Kornimate/medical-research-clean huggingface dataset:
sunitinib in recurrent and refractory ovarian, fallopian tube and peritoneal carcinoma

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: the purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

this study used a two-stage design to evaluate efficacy of sunitinib based on overall response (or) defined as complete response (cr) or partial response (pr). the null and alternative or rate were 5% and 20%. if one or more patients enrolled in the stage one cohort (n=17 patients) achieved pr or better than accrual would proceed to stage two (n=18 patients). there was 42% probability of stopping the trial at stage one if the true or rate was 5%. with 35 patients, this design had 85% power to detect the 15% difference in or rates assuming 2-sided type i error rate of 0.05.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer * recurrent or refractory disease * measurable disease, defined by recist * 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease * adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry * ability to swallow oral medications * 18 years of age or older * ecog performance status must be 0-2 * normal organ and marrow function as outlined in the protocol exclusion criteria: * receiving systemic therapy less than 14 days prior to starting sunitinib * receiving any other investigational agent * received prior sunitinib * untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening ct or mri scans * any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism. * evidence of a bleeding diathesis. major surgery or nci ctca 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment * ongoing cardiac dysrhythmias of nci ctcae version 3.0 grade \> 2 * pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication * prolonged qtc interval on baseline ekg * uncontrolled hypertension * patients who are taking cytochrome p450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or st. john's wort. * psychiatric illness or social situations that wold limit compliance with study requirements * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration * pregnant women * clinical or radiographical evidence of a small bowel obstruction * poor oral intake

Keywords: sutent sunitinib
evolution of respiratory function in lung transplant patients with moderate to severe covid-19 infection

Conditions: COVID-19 Respiratory Infection

Summary: the sars-cov-2 infection pandemic has caused a large number of acute respiratory failures and deaths across the world. certain factors have been identified as associated with a higher risk of developing a severe form and dying. immunosuppression has been identified as a risk factor for progressing to a severe form. lung transplant patients were particularly vulnerable during this period, with a high frequency of respiratory compromise, sometimes progressing towards acute respiratory distress syndrome and, at a later stage, towards fibrotic forms. the impact of the infection on the immunological status of the patient and on the tolerance of the transplant have been little studied. the various treatments implemented during the pandemic have rapidly evolved (immunotherapy, vaccination, convalescent plasma transfusion, etc.) which may have modulated this risk. the evolution of respiratory function may be linked to the respiratory infection itself, or to the severity of respiratory damage during the infection. it is therefore relevant to compare patients with a moderate form of covid-19 (non-intubated patients) to patients with severe forms, requiring invasive ventilation in intensive care. the evolution of respiratory function after infection has not yet been studied.


Eligibility criteria:
inclusion criteria: * adult patient * lung transplant patient (monopulmonary or bipulmonary) * covid diagnosed by rt-pcr between march 1, 2020 and december 31, 2022 * hospitalization at the university hospitals of strasbourg for covid-19 * patient followed in the context of their lung transplant at the university hospitals of strasbourg * absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed his opposition to the reuse of his data for scientific research purposes.

Keywords: covid-19 covid-19 pneumonia covid-19 respiratory infection sars-cov-2
safety and efficacy study of intravitreal ocriplasmin in subjects with amd with focal vitreomacular adhesion

Conditions: Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion

Summary: this study will evaluate the safety and efficacy of ocriplasmin intravitreal injection, in subjects diagnosed with exudative amd with focal vitreomacular adhesion. ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in amd subjects where this adhesion may be causally associated with worse prognosis).


Eligibility criteria:
inclusion criteria: 1. male or female subjects aged \> 50 2. presence of focal vitreomacular adhesion measured by optical coherence tomography (oct). 3. diagnosis of active primary or recurrent subfoveal cnv secondary to amd, including those with predominantly classic, minimally classic or occult lesions with no classic component. 4. the total area of choroidal neovascularization (cnv) (including both classic and occult components) encompassed within the lesion must be \> 50% of the total lesion area 5. the total lesion area must be \< 12 disc areas 6. subjects who have previously received at least three antiangiogenic injections(lucentis® or avastin®) in the study eye. 7. subjects with visual acuity of 20/32 to 20/200 in the study eye 8. written informed consent obtained from the subject prior to inclusion in the study exclusion criteria: 1. evidence of complete macular posterior vitreous detachment (pvd) in the study eye on biomicroscopy, b-scan ultrasound or oct prior to planned study drug injection 2. subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either oct and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus. 3. subjects who have previously received more than 9 antiangiogenic agent injections (whether lucentis® or avastin® or other anti-angiogenic agent) in the study eye 4. subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (pvr) in the study eye 5. subjects with high myopia (\> 8d) or aphakia in the study eye 6. subjects who have had ocular surgery in the study eye in the prior three months 7. subjects who have had a vitrectomy in the study eye at any time.

Keywords: amd
accelerated partial breast irradiation following lumpectomy for breast cancer

Conditions: Breast Cancer; Carcinoma, Ductal

Summary: to determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using iort as a single dose, intracavitary brachytherapy with the mammosite device over 5 days, partial breast 3-d crt in 5 days, or stereotactic apbi over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. the study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.


Eligibility criteria:
inclusion criteria: 1. women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ 2. patient chooses lumpectomy rather than mastectomy as treatment for breast cancer 3. tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen. exclusion criteria: 1. men 2. prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years 3. pregnant women 4. immunocompromised 5. poorly controlled insulin dependent diabetes 6. contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma 7. breast cancer that involves skin or chest wall 8. multifocal or multicentric breast cancer 9. invasive lobular carcinoma 10. diffuse microcalcifications on mammography 11. invasive carcinoma with extensive intraductal component (eic) 12. greater than 12 weeks since definitive surgical excision or completion of chemotherapy 13. involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy 14. patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases) 15. subglandular or submuscular breast implants (does not include patients having implants placed after intra-operative radiotherapy)
a study to evaluate incb099280 in participants with advanced cutaneous squamous cell carcinoma

Conditions: Cutaneous Squamous Cell Carcinoma

Summary: this study is being conducted to determine the safety, tolerability, and preliminary efficacy of incb099280 in participants with advanced cutaneous squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * histopathological diagnosis of cscc. * previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cscc not amenable to curative surgery and/or radiotherapy. * measurable disease based on either radiographic imaging per recist 1.1 or who criteria. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * life expectancy \> 3 months. * willingness to avoid pregnancy or fathering children. exclusion criteria: * known history of an additional malignancy. * central nervous system (cns) metastases requiring treatment and/or leptomeningeal disease. * toxicity from prior therapy that has not recovered. * prior receipt of an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent; treatment with an immune modulator (eg, ctla-4, gitr, lag3, tim3, ox40, icos, il-2, 4-1bb, car-t cell). * received thoracic radiation within 6 months of the first dose of study treatment. * participation in another interventional clinical study while receiving incb099280. * impaired cardiac function or clinically significant cardiac disease. * history or evidence of interstitial lung disease including noninfectious pneumonitis. * presence of gastrointestinal conditions that may affect drug absorption. * any autoimmune disease requiring systemic treatment in the past 5 years. * diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent. * active infection requiring systemic therapy. * history of organ transplantation, including allogeneic stem cell transplantation. * receipt of systemic antibiotics within 28 days of first dose of study treatment. * probiotic usage is prohibited during screening and throughout the study treatment period. * received a live vaccine within 28 days of the planned start of study drug. * laboratory values outside the protocol-defined ranges. * inadequate organ function. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cutaneous squamous cell carcinoma anti-pd-l1 antibody metastatic cutaneous squamous cell carcinoma locally advanced cutaneous squamous cell carcinoma
humanin isoforms in cardiac muscle and blood plasma and major complications after cardiac operation

Conditions: Myocardial Ischemia; Coronary Artery Bypass Surgery

Summary: objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation. hypothesis of the study is that previously described elements are related to each other.

data collection: historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications). specimen collection: * tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 c. * blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. samples are processed and blood plasma is frozen at -80 c.

Eligibility criteria:
inclusion criteria: * age at least 18 years * ischemic heart disease in medical history * planned on-pump coronary artery bypass graft (cabg) operation * signed informed consent by patient exclusion criteria: * age \<18 years * planned isolate valve or aortic operation * patient is in another study with an intervention * absence of signed informed consent
reduced nicotine cigarette purchasing decisions

Conditions: Tobacco Use Disorder

Summary: the goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.


Eligibility criteria:
inclusion criteria: * 21 years or older * smoke five or more cigarettes per day for the past six months * biological confirmation of cigarette use: have an expired carbon monoxide (co) level of more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening exclusion criteria: * intention to quit smoking in the next 30 days * weekly use of nicotine-containing products other than machine-manufactured combustible cigarettes * serious medical or psychiatric disorder precluding participation by study physician guidance * positive urine screening for illicit drugs other than cannabis or current substance use disorder * women who are pregnant, plan to become pregnant, or are breast-feeding * medical contraindications to receiving tobacco products
rehabilitation robotics, cognitive skills training and function

Conditions: Stroke; Cerebrovascular Accident

Summary: this study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.

research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks. this study aims to refine and test a protocol named the active learning program for stroke (alps), which teaches people to use active problem solving strategies and a home program to improve function. therapist-delivered alps instruction may incorporate use of strategies (e.g. stop, think, do, check) modeled after the cognitive orientation for daily occupational performance (co-op) approach to improve real-world use of the paretic upper limb. we will evaluate whether the combination of robot-assisted therapy and alps training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.

Eligibility criteria:
inclusion criteria: * diagnosed with unilateral stroke more than 6 months prior to study enrollment. * stroke type will include both ischemic and hemorrhagic stroke. * moderate ue hemiparesis (characterized by initial scores on upper limb subtest of the fugl-meyer assessment (fma) between 19-47/60) * intact cognitive function to understand and actively engage in the alps robotic therapy procedures (montreal cognitive assessment score \>/=26/30)during the initial evaluation visit exclusion criteria: * no more than moderate impairments in paretic ue sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the fugl-meyer assessment (fma) \[13\] * increased muscle tone as indicated by score of \>/= 3 on the modified ashworth scale \[15\]; * hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the cognitive linguistic quick test \[16\] * aphasia sufficient to limit comprehension and completion of the treatment protocol * currently enrolled or has plans to enroll in other upper limb therapy/research during the study period * treatment with botox injections for the affected arm within the previous 4 months or planned botox injections before the end of the study * contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic ue

Keywords: upper limb function arm and hand weakness
renal doppler to predict acute kidney injury (aki) in ards patients. (red-aki study)

Conditions: Acute Kidney Injury; ARDS, Human

Summary: this is a multicenter international observational prospective cohort study. the main questions it aims to answer are: * primary aim: to describe the capability of irvf demodulation at diagnosis of ards to predict development of aki within 7 days from the ards onset * secondary aims: a)describe the capability of irvf demodulation or pattern of irvf (continuous, pulsatility, biphasic, monophasic) to predict development of aki within 14 days from the ards onset. b) to describe the rd parameters and vexus in the aki and no aki patients over time. c) describe the impact of invasive mechanical ventilation (imv) on the intrarenal venous congestion and vexus., d) evaluation of effect of crrt on irvf pattern, vexus and parameters. e) describe the feasibility of renal doppler to assess irvf in critically ill respiratory patients. f) evaluate the incidence of akd and ckd participants will adult patients with diagnosis of ards admitted to intensive care unit and undergoing invasive mechanical ventilation


Eligibility criteria:
inclusion criteria: * age \> 18 years * critically ill patients admitted to intensive care unit with a diagnosis of ards according to berlino criteria * beginning of imv less than 48 hours or clinical decision to begin imv. * life expectancy \> 24 hours * informed consent signed exclusion criteria: no patient will be excluded from the study because of gender, race, ethnicity, or sexual preference. * aki prior to the onset of ards * chronic respiratory failure due to chronic respiratory diseases * chronic renal disease (ckd stage ≥ 2) and any ureteral obstruction. definition of ckd patient is according to the latest guideline kdigo * chronic heart failure * chronic liver disease * major trauma in the past 3 months * major surgery in the past 3 months * smoking and alcohol drinking * bmi ≥ 35 * patients needing of vv-ecmo and va-ecmo * beginning of positive pressure ventilation more than 48 hours (invasive or no invasive) * life expectancy \<24 hours * cardio circulatory arrest * neoplasm in chemotherapy/radiotherapy * do not resuscitate or comfort measures * pregnancy at icu admission * refused informed consent by the patient or surrogate decision-maker

Keywords: renal doppler
mindful movement for breast cancer survivors

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if participating in a mindful movement program (mmp) (learning how to be mindful in one's movement), positively affects the body's immune functions improves mindfulness and reduces worries about cancer returning. all participants will be in this study about three months.

breast cancer survivors (bcs) may experience psychological and physical effects long after treatment is over. some research shows that practicing mindfulness, and movement types of activities such as qi gong or yoga may lead to improvements in emotional and physical well-being, including improved immune function. immune function can be negatively affected by stress and worry, and this has an unknown effect on the risk of cancer recurrence. psychological and physical interventions that help enhance an individual's wellbeing and reduce stress and worry may have a positive influence on immune function and in turn, reduce the risk of cancer recurrence. while there is limited research in this area, and none with dance therapy, little attention has been given to older bcs. however, understanding of immune function suggests that older women may be the best group to target for such interventions. previous research with bcs age 50 or older who participated in a 12-week program combining mindfulness practice with dance/movement therapy (mindful movement program) demonstrated positive effects: participants were more mindful in their day-to-day living and had less worry about the cancer coming back. participants also reported through focus groups that the mindful movement program (mmp) had improved their overall well-being. no laboratory tests of the body's immune response to mmp were included.

Eligibility criteria:
inclusion criteria: * diagnosed at age 50 or older with stage 0-iii disease * 6 months or more since completion of primary breast cancer treatment * have a medical release from their physician * english-speaking * not pregnant * no weekly practice of yoga, qi gong, tai chi, dance/movement therapy, or mindfulness meditation practice exclusion criteria: * males with breast cancer

Keywords: cancer survivor immune function
sleep promotion program primary care (spp pc) open trial

Conditions: Sleep; Sleep Disturbance; Insufficient Sleep

Summary: investigators developed a brief, scalable, behavioral sleep promotion program (spp) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. this open trial portion of the r34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and spp program, per participant and staff feedback.


Eligibility criteria:
inclusion criteria: youth: * able and willing to provide informed assent (with consent from parent/guardian) * ages 12-18 * currently a patient at kids plus pediatrics * currently depressed * report short sleep duration (\ =2 hours parents: parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week. exclusion criteria: youth: * significant or unstable medical conditions * diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder * diagnosis of ptsd, bipolar disorder, a psychotic disorder, or substance use disorder * currently engaged in cognitive and/or behavioral therapy that aims to improve sleep * changes in medications in the month prior to screening * active suicidality requiring immediate treatment * unable or unwilling to comply with study procedures * have any physical or mental condition that would preclude study participation. parents will be excluded if they: * express active suicidality that requires immediate treatment; * have any physical or mental condition that would preclude study participation; or * are unable or unwilling to comply with study procedures.