Kornimate/medical-research-clean huggingface dataset:
steroid sparing treatment with in newly diagnosed transplant ineligible patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

this is an open label, phase 2 study consisting of daratumumab, lenalidomide and dexamethasone, given upfront in newly diagnosed, transplant ineligible patients with myeloma. patients participating in the study will be recruited from the wilmot cancer institute, university of rochester in rochester, new york and all university of rochester community affiliates. patients will be treated with 1800 milligrams of daratumumab subcutaneously or 16 milligrams/kilograms daratumumab intravenously (iv) weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks. patients will be treated with 25 milligrams of lenalidomide days 1-21 out of a 28 day cycle (dose adjustments for creatinine clearance) and 20 milligrams of dexamethasone at least 60 minutes prior to first infusion of daratumumab. each cycle consists of 28 days (4 weeks). response assessments by international myeloma working group criteria for myeloma will be performed every 4 weeks while on therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma with diagnosis * must not have received previous therapy for multiple myeloma * newly diagnosed and not considered candidate for high-dose chemotherapy * adequate organ system function * a performance status ≤ 3 * ability to swallow and retain oral medication * female subjects of child bearing potential must be surgically sterile, be post-menopausal exclusion criteria: * a diagnosis of primary amyloidosis; monoclonal gammopathy of undetermined significance, smoldering multiple myeloma; non-secretory myeloma * a diagnosis of waldenström's disease * receiving cancer therapy * radiation therapy within 14 days of enrollment * major surgery within 2 weeks before enrollment * human immunodeficiency virus -infected patients must be on effective anti-retroviral therapy with undetectable viral load within the past 6 months * seropositive for hepatitis b, or seropositive for hepatitis c * ongoing systemic bacterial, fungal or viral infection * severe and/or uncontrolled medical conditions * malignancy within 2 years of study enrollment * women who are pregnant or lactating * contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
quantitative computed tomodensitometry in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to conduct a comparative study for the study of bone mineralization evaluated with quantitative computed tomodensitometry (qct) compared to the reference technique, dual-emission x-ray absorptiometry (dxa).

patients with cystic fibrosis can have a deficit in bone mineralization. this is particularly well described in adults. however, in the pediatric population the results are more heterogeneous. the evaluation is hindered by difficulties in standardization of dxa interpretation. this measurement depends from the mass and size of the bone as well as the mass of soft tissue covering the bone area. these two characteristics, intrinsic to the measurement, pose a significant problem of interpretations in children because a change in bone density may reflect both a change in bone mineral content or changes related to growth, for example, the increase in bone size or volume of soft tissue covering the bone of interest. quantitative computed tomography (qct) provides a direct measure of bone mineralization densitometry volume. it quantifies bone mineral content in relation to the volume of the bone, in reference to an external phantom. this method therefore overcomes the size size. this technique can be considered without an additional radiation exposure to patients during a lung ct because it is usual that lumbar vertebrae are included in the measurement window because of pulmonary hyperinflation. this exam would be ideal for patients with cystic fibrosis. all patients have these two evaluations during their routine management. this study compare study on the bone mineralization evaluated by (qct) compared to the reference technique by (dxa) for the patient affected by cystic fibrosis for each patient.

Eligibility criteria:
inclusion criteria: * patients affected by cystic fibrosis * aged over 5 years * patients whose clinical condition warrants an indication of chest ct in relation to the criteria of the french consensus conference on cystic fibrosis in may 2002 (palace of the luxembourg). * patients whose clinical condition warrants an indication of dxa examination in accordance with french recommendations (consensus of the working group "bone mineralization and cystic fibrosis" in children, the examination is recommended for ages 8 every 2 years if the z-score is greater than - 1, every year if the z-score is less than - 1.. in adults, the exam is recommended every 5 years if the t-score is greater than\> - 1, every 2 years if it is between -1 and - 2; annually if less than - 2.) * patient does not exhibit a phase of bronchial exacerbation * collection of non-opposition of the patient * patient affiliated to social security exclusion criteria: * patient transplanted * patient with an infective exacerbation phase

Keywords: cystic fibrosis-dxa-qct-osteopenia- osteoporosis
phase iii randomized study of the inhalation of tobramycin in patients with cystic fibrosis

Conditions: Cystic Fibrosis; Bacterial Infection

Summary: objectives: i. determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with pseudomonas aeruginosa. ii. determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. this treatment is repeated twice, for a total of 3 courses of therapy. patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- documented cystic fibrosis with pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening sweat chloride at least 60 meq/l --prior/concurrent therapy-- at least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic at least 4 weeks since prior administration of any investigational drug no concurrent antibiotics by aerosol --patient characteristics-- renal: * creatinine less than 2 mg/dl * bun less than 40 mg/dl * no proteinuria of 2+ or greater pulmonary: * fev1 at least 75% and at least 25% of predicted * room air oximetry at least 88% saturation * able to perform pulmonary function tests * no hemoptysis of 60 ml or greater within 30 days prior to study * no abnormal chest x-ray other: * not pregnant * fertile females must use effective contraception * no history of positive culture with burkholderia cepacia * no history of glucose-6-phosphate dehydrogenase deficiency * no known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists

Keywords: bacterial infection cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes immunologic disorders and infectious disorders rare disease
assessment of pet tracers to evaluate t cell change and activation in relation to immunotherapy treatment response in non-small cell lung cancer

Conditions: NSCLC

Summary: the irelate is a pet imaging trial to compare two upcoming and promising t cell pet tracers. following chemo-immuno therapy, as part of standard care, nsclc patients will be recruited to receive two pet scans, shortly before their surgery. both pet scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor. this study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting pet tracers.


Eligibility criteria:
inclusion criteria: * histologically confirmed nsclc * t1-4n0-2, lesion size of ≥2cm, at time of the restaging fdg pet/ct * planned to undergo resection after chemo-io according to routine treatment guidelines * willing and able to provide written informed consent for the trial * above 18 years of age on day of signing informed consent * have measurable disease based on recist 1.1 * have a ecog performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing exclusion criteria: * patients deemed inoperable * patients who have received a splenectomy * patients who have received any vaccination within 14 days of enrollment * patients with a condition requiring systemic treatment with either corticosteroids (\&gt; 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. inhaled or topical steroids, and adrenal replacement steroid \&gt;10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.

Keywords: nsclc immunopet 18f-arag arag 89zr-crefmirlimab crefmirlimab tracers pet tracers [18f]f-arag [89zr]zr-df-crefmirlimab iab22m2c
psychosocial support for african-american, latina-american, or european-american cervical cancer survivors

Conditions: Cancer Survivor; Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: telephone counseling may help reduce depression and anxiety and improve the well-being and quality of life of cervical cancer survivors. purpose: this randomized clinical trial is studying how well psychosocial support works in african-american, latina-american, or european-american cervical cancer survivors.

objectives: i. to evaluate the utility of the 6 telephone sessions (low intensity: litx) and 8 telephone sessions (high intensity: hitx) plus survivorship booklet designed to educate and improve awareness of the physical and psychological impact of cancer and increase knowledge of appropriate medical and psychosocial resources for women with cervical cancer. ii. to evaluate the utility of the telephone sessions (litx and hitx) designed to improve psychological functioning (decrease depression and anxiety) of women with cervical cancer. iii. to evaluate the utility of the telephone sessions (litx and hitx) designed to improve social functioning (family support and communication). outline: patients are clinically assigned to 1 of 2 groups. group i: patients receive a survivorship booklet in the mail that contains information about cervical cancer. patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet. group ii: patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. patients also receive a survivorship booklet as in group i.

Eligibility criteria:
inclusion criteria: within 6 months to 3 years of a cervical cancer diagnosis diagnosed with stages 1-3 invasive cervical cancer not diagnosed with another type of cancer no other major disabling medical or psychiatric condition survivors within 6 months to 3 years post diagnosis are included participants must be able to read and/or speak either english or spanish women will not be excluded based on the type of treatment received for their cervical cancer or a history of diagnosis of mild depression or anxiety exclusion criteria: women with metastatic disease women with major medical conditions (e.g., stroke and degenerative illness) survivors with moderate to severe depression or anxiety asian participants stage 0 disease

Keywords: psychosocial effects of cancer and its treatment stage ia cervical cancer stage ib cervical cancer stage iia cervical cancer stage iib cervical cancer stage iii cervical cancer cancer survivor
the effects of fish oils on blood pressure, heart rate variability and liver fat in the polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: we hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with pcos. the purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.

the prevalence of abnormalities of blood pressure (abp), variability of heart rate (hrv) and liver fat content is increased in women with the polycystic ovary syndrome (pcos). we hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with pcos. this crossover study of 40 obese women with pcos will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). subjects with pcos who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.

Eligibility criteria:
inclusion criteria: * overweight/obese women with pcos as per 1990 nih criteria (see below) * non-smokers * age\>18 years, premenopausal * acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia * acceptable to be taking the oral contraceptive pill exclusion criteria: * uncontrolled hypertension (bp\>160/100mmhg) * known co-morbidities including liver or renal disease * already taking fish oil supplements * other intercurrent illness (major surgery, cv event) * smokers * alcohol intake \>20g/day * pregnancy * any metallic implant (contraindication for mri).

Keywords: polycystic ovary syndrome cardiovascular risk metabolism blood pressure liver fat heart rate variability
changes of cardiopulmonary function after thrombolysis in patients with pulmonary embolism

Conditions: Acute Pulmonary Embolism

Summary: the investigators expect to enroll about 80-100 acute pulmonary embolism patients treated with thrombolysis in two hospitals. dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

about 80-100 acute pulmonary embolism(ape) patients treated with thrombolysis are enrolled in the first affiliated hospital with nanjing medical university and nanjing drum town hospital from january 1, 2020, to june 30, 2024. according to the 2019 esc guideline, the standards for thrombolysis in ape patients are as follows: within 2 weeks of onset; high-risk pulmonary embolism; medium-high-risk pulmonary embolism with symptoms of aggravation. investigators dynamically monitor cardiopulmonary function of participants after thrombolysis, including blood pressure, heart rate, respiratory rate, blood gas analysis, 2-dimensional echocardiography (left and right ventricular diameter, pulmonary artery pressure, interventricular septum) and laboratory tests (ctnt,pro-bnp).participants are divided into two groups: thrombolytic success group and thrombolytic failure group according the previously reported criterion which is evaluated 48h after thrombolysis. cardiopulmonary characteristics are analyzed to seek accurate and rapid index to reflect success of thrombolysis.

Eligibility criteria:
inclusion criteria: * medium-high risk or high risk pulmonary embolism and treated with thrombolysis exclusion criteria: * lack of radiologic evidence to diagnose ape * death within 48 hours after thrombolytic therapy * unable to partner treatment and leaving hospitals * missing other necessary data * pregnancy

Keywords: acute pulmonary embolism thrombolysis alteplase cardiopulmonary function
follow-up of ovarian function in young women who underwent ovarian cortex cryopreservation

Conditions: Female Infertility

Summary: evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. a second part of the questionnaire concerns these women's satisfaction regarding the procedure.

between 1997 and december 2013, 546 girls and women underwent ovarian cortex cryopreservation in the investigators' institution for fertility preservation. the main indications were the need for a gonadotoxic treatment, repeated ovarian surgery and a genetic risk for premature ovarian failure . these women will be sent a questionnaire concerning their ovarian function since the procedure and a questionnaire about their satisfaction concerning the procedure. six different questionnaires will be used adapted to the patient's initial indication for cryopreservation and the patient's age at the time of cryopreservation. complementary data will be obtained by medical file analysis and by contacting the patient's family doctor or gynecologist. data will be correlated with received gonadotoxic treatment and surgical interventions. the purpose of the study is to improve the indications and patient selection for ovarian cortex cryopreservation.

Eligibility criteria:
inclusion criteria: * women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013 exclusion criteria: * deceased women in this cohort

Keywords: ovarian cortex cryopreservation ovarian function
clinical investigation of the vytronus ablation system for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: vital is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the vytronus ablation system (vas) for the treatment of symptomatic paroxysmal atrial fibrillation (paf) using low intensity collimated ultrasound (licu) for imaging and ablation.

patients undergoing elective catheter ablation for symptomatic paf who are refractory or intolerant to at least one antiarrhythmic drug (class i-iv) will be screened for enrollment. patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 heart rhythm society (hrs)/european heart rhythm association (ehra)/european cardiac arrhythmia society (ecas) expert consensus statement on catheter and surgical ablation for atrial fibrillation. eligible patients will receive treatment with the vas including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins. up to 100 patients will be enrolled at up to 10 sites in europe (eu) and in the united states (us).

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * history of symptomatic recurrent paroxysmal atrial fibrillation (paf) in the prior year, defined by: 1. two or more symptomatic af episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. an episode of af ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode. 2. at least one episode of paroxysmal atrial fibrillation (paf) documented on 12-lead ecg, event monitor, or telemetry monitor in the prior year * paroxysmal atrial fibrillation refractory to at least one beta blocker, calcium channel blocker, or class i or class iii anti-arrhythmic drug (aad). * subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice. * subject is able and willing to give informed consent. * willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study exclusion criteria: * prior la ablation or surgery * persistent, longstanding persistent, or permanent af * af secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause * nyha class iii or iv congestive heart failure * rheumatic heart disease * atrial myxoma * lvef \<40% measured by acceptable cardiac testing (e.g. tte, tee) * anteroposterior la diameter \>5.5cm or \<3.5cm by tte, ct or mri * presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure * presence of pulmonary vein stent(s) * presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70% * presence of pre-existing pericardial effusion

Keywords: paf atrial fibrillation ablation low intensity collimated ultrasound
acupuncture for fatigue in parkinson's disease

Conditions: Parkinsons Disease

Summary: this is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in parkinson's disease (pd). eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.


Eligibility criteria:
inclusion criteria: * patients with pd * patients 40-99 years of age * patients who have significant fatigue * patients must be on a stable medication regimen for the treatment of pd exclusion criteria: * patients who have had previous acupuncture within the past six months * patients who have had deep brain stimulation (dbs) * patients with dementia, depression, or sleep disorder * patients who are currently taking medications known to affect fatigue, such as stimulants

Keywords: parkinsons disease fatigue
natural history of the progression of x-linked retinitis pigmentosa

Conditions: X-Linked Retinitis Pigmentosa

Summary: the objective of the study is to gain a better understanding of disease progression over time in participants with x-linked retinitis pigmentosa (xlrp).

this study was previously posted by nightstarx ltd. in october, 2020, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: 1. have documentation of a pathogenic mutation in the retinitis pigmentosa gtpase regulator (rpgr) gene. 2. are willing and able to undergo ophthalmic examinations, as required by protocol, for up to 24 months 3. have an etdrs bcva in at least 1 eye of ≥34 letters (equivalent to snellen ≥ 6/60 or 20/200; decimal 0.1; logmar 1.0). 4. mean retinal sensitivity in the eligible eye as assessed by microperimetry: * males with a mean retinal sensitivity of 68 loci ranging from ≥0.1 decibels (db) and ≤20 db. * females with a mean retinal sensitivity of 68 loci ranging from ≥0.1 db and ≤25 db. 5. if female, have symptomatic disease with impairment of visual function. key exclusion criteria: 1. have a history of amblyopia in the eligible eye. 2. have any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may put the participant at risk because of participation in the study, may influence the results of the study, may influence the participant's ability to perform study diagnostic tests, or impact the participant's ability to participate in the study. this includes clinically significant cataracts. 3. have participated in another research study involving an investigational medicinal product in the past 12 weeks or received a gene/cell-based therapy at any time previously (including but not limited to intelligent implant system implantation, ciliary neurotrophic factor therapy, nerve growth factor therapy). note: other protocol defined inclusion/exclusion criteria may apply

Keywords: rp gtpase regulator (rpgr) degenerative retinal disease xlrp natural history rare disease