Kornimate/medical-research-clean huggingface dataset:
a study of jnj-30979754 (decitabine) in patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to to determine the recommended dose level of jnj-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with myelodysplastic syndrome (mds).

this is an open-label (both physician and patient know the name and dosage of drug), multi-center study. this study consists of two parts, phase i and phase ii. in phase i, approximately 9 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of jnj-30979754) and 6 participants for dose level 2 (20 mg/m2 of jnj-30979754). once the tolerability of 20 mg/m2 is confirmed additional 30 participants will be included to receive 20 mg/m2 and approximate total participants in phase ii will be 36. this study will include screening period (within 14 days prior to the day of initial administration of cycle 1) and dosing period (1 cycle consists of administration of study medication for first 5 consecutive days + rested for 23 days; ie, total 28 days). cycles will be reapeated in participants in whom decitabine was expected to be effective. safety evaluations will include assessment of adverse events, vital signs, body weight, clinical laboratory tests: hematology, blood biochemistry and urinalysis, cardiopulmonary function tests: ecg, chest x ray and oximeter analysis.

Eligibility criteria:
inclusion criteria: * myelodysplastic syndrome (de novo or secondary) fitting any of the recognized french-american-british classifications: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia with white blood cells less than 13,000 /mm3 * international prognostic scoring system (ipss) greater than or equal to 0.5 (intermediate-1, intermediate-2 or high risk) by bone marrow assessment and bone marrow cytogenetics within 28 days before study registration * 20 years or older * eastern cooperative oncology group (ecog) performance status of 0-2 * normal renal and hepatic function exclusion criteria: * acute myeloid leukemia (aml) with bone marrow blasts greater than or equal to 30% * participants with a history of high-dose cytarabine (ara-c) therapy (greater than 1,000 mg/m2/day) * participants administered adrenal cortex hormones or anabolic hormones within 7 days of study initiation * participants who have received a colony stimulating factor (csf) formulation within 7 days of study initiation * active double cancer * uncontrolled cardiac disease or cognitive heart failure * uncontrolled restrictive or obstructive pulmonary disease * uncontrolled diabetes mellitus * active viral or bacterial infection * known positive serology for human immunodeficiency virus

Keywords: myelodysplastic syndrome mds decitabine jnj-30979754
effects of chronobiology-guided lifestyle interventions on insomnia severity, cognitive performance, and sleepiness

Conditions: Circadian Rhythm Sleep Disorder

Summary: poor sleep is closely related to circadian misalignment; shift workers often experience shift work disorder characterized by excessive sleepiness and recurrent shift work schedules-associated insomnia. this study aims to examine the effects of a program of chronobiology-guided lifestyle interventions (cgli) on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

this study will use a parallel-group, randomized, assessor-blind, wait-list controlled design to determine the effects of a program of multimodal lifestyle interventions based on chronobiology, consisting of timed bright light exposure, meal timing manipulations, and sleep hygiene education on insomnia severity, cognitive performance (psychomotor vigilance and processing speed), and sleepiness in female nurses undertaking rotating-shift work.

Eligibility criteria:
inclusion criteria: 1. females aged 20 to 60 who work full time as a nurse and work a 3-shift rotation, including day shifts, evening shifts, and night shifts in the most recent 6 months. 2. participants must complain of insomnia symptoms and/or sleepiness in relation to shift work schedule for at least 3 months. 3. participants must have10 workdays (evening or night shift) within a 14-day period during the study period. exclusion criteria: 1. active physical diseases. 2. moderate to severe psychopathology. 3. medications or treatments that may affect sleep. 4. pregnant or breastfeeding. 5. participants must be free of ophthalmic pathology, eye surgery, and diseases affecting the retina or taking photosensitizing drugs. 6. participants who have been diagnosed with sleep-disordered breathing will be excluded. sleep-disordered breathing such as obstructive sleep apnea (osa) will be screened using the snoring, tiredness, observed apnea, high bp, bmi, age, neck circumference, and male gender (stop-bang) questionnaire.

Keywords: chonobiology cognitive performance insomnia shift work sleepiness
comparison of 3d printed composite resin crowns with stainless steel crowns

Conditions: Carious Teeth

Summary: the goal of this splith - mouth clinical trial is to compare 3d printed prefabric composite resin crowns with stainless steel crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars. the main question\[s\] it aims to answer are: * 3d printed composite resin crown's survival rate is as succesful as stainless steel crowns * 3d printed composite resin crowns periodontal integrity is as succesful as stainless steel crowns condition or disease : carious teeth intervention/treatment: procedure/surgery: 3d printed prefabricated composite resin crown group procedure/surgery: prefabricated stainless steel crown group

in this study, 3d printed prefabricated composite resin crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. the study will be conducted in split-mouth to eliminate the effect of potential confounders. the obtained data will be analyzed using appropriate statistical methods.

Eligibility criteria:
inclusion criteria: * healthy children aged 5-9 years with caries on second primary molars * children without systemic disease or developmental dental anomalies that may affect caries susceptibility. * children whose cooperation is 'positive' or 'absolutely positive' according to the frankl behavioral scale (frankl et al., 1962). * those with deep dentin caries that do not extend to the pulp in the teeth to be treated * the molars will be treated with a crown indication. * presence of symmetry of the primary molar to be treated in the opposite arch. * the molar to be treated is in occlusion with the antagonist. * presence of caries on at least two surfaces of the molars to be treated. * absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated * patients whose parents and themselves agree to participate in the treatment exclusion criteria: * children whose treatment cannot be continued on the dental chair due to cooperation * molars that will soon be exfoliated, 1/2 of the root has been resorbed * the presence of bruxism * the presence of erosion or attrition-related wear on the opposing molar * the patient does not come to the control appointment or does not want to continue to the research * have allergy to local anesthetic, nickel or chromium * complications during treatment.

Keywords: 3d printing, stainless steel crowns, composite resin crowns
treatment of polytraumatisms with corticoids

Conditions: Polytraumatism

Summary: interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.


Eligibility criteria:
inclusion criteria: * age superior of 15 years * hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk) * siss score more than 15 * intubation for more than 48 hours. * agreement of a family member * patient with insurance exclusion criteria: * history of corticothérapies within 6 months * history of adrenocortical insufficiency. * treatment by immunosuppressor * immunodeficiency.
efficacy of hemostasis by soft coagulation using endoscopic hemostatic forceps for acute peptic ulcer bleeding

Conditions: Active Peptic Ulcer Disease/GI Bleeding

Summary: endoscopic high-frequency soft coagulation is available for the management of bleeding or nonbleeding visible vessels during endoscopic submucosal dissection. however, its efficacy on peptic ulcer bleeding has not been elucidated so far. the aim of this study was to evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it with argon plasma coagulation (apc) in a prospective, randomized trial.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * peptic ulcer with stigmata of recent hemorrhage exclusion criteria: * malignant ulcer * previous gastric surgery

Keywords: peptic ulcer bleeding hemostatic forceps soft coagulation argon plasma coagulation
evaluation of trilaciclib in chinese patients with extensive-stage small cell lung cancer (es-sclc) for chemotherapy-induced myelosuppression, antitumor effects of combination regimens, and safety in a real-world study

Conditions: Extensive-stage Small-cell Lung Cancer

Summary: this is a single-arm, real-world study in chinese patients with extensive stage small cell lung cancer. the purpose of this study was to evaluate trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in chinese patients with es-sclc in the real world. patients with es-sclc who already use or plan to use trilaciclib will be invited to participate in the study. data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. the end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate and sign informed consent; 2. must be at least 18 years when fisrt dose of trilaciclib, regardless of gender: 3. patients with extensive small-cell lung cancer confirmed by histology or cytology 4. patients suitable for trilaciclib combined with platinum/etoposide or trilaciclib combined with topotecan treatment exclusion criteria: 1. patient is currently participating in other interventional clinical studies; 2. patients received systemic chemotherapy other than the regimens recommended in inclusion criteria 4 during trilaciclib treatment.
comparison of two needles (procore vs echotip) for the diagnosis of pancreatic solid mass under eus

Conditions: Pancreatic Tumor; Fine Needle Aspiration; Endoscopic Ultrasonography

Summary: the negative predictive value of fine needle aspiration under ultrasound endoscopy (eus) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. there is a wide variability of this rate across studies (from 38 to 92%). in case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. to improve the sensitivity of eus echo endoscopy, several methods were used. a new needle (echo tip ® hd procore ™) has received ce mark in the field of eus. this instrument combines the comfortable and handy size of 22 gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. in addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. the theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. a preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%). to determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle procore ™ versus the old echotip ® 22-gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. the caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle procore ™ does not require that one pass through the tumor). the study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. the aim of this study is to compare the diagnostic accuracy of the needle procore™ versus echotip® in etiological cyto histological diagnostic for pancreatic solid tumors under eus.


Eligibility criteria:
inclusion criteria: * solid tumor of the pancreas (\<50% share or anechoic fluid) to receive a biopsy under endoscopic ultrasonography (eus) exclusion criteria: * contraindications to the achievement of an upper gastrointestinal endoscopy * haemorrhagic disease, disorder of hemostasis and coagulation (pt \ 40 sec. and platelets \<60000/mm3) * pancreatic cystic mass (fluid quota valued at more than 50% of the mass lesion on imaging) * pregnant or lactating
prevention of capsular contracture using trental and vitamin e

Conditions: Capsular Contractures

Summary: the main purpose of this research study is to determine if the use of trental and vitamin e will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. another goal is to find out the impact that trental and vitamin e have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. in addition, the investigators want to evaluate the patient's sense of well being and quality of life.

this is a single center, 18-month study in which 30 women will receive trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin e, 400 international units orally twice daily for six months. subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: bakers grade assessment, visual analog scale (vas), implant revision or loss, breast photographs, adverse event assessment and the quality of life tool (sf-12).

Eligibility criteria:
inclusion criteria: * female subjects * \> 18 years of age * expected survival at least \> 6 months * undergone mastectomy with expander or implant reconstruction \> 3 weeks before radiation therapy * completed chest wall irradiation in the past two weeks * willing to stop herbal medications as directed by physician * willing to stop daily use of supplemental vitamin e (multivitamin with vitamin e component is acceptable) * willing to travel to a legacy health system facility * agree to attend study visits outside of standard of care visits * normal pt-inr for subjects taking coumadin exclusion criteria: * \< 18 years of age * pregnant or lactating * have final implant placed \< 3 weeks before start of radiation therapy * have evidence of ongoing infection or implant exposure before start of radiation therapy * radiation completed more than 16 days prior to study start * retinitis pigmentosa * unable to comply with protocol * unable to provide written informed consent * unwilling or unable to stop supplemental vitamin e * pt-inr outside of acceptable range for subjects taking coumadin * investigator does not believe study participation, for any reason is in the best interest of the patient

Keywords: capsular contractures in breast cancer patients
feasibility and acceptability of an educational intervention to improve the management of depression in primary care.

Conditions: Patients With Moderate Depression,; First or Second Episode

Summary: qualitative study based on interviews and questionnaires with patients participating to an educational intervention to improve the management of depression in primary care. objective is to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care to elaborate an educational program for the management of depression in primary care.

to assess feasibility and acceptability of an educational intervention to improve the management of depression in primary care to elaborate an educational program for the management of depression in primary care. and perspectives are to elaborate an educational intervention to care depression in primary care

Eligibility criteria:
inclusion criteria: * age between 18-65y * moderate depression (cim 10) * first or second episode * able to read and understand french language exclusion criteria: * psychotic symptoms * severe depression * bipolar disorder * suicide risk * substance abuse

Keywords: patients moderate depression
a safety and efficacy study of jnj-42165279 in participants with social anxiety disorder

Conditions: Phobic Disorders

Summary: the purpose of this study is to investigate the efficacy of jnj-42165279 during 12 weeks of treatment in participants with social anxiety disorder (sad).

this is a phase 2a randomized (study drug assigned by chance), double-blind (neither the investigator nor the participants know about the study intervention), placebo-controlled, parallel-group, multi-center study of jnj-42165279 in participants with social anxiety disorder. participants will receive 25 milligram (mg) jnj-42165279 or matching placebo orally once-daily from day 1 up to 12 weeks. participants will primarily be assessed for the change from baseline in liebowitz social anxiety scale (lsas) at week 12. safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * must have a primary dsm-5 diagnosis of social anxiety disorder (sad) except those with performance only as a specifier. participants with a diagnosis of comorbid generalized anxiety disorder (gad) or major depressive disorder (mdd) may be included if the investigator considers sad to be the predominant diagnosis. participants with current or lifetime history of attention deficit hyperactivity disorder (adhd) and specific phobia may be included as well * must have a liebowitz social anxiety scale score greater than or equal (\>=) 70 at screening and baseline * participants with a current episode of mdd must have a hdrs17 total score less than or equal to (\<=) 18 * must have a body mass index (bmi) between 18 and 35 kilogram per meter square (kg/m\^2), inclusive, at screening * female participants must be either postmenopausal or surgically sterile exclusion criteria: * participants who have performance only sad are excluded. participants with other current significant psychiatric condition(s) (axis 1 under dsm-iv), including, but not limited to, mdd with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (ptsd) or schizophrenia are excluded. participants with a diagnosis of comorbid gad or mdd may be included * participants is currently receiving specific psychotherapy for sad * has a history of more than two unsuccessful adequate pharmacological treatment trials for sad, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine \>= 40 milligram per day (mg/day) or its equivalent; or clonazepam \>= 2.5 mg/day or its equivalent) * concurrent use of psychotropic medications * has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it

Keywords: social anxiety disorder jnj-42165279
ofatumumab in nodular lymphocyte predominant hodgkin lymphoma (nlphl)

Conditions: Relapsed NLPHL

Summary: the purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant hodgkin lymphoma (nlphl).


Eligibility criteria:
inclusion criteria: * relapsed nodular lymphocyte predominant hodgkin lymphoma * age 18 - 75 * review of diagnosis by experienced pathologist * no major organ dysfunction exclusion criteria: * classical hodgkin lymphoma * cd20 antibody treatment within the last 6 months prior enrollment * chronic or current infectious disease requirering systemic antibiotics * other past or current malignancy
magnetic resonance (mr) spectroscopy and diffusion tensor imaging in determining brain injury and subsequent clinical outcome in patients of moderate brain trauma

Conditions: Brain Trauma

Summary: the purpose of this study is to use magnetic resonance spectroscopy (mrs) and diffusion tensor imaging (dti) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. mr spectroscopy using 2d-csi (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. white matter disruption in these areas is commonly seen after tbi, caused by diffuse axonal injury. it has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies. by the use of dti it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. most tbi subjects have injuries that involved torque to the brain. this results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome. also, to demonstrate that mrs and dti prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date. by comparing fraction anisotropy, adc values, and metabolic ratios by the use of dti and mrs in the adult and pediatric populations, may help to assess differences in recovery. lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after tbi with and/or without links to outcome can be done.

the purpose of this study is to determine if mri imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. this study may show that mri can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.

Eligibility criteria:
inclusion criteria: * patients of acute moderate brain trauma exclusion criteria: * patients who are medically unstable or have ct findings that may interfere with the study such as: * a large hemorrhage or edema * encephalomalacia * prior neurosurgeries * hardware placed in the head or neck * prior head trauma * history of neurological conditions

Keywords: moderate brain trauma