Kornimate/medical-research-clean huggingface dataset:
asthma biomarkers for predicting response to therapy

Conditions: Asthma

Summary: novel asthma biomarkers to predict the response to inhaled corticosteroid brief description: this will be a single center study of asthmatic subjects and healthy controls which will investigate mechanisms underlying different response to inhaled corticosteroid, the mainstay of asthma therapy. only about half of the asthmatic patients have improved lung function after treatment of inhaled corticosteroid. the investigators hypothesize that there are biomarkers such as epithelial cytokines (il-25, il-33, tslp) in airway tissues or plasma of asthmatic patients which could predict the response of asthmatic patients to inhaled corticosteroid. finding novel asthma biomarker will help the clinicians to choose the optimal treatment for individual asthmatic patient.


Eligibility criteria:
group a: inclusion criteria: * male and female subjects between the ages of 18 and 70 years * no respiratory symptoms * normal spirometric value and methacholine pd20 \>2.5mg group b: inclusion criteria: * male and female subjects between the ages of 18 and 70 years * history of asthma * no use of oral or inhaled corticosteroids for the treatment of asthma * no use of leukotriene antagonist for the treatment of asthma * hyperreactivity to methacholine (pd20 fev1 methacholine \< 2.5 mg) and/or ≥12% increase in fev1 following inhalation of 200μg salbutamol * asthma symptoms of episodic cough, wheeze and/or breathlessness exclusion criteria: * current or former smokers * pregnant women * subjects with a history of lung disease other than asthma * subjects with a history of a medical disease, which in the opinion of the investigator may put the subject at extra risk from study-related procedures or because the disease may influence the results of the study
4 year extension study of efficacy and safety of secukinumab in patients with moderate to severe chronic plaque-type psoriasis

Conditions: Moderate to Severe Chronic Plaque-Type Psoriasis

Summary: cain457a2304e1 was an extension study to two phase iii studies, cain457a2304 and cain457a2307 (core studies). this extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. all subjects who completed the full study treatment period (52 weeks) in the cores studies cain457a2304 and cain457a2307 were eligible to participate in this extension study. in this extension study, the prefilled syringe (pfs) liquid formulation of secukinumab was used.


Eligibility criteria:
inclusion criteria: 1. subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. where relevant, a legal representative will also sign the informed consent according to local laws and regulations. 2. subjects who complete week 52 of study cain457a2304 or complete week 40 of study cain457a2307 3. subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator exclusion criteria: 1. a protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject 2. ongoing use of prohibited psoriasis or non-psoriasis treatments. time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. 3. subjects expected to be exposed to an undue safety risk if participating in the trial 4. current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial 5. plans for administration of live vaccines during the study period 6. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>10 miu/ml).

Keywords: psoriasis plaque inflammatory skin disease scaly patches ain457 secukinumab moderate to severe plaque-type psoriasis
chronic pain after surgical intensive care admission: incidence and risk factors: the dolochrorea study

Conditions: Pain, Chronic; Intensive Care, Surgical

Summary: the acute pain remains unfortunately a major health problem in intensive care patients. several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. the acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care. moreover, the acute pain could lead to a long-term chronic pain syndrome. the chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (icu). if many studies have been conducted to improve the management of the acute pain in the icu, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care. the aim of the dolochrorea study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical icu.


Eligibility criteria:
inclusion criteria: * admission in the surgical critical care unit of the university hospital of besançon from february 2015 * age over 18 yr old * informed consent exclusion criteria: * age under 18 yr old * death within the first 6 months after the end of the stay in the surgical intensive unit of the university hospital of besançon * glasgow coma score under 8 at admission and/or at discharge * planned admission after elective surgery * medical history of cognitive disorder * refuse to participate
the impact of the "nutrition enrichment and healthy living model" ( nehlm) on diet quality, physical activity and dental health among children from socioeconomically disadvantaged families in beer sheva

Conditions: Childhood Obesity

Summary: childhood socioeconomic status (ses) is related to poor physical health, obesity, elevated cardiovascular risk factors and iron deficiency anemia. we plan to offer a comprehensive framework allowing the "nutrition enrichment and healthy living model" (nehlm) among a low ses kindergarten children. the model offered is designed to take into account the current economic status of the child's family. we shall conduct a randomized controlled trial to assess the efficacy of the intervention. our main objective: to compare the influence of the intervention on changes in food consumption, physical activity and ,and caries rates in the children in kindergartens where it is applied versus the control kindergartens. the research hypothesis: integrative nutrition enrichment and healthy living model (nehlm) will improve health behaviors among children and parents in comparison to control intervention (physical activity only).


Eligibility criteria:
inclusion criteria: * kindergarten children aged 4-7 children from kindergartens defined as low- ses population (by local municipality) * children whose parents agree to participate in the research exclusion criteria: * children who suffer from any chronic disease * children who suffer from developmental problems * children who participate in a weight reduction treatment or program * children or parents who have any psychiatric problem or diagnosis

Keywords: children obesity lifestyle lses caries
volume effect in peng block for total hip replacement

Conditions: Anesthesia; Post Operative Pain

Summary: this study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.

patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery

Eligibility criteria:
inclusion criteria: * asa i, asa ii, asa iii * age≥18 * total hip replacement surgery in spinal anesthesia * informed consent exclusion criteria: * asa iv * inr\>1.3 * platelet values\<100\*10\^3/ml a * patients on anticoagulant or antiplatelet therapy * general anesthesia for total hip replacement surgery * patients on chronic opioid therapy * altered sensitivity or motility * patients in chronic opioid therapy * refuse to sign informed consent form * unable to sign informed consent form * know allergies to medication used for analgesia

Keywords: postoperative orthopedic surgery
exercise improve sympathetic modulation in chronic heart failure patients

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to verify the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure.

retrospective study. patients were recruited by database from rehabilitation unit of cardiovascular rehabilitation and exercise physiology of the heart institute (incor). the aim of this study is to assess the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure. the investigators studied twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class ii to iii of new york heart association, left ventricular ejection fraction (lvef) ≤40% and peak oxygen uptake (vo2) ≤20. the exclusion criteria were recent myocardial infarction or unstable angina (\<3 months), heart failure duration (\<3 months), permanent pacemaker dependence, atrial fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular exercise program. they were assigned to 2 groups: untrained (n=13) and trained (n=13).

Eligibility criteria:
inclusion criteria: * patients with chronic heart failure * age 30 to 70 years * functional class ii to iii of new york heart association * left ventricular ejection fraction (lvef) ≤40% * peak oxygen uptake (vo2) ≤20 exclusion criteria: * recent myocardial infarction or unstable angina (\<3 months) * heart failure duration (\<3 months) * permanent pacemaker dependence * atrial fibrillation * skeletal muscle abnormality (e.g., arthritis) * participation in a regular exercise program

Keywords: chronic heart failure exercise training sympathetic modulation arterial baroreflex control
paracor ventricular support system (pvss) for patients with heart failure

Conditions: Heart Failure, Congestive

Summary: this is a limited safety and feasibility study to evaluate the pvss introducer and paracor ventricular support system when used to treat patients with heart failure. the implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles. no formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. the results of the study will be used to guide the design and sample size estimation of future studies.

please refer to brief summary.

Eligibility criteria:
inclusion criteria: * nyha functional class ii or iii * best medical therapy * ejection fraction \<= 35% exclusion criteria: * heart measurements too large or small for implant sizes * intra-cardiac thrombus * restrictive cardiomyopathy * not a candidate for sternotomy * expected adhesions * previous coronary artery bypass graft (cabg) * active infection * stroke, surgery, or implantable cardioverter defibrillator (icd) within 3 months * myocardial infarction (mi) within 1 month
case review of the penumbra and indigo systems for mechanical thrombectomy in the periphery

Conditions: Peripheral Arterial Occlusion or Emboli

Summary: the primary objective of this retrospective case review study is to determine the safety and effectiveness of the penumbra and indigo systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. this is a retrospective, single arm, multi-center trial. up to 100 patients at up to 10 centers will be enrolled. angiographic assessment of vessel patency at immediate post-procedure as measured by timi scores and procedural serious adverse events are assessed and recorded.


Eligibility criteria:
inclusion criteria: * evidence of a peripheral or visceral arterial occlusion or embolus (timi 0-1) prior to treatment. * treatment with components of the penumbra and/or indigo system. exclusion criteria: * participation in another clinical investigation that may confound the results of the study.

Keywords: peripheral arterial occlusion visceral emboli limb ischemia adverse events indigo system aspiration mechanical thrombectomy
infant weight gain with trisomy 21 and cavc

Conditions: Congenital Disorders

Summary: failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (chf). infants with trisomy 21 and complete atrioventricular canal defects (cavc) frequently develop uncompensated chf and weight gain failure pre-operatively. a weight of 5 kg has been suggested as optimal for timing of cavc repair. a delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. a retrospective review performed by kogon, et al, of children undergoing surgery for vsd at choa at egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome. the purpose of this study is to determine the optimal timing for surgical correction of cavc in trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.

a retrospective chart review of 100 infants with trisomy 21 and cavc operated at choa at egleston between january 1, 2001 and march 24, 2006 will be performed. graphs of birth weight and rate of weight gain over time will be plotted for each patient and for the group as a whole. the point of reaching a plateau of weight gain will be decided for each patient and indexed for birth weight. medical management will be detailed, i.e. all medications and all dietary information (caloric density of formula, route of administration). this medical management will be indexed as a function on the weight gain chart. medical complications (such as respiratory infections, gastroenteritis, hospitalizations, and additional non-cardiac medications) will likewise be plotted and segmented according to position relative to the weight gain plateau. age at eventual surgery and whether surgical date was delayed by complications will be noted. surgical cardiopulmonary bypass time and morbidity and mortality will be noted. postoperative length of ventilator support, length of stay in the cicu and total length of stay will be determined and also displayed as a function of body weight and as a function of time at plateau weight. postoperative morbidity and mortality for the three months after repair will be noted, including all cause hospital re-admissions and outpatient medical complications (such as respiratory infections, gastroenteritis, and the need for continued medications for chf).

Eligibility criteria:
inclusion criteria: * infants with trisomy 21 and cavc operated on at choa at egleston between january 1, 2001 and december 31, 2005 will be included in the study. exclusion criteria: * patients will be excluded if the following information is not available: a. birth weight b. weight at operation c. incomplete medical records e.g. patient followed preoperatively elsewhere

Keywords: pediatric cardiac weight gain pre-operative trisomy 21 complete atrioventricular canal
a feasibility and safety study of dual specificity cd38 and bcma car-t cell immunotherapy for relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: car-t cell therapy has shown promising results for the treatment of relapsed or refractory multiple myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.dual specificity cd38 and bcma car-t cells can recognize and kill the malignant cells through recognition of cd38 or bcma. this is a phase 1/2 study designed to determine the safety of dual specificity cd38 and bcma car-t cells and the feasibility of making enough to treat patients with relapsed or refractory multiple myeloma.

1. primary objectives: 1. to evaluate the feasibility and safety of dual specificity cd38 and bcma car-t cells in patients with relapsed or refractory multiple myeloma. 2. to evaluate the duration of in vivo persistence of adoptively transferred t cells, and the phenotype of persisting t cells.real time polymerase chain receptor (rt-pcr) and flow cytometry(fcm) analysis of pb,bm and lymph node will be used to detect and quantify survival of universal dual specificity cd38 and bcma car-t cells over time. 2. secondary objectives: 1.for patients with detectable disease, measure anti-tumor response due to dual specificity cd38 and bcma car-t cell infusions. 2.the car-t cells will be administered by i.v. injection over 20-30 minutes as a using day 0: 1-5x10e6/kg total dose on day 0.

Eligibility criteria:
inclusion criteria: 1. male or female participant 2. 12 years to 70 years (child, adult, senior) 3. patient with relapsed or refractory multiple myeloma,multiple myeloma cell express cd38(over 50%) and bcma (over 50%) 4. estimated life expectancy ≥ 12 weeks (according to investigator's judgement) 5. eastern cooperative oncology group (ecog) performance status ≤ 1 6. adequate organ function exclusion criteria: 1. prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease 2. diagnosis of burkitt's leukemia/lymphoma according to who classification or chronic myelogenous leukemia lymphoid blast crisis 3. richter's syndrome 4. presence of grade ii-iv (glucksberg) or b-d (ibmtr) acute or extensive chronic gvhd at the time of screening 5. subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy 6. severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), prophylactic antibiotic, antiviral and antifungal treatment is permissible 7. active hepatitis b, active hepatitis c, or any human immunodeficiency virus (hiv) infection at the time of screening 8. patient has an investigational medicinal product within the last 30 days prior to screening 9. previous treatment with investigational gene or cell therapy medicine products 10. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary 11. pregnant or nursing women
chemotherapy with or without immune checkpoint inhibitors for lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: although several clinical trials provide evidence for efficacy benefit for checkpoint inhibitors plus chemotherapy for lung cancer. however, there was rare evidence for clinical evidence in hunan province.

this prospective study aimed to assess its efficacy and adverse event for checkpoint inhibitors with or without chemotherapy in clincial practice. several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. tissue samples were collected with permission of patients for tme evaluation.

Eligibility criteria:
inclusion criteria: 1. ≥18，lung cancer confirmed by histopathology 2. treated with chemotherapy with or without checkpoint inhibitors. 3. ecog 0 - 1. 4. predicted survival ≥ 12 weeks. 5. adequate bone marrow hematopoiesis and organ function 6. presence of measurable lesions according to recist 1.1. 7. subjects with stable brain metastases may be included in the study. exclusion criteria: patients did not match for the inclusion criteria.

Keywords: chemotherapy, immune checkpoint inhibitors
repeated low-frequency transcranial magnetic stimulation reduces cue-induced craving: a randomized, prospective, double-blind, sham-controlled, cross-over study

Conditions: Pathological Gambling

Summary: the aim of this study is to evaluate the effect of repeated low-frequency transcranial magnetic stimulation (rtms) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. participants are pathological gamblers. a single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).


Eligibility criteria:
inclusion criteria: * pathological gambler (dsm-iv criteria) * seeking treatment at the university hospital of nantes * right-handed * 18-65 years old * increase in the intensity (at least 50%) of the gambling craving with gambling cues non-inclusion criteria: * pregnant woman * no effective contraception * substance use disorders (excluding nicotine) * benzodiazepine use * chronic neurological disease * history of head injury * history of neurosurgery * cochlear implant or other metal objects in the head * history of transcranial magnetic stimulation or repeated transcranial * magnetic stimulation * difficult to read or write french exclusion criteria: * occurrence of side effects (like seizures) * psychoactive substance use 12 hours before the rtms (excluding nicotine)

Keywords: pathological gambling craving repeated transcranial magnetic stimulation craving cues
study comparing pitavastatin and atorvastatin in patients with type ii diabetes mellitus and combined dyslipidemia

Conditions: Type II Diabetes Mellitus; Dyslipidemia

Summary: the purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type ii diabetes mellitus (type ii dm) and combined dyslipidemia.


Eligibility criteria:
inclusion criteria: * males and females (ages 18-75 years) * type ii dm treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy) * must have been following a restrictive diet * diagnosis of combined dyslipidemia exclusion criteria: * homozygous familial hypercholesterolemia * conditions which may cause secondary dyslipidemia * uncontrolled diabetes mellitus * abnormal pancreatic, liver, or renal function * abnormal serum creatine kinase (ck) above the pre-specified level * significant heart disease

Keywords: kowa type ii diabetes mellitus combined dyslipidemia pitavastatin nk-104 atorvastatin