Kornimate/medical-research-clean huggingface dataset:
real world experience with mogamulizumab in the treatment of cutaneous t-cell lymphoma

Conditions: Cutaneous T Cell Lymphoma; Cutaneous T-Cell Lymphoma/Mycosis Fungoides; Cutaneous T-Cell Lymphoma/Sezary Syndrome

Summary: this study is designed to describe the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of ctcl patients in real world setting

mogamulizumab (anti-ccr4) has been recently approved and reimbursed in italy for the treatment of cutaneous t-cell lymphoma (ctcl) after 1 previous systemic treatment based on the favourable results of the mavoric clinical trial. to date, no real-world data on significant series of patients treated routinely with mogamulizumab in clinical practice are available. as real-life data are essential to confirm the preliminary evidence displayed in phase iii trials, this study aims at describing the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of ctcl patients in real world settings.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ctcl according to the eortc 2017 update criteria (trautinger et al, eur j cancer, 2017) * age ≥18 years * have failed at least one previous line of systemic therapy * have received mogamulizumab in real life setting after the approval and reimbursement of the drug from the national health system in december 2020 * have received first dose of mogamulizumab between 01/01/2021 and 31/01/2023 * have received mogamulizumab at the standard approved dose (1.0 mg/kg intravenously on days 1, 8, 15 and 22 of the first cycle and on days 1 and 15 of subsequent cycles) * availability of complete medical records. exclusion criteria: • patients not meeting the above-mentioned inclusion criteria

Keywords: cutaneous t cell lymphoma mycosis fungoides sezary syndrome mogamulizumab mavoric retrospective relapsed refractory
early catheter-directed treatment of high risk pulmonary embolism

Conditions: Pulmonary Embolism Acute Massive

Summary: prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism


Eligibility criteria:
inclusion criteria: 1. pulmonary embolism as confirmed by ct angiogram with high mortality risk as defined by esc guidelines: a) one of the following: i. cardiac arrest or ii. obstructive shock (systolic bp \<90 mmhg or vasopressors required to achieve a bp ≥90 mmhg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/l) and b) signs of right-ventricular dysfunction on transthoracic echocardiogram or ct scan 2. age ≥18 years exclusion criteria: 1. contraindications for catheter-based treatment 2. contraindications to systemic fibrinolytic treatment or anticoagulation\* 1. active, potentially life-threatening bleeding 2. surgery within 24h before screening 3. cranial or spinal surgery within 14d before screening 4. stroke within 14d before screening 5. intracranial tumor 6. any condition not listed here but estimated as clinically relevant as judged by the treating investigator 3. pregnancy * patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

Keywords: pulmonary embolism early catheter-directed treatment
evaluating the pulmonary nodule with imaging and biomarkers

Conditions: Lung Cancer

Summary: the study aims to determine if there are defining ebus and confocal endoscopy features as well as exhaled alveolar gas voc that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. directly sampled alveolar gas voc from patients with lung cancer will be compared against exhaled breath voc for signature compounds that may complement ct in screening the population at risk.

aims 1. to improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and ebus. 2. to determine if characteristic features of ebus and confocal microendoscopy exist as well as voc patterns in alveolar and exhaled gas that can aid in discriminating malignant pulmonary nodule or mass from benign etiology by correlating with pathology. 3. to identify voc patterns specific for lung cancer by correlating voc from directly sampled alveolar gas and exhaled breath with pathology. exhaled breath voc signature may complement ct in screening population at risk.

Eligibility criteria:
inclusion criteria: * all patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses. exclusion criteria: * patients with contra-indications to bronchoscopy and ct-ttna that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

Keywords: exhaled breath condensate (ebc) method volatile organic compounds (vocs) endobronchial ultrasound (ebus) confocal endoscopy exhaled alveolar gas
addressing sleep problems in older adults

Conditions: Sleep

Summary: as many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. the implications of this sleep deprivation are sobering, particularly among older individuals. the primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.

this is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. the purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention. this trial proposes to enroll a total of 60 community based older adults. all study patients will be instructed to take the study product every day for 28 days. during which time, study subjects will return weekly to complete study visits for a total of 4 visits.

Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years old at the time of study registration. 2. individual describes trouble either falling asleep or staying asleep at study entry. 3. willing to participate in all aspects of the study. 4. willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study. 5. willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention). exclusion criteria: 1. allergic to kiwifruit, cherries, honey, apples, or bananas. 2. hospitalized or living in a care facility at the time of enrollment. 3. clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment. 4. any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months. 5. healthcare provider does not think that study candidate has a specific health problem that precludes participation. 6. allergy or intolerance of milk products. 7. women of child bearing potential.

Keywords: sleep fruit honey geriatric
microwave ablation in pulmonary malignancies

Conditions: Lung Cancer

Summary: lung cancer remains to be an important global issue as it is the leading cause of cancer_ related mortality for both men and women worldwide .since more than two thirds of cases are diagnosed at an advanced stage,the survival rate of lung cancer is one of the lowest among all cancers.

currently , surgery is one of the curative treatment option for primary lung cancer but most patients are either diagnosed at an advanced stage or are unfit for surgery due to medical co_morbidities or poor underlying lung reserve , less than a third of all lung cancer patients can undergo surgical resection . lung metastasectomy is considered a therapeutic option increasing the survival rate for patients of pulmonary metastases but only 25%_30% of patients benefits from lung metastasectomy due to multiplicity of pulmonary nodules or medical co_ morbidities . in spite of a significant improvement of lung cancer chemotherapy and radiotherapy in recent years , the overall clinical outcome is less than satisfactory compared with that brought by surgical resection .thus , it is urgent to provide a method which is more effective than chemotherapy and radiotherapy and nearly effective as the surgical treatment for the patients who are not eligible for surgery. local thermal ablation therapy of the tumor is the focus of recent research in the past decades .this method is to deliver specific energy into the tumor tissue under the guidance of image technology , which make the local tissue quickly reach 60°c where an irreversible coagulative necrosis happens leading to necrosis of tumor cells . ct_guided microwave ablation is a minimally invasive technique that may be an alternative treatment option for management of lung cancer in patients who are not candidate for surgery .this method not only kill the insitu lung cancer cells , but also protect lung cancer tissue .it can produce large volumes of cellular necrosis with reduced procedure time , can use multiple antennae and can be used in lesions with cystic component and/or in proximity to vascular structures. thus, ct guided microwave ablation is a promising new technique that is convenient ,easy ,causing less trauma ,associated with no need for general anaesthesia , fast recovery and less complications.

Eligibility criteria:
inclusion criteria: * patient has good compliance and sign the informed consent. * patient with lung cancer who lost the opportunity of surgical resection. * patient has one or more metastatic lung nodules (not more than 5) exclusion criteria: * patient is pregnant or breast feeding . * patient with uncorrectable coagulopathy. * there are large blood vessels or important structures adjacent to lung lesion. * patient with more than five nodules
sglt2 inhibitor or metformin as standard treatment of early stage type 2 diabetes

Conditions: Type 2 Diabetes

Summary: a real-world, nationwide, register-based, randomised trial (rrct) comparing sglt2 inhibitors with metformin as standard treatment in early typ 2 diabetes. an open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.

2067 type 2 diabetes (t2d) patients on monotherapy or drug naive. randomization 1:1, metformin, dosing according to treatment guidelines or sglt2 inhibitor, dapagliflozin 10 mg od. 844 events estimated for study completion (90% power to detect hazard ratio (hr) \<0.8 for dapagliflozin vs metformin ) endpoint collection during study duration (about 4 years) from national health care registers: patient, prescribed drugs, cause of death and population registers; national diabetes register (ndr) primary analysis according to insulin tolerance test (itt)

Eligibility criteria:
inclusion criteria: * men and women ≥18 years old * t2d (according to world health organization (who) criteria) of less than 4 years duration * bmi 18.5-45 kg/m2 * drug naïve or oral monotherapy with glucose-lowering drug. * accepting ndr participation and other register data collection. exclusion criteria: * known or suspected other form of diabetes than type 2 * ongoing or more than \>4 weeks in total of any previous treatment with: insulin, glp-1 receptor agonists, sglt2 inhibitors or combination of any diabetes medications * medical need to start or intensify any specific gld treatment, e.g. insulin due to marked hyperglycemia * hba1c \>70 mmol/mol for patients on monotherapy, \>80 in drug naïve * contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator * history or signs of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, heart failure, stroke, lower extremity arterial disease, any limb amputation (except due to trauma or malignancy) * any serious illness or other condition with short life expectancy (\<4 yr) * renal impairment (egfr \<60 ml/min/1,73m2) * any condition, as judged by the investigator, that suggests that the patient will be non-compliant or otherwise unsuitable to study medication or study participation * pregnancy or breastfeeding, women of childbearing potential (wocbp; including perimenopausal women who have had a menstrual period within 1 year) without adequate anticonception during any part of the study period * involvement in the planning and/or conduct of the study * ongoing participation in another clinical trial.
combined intravitreal fasudil and bevacizumab for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: eligible eyes are randomized to two groups. group a will receive three intravitreal injections of bevacizumab at 4 week intervals. in group b, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency. best corrected visual acuity (bcva) and central macular thickness (cmt) will be evaluated prior to injections and then every 4 weeks for 6 months. fluorescein angiography will be performed at baseline and at weeks 12 and 24. the two groups will be compared in terms of bcva and cmt changes.


Eligibility criteria:
inclusion criteria: * diabetic patients with diabetic macular edema (dme) and: * central macula thickness\> 250μm * visual acuity \< 20/40 * no active proliferative diabetic retinopathy * no history of intravitreal anti-vegf drug injection or macular laser photocoagulation (mpc) within the past 3 months exclusion criteria: * history of vitrectomy * history of cataract surgery within the past 6 months * history of glaucoma or uveitis * presence of any macular disorder other than dme * presence of traction on the macula * significant media opacity * serum creatinine\>3mg/ml
a case-control study of negative pressure platform wound devices (np-pwd) for skin and soft tissue defects

Conditions: Skin Wound; Soft Tissue Injuries

Summary: this study will demonstrate the effectiveness of the np-pwd therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.

a study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. patients will be screened for inclusion criteria and asked to consent to participate in the study. following consent subjects will be randomized to receive treatment of one of the two study arms. arm 1, the standard of care arm, will receive kci wound vac granulofoam. arm 2, the study arm, will receive treatment with np-pwd. prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. the wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device ifu). subjects will be followed for up to nine days post initial application. at minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. follow up data will be gathered at each change/removal of the np-pwd or wound vac. the data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the np-pwd device for wound healing management.

Eligibility criteria:
inclusion criteria all subjects enrolled must meet all the following criteria: 1. patients 18 years of age or older of either gender 2. have an open skin or soft tissue defect requiring treatment exclusion criteria subjects who meet any of the following criteria will be excluded from the study: 1. active malignant disease at the study site 2. any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use 3. on any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study 4. pregnant at enrollment

Keywords: negative pressure therapy
study of the efficacy and safety of somatropin in japanese participants with pws

Conditions: Prader-Willi Syndrome

Summary: this is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of japanese participants with pws.


Eligibility criteria:
inclusion criteria: 1. male or female participants with documentation of genetically confirmed diagnosis of pws. 2. no plan to initiate a new treatment that may affect the body composition, such as gonadal hormone replacement therapy. 3. currently on appropriate diet and exercise programs and willing to continue throughout the study period at the discretion of the investigator. 4. participants, and if required by local/site regulations their parent(s)/legal guardian(s) must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 5. evidence of a personally signed and dated icd (and written assent where applicable based on age and country regulation) indicating that the participant or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. refer to appendix 1 for the detailed process of obtaining consent. for inclusion of gh naïve pediatric cohort, participants must meet criteria 6 to 8: 6. 18 years or younger. 7. naïve to gh treatment. 8. tanner stage 1 (for testes in males, for breasts in females). for inclusion of gh treated pediatric cohort, participants must meet criteria 9 and 10: 9. continued gh treatment for at least 2 years with stable dose for the last 6 months and being on gh at time of inclusion. the recent dose should be higher than 0.084 mg/kg/week. 10. participants who are about to complete gh treatment for his/her short stature (eg, due to meeting the treatment stopping criteria defined as a height sds more than -2.5 for japanese adult standards). for inclusion of adult cohort, participants must meet criteria 11 to 13: 11. 18 years of chronological age or older at day 1 visit. 12. off from gh treatment for at least 1 year. 13. serum igf-i level within +2 sds, adjusted for age and sex. exclusion criteria: 1. participants with uncontrolled diabetes at the discretion of the investigator. 2. participants with malignant tumors. 3. participants with severe obesity or serious respiratory impairment. 4. other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 5. previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half- lives preceding the first dose of study intervention used in this study (whichever is longer). 6. investigator site staff or pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
the impact of udenafil on exercise capacity in severe chronic obstructive pulmonary disease (copd) patients

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Summary: pulmonary hypertension (ph) is a serious complication of copd which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. there is no effective pharmacological treatment for copd-associated ph. therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (pde-5) inhibitor, on exercise capacity of severe copd patients.

study design * prospective, single arm, open-label study * udenafil 50mg qd po for 8 weeks

Eligibility criteria:
inclusion criteria: * severe copd who showed post-bronchodilator forced expiratory volume in 1 second (fev1) less than 50% of predicted value exclusion criteria: * acute exacerbation within 4 weeks of the study entry * coronary heart disease * history of adverse event on pde-5 inhibitors

Keywords: udenafil chronic obstructive pulmonary disease pulmonary hypertension phosphodiesterase 5 inhibitors exercise dyspnea
optimizing cbt implementation among community providers through internet-based consultation and networking (i-can)

Conditions: Anxiety; CBT

Summary: although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment. cognitive-behavioral therapy (cbt) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement cbt with high fidelity, which can detrimentally affect its clinical impact. the goal of this study is to develop and test an online platform to support community providers' effective use of cbt for pediatric anxiety.

stemming from implementation science and, specifically, the theory of planned behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform. this platform, termed internet-based consultation or networking (or i-can) will utilize a professional navigator (i.e., a provider with cbt expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement cbt. once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (rct) with approximately 100 mental healthcare providers who work with anxious children and adolescents. providers who enroll will be randomly assigned to either the experimental condition (i-can) or the control condition (wait-list for i-can). the primary outcome of interest is change in intentions to use cbt.

Eligibility criteria:
inclusion criteria: * provide direct mental healthcare to anxious youth * practice in general community within state of alabama * agree to try i-can exclusion criteria: * none