Kornimate/medical-research-clean huggingface dataset:
a study for patients with egfrm (epidermal growth factor receptor mutant) lung cancer

Conditions: Advanced EGFRm (Del 19 or L858R +/- T790M) NSCLC

Summary: phase 1 - open label, multi-center, non-randomized, safety, pharmacokinetic and pharmacodynamics dose escalation study of pf-06459988 as a single agent in patients with advance egfrm nsclc (del 19, l858r, +/- t790m). the resulting pf-06459988 dose selected from the phase 1 portion will undergo a series of sub-studies to fully characterize the impact of food, antacid and cyp3a4 inhibitors/inducers. the pk studies are in addition to the mtd expansion and will be completed prior to the initiation of phase 2. phase 2 is an open label, multi-center single-arm study of pf-06459988 for the assessment of antitumor activity in patients with advanced egfrm (del 19 or l858r) nsclc with t790m.


Eligibility criteria:
inclusion criteria: * evidence of histological or cytologically confirmed diagnosis of locally advanced or metastatic egfrm (del19 or l858r) nsclc that is resistant to standard therapy. patients must have progressed on treatment with an egfr tki, and may have also received other line of therapy. * tissue available (formalin fixed paraffin embedded (ffpe) block or 10 unstained sections (5 micron) * patients must be willing to participate in additional pk studies as required (cohort dependent); patients will be informed of which pk studies are required prior to consenting for study participation * adequate bone marrow function (complete blood count laboratory test results) * adequate liver function (laboratory test) exclusion criteria: * previously diagnosed brain metastases, unless the patient has completed their treatment and has recovered from the acute effects of radiation therapy or surgery prior to the study registration, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable * systemic anti-cancer therapy within 4 weeks of starting study treatment excluding egfr tkis. patients on egfr tkis must discontinue the agent for a minimum of 5 days prior to starting study drug * hypertension that cannot be controlled by medication (150/100 mmhg despite optimal medical therapy).

Keywords: nsclc, non-small cell lung cancer, egfrm, epidermal grown factor receptor mutation
therapeutic outcomes using contact force handling during atrial fibrillation ablation

Conditions: Persistent Atrial Fibrillation

Summary: catheter ablation has emerged as an effective therapy for atrial fibrillation (af). however, achievement of complete\& durable isolation of the pulmonary veins (pvs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. direct contact force sensing (cfs) is a novel technology that may help to ensure adequate lesion delivery. cfs may also help to improve the safety profile of catheter ablation. the purpose of this study is to compare two strategies of wide antral pv isolation plus linear ablation for persistent af: 1. guided by contact force sensing (cfs) or 2. blinded to contact force sensing (cfs) - i.e. standard approach


Eligibility criteria:
inclusion criteria * age \> 18 years. * patients undergoing first-time catheter ablation for af. * persistent af defined as episodes greater than 7 days duration. * symptomatic af defined as patients who have been aware of their af anytime within the last 5 years prior to enrolment. symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above. * at least one episode of af must have been documented by ecg, holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment. * willing and able to provide informed consent. exclusion criteria * paroxysmal af. * af secondary to a reversible cause. * patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor. * patients who have previously undergone af ablation. * patients with left atrial size \>55 mm (echocardiography, parasternal long axis view). * patients who are or may potentially be pregnant.

Keywords: atrial fibrillation ablation
the prognostic impact of symptoms and lesion depth in partial removal of carious tissue

Conditions: Deep Caries; Pulpitis Reversible; Pulp Hyperemia

Summary: the goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. the main questions the study aims to answer are: * do preoperative symptoms affect the outcome? * does the depth of the carious lesion affect the outcome? one hundred participants will be recruited. patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the finnish national treatment guidelines. participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. the teeth will then be followed up for 12-24 months. the null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.


Eligibility criteria:
inclusion criteria: * the patient is communicating in the finnish or english language * a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph * asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal) * pulp responding to the electric pulp testing and cold testing * the periodontal stage of the tooth should be i or ii. in case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study. exclusion criteria: * general medical condition which makes the patient more susceptible to odontogenic infection complications * pregnancy, breastfeeding * mental retardation, memory disorder * the carious lesion is extending to more than three surfaces or to both proximal surfaces * the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than class i or ii; or iii) class ii filling is not restricted to enamel; or iv) the filling has secondary/residual caries * the tooth is not restorable * periapical changes in the periapical radiograph * sensitivity to percussion; swelling; sinus tract; increased mobility; resorption * furcal lesion more severe than class i * ongoing orthodontic treatment * declining to sign the written consent.

Keywords: vital pulp therapy deep carious lesion selective carious tissue removal
the effect of ivf counseling on psychosocial well-being

Conditions: Infertility; Psychological Distress; Infertility, Female; Depression, Anxiety; Nurse's Role

Summary: in this study, i̇t was aimed to determination of the effect of counseling given in accordance with the roy adaptation model in women in the in vitro fertilization (ivf) process on emotional capacity and well-being.

the study will be conducted in the infertility clinic of a medical school hospital. the study included women receiving ivf treatment. in the pre-initial evaluation, "introductory information form, screening on distress in fertility treatment (screenivf), infertility stress, life quality scale for persons with fertility problems(fertiqol), subjective units of distress scale-sud application is planned. a "consultancy program" will be applied to the experimental group in the form of two modules in addition to drug applications, egg pick up and embryo transfer before, during and after clinical routine health care. the first module of the counseling program is the definition of infertility, the treatment process, its effects on the life process and coping methods. the second module includes the application of breath awareness and emotional freedom technique (eft) within the scope of coping methods with infertility stress. emotional freedom technique-eft is an energy psychotherapy based on the principle that each limiting thought, disturbing emotion and memory of an individual disrupts the energy flow in the body and creates congestion. this technique, the stimulation on the meridian system by focusing on the thought, disturbing emotion or memory that prevents the individual (often by touching) regulates the energy flow and provides the individual to relax. with breath awareness, beneficial results can be obtained, such as physical, sensory and mental control, life-facilitating techniques, individual and social awareness, re-existence and raising the level of consciousness. within the scope of the counseling program, a total of seven follow-ups will be made, five-to-one, via two phone calls. on the day of follicle development (2nd follow-up), egg pick up procedure (4th follow-up) and embryo transfer (5th follow-up), the patient will be given breathing exercises and eft and subjective units of distress scale will be scored. the control group will continue clinical routine health care and will be followed up on the first day of ivf treatment (1st follow-up) and on the seventh day of embryo transfer (2nd follow-up). for ethical reasons, a consultancy program will be applied to the control group after the second follow-up. data collection tools will be applied again to both groups in the final evaluation.

Eligibility criteria:
inclusion criteria: * ivf treatmant * women * women aged18-40 years * sign the informed consent form exclusion criteria: * having a psychiatric diagnosis / * having a situation that prevents communication (language, etc.)
phase 2 dose-finding study to evaluate the effects of ba058 in the treatment of postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to determine whether ba058 is effective in building bone in postmenopausal women with osteoporosis.

this is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of ba058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Eligibility criteria:
primary inclusion criteria: * the patient has a bone mineral density t-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (dxa). women with a bone mineral density t-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by bmd criteria, are also study candidates. * the patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the investigator. primary exclusion criteria: * history of bone disorders (e.g., paget's disease) other than postmenopausal osteoporosis. * prior treatment with approved or as yet unapproved bone-acting investigational agents. * history of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time. * history of radiotherapy (radiation therapy).

Keywords: osteoporosis postmenopausal bone loss
study to explore effectiveness of sublingual fentanyl spray in emergency department patients with acute pain

Conditions: Acute Pain

Summary: this study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ed) patients with acute pain. after screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ed). open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician. adverse events will be collected for five days after initial enrollment.


Eligibility criteria:
inclusion criteria: * is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study * has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender * has a pain score within protocol-specified parameters exclusion criteria: * has allergy to fentanyl or morphine * has oxygen-dependent conditions or oxygen saturation \<95% * has planned or recent drug use outside protocol-specified parameters * has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
evaluate safety and effectiveness of xenosure biological patch in the application of cardiac repair

Conditions: Heart Diseases

Summary: the purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of xenosure biologic patch. this trial is performed to meet the china fda regulations for this kind of device. the clinical trial will be performed solely inside china under gcp regulation and all applicable china regulations on medical device clinical trial.

the purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of xenosure biologic patch. this trial is performed to meet the china fda regulations for this kind of device. the clinical trial will be performed solely inside china under gcp regulation and all applicable china regulations on medical device clinical trial. there will be 144 subjects enrolled, including 72 subjects in the trial arm and 72 subjects in the control arm.

Eligibility criteria:
inclusion criteria: 1. man or woman aged below 6 years old 2. the expected lifetime of no less than 12 months 3. patients with congenital heart disease in symptoms of ventricular septal defect, atrial septal defect and tetralogy of fallot who need the surgical repair. 4. physical conditions and vital signs meet requirements for the surgery. 5. the subjects and/or their guardians sign the written informed consent form. exclusion criteria: 1. patients with severe visceral diseases in liver, kidney, etc. 2. patients have unstable vital signs and not suitable for the indications. 3. patients with severe allergic history (especially allergic to bovine materials) 4. patients with the past medical history of severe immunodeficiency disease 5. the subject has used or plans to use immunomodulatory drugs for more than half a year. 6. the subject with poor blood clotting function, which is defined as that pre-operative inr or aptt is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100\*10\^9/l. 7. the subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[grf\]\<30ml/min/1.73m2. 8. the subject's alt or ast level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus. 9. the subject has participated in another clinical study within past 3 months or is participating in another clinical study now. 10. the investigator believes that the subject has other reasons unsuitable for inclusion.
central corneal thickness and 24-hour fluctuation of intraocular pressure

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure (iop) is associated with central corneal thickness (cct) in subjects with ocular hypertension or open angle glaucoma and in age-matched controls. also to evaluate whether mean iop reduction as a response to latanoprost (0.005% xalatan) is associated with cct, after a 4-weeks period of treatment. also, to evaluate whether 24-hour fluctuation of iop is associated with corneal hysteresis (ch) measured by ocular response analyzer (ora).


Eligibility criteria:
inclusion criteria: males and females \>50 years old with: * primary open-angle glaucoma newly diagnosed or with anti-glaucoma medical treatment \< =12 weeks * pseudoexfoliative glaucoma newly diagnosed or with anti-glaucoma medical treatment \<= 12 weeks * ocular hypertensives newly diagnosed or with anti-glaucoma medical treatment \<= 12 weeks * age-matched controls * iop\>=22mmhg at the eligibility visit for glaucoma patients and ocular hypertensives exclusion criteria: for eye * use of any ophthalmic medication (drops) during the study (except for natural tears) * inflammation of any aetiology * previous eye surgery or laser * corneal abnormalities (oedema, dystrophies etc) for subjects * systemic diseases which affect the cornea (such as autoimmune diseases) * inability to participate due to advanced age or serious illness * mean iop\>36mmhg in either eye at the eligibility visit. * subjects who cannot safety discontinue use of all iop-lowering medication(s) for washout * subjects with severe central visual field loss in either eye. severe central visual field loss is defined as sensitivity \<=10db in at least 2 of the 4 visual field test points closest to the point of fixation * other types of glaucoma (such as angle-closure glaucoma and secondary glaucomas)

Keywords: central corneal thickness 24hour fluctuation of intraocular pressure open angle glaucoma ocular hypertension
multicentric comparative randomized study of the single-incision sling ajust® versus suburethral transobturator slings.

Conditions: Female Stress Urinary Incontinence

Summary: the transobturator tension-free vaginal tape (tot) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (sui) in many cases. the tot procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. in addition it is commonly performed under general or regional anesthesia1-3. the single-incision mini-slings (sims) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. in addition, the use of sims could enable surgeons to perform the procedure truly under local anesthesia. different devices for sims procedure are available. however, the evidence about their efficacy is controversial4-7. the main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. the design of the sims ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. recent prospective studies on the efficacy and safety of the sling ajust® have obtained promising results8,9. even so, the nice guidelines advise to use sims in the context of research studies10. the objective of this study is to establish if the effectiveness of the sims ajust® is non-inferior to that of a standard tot, as well as to compare the comorbidity of both procedures. owing to the new appearance and fast evolution of these procedures, randomized comparative studies with sims are required in order to determine its place in the treatment of sui.


Eligibility criteria:
inclusion criteria: * stress urinary incontinence with urethral hypermobility. exclusion criteria: * incapacity to understand the information or give their consent. * previous anti-incontinence surgery with slings. * urethral hypomobility (q-tip test \<30º). * low pressure urethra (mucp \< 20cmh2o). * detrusor overactivity.

Keywords: stress urinary incontinence. suburethral sling. single-incision suburethral sling. ajust. transobturator tape.
psychiatric outcomes of unruptured intracranial aneurysms (pouia)

Conditions: Anxiety Depression; Aneurysm Cerebral; Mental Health Wellness 1

Summary: the impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. unruptured intracranial aneurysms (uias) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of uia diagnosis has been found to result in worse outcomes of health-related quality of life. this study aims to investigate the impact of awareness of untreated uia on the patients' mental health utilizing the hospital anxiety and depression scale (hads) tool.

this is a controlled, non-randomized, prospective cohort study with parallel arms of treatment arm with microsurgical and endovascular treatment and comparison control arm with conservative management/observation of uia. the goal of this study is to investigate the impact of the awareness of an untreated uia on the psychiatric and mental status of the patients enrolled in the control arm compared to patients with a treated uia. all patients presenting to the outpatient clinic upon the initiation of the trial and for 2 years ahead with uia diagnosed on any of the angiographic imaging modalities including computed tomography angiography (cta), magnetic resonance angiography (mra), and digital subtraction angiogram (dsa) will be included.

Eligibility criteria:
inclusion criteria: * unruptured intracranial aneurysms (uia) * mrs scores between 0-1 * observation group: all patients with uias that are eligible for conservative management. 1. specific locations that are not good candidates for interventional treatment, such as cavernous internal carotid artery and very distally located aneurysms. 2. aneurysm size (largest dimension) is less than 4 mm. * treatment group: all patients with uias that are decided to be treated either with endovascular or microsurgical treatments due to several reasons, such as aneurysm size above 4 mm, patient's decision. exclusion criteria: * prior history of intracranial hemorrhage. * prior history of intracranial aneurysm * severe comorbidities that impact the mental health of the patients, such severe psychiatric disease, and chronic end stage diseases.

Keywords: cerebral aneurysm anxiety depression endovascular clipping
decrease in temperature as a pagtonomic sign by scorpion sting

Conditions: Scorpion Stings

Summary: the scorpion sting is a medical disease, for the signs and symptoms presented; sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented.

the scorpion sting is a medical emergency where 184 patients from the state of guanajuato were divided into 2 groups according to the type of antivenom administered, the dose of antivenom were at the discretion of the attending physician, birmex (n = 117) and alacramyn (n = 67) for the temperature record of the site of sting and other vital signs, this to compare it with the bibliography as a pathognomonic sign.

Eligibility criteria:
inclusion criteria: * scorpion sting * all sex * 3 - 90 ages exclusion criteria: * application of ice at the sting site