Kornimate/medical-research-clean huggingface dataset:
nilotinib + pegylated interferon alpha 2a for untreated chronic phase chronic myelogenous leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: the aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in chronic phase chronic myelogenous leukemia (cp cml) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.


Eligibility criteria:
inclusion criteria: * performans status 0-2 * cp cml diagnosed since less than 3 months without previous tyrosine kinase inhibitor (tki) or interferon treatment * adequate organic functions: * total bilirubin \< 1.5xupper normal range (unr). * aspartate amino transferase (asat) and alanine amino transferase (alat) \< 2.5xunr. * alkaline phosphatase ≤ 2.5xunr * amylase and lipase ≤ 1.5xunr. * creatininemia \< 1.5xunr. * biological blood standards : * potassium ≥ lower normal range (lnr) * magnesium ≥ lnr. * phosphorus ≥ lnr * calcium ≥ lnr. * negative pregnancy test within the last 7 days for women with childbearing potential. * informed consent signed up * compliance to tretament ensured, * valid social insurance exclusion criteria: prior tki or interferon treatment for the cml * contra-indication to ifn * pregnancy, breast feeding * human immunodeficiency virus positive, chronic hepatitis b or c. * other bcr-abl transcript than m-bcr * cardiopathy defined as: * left ventricular ejection fraction (lvef) \< 45%. * left bundle branch block * ventricular pacemaker. * congenital prolonged qt * past ventricular or significant auricular tachyarrythmia * clinically significant bradycardia (\<50 per minute). * qtc (fredericia) \> 450 ms (average on 3 elektrokardiogramm (ekg)). * myocardial infarction in the last 12 months. * unstable angina within the last 12 months. * other significant cardiac diseases. * other uncontrolled severe disease (such as diabetes melittus etc...) * other ongoing malignant disease. * past history of congenital or acquired clinically significant bleeding disorder. * previous radiotherapy ≥25% of bone marrow. * serious surgery within the past 4 weeks * investigational treatment within the last 30 days prior to day 1. * history of non compliance. * cytochrome p450 3a4 (cyp3a4) inhibitors that could not be withdrawn or modified (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil). * severe gastro-intestinal disorders (such as gastric ulcer, uncontrolled nausea, malabsorption syndrome, small intestine resection, gastric shunt). * hepatic, renal or pancreatic chronic disorder unrelated to cml * recent history of acute pancreatitis within a year or history of chronic pancreatic disease . * any concommittant treatment inducing qt prolongation.

Keywords: chronic myelogenous leukemia nilotinib pegylated interferon bcr-abl philadelphia chromosome hematologic, cytogenetic and molecular response rates and kinetics will be studied in addition to the safety of the combination
phase ii open label multicenter study for age related macular degeneration comparing pf-04523655 versus lucentis in the treatment of subjects with cnv (monet study).

Conditions: Age Related Macular Degeneration

Summary: the aim of the study is to evaluate whether pf-04523655 is effective in the treatment of neovascular/wet amd and at which dose.


Eligibility criteria:
inclusion criteria: * males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd). active cnv is defined as any leakage detected on ffa or oct. note: female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum fsh level within the laboratory reference range for postmenopausal women * the total area of cnv (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area. * the total lesion size ≤12 disc areas. * best corrected visual acuity using etdrs protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit. * best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the screening visit. note: only one eye will be treated (study eye) through the duration of the study. in the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. the non-study eye may be treated with an approved amd therapy * subject has retinal central subfield thickness ≥250µm measured using stratus oct. exclusion criteria: * prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye * previous subfoveal focal laser photocoagulation in the study eye * laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding baseline * history of vitrectomy, submacular surgery or other surgical intervention for amd in the study eye * previous participation in any studies with investigational drugs or treatments administered 1 month preceding baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (macugen), ranibizumab (lucentis), bevacizumab (avastin) in the study eye * subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size * cnv in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia * presence of subfoveal scarring * retinal pigment epithelial tear involving the macula in the study eye

Keywords: amd age related macular degeneration choroidal neovascularization monet
level of physical activity and its associations with fatigue and quality of life in multiple myeloma survivors

Conditions: Multiple Myeloma

Summary: the purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. as multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize qol. a positive correlation may suggest that exercise is such an intervention. the hypothesis are multiple myeloma survivors are performing low levels of physical activity. higher levels of physical activity will be associated with higher levels of qol and lower fatigue levels.

multiple myeloma its associated treatment often result in persistent symptoms such as fatigue, pain, neuropathy and diminished functional performance that can affect the survivor's quality of life (qol). and as survival for multiple myeloma continues to improve, physical activity may be a supportive therapy that can help to address the multitude of qol concerns. physical activity is a modifiable behavior, and has been proposed as an important non-pharmacologic intervention to improve health-related outcomes among cancer survivors. the american college of sports medicine examined evidence of the impact of physical activity in cancer survivors, and concluded that physical activity is safe for cancer patients, both during and after cancer treatment, and may lead to improved physical functioning, decreased physical fatigue, and improved qol in a number of cancer survivor groups, including hematopoietic malignancies. while a small number of studies have suggested that exercise may reap benefits in qol and fatigue in multiple myeloma survivors, none were conducted in the local context.given the limited evidence, the primary objectives of this preliminary study is to estimate the prevalence of physical activity among a local sample of multiple myeloma survivors, and to investigate its associations with reported fatigue and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma * able to complete questionnaires exclusion criteria: - unable to complete questionnaires
study of dcr-a1at in healthy adult volunteers

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this is a research study to test an experimental study drug (belcesiran, also known as dcr-a1at). this drug is being tested to see if it helps people with a rare condition known as alpha-1 antitrypsin deficiency, or a1atd. prior to initiation of this study belcesiran had not yet been tested in humans. all study participants will be randomly assigned to either receive the study drug or a placebo. this will allow for the sponsor to compare the effects of the study drug with that of the placebo. a placebo looks like the study drug but does not contain any of the study drug. the main purpose of the first part of the study is to evaluate the safety profile of the study drug in people who do not have a1atd. this part of the study will also help find the dose of the study drug that has an acceptable safety profile for testing.

a1atd- associated liver disease is a progressive alpha-1 antitrypsin-deficiency associated liver disease condition resulting in liver fibrosis, cirrhosis, and hepatocellular carcinoma. the lack of functional a1at in individuals with pizz genotype, in conjunction with other precipitating factors, can lead to unchecked activity in neutrophil elastases in the alveoli; causing emphysema and chronic obstructive pulmonary disease (copd). this loss-of-function mechanism can be addressed with intravenous augmentation therapy, which aims to substitute the missing a1at by infusing alpha1 proteinase inhibitor (a1pi), purified from pooled human plasma. while augmentation therapy can address the loss of a1at in the lungs, no treatment exists for the associated liver disease. given the severity of the disease, with approximately 10% of affected patients developing liver cirrhosis and a subgroup of those patients in need of liver transplantation, and lack of an effective treatment that addresses the toxic hepatic "gain-of-function" mechanism, there is an urgent unmet medical need to develop a therapy that can help in this particular patient population.

Eligibility criteria:
inclusion criteria: * male or female aged 18 to 55 years, inclusive. female participants must be either surgically sterile or postmenopausal. no women of childbearing potential are eligible for enrollment. * overtly healthy, as determined by the investigator. * serum a1at protein concentration \>100 mg/dl * adequate forced expiratory volume in one second (fev1) and adequate fev1/forced vital capacity (fvc) ratio * non-smokers with a \<2 pack-year history and smoking cessation for at least 6 months with a negative urinary cotinine test a screening exclusion criteria: * presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially affect participant safety * clinically significant abnormal laboratory tests * received an experimental drug within past 4 months * prior to use of rnai drug or oligonucleotide-based therapy * known human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b (hbv) * serum creatinine or estimated glomerular filtration rate (egfr) outside normal reference ranges.
kansas intensive permanency project

Conditions: Serious Emotional Disturbance; In Foster Care

Summary: the intervention provides services to children with serious emotional disturbance (sed) who are in foster care and to their parent(s) to prepare the families for reunification.

the intervention provide services to children with serious emotional disturbance (sed) who are in foster care and to their birth parents to prepare the families for reunification. the evaluation follows a randomized design. the pretest will assess the procedures and instruments for collecting data on child, youth, and family functioning. ultimately, after the pretest is complete, the data collected through the evaluation will provide information on the extent to which the intervention achieved its goal of improving parenting skills and enhancing readiness for reunification among the families who received the services.

Eligibility criteria:
inclusion criteria: * children age 3-16 with severe emotional disturbances * in foster care and their families (parents). exclusion criteria: -

Keywords: serious emotional disturbance foster care child protective services
safety and efficacy of spd503 in treating adhd in children and adolescents aged 6-17

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine the efficacy of spd503 compared to placebo in the treatment of children and adolescents aged 6-17 with adhd.


Eligibility criteria:
inclusion criteria: * subjects with a primary diagnosis of adhd * females of childbearing potential must have a negative serum beta human chorionic gonadotropin (hcg) pregnancy test * male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements exclusion criteria: * subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid axis ii disorders or severe axis i disorders * subject weighs less than 55 lbs or is morbidly overweight with a bmi =\> 35 * subject has a history of seizure during the last 2 years or a serious tic disorder, including tourette's disorder * subject is pregnant or lactating
comparison of time-restricted feeding and continuous feeding in critically ill patients

Conditions: Feeding Behavior

Summary: in the nutrition guideline (a.s.p.e.n guideline), there was no recommendation about the feeding type in enteral feeding of critically ill patients. continuous feeding is the most popular feeding type in icu because of its less nursing burden and reducing the aspiration incidence theoretically. however, some previous studies demonstrated that there were no complications differences between continuous and time-restricted feedings（such as intermittent feedings）. in icu, the disorder of protein synthesis is a universal problem and is associated with icu acquired weakness. time-restricted feeding is more physical than continuous feeding. in some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding. besides of light, time-restricted feeding can may also adjust the biological rhythms. it is known that biological clocks could affect energy metabolism, emotion and so on. until now, there are no enough clinical studies to prove the advantages in time-restricted feeding in icu patients.so researchers designed the study to compare the time-restricted feeding and continuous feeding effect(especially protein synthesis) on icu patients.

enteral nutrition support can be administered by continuous administration or by time-restricted administration in icu. continuous feeding is the most popular feeding schedule because of its less nursing burden and reducing the aspiration prevalence theoretically. however, previous studies demonstrated that there was no complications (diarrhea, distension, ventilator associated pneumonia-vap incidence, and so on) difference between these two feeding schedule. so in the nutrition guideline (a.s.p.e.n guideline), there was no recommendation about the feeding schedule. however, time-restricted feeding is more physical than continuous feeding. in icu, the disorder of protein synthesis is a universal problem and is associated with icu acquired weakness. in some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding. besides of light, time-restricted feeding can adjust the biological rhythms. it is known that biological clocks could affect energy metabolism, emotion and so on. in the "zi wu liu zhu" theory of traditional chinese medicine, feeding time should be at 7:00-9:00, 11:00-13:00 and 17:00-19:00. so researchers designed the study to compare the time-restricted feeding according to traditional chinese medicine and continuous feeding effect(especially protein synthesis) on icu patients.

Eligibility criteria:
inclusion criteria: icu patients asking for enteral nutrition by gastric tube exclusion criteria: patients with gastrectomy; patients with enterectomy; patients with gastrointestinal hemorrhage; patients with diabetes; patients with intestinal fistula
evaluating forced oscillation technique (fot) in abolishing flow limitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to validate the capability of the respironics synchrony ventilator to properly detect expiratory flow limitation (efl) as compared to the gold standard method of detecting efl via the mead and wittenberger technique.

positive end expiratory pressure (peep) is used in copd patients to counteract the intrinsic peep (peepi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (dh). dh commonly occurs in copd, where the presence of expiratory flow-limitation (efl) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting efl expiratory flow. to be effective, the peep level applied to the patient should be equal to peepi. the continuous monitoring of efl could be a useful tool to select the minimum peep level required to abolish it. efl can be detected using the forced oscillation technique (fot) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta xrs) at 5hz.

Eligibility criteria:
inclusion criteria 1. age \< 80 years 2. moderate - severe copd diagnosed by spirometry (according to the gold criteria - global initiative for chronic obstructive lung disease criteria) 3. free from any exacerbation in the 6 weeks preceding the study exclusion criteria 1. any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome 2. clinically unstable; exacerbation within the preceding 6 weeks 3. the presence of pulmonary or extra-pulmonary neoplasia that is still active 4. the presence of a bleeding diathesis 5. unstable coronary artery disease 6. presence of tuberculosis, current infection or potentially infectious pathogen 7. inability to provide informed consent to the study

Keywords: copd
analysis of the glycemic profile of people suffering from compulsive eating disorders aiming to offer an innovative nutritional approach (glucopulse)

Conditions: Bulimia; Binge Eating; Blood Glucose, Low; Crisis State; Compulsion

Summary: eating disorders (ed) are a major public health problem. current care remains only partially effective and the pathophysiology of the disorders remains to be deepened. with regard to compulsive ed (bulimia and binge eating disorder), our clinical experience suggests that one of the major triggers for crisis may be related to glycemia. in fact, bulimia could be considered as a vicious circle where the binge eating disorder is going to be followed by a food restriction in order to control weight , putting the subject in a situation of "energy deficiency" which will favor the emergence of new crises . technological advances have resulted in the emergence of new measuring devices, such as "tracking", which records continuous glycemia, which would allow us to explore these clinical hypotheses.

this is an open-label, exploratory, proof-of-concept study. 20 patients will be recruited from the day hospital of the endocrinology and nutrition department of the university hospital of montpellier, lapeyronie and from emergencies and post-psychiatric emergencies department. during the inclusion visit, the dietician will explain to the patient the use of the dietary book and the glycemic sensor which will be allocated to it. the patient will also answer to self-questionnaires about his eating behavior. no nutritional approach will be addressed so as not to alter the patient's eating behavior and not to influence the results. they will be followed-up during 14 days.

Eligibility criteria:
inclusion criteria: * subject suffering from eating disorders with at least 3 episodes of bulimia per week for at least 2 months * subject affiliated to a health insurance or beneficiary of such a plan * subject able to understand the nature, purpose and methodology of the study * subject signed informed consent exclusion criteria: * subject suffering from eating disorders such as anorexia nervosa * subject unable according to the investigator's opinion to keep updated a dietary book or to perform correctly the glycemic recordings * subject suffering from somatic pathology (ex: diabetes) or psychiatric pathology assessed by the mini (ex : severe current major depressive episode) that may interfere with the protocol according to the the investigator * major subject legally protected (guardians or curators) or deprived of freedom by judicial or administrative order * pregnant or nursing woman
ultra-protective ventilation monitored by electrical impedance tomography in patients with severe acute respiratory distress syndrome on veno-venous ecmo

Conditions: Severe ARDS

Summary: for ecmo supported patients with severe ards (acute respiratory distress syndrome), usual care include use of "ultraprotective" mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ards. although very low tidal might also cause pulmonary derecruitment. the aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography. secondary aim is to describe the evolution of the optimal peep (positive end expiratory pressure) during the decrease of the tidal volume

patients requiring venovenous ecmo support for severe ards will be monitored with electrical impedance tomography during introduction of "ultraprotective" mechanical ventilation. monitoring will start with pre-ecmo ventilator setting, then the tidal volume will be lowered step by step. other parameters of the ventilator will be kept constant. then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse. also, at the end of each step, peep titration will be performed to identify the optimal peep setting that combines the best alveolar recruitment with minimal overdistention. the aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of pep. then, comparison of the different tidal volumes with application of ideal peep will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal peep.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * patient with ards on venovenous (vv)-ecmo * written informed consent * patient affiliated to a social security scheme exclusion criteria: * pregnancy * adult patient subject to a legal protection measure (tutor, curator, etc.) * patients with a pacemaker, automatic implantable cardioverter defibrillator, * contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) * undrained pneumothorax, bronchopleural fistula * hemodynamic instability (i.e., use of intravenous fluids of more than 10 ml/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Keywords: ecmo ards ultra-protective mechanical ventilation