Kornimate/medical-research-clean huggingface dataset:
language environment in children with cochlear implants

Conditions: Language Development

Summary: the language environment analysis (lena) system is a specific tool for the language environment analysis. children aged from 18 months to 6 years old, with cochlear implants (cis), wear an electronic device during a day and their language interactions are registered. then the investigators can analyze with a specific software four different parameters (adult words, conversational turns, child vocalizations and media exposure) and compare them to the language ability of the children assessed by a speech therapist. with the results, the speech therapist can advise the parents how to improve the language environment to help their children with cis for their language development. parents are encouraged to follow these advices at home during few months (5 months +/-1 month). then there is a new registration of the lena device and another language assessment are performed, to see if there is any improvement. the investigators also measure the family participation. hypothesis : there is an influence of the language environment measured by the lena system on language development in children with cochlear implants.

over 24 months the investigators will recruit 90 patients with cochlear implants (cis) in 2 centers. each patient will follow during 5 months and will have three or five visits according to the arm.

Eligibility criteria:
eligibility criteria:\* inclusion criteria: * congenital profound deaf children * aged from 18 months to 5 years old 11 months * with a cochlear implant at least since 6 months * regular following in speech therapy exclusion criteria: * non-francophone parents * syndrome (like charge syndrome) or aplasia * partial insertion of the electrode array * associated troubles (autism spectrum disorders, mental retardation...) * visual troubles * irregular use of the cochlear implant (externe part) * absence of parental consent

Keywords: cochlear implant language environment speech therapy assessment lena technology
expanded access trial of belimumab antibody in ra patients who were previously treated under hgs protocol lbra99

Conditions: Rheumatoid Arthritis

Summary: an expanded access trial of belimumab for named patients who participated in lbra99.

an expanded access trial of belimumab for named patients with rheumatoid arthritis (ra) who have experienced continued benefit under hgs protocol lbra99.

Eligibility criteria:
inclusion criteria: 1. have in the clinical judgment of the investigator, experienced significant clinical benefit while on belimumab treatment in the hgs protocol lbra99. 2. over the course of the study and for 60 days after the last dose of study agent, any woman with an intact uterus who is not post-menopausal must agree to practice a medically accepted method of contraception. 3. over the course of the study and for 60 days after the last dose of study agent, all men must agree to practice a medically accepted method of contraception. 4. have the ability to understand the requirements of this study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the required study visits. exclusion criteria: 1. had not been previously treated with belimumab in lbra99 or were discontinued from treatment prior to hgs' decision to terminate lbra99. 2. had clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to ra (ie, cardiovascular, pulmonary, anemia, gastrointestinal, hepatic, renal, neurological, cancer or infectious diseases) that could, in the opinion of the principal investigator, put the patient at undue risk. 3. are a pregnant female or nursing mother.

Keywords: rheumatoid arthritis ra
behavioral treatment, drug treatment, and combined treatment for attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with attention deficit hyperactivity disorder (adhd). this study will also examine the interactions between different levels of behavioral and drug treatments.

participants attend a summer treatment program each monday-friday for 9 weeks. they participate in group recreational and classroom activities, with 12 children and 5 staff per group. three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition. measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. parents attend training sessions and implement behavioral programs at home.

Eligibility criteria:
inclusion criteria: * attention deficit hyperactivity disorder * iq \>= 80 exclusion criteria: * history of seizures or other neurological problems * medical history that would involve considerable risk in taking stimulant medication * history or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
a study to evaluate itca 650 compared to glimepiride as add on therapy for the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: phase 3 study to examine treatment with itca 650 compared to glimepiride when added to metformin monotherapy in reducing hba1c in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * hba1c between 7.5% - 10.5% * on metformin monotherapy * bmi between 25 \& 45 kg/m2 exclusion criteria: * on thiazolidinedione, sulfonylurea, dpp-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months * history of pancreatitis
energi-f701 for female hair loss treatment

Conditions: Female Pattern Baldness; Hair Loss; Alopecia

Summary: the objective of this study is to evaluate the efficacy and safety of energi-f701 solution in female subjects with hair loss.


Eligibility criteria:
inclusion criteria: 1. female, aged at least 20 years old 2. with hair loss over 100 hairs/day 3. willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing icf and throughout the study 4. the subject of childbearing potential must show a negative urine or serum pregnancy test at screening visit 5. have signed the written informed consent form exclusion criteria: any subject meeting any of the exclusion criteria will be excluded from study participation. 1. with alopecia areata or cicatricial alopecia 2. with other scalp or hair disorders 3. with prior hair transplant 4. use wigs or hair weaves 5. plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study 6. have taken any topical or systemic prescription of otc medications for treating hair loss, hair regrowth and/or hair volume 7. have used medications known to cause hair thinning, such as coumadin and anti-depressants/anti-psychotics 8. have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp 9. have initiated or terminated the use of hormones for birth control or hormone replacement therapy within 6 months. subject will also be excluded from the study if she plans to initiate or terminate the use of hormones for birth control or hormone replacement therapy during the study. 10. with known or suspected hypersensitivity any ingredients of study product and active control 11. any hematologic abnormalities. 12. any serum chemistry abnormalities. 13. pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control. 14. enrollment in any investigational drug trial 15. with any condition judged by the investigator that entering the trial may be detrimental to the subject

Keywords: alopecia hair loss female pattern baldness
a study of pf-03463275 as add-on therapy in outpatients with persistent negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this study is examining the efficacy of pf-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.

the study was terminated on august 25, 2010 because the study's scientific validity could no longer be supported. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase. * subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. subjects must be on a stable medication treatment regimen for at least 2 months. * evidence of stable symptomatology at least 3 months. exclusion criteria: * female subjects who are pregnant or breastfeeding. * subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results. * subjects who have dsm iv defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.

Keywords: schizophrenia negative symptoms adjunctive
study of gemcitabine and herceptin versus xeloda and herceptin in her-2 (+) metastatic breast cancer patients

Conditions: Breast Cancer

Summary: the optimal treatment for pretreated patients with metastatic breast cancer has not been established. gemcitabine and capecitabine are two active agents in this setting. for women with her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (xeloda) plus herceptin has been proved active and well tolerated.

this trial compares the efficacy of the combinations gemcitabine plus herceptin versus capecitabine (xeloda) plus herceptin in pretreated patients with metastatic her-2 positive breast cancer.

Eligibility criteria:
inclusion criteria: * informed consent * histologically confirmed metastatic breast adenocarcinoma (stage iv) without any prior chemotherapy received * her-2 overexpression 2+ or 3+ using ihc or fish + * measurable disease * at least one prior chemotherapy regimen * not in a prior irradiation field * no patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation * no more than 25% of myeloproductive bone marrow irradiated. more than 4 weeks since prior radiotherapy and recovered * age 18 - 75 year old * performance status (who) 0-2 * life expectancy more than 12 weeks * absolute neutrophil count \> 1500/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3) * adequate liver (bilirubin \< 2 mg/dl, sgot/sgpt \< 2 times upper limit of normal, alp \< 3 times upper limit of normal, creatinine \< 1.5 upper limit of normal * adequate cardiac function (lvef \> 50%) exclusion criteria: * pregnant or nursing * positive pregnancy test * concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce p-450 cytochrome * motor or sensory neuropathy \> grade 1 according to ncic toxicity criteria * history of allergic reaction attributed to docetaxel * psychiatric illness or social situation that would preclude study compliance * other concurrent uncontrolled illness * other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Keywords: cancer metastatic breast cancer her-2 expression gemcitabine capecitabine herceptin
coeliac disease in the nord-trøndelag health study (hunt)

Conditions: Celiac Disease

Summary: in this study, all citizen of nord-trøndelag county, norway, above 20 years of age are invited to participate in a population-based health study, the hunt study. blood samples are drawn from the participants and assessed for celiac disease by a serological assay. celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. the diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. the aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.


Eligibility criteria:
inclusion criteria: * participants of the forth round of the hunt study exclusion criteria: * none

Keywords: prevalence general population diagnosis prognosis etiology genes
quality-of-life qlq-ginet21 questionnaire in the treatment of patients with gastrointestinal neuroendocrine tumours

Conditions: Gastrointestinal Neuroendocrine Tumours

Summary: the purpose of this study is to evaluate the utility of the qlq-ginet21 in making clinical and therapeutic decisions.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of gastrointestinal endocrine tumour. * patient able to read and understand the study questionnaires. * patient who has given informed consent in writing to take part in the study. exclusion criteria: * patient who is taking part in another clinical study during the study. * patients with another serious malignancy. * patients unable to meet the requirements of the protocol (non-compliant patients or those unfit to answer the questionnaires).
alternative surgical policy for central liver tumors

Conditions: Colorectal Liver Metastases; Hepatocellular Carcinoma

Summary: major hepatectomies have not negligible morbidity and mortality. however, when tumors invade middle hepatic vein (mhv) at caval confluence major surgery is usually recommended. ultrasound-guided hepatectomy might allow conservative approaches. we prospectively check its feasibility in a series of patients carriers of tumors invading the mhv at the caval confluence.

major hepatectomies have not negligible morbidity and mortality. however, when tumors invade middle hepatic vein (mhv) at caval confluence trisectionectomy (ts) is generally performed, and central hepatectomy or mesohepatectomy (mh) (segments 4, 5 and 8), is considered by some authors to be the conservative alternative to the previously cited approach. between these two surgical interventions there is not, up to now, any evidence that one of them should be clearly preferred; anyway both are mojor resections. we previously reported that a surgical approach based on ultrasound-guided hepatectomy might minimize the need for major resection, whose rates of morbidity and mortality are not negligible. this policy could be useful also for disclosing new, more conservative, and better tolerated approaches for tumors invading the mhv at caval confluence in alternative to mh and ts. this study analyses the feasibility, safety and effectiveness of ultrasound-guided resections applied to these patients enrolled prospectively from a cohort of consecutive patients who undergo hepatectomy for tumors.

Eligibility criteria:
inclusion criteria: * patients carriers of hcc or colorectal cancer liver metastases (clm) who have macroscopic signs of vascular invasion (preoperative imaging and/ious) of the mhv close to the hepato-caval confluence (within 4 cm) demanding for that mhv resection. minimum follow-up for patients' inclusion was established at 6-months from surgery. exclusion criteria: * patients carriers of tumors occupying entirely the right paramedian section and the segment 4, for whom at least a mh would have been compulsorily carried out.

Keywords: intraoperative ultrasonography hepatectomy colorectal liver metastases hepatocellular carcinoma contrast enhanced intraoperative ultrasonography.
midodrine, octreotide and albumin: impact on renal function of patients with liver cirrhosis and renal failure

Conditions: Fibrosis; Renal Failure; Hepatorenal Syndrome

Summary: the aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. fifteen patients will be enrolled and followed during 16 weeks. the effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * cirrhosis of the liver defined by clinical, biochemical or histological * functional renal failure with serum creatinine greater than 1.2 mg / dl and less than 2.5 mg / dl. * that, properly informed, give their consent to participate in the study and undergo tests and examinations that entails * women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose exclusion criteria: * pregnant women, nursing mothers, or those who intend to become pregnant during the study period * systolic blood pressure ≥ 150 mmhg and / or diastolic blood pressure ≥ 90 mmhg * previous treatment with transjugular intrahepatic portosystemic shunt (tips) or surgical portosystemic shunts * use of antibiotics in the seven days prior to inclusion in the study except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis) * cardiac or respiratory failure * positive for human immunodeficiency virus * urinary retention * ischemic heart disease or peripheral vascular disease. * narrow angle glaucoma * cerebrovascular occlusions * aortic aneurysm * thyrotoxicosis * pheochromocytoma
efficacy and safety of idelalisib in combination with rituximab in patients with previously untreated chronic lymphocytic leukemia with 17p deletion

Conditions: B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Summary: the primary objective of this study is to evaluate overall response rate (orr) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (cll) with 17p deletion. an increased rate of deaths and serious adverse events (saes) among participants with front-line cll and early-line indolent non-hodgkin lymphoma (inhl) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (dmc) during regular review of 3 gilead phase 3 studies. gilead reviewed the unblinded data and terminated those studies in agreement with the dmc recommendation and in consultation with the us food and drug administration (fda). all front-line studies of idelalisib, including this study, were also terminated.


Eligibility criteria:
key inclusion criteria: * documented diagnosis of b-cell cll, according to international workshop on chronic lymphocytic leukemia 2008 * presence of 17p deletion in cll cells as demonstrated by fluorescence in-situ hybridization (fish) testing * no prior therapy for cll other than corticosteroids for disease complications * cll that warrants treatment * presence of measurable lymphadenopathy * eastern cooperative oncology group (ecog) performance status of ≤ 2 key exclusion criteria: * known histological transformation from cll to an aggressive lymphoma (ie, richter transformation) * known presence of myelodysplastic syndrome * history of a non-cll malignancy except for the following: * the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or * carcinoma in situ of the cervix, or * adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or * asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or * ductal carcinoma in situ (dcis) of the breast treated with lumpectomy alone, or * other adequately treated stage 1 or 2 cancer currently in complete remission * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment * ongoing liver injury * history of noninfectious pneumonitis * ongoing inflammatory bowel disease * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * ongoing immunosuppressive therapy other than corticosteroids * received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment * prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ecg) finding, or laboratory abnormality note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: chronic lymphocytic leukemia cll