Kornimate/medical-research-clean huggingface dataset:
body image and psychosocial functioning in women with breast cancer: can we fix what we've broken?

Conditions: Breast Neoplasms

Summary: the purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.

breast cancer is the most frequently diagnosed cancer in women with 1 in 10 canadian women being diagnosed in their lifetime. there has been an increase in the number of survivors due to advances in treatment and early detection, and increased scientific attention has been focused on patients' quality of life during and after treatment. the majority of survivors do well after the initial adjustment within the first 2 years post-treatment. however, depending on when assessed after treatment completion, a wide range of cancer survivors either score at levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem. furthermore, a subset of survivors experience adjustment problems long after treatment completion. approximately 20% to 40% of survivors develop sexual and body image problems following breast cancer and treatment and these difficulties tend to persist several years after treatment completion. this study aims to test an innovative intervention geared towards issues of identity, body image and sexuality and to examine the intervention for its impact on body image and quality of life, psychosocial and sexual functioning and relational functioning. one hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention: an 8 weekly psychosocial group support or control condition (standard care + written educational material). all subjects will be followed for 1 year post-intervention. it is hypothesized that, compared to control subjects who receive standard care and educational materials, subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship support/functioning, and that the group differences will be maintained over the 1-year follow up period.

Eligibility criteria:
inclusion criteria: * women with primary breast cancer * age between 18 and 65 years * completed adjuvant treatments * stage i,ii,iii cancer of the breast with no metastatic disease exclusion criteria: * presence of any metastases * history of major psychiatric disorder as defined by the dsm-iv * inability to speak or read english for questionnaire completion * failure to provide informed consent * currently participating in a therapist-led psychosocial support group

Keywords: breast cancer,group psychotherapy,rct,women's mental health
ultrasound guided transversus abdominis plane (tap) vs. trigger point injection (tpi) for abdominal wall pain

Conditions: Abdominal Pain

Summary: patients with chronic abdominal pain- with a component of abdominal wall pain- are often treated with trigger point injections. this study will help to determine if a block within the transversus abdominis plane (tap) will provide superior analgesic benefit to a trigger point injection as therapy for these patients.

only patients referred to the pain clinic for abdominal trigger point injections for abdominal wall pain will be considered for study recruitment. following informed consent, patients will complete a baseline questionnaire in the pain clinic which gathers basic demographic data, pain scores and functional scores. patients will be randomized to receive either a tap injection or a tpi. because the tap injection involves a larger area to be anesthetized, a larger volume of medication will be used. thirty minutes after the injection, a sensory exam will be performed on the patient to determine the level of block. at one week, one month, three months and six months after the injection, a staff member will telephone the patient to assess how they are doing. the call will take approximately 10 minutes and will consist of relaying a pain score as well as daily functioning and sleep questions. subjects are responsible for all clinical costs associated with the injection. there is no remuneration offered for study participation.

Eligibility criteria:
inclusion criteria: only patients referred to pain clinic for a trigger point injection. * non-cancer pain greater than 3 months duration. * unilateral abdominal pain. * positive carnett's sign (a test in which acute abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed.) * an identifiable abdominal trigger point. exclusion criteria: * history of chronic psychotic disorder. * history of dementing illness. * active abdominal visceral disease as a known contributor of the pain. * abdominal surgery in the past 6 months. * more than one trigger point. * abdominal wall hernias. * bmi\>40.

Keywords: trigger point injection transversus abdominis plane abdominal wall pain
non-inferiority study of the fresca airbox positive airway pressure system

Conditions: Sleep Apnea

Summary: prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the united states

this study is designed to demonstrate that the fresca airbox positive airway pressure system is non-inferior to the existing fresca positive airway pressure system. subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing fresca device programmed to fixed pressure and one sleep night with the investigational fresca device programmed to auto-adjusting pressure and exhale pressure relief.

Eligibility criteria:
inclusion criteria: 1. male or female aged 22 - 75 years old. 2. bmi: ≤ 40 kg/m2. 3. subjects diagnosed with osa (either newly diagnosed (naive) osa subjects or current cpap subjects). 4. must be able to be fitted properly with fresca mask. 5. must be able to comply with all study requirements as outlined in the protocol. 6. subject must complete a valid psg titration night. exclusion criteria: 1. subjects with non-osa sleep disorders (including periodic limb movement (plm) disorder and chronic insomnia). 2. subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.). 3. subjects with prior surgical intervention for osa. 4. subjects with frequent or sustained episodes of o2 saturation ≤75%. 5. subjects with obesity-related hypoventilation. 6. subjects currently using a cpap full face mask. 7. subjects who are medically unstable. 8. subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease). 9. subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication. 10. subjects with hypotension or uncontrolled htn. 11. subjects with chronic lung disease, including copd. 12. subjects with significant cardiopulmonary disease. 13. subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask. 14. subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year. 15. subjects currently working nights, rotating night shifts or with planned travel during the study period. 16. subjects on a non-stable dose of medications or other agents that may affect sleep and/or psg (e.g., sedatives or hypnotics). 17. subjects who consume \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee). 18. subjects who consume \> 14 alcoholic drinks/week. 19. subjects who are pregnant (confirmed verbally). 20. subjects currently enrolled in any other research study.
vestibular function outcome after cartilage cap occlusion surgery

Conditions: Vestibular Dizziness; Superior Semicircular Canal Dehiscence

Summary: the primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.

one option for managing a dehiscent superior semicircular canal is surgical intervention. one of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.

Eligibility criteria:
inclusion criteria: * ambulatory * independent self-sufficient adults * good general health * medically stable exclusion criteria: * medically unstable * pregnant

Keywords: superior semicircular canal non-vestibular dizziness vestibular dizziness
smoking cessation medications: efficacy, mechanisms and algorithms

Conditions: Nicotine Dependence

Summary: the proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

this research study will last for three years. the first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. the results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. in addition, the first year of this study may help to clarify how these medications work.the purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. the results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Eligibility criteria:
inclusion criteria: * smoke at least 10 cigarettes per day for the previous 6 months - expired co \> 9 ppm - motivated to quit smoking - able to read and write english - willing to complete required study assessments exclusion criteria: * uncontrolled hypertension (systolic \>180mm hg or diastolic \>110mm hg) - history of bipolar disorder or psychosis - myocardial infarction or other serious cardiac problem in the previous 4 weeks - history of diagnosed anorexia and/or bulimia - diagnosis of alcohol dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - history of seizure and/or serious head injury involving loss of consciousness - use of contraindicated medications (mao inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - currently pregnant or breast-feeding - unwilling to use effective contraception during the treatment phase - more than one participant from the same household - allergic reactions to 3 or more classes of drugs
aprepitant effects on oxycodone response

Conditions: Narcotic Abuse

Summary: addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. recent preclinical data suggest a role for substance p (nk-1) receptors in modulating both the acute and chronic response to opioids. the objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (nk-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.

healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. they will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. data will be analyzed using parametric approaches to within-subject designs.

Eligibility criteria:
inclusion criteria: * recreational user of opioids * healthy * ages 18-55 years old * able to provide informed consent exclusion criteria: * ongoing medical or psychiatric condition that would be contraindicated for participation * past 30 day use of and p4503a4 inhibitor

Keywords: opioid oxycodone nk1 antagonist aprepitant intranasal abuse
risk of oxygen during cardiac surgery trial

Conditions: Cardiac Surgery

Summary: the investigators will recruit and randomize 200 elective cardiac surgery patients to receive physiologic oxygenation (normoxia) or hyper-oxygenation (hyperoxia) during surgery to test the hypothesis that intraoperative physiologic oxygenation decreases the generation of reactive oxygen species, oxidative damage, and postoperative organ injury compared to hyper-oxygenation.


Eligibility criteria:
inclusion criteria: * open-heart cardiac surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy. exclusion criteria: * current acute coronary syndrome (defined as st elevation myocardial infarction or non-st elevation myocardial infarction (troponin leak within 72 hours of surgery or consent +/- ekg changes consistent with myocardial ischemia)). * home supplemental oxygen use. * preoperative supplemental oxygen requirement to maintain arterial o2 sat of 92%. * right to left intracardiac shunt including atrial septal defect and ventricular septal defect with cor pulmonale. * carotid stenosis defined as \>50% stenosis. * cardiac surgery that requires intraoperative circulatory arrest, such as aortic arch replacement. * current use of hemo- or peritoneal dialysis. * pregnancy

Keywords: oxygen hyperoxia reactive oxygen species oxidative stress oxidative damage endothelial function vascular reactivity mitochondrial function surgery anesthesia kidney injury renal failure delirium myocardial injury arrythmia
impact of image-defined risk factors on the outcome of patients with neuroblastoma: a retrospective study

Conditions: Neuroblastoma

Summary: the aim of this study is to evaluate image-defined risk factors (idrf) in patients with neuroblastoma, at the time of their initial presentation, as a prognostic factor for prediction of subsequent outcome \& complications related to surgery, in the accordance with the experience of south egypt cancer institute (seci), which is the largest referral site in upper egypt.

background: neuroblastoma is the third most common childhood cancer, after leukemia and brain tumors, and is the most common solid extracranial tumor in children. the concept of surgical risk factors in neuroblastoma surgery was introduced with the european multicenter study (lnesg1) study. in 2005 the international neuroblastoma risk group (inrg) task force, representing all major co-operative pediatric cancer groups, adopted the principle of surgical risk factors and incorporated it in the inrg staging system. the inrg task force preferred the term image-defined risk factors (idrf) to surgical risk factors, and agreed upon a list of idrf. patients \& methods: this retrospective study will be carried out by reviewing the medical records of patients with neuroblastoma seen at the pediatric oncology department, in the period from 2001 january till 2015 december. data from patients' medical records will be gathered, pathologic diagnosis of neuroblastoma will be verified before the enrollment into the study. as an initial imaging was done for all patients at presentation, as a routine for diagnosis \& staging, the reports of the computed tomography scans will be reviewed for verification of the presence or absence of the idrf. this historical cohort will be followed forward with time for ascertainment of the role of surgery in treatment, and treatment outcomes of these patients. any complications occurred due to surgery will be reported, as collected from surgical reports of these patients.

Eligibility criteria:
inclusion criteria: * patients whose age less than 19 years. * patients diagnosed with non-metastatic neruoblastoma. exclusion criteria: * patients whose age more than 18 years.

Keywords: childhood cancer image-defined risk factors pediatric oncology
therapeutic approaches for subjects with scapula dyskinesis

Conditions: Shoulder Impingement

Summary: the investigators will test whether conscious control with manual guides and video or emg biofeedback will enhance 3-d kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. the investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.


Eligibility criteria:
inclusion criteria: * at least three positive of five tests, including neer's test, hawkin's test, empty can test, tenderness in tendon of rotator cuff and resisted external test. * each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms exclusion criteria: - shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy

Keywords: shoulder dyskinesis emg biofeedback training intensive scapula-focused intervention
a study of mrg003 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the objective of this study is to assess the safety, efficacy, and pharmacokinetics of mrg003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ada) of mrg003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.

this study consists of two parts: phase ia dose escalation and phase ib dose expansion. the objective of phase ia is to determine mtd or rp2d, and phase ib is conducted to evaluate efficacy of mrg003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (scchn), and nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * willing to sign the icf and follow the requirements specified in the protocol. * age: ≥18 years and ≤75 years, both genders * expected survival time≥12 weeks * phase ia: patients with histologically and cytologically confirmed advanced or metastatic solid tumor * phase ib: patients with histologically and cytologically confirmed egfr-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma * subjects must have measurable lesions according to the response evaluation criteria in solid tumors（recist v1.1） * ecog performance score 0 or 1 * acceptable liver, renal, and hematologic function * patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment exclusion criteria: * history of hypersensitivity to any component of the investigational product * presence of central nervous system metastasis * prior history of other primary malignancies * known history of clinically significant hepatic diseases * evidence of active infection of human immunodeficiency virus (hiv) * history of ophthalmic abnormalities * any severe or uncontrolled systemic disease judged by the investigator * patients with poorly controlled heart diseases * received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment * major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug * planned surgery or surgery is the best interest of patients as determined by investigator * history of severe skin disease requiring interruption of previous egfr targeted therapy; or chronic skin disease requiring oral or intravenous therapy * active concomitant diseases that might increase risks of toxicity * pregnancy, or breast feeding

Keywords: mrg003 antibody drug conjugate (adc) solid tumors
eus-fni for men1-related pancreatic neuroendocrine tumors

Conditions: Multiple Endocrine Neoplasia Type 1; Pancreatic Neuroendocrine Tumor

Summary: the present study aims to evaluate the feasibility, safety and efficacy of eus-fni for men1-related pnets

the management of multiple endocrine neoplasia type 1 (men1-1)-related pancreatic neuroendocrine tumors (pnets) remains controversial. in general, surgical resection is currently the first-line therapy for men1-1-related pnets. however, the surgical resection of pnets is conditional for specific patients, and the incidence of postoperative adverse events is still high. recently, several studies have demonstrated that endoscopic ultrasonography (eus)-guided fine-needle injection (eus-fni) with ethanol or lauromacrogol may provide an alternative to surgical resection of pnets. nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. therefore, a multicenter prospective study is being performed to further access the efficacy and safety of eus-fni for men1-1-related pnets.

Eligibility criteria:
inclusion criteria: 1. patients with men1-1-related pnets are evaluated by histopathology and genetic testing. 2. patients who refuse surgery. 3. patients who have given their fully informed consent. exclusion criteria: 1. patients who are not suitable for the endoscopic procedure. 2. patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.

Keywords: multiple endocrine neoplasia type 1 pancreatic neuroendocrine tumor endoscopic ultrasonography-guided fine-needle injection ablation
side effects of atropine (sea) study

Conditions: Myopia

Summary: this study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. these measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.

atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.this study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. this will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. the investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. the investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.

Eligibility criteria:
inclusion criteria: -n/a exclusion criteria: * outside of age range * history of accommodative (focusing) issues or therapy

Keywords: atropine photophobia pupil reading speed myopia surveys and questionnaires