Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy of wsd0922-fu in patients with c797s+ advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a phase ii, open label, multicenter, single arm study of wsd0922-fu for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with first-line osimertinib treatment and whose tumors harbor a c797s mutation within the epidermal growth factor receptor gene.

wsd0922-fu is a potent reversible inhibitor of both the single egfrm+ (tki sensitivity conferring mutation) and dual egfrm+/c797s+ (third-generation tki as first-line resistance conferring mutation) receptor forms of egfr with selectivity margin over wild-type egfr. therefore wsd0922-fu has the potential to provide clinical benefit to patients with advanced nsclc harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation egfr tki (e.g., osimertinib). the clinical development program with wsd0922-fu will assess the safety and efficacy of wsd0922-fu in patients with advanced nsclc whose cancers have progressed with or without brain metastasis following a first-line osimertinib treatment.

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses. * male or female aged ≥18 years old. * histological or cytological confirmation diagnosis of nsclc. * locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy. * evidence of radiological disease progression while on a previous continuous treatment with first-line osimertinib treatment. * documented egfr mutation . * eastern cooperative oncology group (ecog) 0-1 and a minimum life expectancy of 12 weeks. * at least one lesion, not previously irradiated and not chosen for biopsy during the study. * females should have evidence of non-childbearing potential. exclusion criteria: * any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * any unresolved toxicities from prior therapy greater than ctcae grade 1. * symptomatic brain complications that require urgent neurosurgical or medical intervention. * any evidence of severe or uncontrolled systemic diseases. * refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection. * past medical history of ild. * inadequate bone marrow reserve or organ function as demonstrated. * males and females of reproductive potential. * known intracranial hemorrhage which is unrelated to tumor. * seizures requiring a change in anti-epileptic medications.

Keywords: c797s bm wsd0922-fu nsclc egfr
wellclub shoulder therapy outcome validation

Conditions: Shoulder Pain

Summary: preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. the investigator's hypothesis is that patients using the wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.

patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iphones with ios 8 or later. patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. the study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. the app communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. the control group will only have traditional in-clinic therapy as deemed clinically necessary by the pt.

Eligibility criteria:
inclusion criteria: * shoulder impingement not requiring immediate surgery exclusion criteria: * rotator cuff tear (rct) * surgical history of rotator cuff repair (rcr) * cortisone injection or other injectable for past 6 months * prescription nsaids in the past 6 months * frozen shoulder syndrome * neurological conditions * other orthopaedic conditions (spine/neck)

Keywords: shoulder pain
new treatment of cardiac device infections; immediate reimplantation after removal of infected system

Conditions: Endocarditis, Bacterial

Summary: the goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date. the primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of * death * symptomatic embolism (systemic arterial embolism or pulmonary embolism) * bacteremia og pocket-infection * removal of a cied due to new infection


Eligibility criteria:
inclusion criteria: * culture positive or negative infection of a cied acording to pi * indication for removal of device * indictation for reimplantation of new device * a minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered * stabilization criteria fulfilled i.e. i) negativ blood cultures, ii) wbc \< 15 mia/l or reduction of min. 25% and iii) crp \<50 or min. 25% reduction. exclusion criteria: * immunoincompetence (active chemotherapy or prednisone treatment \> 20mg/day * device-infection within last 6 months (relaps) * septic shock * stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment
bone lead levels and college achievement scores

Conditions: Lead Poisoning

Summary: this project studies the relationship between lead exposure and academic achievement in college students. most studies of the neurobehavioral effects of lead have focused on performances at the low end of the distribution. there is evidence that lead affects outcome across the entire distribution. this is a retrospective cohort study of subjects whose cognitive function is adequate to gain admission to college. we will use x-ray fluorescence to measure bone lead concentrations in undergraduate college students and test the hypothesis that achievement scores are related to early lead exposure. early lead exposure has been shown to have measurable effects on academic performance and neurobehavioral outcomes at 18 years of age. should an effect be found in this study, the spectrum of lead toxicity would be expanded to include subjects with above average function.


Eligibility criteria:
current undergraduate student at the university of pittsburgh who have taken the scholastic aptitude test (sat).

Keywords: lead exposure bone lead cognitive function academic achievement neurobehavior
safety and efficacy study of urokinase for the treatment of diabetic foot syndrome and critical limb ischemia

Conditions: Diabetic Foot; Critical Limb Ischemia

Summary: in this randomized clinical trial (rct) the investigators are trying to find out whether a low-dose therapy with daily short infusions of urokinase using 10 to 21 doses over a maximum of 30 days is capable of prolonging the survival time without major amputation.

august-2 is a trial embedded in the august-1 registry study. all patients enrolled in august-2 are also part of august-1, but there will be patients who are documented in the register, but will not take part in august-2. the investigators want to find out to which extent the patients in the registry are representative to the overall population suffering from this condition and how the therapeutic success of other therapy regimes can be described.

Eligibility criteria:
inclusion criteria: * age 18 years or older * angiopathic or angioneuropathic critical limb ischemia (at least wagner-armstrong stadium ii) * participation in the august-1 register * revascularization not possible or residual ischemia after revascularization * persisting ulcerations despite antibiosis, adjustment of blood glucose levels and debridement * expected further hospitalization for at least 3 weeks (pressure relief and antibiosis) * fibrinogen \>= 4g/l * signed informed consent exclusion criteria: * life expectancy \< 1 year * prior major amputation * planned major amputation * prior therapy of the current episode of diabetic foot syndrome with urokinase (except in cases of revascularization when the duration between the intervention and randomization must not exceed 7 days) * mechanical heart valve substitute * cerebral event with ct-detectable changes in the last 3 months * non-remediated proliferation retinopathy * uncontrolled hypertension (systolic \>180 mmg, diastolic \>100 mmhg) * hemorrhagic diathesis (spontaneous quick \ 40 s, thrombocytes \< 100 gpt/l) * gastrointestinal bleeding or ulcers in the last 4 weeks * prior reverse bypass operation * contraindications against therapy with urokinase acc. to the smpc * concurrent participation in another clinical trial * insufficient compliance * pregnancy
the drug-drug interaction of shr3824 and sp2086

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the potential interaction between multiple oral doses of shr3824 and multiple oral doses of sp2086 in healthy adult volunteers.

this is an open-label (volunteers will know the names of treatments they are assigned) single-center study of shr3824 and sp2086 in healthy adult volunteers. shr3824(a sodium-glucose cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (t2dm) ,and sp2086(a dipeptidyl peptidase iv inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (t2dm).sp2086 will be administered orally (by mouth) as 100mg on days 1, 2, 3, 4, 15, 16, 17 and 18, shr3824 will be administered orally (by mouth) as 20mg on days 11, 12, 13, 14, 15, 16, 17 and 18. both shr3824 and sp2086 tablets will be taken with 8 ounces (240 ml) of water.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index (bmi, a measure of a person's weight in relation to height) between 19 and 24 kg/m2. exclusion criteria: * history of diabetes * history of heart failure or renal insufficiency,urinary tract infections, or vulvovaginal mycotic infections * history of or current clinically significant medical illness as determined by the investigator * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * known allergy to shr3824 or sp2086 or any of the excipients of the formulation of shr3824 or sp2086

Keywords: shr3824 sp2086 drug-drug interaction
comparison of the analgesic effects of acupuncture and modulated electroanalgesia in cold induced pain

Conditions: Cold Exposure

Summary: physiotherapy offers a range of therapeutic modalities for pain management including transcutaneous electrical nerve stimulation (tens), interferential current (ic) and acupuncture. the objective of this study was to investigate the hypoalgesic effect of tens, ci and acupuncture in a cold-induced pain model.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * subjects with no history of any kind of disease
a safety and efficacy study of estradiol vaginal capsule in postmenopausal women with vulvovaginal atrophy

Conditions: Vulvovaginal Atrophy; Menopause; Dyspareunia

Summary: this study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of vulvovaginal atrophy due to post menopause * age ≥ 40 years or if bilateral oophorectomy ≥ 35 years * moderate to severe vaginal dryness * normal breast exam; if \> 40 years * vaginal ph \> 5.0 * \< 5% superficial cells on vaginal wall cytology smear exclusion criteria: * known hypersensitivity to estrogen and/or progestin therapy * known or suspected premalignant or malignant disease * undiagnosed abnormal genital bleeding * a history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke * active or known protein c, protein s, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events * increased frequency/severity headaches with estrogen therapy * smokes ≥ 15 cigarettes/day
a study of romiplostim for the treatment of refractory transfusion-dependent nsaa

Conditions: Aplastic Anemia

Summary: efficacy and safety of romiplostim in the treatment of refractory transfusion-dependent nsaa.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, male or female. 2. diagnosis consistent with refractory transfusion dependence nsaa defines refractory as patients who have failed to respond to at least 6 months of prior first-line treatment with adequate doses of cyclosporine (3-5 mg/kg) and who have been treated with an adequate dose of at least one povidone for 3 months. definition of transfusion dependence: at least 1 component transfusion on average every 8 weeks and duration of transfusion dependence ≥ 4 months. 3. satisfy at least one of the following conditions at the time of enrolment: haemoglobin \<90 g/l, platelets \<30×10\^9/l, neutrophils \<1.0×10\^9/l. 4. agree to sign the consent form. 5. an eastern cooperative oncology group (ecog) score of 0-2. exclusion criteria: 1. other causes of whole blood cytopenia, such as myelodysplastic syndromes (mds). 2. presence of cytogenetic evidence of clonal haematological bone marrow disorders (mds, aml). 3. pnh clones ≥50%. 4. haematopoietic stem cell transplantation (hsct) prior to enrolment. 5. prior treatment with atg. 6. infection or haemorrhage uncontrolled by standard therapy. 7. allergy to roprostin. 8. active hiv, hcv or hbv infection or cirrhosis or portal hypertension. 9. any concomitant malignancy, localised basal cell carcinoma of the skin within 5 years. 10. liver and renal function at baseline that is more than two times normal. 11. active infection. 12. past history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants. 13. pregnant or lactating (breastfeeding) women. 14. participation in another clinical trial within 3 months.
developing and testing implementation strategies for evidence-based obesity prevention in childcare

Conditions: Obesity

Summary: investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. investigators will test the hypothesis that better fidelity to the implementation strategy (wise) is positively related to child outcomes (e.g., child fruit and vegetable intake, bmi).

investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a hybrid type 3 implementation design. investigators expect that the effectiveness of wise on child outcomes will vary by the level of implementation fidelity, and a hybrid 3 design allows for us to explore this hypothesis).

Eligibility criteria:
inclusion criteria: * early childhood educators from our partnering head start agency exclusion criteria: * secondary outcome inclusion criteria: * children aged 3-5 years old in our partnering head start agency
flu+cpm+ratg conditioning regimes for unrelated bone marrow transplantation (ubmt)(or mobilized peripheral blood)in severe aplastic anemia (saa)

Conditions: Anemia, Aplastic

Summary: anti-thymocyte globulin (atg) has been used in severe aplastic anemia as a part of the conditioning regimen. among the many kinds of atg preparations, thymoglobulin had been found to be more effective in preventing gvhd and rejection of organ transplants. as the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for bmt/pbsct from alternative donors in saa, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce gvhd and to allow good engraftment in ubmt/upbsct.

gvhd prophylaxis recommendation tacrolimus (0.03 mg/kg/day i.v. by continuous infusion from day -2 and taper with an oral form until 1 year after bmt/pbsct) methotrexate (15 mg/m2 i.v. on days 1 and 10 mg/m2 i.v. on days 3, 6, 11)

Eligibility criteria:
inclusion criteria: * diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria * and either marrow criterion. * peripheral blood 1. neutrophils \< 0.5 x 109/l 2. platelets \< 20 x 109/l 3. corrected reticulocytes \< 1% * bone marrow 1. severe hypocellularity (\< 25%) 2. moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells * no prior hematopoietic stem cell transplantation. * age: no limits. * performance status: ecog 0-2. * patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. heart: a shortening fraction \> 30%, ejection fraction \> 45%. 2. liver: total bilirubin \< 2 × upper limit of normal; alt \< 3 × upper limit of normal. 3. kidney: creatinine \ 60 ml/min/1.73m2. * patients must lack any active viral infections or active fungal infection. * appropriate donor is available: matched in 6/6 of a, b, dr loci. * patients (or one of parents if patients age \< 19) should sign informed consent. exclusion criteria: * pregnant or nursing women. * malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. * psychiatric disorder that would preclude compliance. * congenital aplastic anemia including fanconi anemia. * manipulated bone marrow.

Keywords: pediatric ubmt severe
wearable technology to assess gait function in sma and dmd

Conditions: Spinal Muscular Atrophy Type 3; Duchenne Muscular Dystrophy

Summary: the purpose of this project is to devise instrumented insoles capable of accurately measuring gait at each footfall, over multiple hours in any environment. to achieve high accuracy, the investigators will develop a new learning-based calibration framework. features will be tested in controlled lab settings 39 during a single visit in people with sma (13), dmd (13) and healthy controls (13) and in 15 participants in real-life environments.

spinal muscular atrophy (sma) and duchenne muscular dystrophy (dmd) are genetic disorders that often result in progressive weakness and impaired function. results from this study will help characterize how gait is affected in sma and dmd. this novel device can serve as a more affordable and versatile measurement instrument for neuromuscular disorders that affect gait and balance. all participants will be observed and measured while wearing the instrumented insoles in the lab and in real-life environments.

Eligibility criteria:
inclusion criteria: 1. one of the following categories: * genetic confirmation of spinal muscular atrophy * genetic confirmation of duchenne or becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with dmd/bmd * healthy individuals. 2. able to walk independently at least 25 meters exclusion criteria: 1. unable to walk 25 meters independently. 2. use of investigational medications intended for the treatment of sma or dmd/bmd within 30 days prior to study entry.

Keywords: spinal muscular atrophy sma duchenne muscular dystrophy dmd instrumented insole neuromuscular disease six minute walk test machine learning model gait analysis wearable ambulatory stride foot-worn
heterogeneity and development of early copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (copd), to determine the disease development of early copd, and to establish a multidimensional model for predicting the outcomes of early copd.


Eligibility criteria:
inclusion criteria: * the individuals who meet the defining criteria of prism, copd stage 0, pre-copd, early copd, young copd, and mild copd, according to the latest gold documents and publications. exclusion criteria: * age \ 80 years; * pregnant or maternal women; * having malignant and active tumor(s), and receiving treatment; * undergoing a surgical operation; * having problems with mental awareness; * having difficulties in daily activities; * participating in other interventional clinical trials.

Keywords: chronic obstructive pulmonary disease early copd heterogeneity disease development
efficacy and safety of ketoprofen topical patch 20% in the treatment of pain associated with shoulder, elbow or knee tendonitis or bursitis

Conditions: Tendonitis; Bursitis

Summary: the purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

this randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the ktp or a matching placebo patch to be applied once daily for 21 days. patients will return to the clinic for assessments on day 3, day 7, day 14 and day 21; a follow-up assessment will be conducted by telephone on day 35. at each visit through day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. the use of study treatment and rescue medication will be recorded in the diary each day. ibuprofen will be provided as prn rescue medication.

Eligibility criteria:
inclusion criteria: * males or females 18 years of age or older * diagnosis of tendonitis or bursitis of the shoulder, elbow or knee * meet pain entry criteria * willing to discontinue use of any pain medication not provided by study exclusion criteria: * have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery * have received corticosteroids in the 30 days preceding screening * have a history or physical examination finding that is incompatible with safe participation in the study * have a history or physical examination finding that is incompatible with study product use * are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. * are taking medications that may significantly affect renal function

Keywords: tendonitis bursitis pain shoulder pain elbow pain knee pain tendon injury muscle, bone and cartilage disorders