Kornimate/medical-research-clean huggingface dataset:
vitamin d3 in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: there are approximately 90,000 individuals in the united states with sickle cell disease (scd). studies have shown that up to 98 percent of patients with sickle cell disease have a vitamin d deficiency, defined as a 25-hydroxyvitamin d level (25(oh)d) less than or equal to 20 ng/ml. as a result, of low bone density, patients may develop osteonecrosis, chronic inflammation and related pain. this study will be coordinated with patients' regularly scheduled visits for medical care and will require patients to submit blood sample at the start of the study and at 3, 6, 9, and 12 month visits. patients will also be scheduled for a bone density measurement (dxa scan) at the start of the study and after 12 months of supplementation to assess for any bone re-mineralization. thus, the main purpose of this study is to find the amount of nutritional vitamin d that needs to be taken by patients with sickle cell disease in order to correct vitamin d deficiency. the study will also test whether vitamin d supplements improve bone health and reduce inflammation.

this is an observational cohort study to follow vitamin d levels over time in patients with sickle cell disease receiving doses of vitamin d as part of their clinical care for vitamin d deficiency.

Eligibility criteria:
inclusion criteria: * adult patients (18 years and older) * diagnosis of sickle cell disease by hemoglobin electrophoresis (hbss, hematopoietic blood stem cell \[hbsc\], sickle cell b0 thalassemia, sickle cell b+ thalassemia) * able to give informed consent * any race/ethnicity/socioeconomic status exclusion criteria: * pediatric patient (less than 18 years of age) * unable to give informed consent * untreated primary hyperparathyroidism (icd9 codes 252.01xx and 252.00xx) * hypercalcemia (serum calcium level \> 11 mg/dl; icd9 codes 275.42xx, 259.3xx, 252.00f) * pregnancy: a urine pregnancy test, or a serum pregnancy test, will be obtained at the time of enrollment in addition to reviewing the medical record; pregnant patients will be excluded because they should not undergo dxa scanning * patients taking atorvastatin, thiazide diuretics and digoxin, which are medications that can interact with vitamin d * non-english speakers

Keywords: sickle cell disease vitamin d
first-in- human imaging of multiple myeloma using 89zr-dfo-daratumumab, a cd38-targeting monoclonal antibody

Conditions: Multiple Myeloma

Summary: the purpose of this study is to test 89zr-dfo-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.


Eligibility criteria:
inclusion criteria: * age 21 years or greater * histologically/immunohistochemistry confirmed cd38-positive multiple myeloma * at least one tumor lesion on ct, mri, or fdg pet/ct within 60 days of protocol enrollment * ecog performance status 0 to 2 * for phase ii patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy. exclusion criteria: * life expectancy \< 3 months * pregnancy or lactation * patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds. * history of anaphylactic reaction to humanized or human antibodies or a grade 3 or 4 administration reaction during a daratumumab administration.

Keywords: 89zr-dfo-daratumumab cd38-targeting monoclonal antibody ct mr fdg pet/ct 18-267
a double-blind study of e2020 (donepezil hydrochloride) in patients with dementia with lewy bodies (dlb) (study e2020-j081-431)

Conditions: Dementia With Lewy Bodies (DLB)

Summary: the purpose of this study is to evaluate the efficacy and safety of e2020 in patients with dementia with lewy bodies (dlb).


Eligibility criteria:
inclusion criteria: patients diagnosed as probable dementia with lewy bodies (dlb) according to the diagnostic criteria for dlb. participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution. exclusion criteria: participants with past experience of donepezil (aricept) therapy at the same study institution. participants treated with donepezil in 3 months immediately before starting the observation period. participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency. participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion participants with severe extrapyramidal disorders (hoehn \& yahr staging score is ≥iv) participants whose systolic blood pressure is \<90 mmhg or pulse rate is \<50 beats/min. participants suspected to have a complication of vascular dementia based upon neurological findings.

Keywords: lewy body disease dementia clinical trial phase ii e2020 donepezil hydrochloride
uterine rupture international data acquisition

Conditions: Uterine Rupture Gravid

Summary: uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth. uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. its prevalence ranges between 0.006% for women without previous cesarean section (cs) in the western countries, to 25% for women with obstructed labor in african countries. pregnancy after myomectomy or cs, vaginal delivery after cesarean sections (vbacs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture. despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. in this scenario, the "uterine rupture international data acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.


Eligibility criteria:
inclusion criteria: * women with uterine rupture occurred during pregnancy. exclusion criteria: * none.

Keywords: uterine rupture cesarean section labour myomectomy delivery
d-0316 first time in patients ascending dose study

Conditions: Advanced Non Small Cell Lung Cancer

Summary: this is a phase 1 open label multicentre study of d-0316 administered orally in patients with advanced nsclc who have progressed following prior therapy with an egfr-tki (epidermal growth factor receptor tyrosine kinase inhibitor agent). this is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of d-0316.


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses * histological or cytological confirmation diagnosis of non small cell lung cancer (nsclc). * radiological documentation of disease progression while on a previous continuous treatment with an egfr tki e.g. gefitinib or erlotinib. in addition other lines of therapy may have been given. all patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. * confirmation that the tumour harbours an egfr t790m mutation. * no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks. * evaluable or measurable disease per recist v1.1 exclusion criteria: * treatment with an egfr tki (erlotinib or gefitinib) within 14 days of the first dose of study treatment. * any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced nsclc from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. other protocol defined inclusion/exclusion criteria could apply
a clinical study to compare the safety and efficacy of an aliskiren-based regimen with a lisinopril based regimen in patients with severe hypertension

Conditions: Hypertension

Summary: to compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension


Eligibility criteria:
inclusion criteria * patients with essential severe hypertension exclusion criteria * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident. * diabetic patients requiring insulin other protocol-defined inclusion/exclusion criteria also apply
non-alcoholic fatty liver disease in low birth weight individuals

Conditions: NAFLD

Summary: the investigators will conduct a proof-of-principle deep phenotyping 4-weeks caloric restriction intervention study in low birth weight (lbw) subjects with nafld and normal birth weight (nbw) controls. furthermore, the investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (sat) expandability in ectopic fat deposition in lbw subjects in lbw individuals with and without nafld.

an adverse fetal environment characterized by low birth weight (lbw) plays a key role in the development of type 2 diabetes (t2d). the investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged lbw compared to 22 normal birth weight (nbw) men, and 20% of the lbw - but none of the normal birth weight (nbw) - men had previously unknown non-alcoholic fatty liver disease (nafld). the investigators hypothesize that ectopic fat deposition and nafld is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in lbw. the investigators furthermore hypothesize, that lbw individuals exhibit ectopic liver fat due to reduced capacity to store fat in the subcutaneous adipose tissue (sat) depot, and that early detection and subsequent intensive caloric restriction, in middle-aged lbw individuals with overt nafld, may represent a targeted and highly efficient way forward to prevent more severe cardiometabolic disease manifestations in lbw subjects. to further explore the recent findings, the investigators aim to perform an extended nested case-control screening study for nafld in 250 early middle-aged non-obese lbw men and women, and subsequently to conduct a deep-phenotyping, proof-of-principle 4 week time-restricted eating (tre) intervention study in 12 lbw subjects with nafld including measures of hepatic fat content, glucose, insulin and lipid metabolism, as well as 24h metabolic profiles using respiratory chambers. finally, the investigators will provide extended in-depth mechanistic insight into transcriptional, epigenetic as well as functional sat and preadipocyte perturbations underlying impaired sat expandability in lbw individuals with and without nafld and nbw controls studied before and after different dietary interventions including tre and high carbohydrate overfeeding.

Eligibility criteria:
inclusion criteria: * lbw subjects with nafld (liver fat content ≥5% liver fat content verified on mrs) * gender- and body mass index-matched nbw controls without nafld * born at term (weeks 39-41) exclusion criteria: * bmi\ 30 kg/m2 * family history of diabetes (siblings, parent, and grandparents) * disease/medication known to affect primary outcome * self-reported high physical activity level * alcohol intake above general recommendations. * metabolic/liver disease * weight gain/loss of \>3 kg within the past 6 months

Keywords: adipose tissue biology caloric restriction insulin resistance energy expenditure insulin secretion
effects of virtual reality on brain hemodynamic activity in chronic pain

Conditions: Chronic Pain; Rheumatoid Arthritis; Virtual Reality

Summary: virtual reality systems have been applied in recent years to reduce pain intensity and fear of movement in individuals with acute and chronic pain. the main mechanism of virtual reality methods in pain control is to provide the effect of distraction from pain. virtual reality systems allow the individuals to feel themselves in a different environment and shift their attention to the game they are playing or the virtual world created rather than the pain they feel. this is thought to be the main mechanism of pain control. however, the cortical mechanism of the reduction in pain caused by virtual reality methods, especially in individuals with chronic pain, has not been fully elucidated. it is predicted that the integration of virtual reality methods into treatment protocols will gradually increase by time, especially as a result of the reflection of technological developments in clinical practice. at this point, fnirs, which enables the assessment of the functionality of brain areas during movement, has the potential to reveal the response of the effect provided by virtual reality technology in the prefrontal cortex. the aims of our study were to examine brain hemodynamic activity during the experience of non-immersive and immersive virtual reality environments and the change in pain intensity after virtual reality applications in individuals with rheumatic diseases with chronic pain.


Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis, * right hand dominant, exclusion criteria: * a history of acute pain up to 3 days prior to the date of evaluation, * any psychiatric and neurological diagnosis, * have a cognitive problem that prevents them from adapting to the working procedure, * using centrally acting medications and anti-depressants. * presence of neuropathic pain, * presence of vision or hearing problems, * any psychiatric and neurological diagnosis
chemotherapy with or without radiation therapy or observation in treating young patients with advanced retinoblastoma who have undergone surgery to remove the eye

Conditions: Retinoblastoma

Summary: rationale: drugs used in chemotherapy, such as carboplatin, vincristine, etoposide, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. radiation therapy uses high-energy x-rays to kill tumor cells. giving chemotherapy with or without radiation therapy after surgery may kill any tumor cells that remain after surgery. sometimes, after surgery, the tumor does not need more treatment until it progresses. in this case, observation may be sufficient. purpose: this clinical trial is studying how well chemotherapy with or without radiation therapy or observation works in treating young patients with advanced retinoblastoma who have undergone surgery to remove the eye.

objectives: * compare outcome data in children with advanced unilateral retinoblastoma with historical controls in order to determine whether post-enucleation chemotherapy with or without radiotherapy improves outcome. * determine the disease-free and overall survival of children with unilateral retinoblastoma with no adverse histological features who undergo observation after enucleation. * determine the toxicity of these regimens in these patients. outline: this is a nonrandomized study. patients are assigned to 1 of 3 treatment groups according to histological features. * group 1 (no adverse histological features): patients are observed and monitored for the development of orbital recurrence and metastatic disease. * group 2a (deep choroidal invasion and/or retrolaminar invasion of the optic nerve and disease in the anterior chamber): patients receive carboplatin iv over 1 hour, vincristine iv, and etoposide iv over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. treatment repeats every 21 days for 4 courses. * group 2b (invasion of the cut end of the optic nerve): patients receive carboplatin iv over 1 hour, vincristine iv, and etoposide iv over 4 hours on day 1, and, if necessary, intrathecal cytarabine on day 2. treatment repeats every 21 days for 6 courses. patients also undergo orbital radiotherapy 5 days a week for 4 weeks. after completion of study treatment, patients are followed periodically for up to 10 years. projected accrual: not specified

Eligibility criteria:
disease characteristics: * histologically confirmed unilateral retinoblastoma * prior primary enucleation required * no metastatic spread patient characteristics: * not specified prior concurrent therapy: * see disease characteristics * no prior chemotherapy * no concurrent steroids as antiemetic agents

Keywords: intraocular retinoblastoma extraocular retinoblastoma
trial of docetaxel, cisplatin, fluorouracil (5-fu) for unresectable advanced esophageal squamous cell carcinoma (escc)

Conditions: Esophageal Cancer

Summary: this phase i/ii study is being conducted to determine the maximum-tolerated dose (mtd), dose-limiting toxicity (dlt), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (dcf) in unresectable advanced esophageal cancer. the usefulness of the this regimen is evaluated by recist, time to progression and median survival time.

\ primary objective: to establish the safety of combination chemotherapy comprising docetaxel (escalating doses: 25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil (600mg/m2,day1-5) (dcf) in unresectable advanced esophageal cancer. secondary objective: to observe the efficacy of this regimen in these patients. \ primary objective: to assess the response rate of combination chemotherapy comprising docetaxel (recommended dose determined in phase i study,day1 and day8), cisplatin (12 mg/m2, day1-5), and fluorouracil (600 mg/m2, day1-5) (dcf) in unresectable advanced esophageal cancer. secondary objectives: to determine the adverse reactions of this regimen in these patients. to determine ttp(time to progression) of patients treated with this regimen. to determine mst(median survival time) of patients treated with this regimen.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by ct scan * ecog performance status 0-1 * 20 years and older * patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor * tissue from tumor must be available * patients must have measurable disease * patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month * life expectancy \> 3 months * laboratory values as follows * 3000/mm3 \< wbc \< 12000/mm3 * 1500/mm3 \< granulocyte count * 8.0 gm/dl \< hemoglobin * platelet count \> 100000/mm3 * aspartate transaminase \< 150 iu/l * alanine transaminase \< 150 iu/l * creatinine \< 1.5 mg/dl * able and willing to give valid written informed consent exclusion criteria: * pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) * active or uncontrolled infection * prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week * clinically significant heart disease * patients with a history of myocardial infarction within the previous three months * patients with uncontrolled diabetes mellitus or hypertension * presence of clinically apparent central nervous system metastases * patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study * decision of unsuitableness by principal investigator or physician-in-charge
determination of peripheral immune cell activity during treatment with either surgery or radiotherapy in patients with early stage nsclc

Conditions: Non-small Cell Lung Cancer

Summary: rationale: an anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (nsclc). however, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage i/ii nsclc, and in patients who have significant co-morbidity. following the introduction of stereotactic ablative radiotherapy (sabr), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in the netherlands increased by 9.3 months. randomized trials comparing sabr and surgery have yet to be completed and results of the ongoing acosog z4032 studies will not be available in the within 5 years. a recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. it was found that a better loco-regional disease control rate was achieved with sabr. objective: to study the effect of surgery and sabr on both immunostimulatory (with primary endpoint cd8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality. study population: 40 patients with ct1-2an0m0 either cytologically or histologically proven nsclc. main study parameters/endpoints: to determine whether an increase in cd8 activity can be established after sabr in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. nature and extent of the burden and risks associated with participation, benefit and group relatedness: only risks in participation are the risks with drawing blood. subjects will not have any benefits. this pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients.


Eligibility criteria:
inclusion criteria: * cytologically or histologically proven ct1-2an0m0 nsclc * patients ≥ 18 years old * patients should be fit to undergo both treatments in accordance with institutional protocols exclusion criteria: * patients with any signs of any co-existing infectious disease or immunosuppressive treatment (inhalation steroids are permitted) * mentally incapacitated subjects

Keywords: immune monitoring t cell activation early stage