Kornimate/medical-research-clean huggingface dataset:
safety of lbh589 alone and in combination with iv docetaxel and prednisone

Conditions: Hormone Refractory Prostate Cancer

Summary: this is a parallel, two-arm, open-label, multicenter phase ia/ib study of lbh589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. this study is designed to determine the maximum tolerated dose of lbh589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile


Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma of the prostate. * patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (ct), or magnetic resonance imaging (mri) and/or detectable lesion(s) on bone scintigraphy scan. patients with only elevated prostate specific antegen (psa) levels are not eligible for entry. * patients who have undergone medical castration must continue luteinizing hormone-releasing hormone (lhrh) agonist or antagonist therapy during study treatment * patients must be able to provide written informed consent exclusion criteria: * patients with prior or concurrent brain metastases * impaired cardiac, gastrointestinal, kidney, or liver function * use of therapeutic androgens other protocol-defined inclusion/exclusion criteria may apply

Keywords: lbh589 prostate cancer hrpc hormone refractory prostate cancer
better sleep in psychiatric care - adhd pilot study

Conditions: Attention Deficit Disorder; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Summary: comorbidities, including sleep problems, are common in adult attention deficit hyperactivity disorder (adhd). treatment of choice for insomnia is cognitive behavioral therapy (cbt-i), but evidence is lacking for cbt-i in patients with adhd and sleep problems. the purpose of this study was to investigate if patients at a specialist clinic for adhd benefit from a group delivered cbt-i treatment; whether insomnia severity improves following this treatment. this pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult adhd. as an adjunct to care-as-usual at the clinic, a cbt-i-based group treatment targeting sleep problems prevalent in the adhd-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support. all outcome measures were subjectively reported by participants. data analyzed with dependent t-tests according to intent-to-treat.


Eligibility criteria:
inclusion criteria: * being a patient at the clinic (i.e. having a diagnosis of ad(h)d) * self-reported sleep problems * returning pre-treatment questionnaires and signed consent form exclusion criteria: * none
safety & performance study of the fantom sirolimus-eluting bioresorbable coronary scaffold

Conditions: Coronary Artery Disease

Summary: the fantom ii trial is intended to assess safety and performance of the fantom bioresorbable coronary scaffold in native coronary arteries.


Eligibility criteria:
inclusion criteria: * patient has evidence of myocardial ischemia or a positive functional study * target lesion has a visually estimated stenosis of ≥50% and \<100% * target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm * lesion length ≤ 20 mm by visual estimate (n/a for cohort c) * baseline timi flow ≥ 2 exclusion criteria: * the patient has experienced an acute myocardial infarction (ami: stemi or nstemi) within 72 hours of the procedure and either ck-mb or troponin has not returned to within 2x uln. * patient has a left ventricular ejection fraction \< 40% * patient has unprotected left main coronary disease with ≥50% stenosis * the target vessel is totally occluded (timi flow 0 or 1) * target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis). * target lesion is located within a bypass graft * target lesion has possible or definite thrombus
neurovascular complications and white matter damage in acquired anemias

Conditions: Anemia; Iron-deficiency Anemia; Healthy Controls

Summary: this is an observational trial, in patients with moderate to severe anemia and control subjects. the main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. the investigators will perform baseline mri monitoring for all subjects. all eligible subjects will be asked to provide informed consent before participating in the study.

this is an observational trial, in patients with moderate to severe anemia and control subjects. the main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. the investigators will perform baseline mri monitoring for all subjects. all eligible subjects will be asked to provide informed consent before participating in the study. comprehensive cerebrovascular mri, baseline bloodwork, and neurocognitive testing will be collected from all subjects.

Eligibility criteria:
inclusion criteria (observational component): * age between 16 and 60 years of age. * any ethnicity. * either sex. * anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin. * control group: hemoglobin \>13.2 g/dl for females, \>14.6 g/dl for males, comparable age, sex and ethnicity to currently enrolled anemic subjects. exclusion criteria (observational component): * diabetes requiring medication. * hypertension requiring medication. * sleep disordered breathing requiring intervention. * body mass index \>35 (morbid obesity) * contraindications to mri, including pacemaker, severe claustrophobia, pregnancy. * known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma. * known hiv. inclusion criteria (interventional component): * criteria for observational component, plus * ron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-crp, mma. exclusion criteria (interventional component): * criteria for observational component, plus * prior reaction to intravenous iron. * history of multiple drug allergies. * history of severe asthma, eczema, or atopy. * systemic mastocytosis. * severe respiratory or cardiac disease.
effect of lithium carbonate on postoperative sleep in patients undergoing videoassisted thoracic surgery

Conditions: Sleep Deprivation

Summary: it has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. the aim of the present study is to evaluate postoperative sleep quality of patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours after surgery.

this study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. all patients undergoing video assisted thoracic surgery during morning will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (baoqing, hunan, china) or calcium carbonate 500mg (reneed, beijing, china) 6 hours after surgery. the objective of the trial is to evaluate the lithium carbonate 250mg on the first postoperative night sleep quality. the patients received standardized general anesthesia supplemented by paravertebral nerve block. the ultrasound-guided approach for paravertebral nerve block was used with the patient in the lateral decubitus position, and the paravertebral nerve block was administered at the t4-t6 level according to the incision protocol at our center. general anesthesia for maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (fresenius kabi, austria gmbh) at a plasma target concentration (marsh pharmacokinetic model software) of 2.5-4 μg/ml. remifentanil (0.2-0.5 μg/kg/min, renfu, yichang, china) was given to all patients during the operation. all patients accepted patient-controlled intravenous analgesia with 1 μg ml-1 sufentanil (renfu, yichang, china). duration of sleep was defined as the duration of all bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).

Eligibility criteria:
inclusion criteria: * • 1. ethnic chinese; * • 2. age, 18 to 75 years old; * • 3. american society of anaesthesiologists (asa) physical status i or ii; * • 4. required vats for lung surgery and one lung ventilation exclusion criteria: * cognitive difficulties * • partial or complete gastrectomy * • previous esophageal surgery * • previous treated by radiotherapy or surgery * • inability to conform to the study's requirements * • body mass index exceeding 30 kg/m2 * • deprivation of a right to decide by an administrative or juridical entity * • ongoing participation or participation in another study \<1 month ago * • preoperative pittsburgh sleep quality index global scores higher than 6 * • recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional chinese medicine

Keywords: bispectral index lithium carbonate
hydroxychloroquine administration for reduction of pexophagy

Conditions: Zellweger Syndrome; Peroxisome Biogenesis Disorders

Summary: a series of n-of-1, crossover, randomized, placebo-controlled, double-blinded trial. hydroxychloroquine (hcq) and a crossover to placebo (order is randomized and blinded) will be administered in liquid suspension for 84 days (12 weeks) each with an 84 day washout in between. we hypothesize that hcq will reduce peroxisomal turnover, which will arrest ongoing injury in pbds caused by pex1, pex6 or pex26.

harp is a phase ii/iii, double-blind, placebo-controlled, randomized, crossover series n-of-1 study of the effect of hydroxychloroquine (hcq) in patients with peroxisomal biogenesis disorders (pbd-zsd). patients eligible for the study must have a laboratory diagnosis of pex1, pex6 or pex26 dependent pbd-zsd from a clia or scc-certified clinical laboratory, a history of abnormal vlcfa levels, and must be at least 84 days from their last hcq dose. patients will be excluded for known sensitivity to hcq, known glucose-6-phosphate dehydrogenase deficiency, if they have an expected survival of less than 9 months or if they are participating in another interventional clinical trial. hcq will be administered at a dose of 4mg/kg/day divided into two doses, as a liquid suspension that can be given orally or through nasogastric or gastric tube. within the study, hcq or placebo will be given for 84 days, followed by a washout period of 84 days followed by an 84 day crossover to the alternative therapy to assess the effect the study measures. study measures will be completed at four intervals (initiation, end of period 1, start of period 2, end of trial). ophthalmological monitoring of patients has three components, electroretinogram (erg), visual acuity testing and optical coherence tomography (oct). plasma levels of very long-chain fatty acids (vlcfa), plasmalogen and phytanic acid will be assessed. parents will also be administered the pediatric inventory for parents (pip), a questionnaire that was developed to evaluate the stress associated with parenting a seriously ill child, at the end of period 1 and period 2.

Eligibility criteria:
inclusion criteria: * diagnosed with a peroxisomal defect due to pex1, pex6 or pex26 through a scc or clia-certified clinical genetic testing laboratory. * abnormal plasma very-long-chain fatty acid levels. * all therapies available in canada have been considered and ruled out, have failed or were justified as being unsuitable for the patient. we note that there are no therapies available. * at least 84 days from last hcq dose exclusion criteria: * known sensitivity to hcq. * known glucose-6-phosphate dehydrogenase deficiency. * expected survival is less than six months. * the patient does not provide informed consent. * the patient is participating in another interventional clinical trial.

Keywords: pbd, zellweger spectrum, pbd-zsd
effects of aerobic exercise on pain in patients with myogenous temporomandibular disorders and suspicion of central sensitization

Conditions: Temporomandibular Disorder; Central Sensitisation; Myofascial Pain Syndrome; Endurance Training

Summary: temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. the best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. however, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.


Eligibility criteria:
inclusion criteria: * diagnosis of a myogenic temporomandibular disorder (dc/tmd) by an odontologist. * a minimum score of 30 in the central sensitization index * positive frt exclusion criteria: * history of trauma, tmj or cervical fracture the past three months * history of tmj or cervical surgery * systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant * history of cardiovascular diseases which contraindicate aerobic exercise * current orthodontic treatment, splints for bruxism * drug addiction, alcoholism * pregnancy * use of analgesic medication less than 48 hours before each data collection * physical therapy treatment during the past three months
comparison of tofacitinib and prednisolone in the treatment of active takayasu's arteritis

Conditions: Takayasu Arteritis

Summary: this is a prospective, double-blinded, single center, randomized clinical trial. it compares the clinical efficacy and safety of thees 2 drugs in the treatment of active takayasu's arteritis patients.

in this study, 40 takayasu's arteritis patients with active disease will be enrolled. patients are randomized into the tofacitinib treatment group and prednisolone treatment group. patients will follow the same reduction steps for prednisolone and its placebo. the primary end point is the percentage of patients who are in complete response at week 24. the efficacy will be evaluated at week 4, 12 and 24. safety is also monitored during the study.

Eligibility criteria:
inclusion criteria: 1. patients aged between 18-65 years old; 2. fulfilled the classification criteria of takayasu's arteritis by acr 1990; 3. active tak: defined by the definition of active disease in the recommendations released by eular in 2018 or kerr's criteria by nih; 4. patients who signed the informed consent form. exclusion criteria: 1. patients who failed or intolerant to either tofacitinib or its similar drugs; 2. patients with severe liver disease defined by the serum alt or ast elevated more than 2 times the upper limits; 3. not well controlled diabetes; 4. moderate and severe hyperlipedimia; 5. patients with history of thrombus; 6. uncontrolled heart failure od renal dysfunction (egfr \<30ml/min); 7. patients with active infection, including tuberculosis, hepatitis b and c, hiv infection, bacterial or fungal infection; 8. upper gi bleeding happened in 3 months before enrollment; 9. refractory hypertension; 10. pregnant or intended to be pregnant recently; 11. severe coronary artery involvement demonstrated by cta; 12. severe cranial or cervical or renal artery diseases that need surgery; 13. patients that should not be included judged by the investigator.

Keywords: tofacitinib prednisolone
development of novel biomarkers for the early diagnosis of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to measure the levels of certain substances (biomarkers) in the body that may indicate the triggers of type 1 diabetes, to find a better way to diagnose the disease, as well as to follow its progression.


Eligibility criteria:
inclusion criteria: type 1 diabetes (t1d) 1. age 12-18 years inclusive 2. diagnosis of t1d according to american diabetes association (ada) criteria with an acute onset and presence of islet associated autoantibody by history. 3. t1d duration of ≤ 3 months from the diagnosis healthy normal volunteers (hnv) 1. age 12-18 years inclusive 2. no personal history of diabetes according to ada criteria 3. no history of t1d or insulin treated diabetes in first degree relatives (fdr) exclusion criteria: acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic and immune function including, but not limited to: 1. history of type 2 diabetes 2. suspicion of non-type 1 diabetes (e.g. maturity onset diabetes of the young or secondary diabetes) 3. history of thyroid dysfunction in which the participant has not been on a stable dose (at least 6 weeks prior to enrollment) of thyroid replacement medication or antithyroid drugs. 4. history of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable). 5. history of organ transplant 6. history of hiv, active hepatitis b or c, or tuberculosis 7. pregnancy, lactation or 6 months postpartum from the scheduled date of collection 8. psychiatric disease prohibiting adherence to study protocol 9. use of oral or injectable anti-hyperglycemic agents: metformin, sulfonylureas, dpp-4 inhibitors, sglt2 inhibitors, thiazolidinediones, acarbose, glp-1 analogs. 10. use of any other medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids \[steroids\], prescribed medications for weight loss, etc.) 11. presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete study visits
evaluation of a smartphone based screening tool for neonatal jaundice in surabaya, indonesia

Conditions: Jaundice, Neonatal

Summary: a cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in surabaya.

a cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at airlangga university hospital and rsia kendangsari merr in surabaya. this cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in indonesian newborns. the picterus calibration card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. a validated smartphone with picterus jp was used to collect digital images.

Eligibility criteria:
inclusion criteria: * infants born with gestational age \>31 * birth weight ≥ 1500g * age 0 - ≤14 days * consent obtained from the parents exclusion criteria: * infants born with congenital abnormalities; * infants respiratory support; * infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; * infants who have received phototherapy in the last 24 hours.
universal granulocyte-macrophage colony-stimulating factor (gm-csf)-producing and cd40l expressing bystander cell line for tumor vaccine in melanoma

Conditions: Melanoma (Skin)

Summary: the purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). we want to check how the patient's immune system reacts, both before and after the vaccine treatment.

the vaccine will be made by mixing two kinds of cells: 1) some of the patient's own malignant melanoma cells which were removed by surgery and then processed in the cell therapy laboratory, and 2) experimental "bystander" cells. all the cells in the vaccine will be treated with high-dose x-rays to make sure that none of them grow and cause more cancer. the bystander cells, called "gm.cd40l", are human cells that have been genetically changed. the original cells, called k562, had the genes for human gm-csf and cd40l inserted into them. these changes are designed to help boost the patient's immune system to better fight the cancer in their body.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iiic or stage iv melanoma * measurable disease * age 18 or older * eastern cooperative oncology group (ecog) performance status of 0 or 1 * no radiation therapy within 2 weeks prior to first vaccine administration * no chemotherapy within 4 weeks prior to first vaccine administration * no steroid therapy within 4 weeks prior to first vaccine administration * no surgery within 10 days prior to first vaccine administration * patient's written informed consent * patient's ability to comply with the visit schedule and assessments required by the protocol * adequate organ function (measured within a week of beginning treatment): * white blood count (wbc) \> 3,000/mm\^3 and absolute neutrophil count (anc) \>1500/mm\^3 * platelets \> 100,000/mm\^3 * hematocrit \> 25% and hgb \> 8 g/dl * bilirubin \< 2.0 mg/dl * creatinine \ 60 ml/min exclusion criteria: * symptomatic or untreated brain metastasis * any serious ongoing infection * current corticosteroid or other immunosuppressive therapy * any other pre-existing immunodeficiency condition (including known hiv infection) * pregnant or lactating women -- patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*a pregnancy test will be obtained before treatment) * ecog performance status of 2, 3, or 4 * any second active primary cancer

Keywords: recurrent melanoma stage iii melanoma stage iv melanoma