaluate the real world results of aortic valve replacement with the avalus valve. this will result in clinical and hemodynamic knowledge of this particular valve. the investigators are aiming for 1000 patient inclusions distributed over 40 sites across europe and potentially also involving canada. intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. outcome is evaluated in accordance with the varc-2 criteria up to 1-year postoperatively.

Eligibility criteria:
inclusion criteria: * clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis * age \>= 18 years * patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry. exclusion criteria: * patient requires salvage surgery (according to euroscore ii definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. this does not include cardiopulmonary resuscitation following induction of anaesthesia") * not been able to provide informed consent
cll11: a study of obinutuzumab (ro5072759 [ga101]) with chlorambucil in patients with previously untreated chronic lymphocytic leukemia (stage 2)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) ro5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (cll). patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either ro5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m\^2 cycle 1, 500 mg/m\^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. anticipated time on study treatment is \>6 months and follow-up for disease-progression and safety will be at least 5 years. in the us, this trial is sponsored/managed by genentech.

protocol bo21004 is divided into 3 separate unique protocol ids for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points. * bo21004 (stage 1a) \[nct01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to chlorambucil (clb) reported separately. * bo21004 (stage 1b) \[nct01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (rclb) compared to chlorambucil (clb) reported separately. * bo21004 (stage 2) includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (glb) compared to rituximab plus chlorambucil (rclb) reported here.

Eligibility criteria:
inclusion criteria: * adults \>/=18 years * documented cluster of differentiation antigen 20 (cd20) + b-cell chronic lymphocytic lymphoma (b-cll) * previously untreated chronic lymphocytic leukemia (cll) requiring treatment according to the national cancer institute (nci) criteria * total cumulative illness rating scale (cirs) \> 6 and/or creatinine clearance \< 70 ml/min. exclusion criteria: * prior cll therapy * transformation of cll to aggressive non-hodgkin's lymphoma (nhl) (richter's transformation) * history of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (dcis) of the breast treated with lumpectomy alone * positive hepatitis serology (hbv, hcv) or positive hiv or human t-cell leukemia virus (htlv) testing * patients with active infection requiring systemic treatment.
telitacicept in primary aps patients

Conditions: Anti Phospholipid Syndrome

Summary: this is a single-arm pilot study in peking union medical college hospital. telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (aps) patients with three positive antiphospholipid antibodies (apl) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, apl associated nephropathy, heart valvular disease, non-stroke neurological manifestations. this study aims to evaluate the efficacy of telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk aps patients.

the study started on july 2021 and will last 1.5 years. primary aps patients with three positive apl and extra-criteria manifestations with be enrolled. this is a single-arm pilot study. telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. patients will be followed on week 12 and week 24. the primary endpoint is new thrombotic event. the secondary endpoints are improvement of extra-criteria manifestations, and titer change of apl.

Eligibility criteria:
inclusion criteria: * meet 2006 sapporo classification criteria of aps; * diagnosis of primary aps, exclude other etiologies of thrombosis; * with three apl medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody; * with at least one extra-criteria manifestations of aps, including thrombocytopenia, hemolytic anemia, apl nephropathy, valve heart disease and neurological manifestations. exclusion criteria: * overlap with other connective tissue diseases, such as systemic lupus erythematosus; * during pregnancy; * can not follow-up.

Keywords: anti phospholipid syndrome
web-based cognitive-behavior therapy (cbt) for opioid-treated, chronic pain patients with aberrant behavior

Conditions: Chronic Pain

Summary: the purpose of this study is to develop and evaluate an innovative, web-based self-management intervention for opioid-treated chronic pain patients who display aberrant drug-related behavior.

within the past decade, there has been increasing recognition of the limitations and risks of opioid therapy for chronic pain, spurred by the u.s.' widespread epidemic of opioid misuse. within the clinical context, concerns about long-term opioid therapy persist due to limited evidence of efficacy and the occurrence of medication misuse/abuse (termed aberrant drug-related behavior). psychosocial approaches, particularly self-management strategies such as cognitive-behavior therapy (cbt), have been found to be efficacious for the treatment of chronic pain. however, most chronic pain patients are not exposed to comprehensive psychosocial interventions, due to factors including pain specialty physicians' lack of familiarity with and time to provide behavioral treatments and insufficient payer coverage for these therapies. to address these public health concerns, this study developed, implemented and evaluated an innovative, web-based cbt intervention for the treatment of chronic pain tailored to the specific needs of patients who are prescribed opioids and present with aberrant behavior. the development of this interactive, web-based intervention was informed by iterative feedback from pain experts and chronic pain patients. in a randomized, controlled trial, chronic pain patients receiving opioid therapy at a pain specialty practice were assigned to receive 12 weeks of either treatment-as-usual (tau; n=55) or treatment-as-usual plus the web-based intervention (web-cbt; n=55). the trial evaluated the relative effectiveness of these treatments on the primary outcomes of pain severity, pain interference and aberrant opioid-taking behavior, and the secondary outcomes of pain catastrophizing and pain-related emergency department visits. additional analyses explored the impact of the intervention on several supplementary outcomes, such as various categories of activities, psychiatric distress and positive affect, and examined hypothesized mediators of treatment outcome, including quality of life, social support and expectations about the future.

Eligibility criteria:
inclusion criteria: * moderate-to-severe pain for at least 3 months (score of 5 or greater on brief pain inventory) * patient at pain treatment program study site * prescribed opioid analgesics * aberrant drug-related behavior within the past 30 days (endorsing 4 or more items on the current opioid misuse measure) exclusion criteria: * primary headache or cancer pain * scheduled for major surgery within the next 6 months * described by physician as likely to die within the next year * plans to move out of the area within the next 3 months * insufficient ability to provide informed consent or insufficient english to participate in consent process, assessments or computer intervention

Keywords: chronic pain cognitive behavior therapy web-based intervention
to investigate the pharmacokinetics of intravenous wck 5222 (fep-zid) in patients with renal impairment

Conditions: Renal Impairment

Summary: this is a phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. the study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function). the severity of renal impairment will be assessed based on estimated creatinine clearance (clcr) by the cockcroft-gault equation


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) 18.0 and 40.0 (kg/m2) and body weight of at least 50 kg. patients with renal impairment: 2. have a diagnosis of renal impairment that has been stable, without any change in overall disease status in the last 1 month healthy subjects: 3. have normal renal function with creatinine clearance more than 90 ml/min and no evidence of any disease or condition that may affect pharmacokinetics of fep zid. 4. a resting blood pressure 90-145 (systolic) / 60-95 (diastolic) mmhg for healthy volunteers and 90-155 (systolic) / 50-100 (diastolic) mmhg for patients with renal impairment. exclusion criteria: 1. history or presence of significant hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, hepatic, urologic, immunologic, infectious, skin and subcutaneous tissue, psychiatric or mood disorders (including any past suicide attempt), or uncontrolled metabolic or endocrine disorders (including diabetes, hypercholesterolemia, or dyslipidemia) that in the opinion of the investigator would confound subject's participation and follow-up in the clinical trial. 2. evidence of hepatorenal syndrome or acute glomerulonephritis
muscle relaxants and laryngeal local anesthetics for laryngeal mask airway insertion decreasing propofol in elderly

Conditions: Anesthesia, General

Summary: laryngeal mask airway (lma) is currently the most widely used supraglottic airway device with advantages of simple and fast placement, reduced anesthesia drug use, more stable hemodynamics, and less throat discomfort after anesthesia compared to endotracheal intubation. some studies claimed the use of muscle relaxants or local anesthetics (sprays or lubricants containing local anesthetics) for the throat before lma placement can reduce the dosage of induction agents and postoperative throat complications. in modern society, more and more elderly people undergo elective surgery with the need of general anesthesia. however, they are the more vulnerable population with tendency of greater hemodynamic changes with more induction agent usage. propofol is one of the most used induction agents which may lead to a drop in blood pressure. the objective of this study is to observe whether the dose of propofol and the changes in hemodynamics can be reduced by using muscle relaxants or laryngeal local anesthetics in elderly who receiving general anesthesia with lma insertion.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-iii * age: over 65 years * elective orthopedic surgery undergo general anesthesia in supine position exclusion criteria: * anticipated difficult airway (mallampati score 3-4), limited mouth opening, intra-oral and pharyngeal pathology * risk of pulmonary aspiration of gastric contents (full stomach) * obesity (body mass index \> 35) * significant lung abnormalities (low lung compliance, high airway resistance, impaired oxygenation) * loosening teeth * allergic to cisatracurium or lidocaine * failure in successful lma insertion after second attempts

Keywords: muscle relaxants laryngeal local anesthetics laryngeal mask airway, laryngeal masks, lma propofol elderly, aged
first-in-man study of titanium-nitride coated woven-nitinol peripheral arterial stent

Conditions: Peripheral Arterial Disease

Summary: the goldenflow (lifetech scientific, shenzhen, china) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. this is a first-in-man study to evaluate the safety and efficacy of goldenflow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. the titanium-nitride coated woven-nitinol peripheral arterial stent system (goldenflow, lifetech science, shenzhen, china) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. compared to another commercially available woven-nitinol stent, the goldenflow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. this is a first-in-man study is to evaluate the safety and efficacy of goldenflow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. symptomatic leg ischemia (rutherford class 2 to 4) 3. ankle brachial index \<0.9 4. de novo femoropopliteal stenosis (≥70%) or occlusion 5. reference diameter 4 and 7mm 6. lesion length 4 to 15cm 7. at least one patent (\<50% stenosis) infrapopliteal run-off vessel 8. the lesion(s) can be successfully crossed with a guidewire and dilated 9. patients with bilateral femoropopliteal disease is eligible for enrollment into the study - staged contralateral limb procedure can be performed \>30 days after index procedure 10. able to provide written informed consent and willing to comply with specified follow-up evaluation schedule exclusion criteria: 1. tissue loss or gangrene (rutherford class 5 and 6) 2. previous bypass surgery or stenting in target vessel 3. untreated aortoiliac or common femoral artery inflow disease \>50% 4. intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Keywords: femoropopliteal disease restenosis