Kornimate/medical-research-clean huggingface dataset:
study of oral ixazomib in adult participants with relapsed or refractory light chain amyloidosis

Conditions: Light-Chain Amyloidosis

Summary: this study will include participants with previously treated systemic relapsed or refractory light-chain (al) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of mln9078 (ixazomib) administered orally.


Eligibility criteria:
inclusion criteria: * male or female participants 18 years or older * biopsy-proven systemic relapsed or refractory light-chain (al) amyloidosis, which after at least 1 prior therapy, in the investigator's opinion, requires further treatment * if received stem cell transplant, must be at least 3 months posttransplantation and recovered from side effects * must have measurable disease defined as serum differential free light chain concentration ≥ 40 mg/l * must have objective measurable organ (heart or kidney) amyloid involvement * must have cardiac biomarker risk stage i or ii disease * must have adequate hematologic, hepatic, and renal function * eastern cooperative oncology group (ecog) performance status of 0 to 2 * female participants who are postmenopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse * male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse * voluntary written consent exclusion criteria * peripheral neuropathy that is greater or equal to grade 2 * cardiac status as described in protocol * severe diarrhea (≥ grade 3) not controllable with medication or requires administration of total parenteral nutrition * known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of mln9708 * uncontrolled infection requiring systematic antibiotics * known human immunodeficiency virus (hiv) positive, hepatitis b surface antigen-positive status, or known or suspected active hepatitis c infection * presence of other active malignancy with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate-specific antigen is within normal limit, or any completely resected carcinoma in situ * female participants who are lactating or pregnant * major surgery within 14 days before the first dose of study drug * serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol

Keywords: drug therapy
development of the tool " ipsc " for the functional study of mutations responsible for mental retardation

Conditions: Intellectual Deficiency; Asymptomatic Carrier of the Mutation of the Gene MYT1L; Healthy Volunteers

Summary: according to the world health organization (who), mental retardation (mr) is defined by an intelligence quotient (iq) \< 70 and touches between 1 to 3 % of the general population. profound mental retardation (qi \<25), severe (iq: 25-40) and moderate (qi : 40-50) have a prevalence of 0,3-0,5% while the prevalence of mild mr, defined by an iq between 50 and 70 is evaluated to about 1,5 %. the origin of mr can be infectious, toxic, traumatic, genetic or environmental. genetic causes of mr gather the number and structure anomalies of the chromosomes, the genomic microreorganization, monogenic diseases and more rarely other non mendelian-inherited anomalies like print or epigenetic anomalies, mutations of the mitochondrial genome etc... genetic causes represents 50% of moderate to severe, whereas environmental factors (malnutrition, cultural deprivation,...) plays an important role in mild mr. the main goal of this study is to get an innovative tool (neuronal distinction of ipsc) that wil allow to study the functionnal impact of mutations uppon genes probably involved in mr like myt1l. the main criteria associated to characterisation of the tool by the trial is the study of the pluripotency of ipsc obtained and to highlight the mutation of the gene myt1l in the ipsc. neurons from the ipsc of the patient and his father du patient wille also be morphologically characterised, but also thanks to the expression of specifically neurals genes. characteristics of ipsc and neurons from d'ipsc with myt1l mutation will be compared among the patient and his father, in relation with the same cells coming from the two witnesses.


Eligibility criteria:
inclusion criteria : * patient with an intellectual deficiency and/or associated signs that received a chromosomic analysis by cgh-array revealing a variant of unknown signification involvingone or more genes candidates for mental retardation. * certificate of genetic genetic counselling and signed consent. * under 18 persons may be necessary because intellectual deficiency is often diagnosed before the adult age. * number of cases is very limited in this preliminary study and only one patient showing a rare mutation of myt1l gene and his father ( asymptomatic carrier of the same mutation) will be study. * affiliation to a social security system exclusion criteria : * persons mentionned l1121-5 to l1121-8 of csp (all protected persons) * persons suffering from acute infections for the practice of cutaneous biopsy under local anesthesia. * persons showing an hemostasis disorder acquired or induced * persons sous traitement antiagrégant anticoagulant * persons with a mutation in th gene myt1l

Keywords: mental retardation mr iq mutation gene myt1l
glycemia and ischemia reperfusion brain injury in patients with acute cerebral infarction treated with mechanical thrombectomy

Conditions: Cerebral Infarction

Summary: postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. thus, those patients with glycemia values \< 155 mg/dl during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in mirna expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema. the main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: * men and women over 18 years of age * neuroimaging studies such as computed tomography (ct), angio-ct or angio-mri compatible with the diagnosis of acute cerebral infarction due to occlusion of a large vessel of the anterior circulation, including the internal carotid artery (intra- or extracranial) or middle cerebral artery (m1 or m2 segments). * indication of mechanical thrombectomy according to clinical practice. * inclusion of the patient in the study before the endovascular procedure. * modified rankin scale (mrs) score prior to stroke of 0-1. * signature of informed consent. exclusion criteria: * ct, angio-ct or angio-mri showing posterior circulation occlusion. * severe or life-threatening concomitant disease that precludes follow-up for 3 months after stroke, * alcohol or drug abuse * participation in a therapeutic clinical trial.
clinical significance of circulating tumor cells (ctcs) in blood of patients with advanced/metastatic gastric cancer

Conditions: Gastric Cancer

Summary: to identify the correlation of ctcs with clinical prognosis in advanced/metastatic gastric cancer. confirm the presence of ctcs are sensitive for monitoring response to chemotherapy.


Eligibility criteria:
inclusion criteria: * having signed informed consent * age≥ 18 years old * histologically confirmed gastric adenocarcinoma * unresectable recurrent or metastatic disease * previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. * measurable disease according to the recist criteria * karnofsky performance status ≥60 * life expectancy of ≥2 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<uln, and ccr \< 60ml/min * bilirubin level \< 1.5 uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * brain metastasis (known or suspected) * previous systemic therapy for metastatic gastric cancer * inability to take oral medication * previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * allergic constitution or allergic history to protium biologic product or any investigating agents. * severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ecg findings, cardiac infarction , or retractable hypertension. * pregnancy or lactation period * any investigational agent within the past 28 days * other previous malignancy within 5 year, except non-melanoma skin cancer * previous adjuvant therapy with capecitabine+platinum, * pre-existing neuropathy\>grade 1 * legal incapacity

Keywords: no-prior chemotherapy
a smartphone-based intervention to improve colorectal cancer screening in african american men

Conditions: Colorectal Cancer

Summary: the goal of this clinical trial is to test a new smartphone-based program designed to help african american men get screened for colorectal cancer (crc). the main question it aims to answer is: ° are african american men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not? participants will: * complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system. * be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the centers for disease control (cdc). the new program sends text messages with information about colorectal cancer. some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened. * complete a follow-up survey 6 months after the baseline survey. this survey will ask the same questions as the baseline survey. * a medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period. researchers will compare participants who receive the new smartphone-based program to participants who receive the cdc information. the goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.


Eligibility criteria:
inclusion criteria: * african american/black * not compliant with current united states preventive services taskforce colorectal cancer screening recommendations * owns a mobile phone capable of text messaging and accessing webpages * able to speak/understand english exclusion criteria: * personal history of colorectal cancer
immune response & safety of a hepatitis a vaccine given together with a pneumococcal vaccine in healthy children 15 m of age

Conditions: Hepatitis A

Summary: this is a study to evaluate the immunogenicity and safety of gsk biologicals 2-dose inactivated hepatitis a vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

an open, controlled comparison of havrix administered alone or with prevnar. the three groups evaluated are: 1) havrix alone, 2) havrix plus prevnar and 3) prevnar followed by havrix one month later.

Eligibility criteria:
inclusion criteria: * a male or female child 12 or 13 months of age at the time of entry into the enrollment phase, * free of obvious health problems, * subjects must have previously received three doses of prevnar in his/her first year of life. exclusion criteria: * use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period, * chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (for corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. inhaled, nasal and topical steroids are allowed.), * administration of the acip-recommended fourth dose of prevnar prior to entering the enrollment phase of the study, * planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s), * previous vaccination against hepatitis a, * history of hepatitis a or known exposure to hepatitis a, * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection, * a family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for hiv infection, * history of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of havrix (e.g., neomycin, 2-phenoxyethanol) or prevnar (e.g., diphtheria toxoid), * major congenital defects or serious chronic illness, * history of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject), * acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination, * administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
preventive strategies in colorectal carcinogenesis production and meat processing

Conditions: Colorectal Cancer

Summary: colorectal cancer is, in non-smokers for both sex, first cause of cancers mortality in western country. the main risk factors associated with colorectal cancer depend of lifestyle, and processed meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound linked to lipid peroxidation and nitrosation. the aim of this study is to study the impact of the daily consumption of beef, processed or not, on lipid peroxidation induced heme iron ; and to study the impact of the daily consumption of ham, processed or not, on the nitrosilation induced heme iron.

24 healthy volunteers will be randomized and will start the study. the study will last 12 weeks for each subject. the first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. during this period, they will collect 3 samples of stools and urine. then subjects will alternate 4 days of diet either with ham, or with ham and pomegranate extract, or with ham enriched with vitamin e or sirloin steak, marinated sirloin steak or marinated cooked sirloin steak. at least, 3 days will separate every period (wash-out) of nutritional intervention. urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.

Eligibility criteria:
inclusion criteria: * male * body mass index 20 \<= bmi \<= 30 kg/m2 * affiliated to french national health insurance * subject giving his written informed consent * subject considered as normal after clinical examination and medical questionnaire exclusion criteria: * previous medical and/or surgery judged by the investigator as incompatible with this study * previous familial of colon, ovarian or breast cancer * chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments * dislike ham or red meat * heavy consumer of alcohol * practising intensive physical exercise (\> 5 hours) * being under someone's supervision * refusal to be registered on the national volunteers data file * dietary habits unreliable to controlled food intake * being in exclusion on the national volunteers data file
comparison of senofilcon a toric lenses to balafilcon a toric lenses over extended wear period

Conditions: Astigmatism

Summary: to evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.


Eligibility criteria:
inclusion criteria: * able to wear study lenses in parameters available * non-presbyopes between the ages of 18-45 * understand and sign informed consent * willing to follow the protocol * achieve at least 20/30 (6/9) visual acuity (va) in right eye (od) and left eye (os) with study lenses * myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (d) (axis 90 +/- 15, 180 +/- 15) or -1.75 d (axis 90 +/- 10, 180 +/- 10) * adapted soft contact lens wearer * swims no more than once a week * has a wearable pair of spectacles. exclusion criteria: * any ocular or systemic disorder which may contraindicate contact lens wear * any topical ocular medication * aphakic * corneal refractive surgery * corneal distortion from hard cl wear or keratoconus * pregnant or lactating * grade 2 or worse slit lamp signs * infectious disease * previous clinical study within 2 weeks * don't agree to participate * polymethyl methacrylate (pmma) or rigid gas-permeable (rgp) lens wear in last 8 weeks * previous adverse effects that contraindicate extended lens wear. * self-reported symptoms of itchiness or scratchiness with habitual lenses.
effect of vitamin d3 supplementation in treatment of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether vitamin d3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to irritable bowel syndrome (ibs).

this randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with ibs. the intervention group will receive 50000 iu vitamin d3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin d, anthropometric indicators and blood pressure will be measured at baseline and end of the study. the investigators will use rome iii questionnaire for evaluating the clinical signs of the disease. the questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.

Eligibility criteria:
inclusion criteria: * the patients who are diagnosed with irritable bowel syndrome (ibs) according to rome iii criteria; signed consent by the patient. exclusion criteria: * patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests) * any other diseases of the gastrointestinal tract such as inflammatory bowel disease (ibd) * any kind of abdominal surgery * chronic disease such as diabetes * cardiovascular, hepatic * kidney and severe infection * pregnancy * breastfeeding * smoking * alcohol consumption * use of dietary supplements * use of vitamin d and calcium supplement during the last year before the study * use any medication for signs improvement during the study period.

Keywords: irritable bowel syndrome inflammation oxidative stress clinical signs vitamin d3
a study to assess the safety and efficacy of asp1941 in combination with α-glucosidase inhibitor in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to evaluate long-term safety and efficacy after concomitant administration of asp1941 and α-glucosidase inhibitor in japanese patients with type 2 diabetes mellitus.

this is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-glucosidase inhibitor alone. dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients receiving with α-glucosidase inhibitor mono-therapy for at least 4 weeks * hba1c value between 6.5 and 9.5% * body mass index (bmi) 20.0 - 45.0 kg/m2 exclusion criteria: * type 1 diabetes mellitus patients * serum creatinine \> upper limit of normal * proteinuria (albumin/creatinine ratio \> 300mg/g) * dysuria and/or urinary tract infection, genital infection * significant renal, hepatic or cardiovascular diseases * severe gastrointestinal diseases

Keywords: diabetes mellitus alpha glucosidase inhibitor asp1941 long-term safety
the helsinki unruptured intracranial aneurysm quality of care study

Conditions: Intracranial Aneurysm

Summary: a research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. all consecutive patients with a non-ruptured intracranial aneurysms treated at helsinki university hospital will be included. safety is measured by postoperative magnetic resonance imaging (mri) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.


Eligibility criteria:
inclusion criteria: * all patients with an unruptured intracranial aneurysm undergoing treatment exclusion criteria: * arteriovenous malformation related intracranial aneurysm * moyamoya-disease related intracranial aneurysm * ruptured intracranial aneurysm

Keywords: intracranial aneurysm surgery neurosurgery endovascular interventional neuroradiology neurointervention unruptured