Kornimate/medical-research-clean huggingface dataset:
a phase ii trial measuring the integration of stereotactic radiotherapy plus surgery in early non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: stereotactic ablative radiotherapy (sabr) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. the study combines sabr and surgery to treat non-small cell lung cancer. sabr will be done first, with surgery done approximately 10 weeks later. there will be some extra imaging done before and after the sabr. the purpose of this study is to determine how effective sabr is in killing the cancer cells, and if sabr can help make surgery more effective.

the advent of stereotactic ablative radiotherapy (sabr) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. sabr uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy. the use of sabr as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. in oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. although radiologic outcomes after sabr illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence. the goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant sabr followed by surgical resection in patients with t1t2n0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after sabr, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.

Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * histologically confirmed non-small cell lung cancer * tumor stage t1 or t2a (less than or equal to 5 cm) * no evidence of nodal disease (n0) * no evidence of distant metastases (m0) * eastern cooperative oncology group (ecog) performance status 0-2 life expectancy \> 6 months * adequate forced expiratory volume at one second (fev1), defined as a predicted post-operative fev1 of 30% or greater exclusion criteria: * serious medical comorbidities or other contraindications to radiotherapy or surgery * prior history of lung cancer within 5 years * prior thoracic radiation at any time * inability to attend full course of radiotherapy, surgery, or follow-up visits * contrast allergy * pregnant or lactating women
a study of retreatment with brentuximab vedotin in subjects with classic hodgkin lymphoma or cd30-expressing peripheral t cell lymphoma

Conditions: Hodgkin Lymphoma; Peripheral T Cell Lymphoma; Anaplastic Large Cell Lymphoma

Summary: this study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. to be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

this is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic hodgkin lymphoma (chl) and systemic anaplastic large cell lymphoma (salcl) or other cd30-expressing peripheral t cell lymphoma (ptcl) who experienced complete response (cr) or partial response (pr) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.

Eligibility criteria:
inclusion criteria: * histologically confirmed chl, salcl, or other cd30-expressing ptcl * previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment * documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin * fluorodeoxyglucose positron emission tomography- (fdg-pet) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique * eastern cooperative oncology group (ecog) performance status of less than or equal to 2 * must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug exclusion criteria: * previously discontinued brentuximab vedotin due to any grade 3 or higher toxicity * existing grade 2 or higher peripheral neuropathy * previously refractory to treatment with brentuximab vedotin * history of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose * history of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy * acute or chronic graft-versus-host-disease (gvhd) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against gvhd * active cerebral/meningeal disease * history of progressive multifocal leukoencephalopathy (pml) * active uncontrolled grade 3 (per nci ctcae v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug * chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment

Keywords: cd30-expression salcl ptcl chl seattle genetics
comparison of obturator nerve blockade and neuromuscular blockade

Conditions: Cancer of Bladder

Summary: patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. subjects will be randomized to receive an ultrasound-guided obturator block or a neuromuscular blocking agent after the induction of general anesthesia in an attempt to block the obturator reflex during surgery.

the purpose of this research is to compare the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents versus obturator block. transurethral resection of bladder tumor(s) (turbt) is a commonly performed procedure to diagnose and treat bladder cancer. the obturator nerve is located lateral to the bladder wall in the pelvis prior to innervating the adductor muscles of the thigh. depending on the location of the tumor(s), electrocautery or surgical stimulation may result in stimulation of the obturator nerve, resulting in adduction of the leg, which is called the adductor reflex or spasm. this may occur violently and unexpectedly, and result in bladder perforation, bleeding, or cancer dissemination.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * planned turbt for unilateral or bilateral posterolateral bladder tumors * ability to understand and provide informed consent exclusion criteria: * patient refusal or inability to provide informed consent * true allergy, not sensitivity, to local anesthetics * true allergy, not sensitivity, propofol * true allergy, not sensitivity, general anesthetic agents * pregnancy * severe hepatic impairment * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit of the lower extremity, whether acute or chronic * inability to walk without assistance * lower extremity joint replacement surgery in the preceding six months
evaluation of the effectiveness of different procedures on palatinal wound healing after free gingival graft surgery.

Conditions: Insufficient Keratinized Gingiva

Summary: this study aimed to help determine the appropriate method to accelerate wound healing at the free gingival graft donor site and to minimize the patient's postoperative complaints. for this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (i-prf), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (ha) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate. the main questions aimed at being answered are: * does the use of i-prf or ha accelerate wound healing in patients? * does the use of i-prf or ha reduce pain and burning symptoms? * for this purpose, gelatin sponge impregnated with injectable platelet-rich fibrin (i-prf), gelatin sponge impregnated with 0.8% polyvinylpyrrolidone sodium hyaluronate (ha) gel, and standard gelatin sponge application were compared to the secondary wound site on the palate. participants will: * they will record whether there is pain and burning for 7 days after the operation. * they will record if there is bleeding in the palate area. * they will write the number of painkillers they use daily. * they will visit the clinic on the 3rd, 5th, 7th, 14th, 21st, 28th days and 1st and 3rd months after the operation.


Eligibility criteria:
inclusion criteria: * inclusion criteria for the study were; * patients older than 18 and * systemically healthy patients, * who didn't use drugs that affect wound healing, * didn't have coagulation disorder and nausea, and * were not anti-inflammatory drug allergy sufferers. exclusion criteria: * exclusion criteria for the study were; * patients who had systematic disorders (such as diabetes, hypertension, radiotherapy, chemotherapy), * patients who were former or active smokers and alcohol users, * pregnant and breastfeeding, lactation, menstruation, * patients with poor oral hygiene, and patients who didn't attend regular check-ups.

Keywords: wound healing analog pain scale free gingival graft injectable plathelet rich fibrin palate wound epithelization topical hyaluronic acid
an open-label trial of buspirone for the treatment of anxiety in youth with autism spectrum disorders

Conditions: Autism Spectrum Disorders; Anxiety

Summary: the main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. the study results will be used to generate hypothesis for a larger randomized controlled clinical trials with explicit hypotheses and sufficient statistical power.


Eligibility criteria:
inclusion criteria: * male or female participants between 6 and 17 years of age * fulfills diagnosis of autism spectrum disorders by meeting dsm-iv-tr pdd diagnostic criteria of autistic disorder, asperger's disorder, or pdd-nos as established by clinical diagnostic interview * participants with a score of ≥13 on the pediatric anxiety rating scale (pars) * participants with a score of ≥60 or more on the anxiety/depression subscale of cbcl and cgi-anxiety severity of ≥ 4 * subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating trial treatment and if they are stable, provided the medication is not listed in the concomitant medications section of the protocol. * subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria exclusion criteria: * i.q. \< 70 * dsm-iv-tr pdd diagnoses of rett's disorder, and childhood disintegrative disorder * history of active seizure disorder (eeg suggestive of seizure activity and/or history of seizure in last 1 month) * subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: * pregnant or nursing females * organic brain disorders * uncorrected hypothyroidism or hyperthyroidism * clinically significant abnormalities on ecg (e.g., qt prolongation, arrhythmia) * history of renal or hepatic impairment * clinically unstable psychiatric conditions or judged to be at serious suicidal risk * current diagnosis of schizophrenia * history of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse * current treatment with medication with primary central nervous system activity (as specified in the concomitant medication section of the protocol) * a non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician * subjects currently taking monoamine oxidase inhibitors (maoi) and/or cyp3a4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.

Keywords: autism spectrum disorders anxiety children adolescents buspar buspirone pervasive developmental disorders
prospective first evaluation in chest pain trial

Conditions: Chest Pain; Shortness of Breath; Suspected Acute Coronary Syndrome

Summary: the purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.

currently, physicians can either choose a stress test or a ct scan of the heart to evaluate patients admitted with with chest pain. very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. to study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary ct angiography. the investigators will then follow these patients for a 2 year period.

Eligibility criteria:
inclusion criteria: * patients with chest pain or sob admitted for rule out acute coronary syndrome * age ≥45 years * ekg non-diagnostic for acute coronary syndrome * at least 1 set of negative troponin i exclusion criteria: * patient with st elevation myocardial infarction. * patients with non-st elevation myocardial infarction. * patients with known cad. * patients with serum creatinine \> 1.5. * atrial fibrillation or marked irregular heart rhythm. * patients in whom heart rate cannot be controlled. * patient with allergies to iodinated contrast agents. * pregnant women * patients unable to give informed consent

Keywords: chest pain shortness of breath suspected acute coronary syndrome stress testing coronary computed tomography angiography
study evaluating the efficacy and safety of xyntha in children less than 6 years of age

Conditions: Hemophilia A

Summary: this study will be investigating the safety and efficacy of xyntha (moroctocog alfa (af-cc)) in male patients less than 6 years old. annualized bleeding rates and physician / caregiver assessments of responses to treatment will be characterized. fviii inhibitor levels will be assessed throughout the study.

the study was terminated on 22 sept 2009 due to competition with another wyeth study for a similar patient population. the decision to terminate the trial was not based on any safety issues.

Eligibility criteria:
inclusion criteria: * male patients less than 6 years of age with moderately severe to severe hemophilia a (fviii less than or equal to 2%). * treatment history of less than 50 exposure days to prior recombinant or plasma-derived fviii replacement products. * not receiving treatment for hiv or hepatitis infection, or the patient is on a stable antiviral regimen at the time of enrollment in the study. exclusion criteria: * presence of any bleeding disorder in addition to hemophilia a. * inhibitor titer of greater than or equal to 5 bethesda units (bu) at screening. * treated with immunomodulatory therapy during the screening period * treatment history of more than 5 exposure days (ed) to xyntha. * known hypersensitivity to hamster protein.

Keywords: hemophilia a xyntha refacto moroctocog alfa bleeding disorder
a study of aleglitazar in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy

Conditions: Diabetes Mellitus Type 2

Summary: this multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. the anticipated time on study treatment is 26 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of diabetes mellitus, type 2 within 12 months prior to screening * patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past * hba1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit * fasting plasma glucose \</=240 mg/dl at pre-randomization visit * agreement to maintain diet and exercise habits during the study exclusion criteria: * patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months * any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (ppar) agonist * any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin) * symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
cardioneuroablation in reflex syncope (cardiosyre trial)

Conditions: Reflex Syncope

Summary: background: reflex syncope is a disease of benign etiology but in severe cases it can be disabling and it carries a risk of severe trauma. today, there is no proven etiological treatment and only palliative treatments are used, namely a change in hygienic and dietary habits, certain drugs or, in the most severe cases, the implantation of a pacemaker. cardioneuroablation is a novel technique that acts by ablating the parasympathetic ganglia located on the external walls of the atria. several prospective series with promising results have been published, but there are no randomized studies that have validated its efficacy compared to conventional treatment. methods: the cardiosyre study is a multicenter, randomized, single-blinded study of patients with reflex syncope. the aim is to recruit, between june 2022 and june 2025, 92 patients with reflex cardioinhibitory syncope in 15 centers and randomize them (1:1 ratio) to two treatment groups: 1) cardioneuroablation intervention; 2) conventional treatment (control group). the primary end-point will be the time to the first syncope and the secondary end-point will be the total incidence of syncope after one year of follow-up. at least 20 recurrences of syncope are expected during a 1-year follow-up. a relative risk of 0.3 and a statistical power of 80% are assumed. the follow-up will be carried out at 3, 6 and 12 months. cox models will be used to estimate adjusted hazard ratios.


Eligibility criteria:
inclusion criteria: * patients with reflex syncope (two or more episodes in the last year) and cardioinhibitory response (documentation of asystole \>3 seconds coinciding with syncope or \>6 seconds outside of syncope or cardioinhibitory response on the tilt test) defined such as heart rate \ 3 seconds exclusion criteria: * patients under 18 years * any pathology or medical condition that limits survival to less than one year; * illegal drug use, chronic alcoholism, or total alcohol use \>80 g/d * participation in a clinical trial conducted with drugs or use of a drug in an experimental state during the year prior to inclusion * patients institutionalized for chronic treatment, with a lack of autonomy and with the impossibility of carrying out clinical follow-ups * patients with pacemakers, patients with intrinsic disease of the cardiac conduction system or bundle branch block * patients with structural heart disease.

Keywords: reflex syncope cardioneuroablation randomized
young adults with violent behavior during early psychosis

Conditions: Schizophrenia; Schizo Affective Disorder; Schizophreniform Disorders; Delusional Disorder; Other Specified Schizophrenia Spectrum and Other Psychotic Disorder

Summary: this study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

the investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the ontrackny network. the focus of this open pilot is to explore the acceptability and feasibility of the intervention. the study will enroll early intervention service (eis) clinician - eis participant dyads. the planned sample size is 3-4 eis clinicians and 10-16 eis participants (up to n=16 dyads). this real-world open pilot will provide feedback to help tailor the intervention to the ontrackny setting.

Eligibility criteria:
inclusion criteria for eis participants: * ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (international classification of disease clinical modification (icd-10-cm) diagnosis code f20.x) * receive first episode psychosis (fep) treatment in one of ontrackny clinics/sites with an eligible eis clinicians * willing to participate in research interviews after each study visit during the study period exclusion criteria: * unable to provide informed consent * not fluent (speaking, reading, writing) in english

Keywords: psychosis schizophrenia violence aggression intervention
effect of curodont™ repair in patients with early approximal carious lesions

Conditions: Dental Caries

Summary: the purpose of this study is to evaluate the therapeutic benefit of curodont repair for the treatment of early approximal carious lesions compared to fluoride.

all study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). one lesion will be treated with curodont repair and one with fluoride as control. study duration is 24 months. for assessment x-ray pictures, diagnodent pen and diagnocam is used.

Eligibility criteria:
inclusion criteria: 1. two approximal carious lesions on different teeth with at least one tooth in between 2. both study lesions must not require an invasive treatment 3. size and form of the lesions: the lesions must be fully visible and assessable on radiographs 4. the two carious lesions must fall into classes: * d2 (inner half of enamel) * d3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) 5. able and willing to observe good oral hygiene throughout the study 6. age ≥ 18 years and ≤ 65 years 7. willing and able to attend the on-study visits 8. willing and able to understand all study-related procedures 9. written informed consent before participation in the study exclusion criteria: 1. the two study test lesions are located on adjacent teeth 2. fluoride varnish application \< 3 months prior to study treatment 3. tooth with numerous carious lesions 4. evidence of tooth erosion 5. history of head and neck illnesses (e.g. head/neck cancer) 6. any pathology or concomitant medication affecting salivary flow or dry mouth 7. any metabolic disorders affecting bone turnover 8. patient suffers from diabetes 9. concurrent participation in another clinical trial 10. women who are breast-feeding, pregnant or who plan a pregnancy during the study 11. women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

Keywords: dental caries curodont repair p11-4