Kornimate/medical-research-clean huggingface dataset:
assessing the efficacy and safety of dextenza in pseudo phakic patients undergoing gas bubble repair and laser following retinal detachment

Conditions: Retinal Detachment

Summary: this prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with dextenza compared to topical prednisolone acetate following gas bubble repair and laser for rd.

subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to dextenza (placed once in the lower punctum) or the use of topical prednisolone acetate 1% drops (four times daily). they will be observed for a period of 3-months for both pain and inflammation of the eye.

Eligibility criteria:
inclusion criteria: * pseudophakic * retinal detachment * age 18 years and older * scheduled for gas bubble repair and laser surgery following retinal detachment * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: * patients under the age of 18. * pregnancy (must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * obstructed nasolacrimal duct in the study eye(s) * hypersensitivity to dexamethasone * patients being treated with immunomodulating agents in the study eye(s) * patients being treated with immunosuppressants and/or oral steroids * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
mr-guided tumour boost

Conditions: Prostate Cancer

Summary: this is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and mri-defined lesion(s). participants in this study will get mr-guided radiotherapy boost to mri visible tumour before or after whole gland radiation. participants will be followed-up as per standard of care schedule up to 5 years post-treatment.


Eligibility criteria:
inclusion criteria: * histologically-proven localized prostate cancer. * low, intermediate, and high-risk prostate cancer (ideally limited to 1 risk factor) * low-risk: ct1-t2a, psa \<10, and gleason score 6 * intermediate-risk: ct2b-c, psa 10-20, and/or gleason score 7 * high-risk limited to 1 risk factor: \>t2, psa \>20, or gleason score \>7 * intra-prostatic tumour(s) demonstrated on mpmri histologically confirmed limited to =/\< 1/3 total prostate volume * planned for ebrt (+/- adt) * ecog 0 or 1 * 18 years of age or older * ability to provide written informed consent to participate in the study exclusion criteria: * prior radiotherapy to pelvis * radiological evidence of regional or distant metastases at the discretion of the treating physician. * active ulcerative colitis or crohn's disease, at discretion of treating physician * ataxia telangectasia and sle * contraindications to mri; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury * severe claustrophobia

Keywords: prostate cancer sbrt stereotactic body radiotherapy tumour boost
combination therapy with 5-fluorouracil and photodynamic therapy in post-transplant premalignant skin disease

Conditions: Actinic Keratosis; Organ or Tissue Transplant; Complications

Summary: this randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5fu) and photodynamic therapy (pdt), versus pdt alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin ix (ppix), in lesions of actinic keratoses (aks) and to more effectively treat and prevent recurrence of aks. the target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.

this clinical trial will test a new combination of 5-fluorouracil cream (5fu) and methylaminolevulinate photodynamic therapy (mal-pdt), versus mal-pdt alone, as treatment for actinic keratoses (aks) in immunosuppressed organ transplant recipients (otrs) and an immunocompetent control group. objectives: 1) determine whether topical pretreatment with 5-fu selectively increases the amount of photosensitizer (ppix) produced within ak lesions, relative to non-pretreated lesions. 2) determine whether the combination treatment improves lesion resolution and reduces the incidence of new aks. 3) determine whether biomarkers in tissue and blood are predictive of patient responsiveness to 5fu (ppix induction, new lesion incidence, and clinical toxicity). we plan to enroll 20 organ transplant recipients and 20 normal patients, with aks on face, scalp, ears, forearms or back of the hand through dermatology and transplant clinic at cleveland clinic. women of childbearing age must use contraception and have a negative pregnancy test. study participants will apply 5fu daily for 6 days; mal/pdt is administered on 7th day. ppix will be measured in lesions using a noninvasive dosimeter. biopsies will be taken from selected lesions, and aks will be photographed. participants will be asked to complete a questionnaire to document adverse events. patients are evaluated at day 14, and months 3, 6, 9, 12, to document ak clearance and new lesion appearance.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * at least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or dorsal hands. - patients in the solid organ transplant arm of the study must have had either a kidney or liver transplant, and the transplantation surgery must have occurred at least 2 years prior to enrollment. exclusion criteria: * pregnant or nursing * currently participating in another clinical trial * using any topical treatment for their actinic keratoses * currently being treated for other cancers with medical or radiation therapy * patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any component of the study material * patients with a history of a photosensitivity disease, including porphyria cutanea tarda

Keywords: actinic keratosis photodynamic therapy
combination chemotherapy in treating children with relapsed or refractory acute lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.

objectives: i. evaluate the complete response rate to combination fludarabine, idarubicin, and cytarabine in children with relapsed or refractory acute lymphocytic leukemia. ii. evaluate the safety and tolerance of this treatment in these patients. iii. evaluate the time to progression, disease free survival, and overall survival of these patients. outline: this is an open label, multicenter study. patients receive idarubicin iv over 1 hour on days 1-3. fludarabine iv is administered over 30 minutes on days 1-5. cytarabine iv is administered over 4 hours on days 1-5. if partial response is obtained, patients receive a second course of treatment. patients receive a consolidation course in the absence of disease progression and unacceptable toxicity. idarubicin iv is administered over 1 hour on days 1 and 2. fludarabine iv is administered over 30 minutes, followed by cytarabine iv over 4 hours on days 1-5. patients are followed every 3 months for 2 years or until death. projected accrual: a total of 24-45 patients will be accrued for this study within 27 months.

Eligibility criteria:
disease characteristics: cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy fab l1 or l2 bone marrow relapse either isolated or associated with cns or testicular relapse bone marrow blast cells greater than 10% no isolated cns relapse patient characteristics: age: under 18 performance status: who 0-2 play-performance scale at least 60% life expectancy: not specified hematopoietic: not specified hepatic: bilirubin less than 2.5 times normal renal: creatinine less than 2.5 times normal cardiovascular: no symptoms of cardiac failure no decline of ejection fraction by more than 20% of the lower limit of normal shortening fraction at least 25% other: no psychological, familial, sociological or geographical condition that would hamper compliance no uncontrolled infection prior concurrent therapy: at least 6 months since prior autologous bone marrow transplantation no prior allogeneic bone marrow transplantation no concurrent treatment with other experimental drug

Keywords: recurrent childhood acute lymphoblastic leukemia l1 childhood acute lymphoblastic leukemia l2 childhood acute lymphoblastic leukemia
ivf clinical trial of two different treatment protocols.

Conditions: Infertility

Summary: the purpose of this study is to compare two different in vitro fertilization (ivf) treatments: conventional ivf protocol and minimal stimulation ivf protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

a random population of 564 sub-fertile women or couples with a female between ages of 18 and 38 years and a desire to undergo their first ivf cycle will be included in this outpatient clinical trial. the participation in this study will be approximately six months with a total of 20 to 25 visits. after successful completion of the pre-screening tests participants are randomized into one of the two arms of the study: arm a - mini ivf protocol, and arm b - conventional ivf protocol.

Eligibility criteria:
inclusion criteria: * valid indication for ivf treatment * first ivf attempt * female age between 18 and 38 years * male partner 18 years of age or older * both partners std free * must be able to understand that they may not become pregnant exclusion criteria: * not willing or able to sign the consent form * pre-existing medical condition preventing/interfering with ivf treatment * abnormal ivf screening tests, which includes complete blood count, varicella titer, rubella titer, pap smear, syphilis, hiv 1\&2, hepatitis b, hepatitis c, chlamydia, and gonorrhea * abnormal pap smear * body mass index (bmi) falls below 18.5 or above 32.0 * female participant with irregular menstrual cycles

Keywords: ivf research study infertility sudy in vitro fertilization mini ivf conventional ivf
impact trial: intervention to improve adherence equitably

Conditions: Breast Cancer

Summary: to determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (cvd) medication on adherence to endocrine therapy and to cvd medication at 24 weeks assessed by self-report using the domains of subjective extent (dose)-nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (ehr).


Eligibility criteria:
inclusion criteria: * women or men age \>18 years * diagnosed with stage i-iii breast cancer prescribed endocrine therapy * within 3-years of the end of early active treatment (e.g., surgery, chemotherapy not including human epidermal growth factor receptor 2 (her2)-directed therapy, radiation) * patients must be prescribed at least 1 antihypertensive or statin medication for cvd prevention * self-report of at least some nonadherence et or cvd medication on dose-nonadherence extent of nonadherence questionnaire exclusion criteria: * evidence of breast cancer recurrence * non-english or non-spanish speaking * not cognitively able to complete study requirements * do not follow with either a primary care provider or cardiologist within the new york presbyterian health system's epic ehr * inability to provide informed consent
markers in the diagnosis of tia

Conditions: Transient Ischemic Attack

Summary: mind-tia is primarily an observational diagnostic study that aims to evaluate the role of novel biomarkers in the diagnosis of transient ischemic attack (tia)in primary care. rapid and adequate diagnosis of tia is of great importance to enable a rapid start of treatment, and thereby decrease the risk of subsequent ischemic stroke.

rationale: a transient ischaemic attack (tia) does not cause permanent damage of brain tissue, but the risk of a subsequent ischemic stroke in the short term is high. timely recognition of tia would result in early treatment and reduce the risk of ischaemic stroke, and other adverse cardiovascular events. to improve the management of tia adequate diagnosis is of imminent importance. however the diagnosis is notoriously difficult, for both gp and neurologist. adequate biomarkers for brain ischaemia could improve the early diagnosis and thus the subsequent management of tia. objectives: 1. to assess the added diagnostic value of biomarkers beyond the clinical assessment (medical history, signs and symptoms) in patients suspected of tia. secondary objectives 2. to assess the prognostic value of biomarkers in patients with an established diagnosis of tia. 3. to assess the time delay and factors related to delay in patients suspected of tia. study population: 350 adult persons suspected of tia from primary care. methods: recruitment of patients will be performed at the general practices of 200 gps in the vicinity of 4 to 5 participating hospitals. during a home visit a research nurse collects a blood sample, and takes two health-related questionnaires. participants will be referred by their gp to the regional tia outpatient clinic for additional investigations, including brain imaging. the diagnostic accuracy of a set of biomarkers will be assessed with the 'definite' diagnosis of tia by a panel of neurologists as the reference standard.

Eligibility criteria:
inclusion criteria: * being adult (18 years and older) * presenting to the gp with a new episode of symptoms suspected of tia and the gp considering further investigations to confirm or exclude tia at the tia outpatient clinic. * a blood sample can be collected within 72 hours after onset of symptoms. exclusion criteria: * the patient still has active symptoms or signs suspected of an ongoing ischemic stroke and immediate referral to the neurologist seems indicated. * valid history taking is impossible because of severe cognitive impairment or insufficient knowledge of the dutch language. * patient with a life expectancy of \< 6 months. * patient is not willing or able to give written informed consent

Keywords: biomarkers tia diagnosis
high intensity focused ultrasound (hifu) to treat breast fibroadenoma

Conditions: Breast Fibroadenoma

Summary: this study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (hifu). this study will be conducted in france in 20 patients with breast fibroadenoma with indication for a surgical resection. the patient will receive an hifu treatment and 6 months after treatment, the need of the surgery is evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of breast fibroadenoma based on:clinical examination, ultrasound image and mammogram for women older than 35 years, and histology * fibroadenoma size superior at 1 cm at its largest dimension (measured by ultrasound) exclusion criteria: * patient pregnant or lactating * microcalcifications within the lesion at the mammogram. * history of breast cancer or history of laser or radiation therapy to the target breast * breast implant in the target breast. * fibroadenoma not clearly visible on the ultrasound images (in b mode) * patient participating in other trials using drugs or devices

Keywords: breast fibroadenoma high intensity focused ultrasound
therapist-guided smartphone-delivered cbt for mdd

Conditions: Major Depressive Disorder

Summary: we are testing a smartphone app that provides therapy for depression. participants will also receive short weekly virtual appointments with a therapist. researchers want to know if this new treatment is usable, whether participants are satisfied with it, and whether it can help lower symptoms.

the purpose of this project is to conduct an open trial to test the feasibility, acceptability, and preliminary efficacy of a new therapist-guided smartphone-delivered cognitive behavioral therapy (cbt) for major depressive disorder (mdd). this treatment will include unlimited access to the mobile cbt for depression app over 8 weeks plus 8 virtual visits with a doctoral-level psychologist or psychology intern with their master's degree. the therapist will be assigned once eligibility is determined. all virtual sessions will be no longer than 16-25 min. the combined cbt app plus virtual treatment will be tested in 28 patients. clinical assessments will occur at baseline, mid-treatment (week 4), end-of-treatment (week 8), and 3 month follow-up. the investigators hypothesize that this treatment will be feasible, acceptable to participants, and lead to reductions in depression symptoms and functional impairment as well as improvements in quality of life from baseline to end-of-treatment.

Eligibility criteria:
inclusion criteria: * adults * living in massachusetts * current primary diagnosis of depression * at least moderately severe current symptoms of depression exclusion criteria: * recent or anticipated changes in psychotropic medication use * past participation in a course of cbt for depression * current severe substance use disorder * lifetime bipolar disorder or psychosis * acute, active suicidal ideation * concurrent psychological treatment * does not own a supported mobile smartphone with a data plan * lack of technology literacy that would interfere with ability to engage with smartphone treatment

Keywords: digital health cognitive behavioral therapy depression smartphone apps mhealth feasibility acceptability mobile app mental health
comparison of the effects of support and non-support online cbt-i

Conditions: Insomnia

Summary: insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. cognitive behavioral therapy for insomnia (cbt-i) has been found to be effective in both adults and adolescents. however, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. therefore, digital cbt-i has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. therefore, the objectives of current study are 1) evaluate the efficacy of mobile-app based cbt-i in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.


Eligibility criteria:
inclusion criteria: * chinese aged 12-24 years old; * informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18); * being able to comply with the study protocol; * having a dsm-5 diagnosis of insomnia disorder, with a score on insomnia severity index (isi) \>= 9 (suggested cut-off for adolescents) exclusion criteria: * a current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities; * having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease); * having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome; * concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids); * in the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt); * having been enrolled in any other clinical trial investigational products within one month at the entry of the study; * initiation of or change in antidepressant medication within past 2 months; * having been or is currently receiving any structured psychotherapy; * with hearing or speech deficit; * night shift worker.
effect of capecitabine on the pharmacokinetics of bms-247550 and bms-247550 on the pharmacokinetics of capecitabine and its metabolites in patients with advanced malignancies

Conditions: Advanced Solid Tumors; Neoplasms

Summary: the purpose of this study is to test how bms-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of bms-247550 from the body.


Eligibility criteria:
inclusion criteria: * recovery from surgery or radiation therapy * measurable or non-measurable disease * available for follow-up exclusion criteria: * neuropathy * uncontrolled pulmonary or cardiovascular disease * known history of hiv infection
obesity paradox in non valvular atrial fibrillation regarding outcomes: fact or fiction

Conditions: Obesity Paradox

Summary: obesity paradox in patient with non valvular atrial fibrillation

study role of obesity in outcomes of anticoagulation in patients with non valvular atrial fibrillation

Eligibility criteria:
inclusion criteria: * patients presented with non valvular af * patients on oral anticoagulant exclusion criteria: * valvular af * mental illness * history of cerebrovascular stroke * history of bleeding tendency * history of chronic renal failure
clinical outcomes of surgery after neoadjuvant chemotherapy in locally advanced pancreatic cancer

Conditions: Postoperative Complications

Summary: the purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (la-pc) who underwent surgery after neoadjuvant chemotherapy (nact) at asan medical center's department of hepato-biliary-pancreatic surgery from 2017 to 2020.

pancreatic cancer (pc) has a very low survival rate. most pc patients have non-specific symptoms that are advanced enough to be contraindications for surgical treatment; therefore, surgery is often impossible by the time pc is diagnosed. according to the nccn guidelines, pcs with no metastases can be divided into resectable, borderline resectable , and locally advanced cases. patients with borderline resectable pc (br-pc) and locally advanced pc (la-pc) currently receive multimodal therapy before surgery. the goal of these neoadjuvant treatments, including chemotherapy and radiation therapy, is to ultimately reduce local recurrence after surgery in patients with br-pc and further improve their survival time. additionally, several recent studies have reported results on the prognosis when surgery is performed after neoadjuvant chemotherapy (nact) in patients with la-pc. in the patients with la-pc, surgery technically difficult because of major vascular invasion before nact. therefore, this study investigated the clinical outcomes of patients with la-pc who underwent surgery after nact. additionally, the investigators evaluated factors affecting the prognosis related to survival after surgery in patients with la-pc.

Eligibility criteria:
inclusion criteria: * the study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between january 2017 and december 2020 exclusion criteria: * none