Kornimate/medical-research-clean huggingface dataset:
a study of avastin (bevacizumab) plus taxane-based therapy in patients with locally recurrent or metastatic breast cancer.

Conditions: Breast Cancer

Summary: this single arm study will assess the safety and efficacy of a regimen of avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. all patients will receive avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. if taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. the anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * patients, \>=18 years of age; * her-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (her-2 positive patients only if previously treated with herceptin in the adjuvant setting; * candidates for chemotherapy. exclusion criteria: * previous chemotherapy for metastatic or locally recurrent breast cancer; * concomitant hormonal therapy for metastatic or locally recurrent disease; * concomitant herceptin therapy for treatment of metastatic or locally recurrent her-2 positive disease; * previous radiotherapy for treatment of metastatic disease; * evidence of cns metastases.
fetal growth restriction: management using two guidelines - fetal growth antenatal management evaluation

Conditions: Fetal Growth Retardation

Summary: the purpose of this study is to compare the composite neonatal adverse outcomes (cnao) among pregnancies complicated by fetal growth restriction (fgr) managed using the society of maternal-fetal medicine (smfm) versus international society of ultrasound in obstetrics and gynecology (isuog) antepartum ultrasound guidelines, to measure the rate of the individual components of cnao, to record the rate of cesarean delivery during labor, to tabulate the rate of deviation from the management protocol assigned at the time of evaluation, to record neonatal intensive care unit (nicu) admission rates and to measure the rate of the composite maternal adverse outcome (cmao).


Eligibility criteria:
inclusion criteria: * fgr diagnosed during sonographic examinations * estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile exclusion criteria: * multiple gestations with fgr

Keywords: antepartum surveillance
malabsorption as a cause of iron treatment failure in infants

Conditions: Iron Deficiency; Malabsorption

Summary: infants should receive prophylacatic iron supplementation since age 4 months till one year. patients suffering from malabsorption, mainly giardia infestation may develop iron deficiency resistent to further iron treatment. the purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.


Eligibility criteria:
inclusion criteria: * all infants referred to the pediatric hematology unit because lack of response to iron treatment. exclusion criteria: * patients diagnosed with specific malabsorption causes like celiac or cystic fibrosis.

Keywords: iron deficiency malabsorption giardiasis
recent-onset type 1 diabetes trial evaluating efficacy and safety of teplizumab

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with t1d in the previous 6 weeks.. subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

this is a phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-cd3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis). approximately 300 participants will be randomized at a ratio of 2:1 to either the teplizumab group or the placebo group. teplizumab or matching placebo will be administered in two courses 6 months apart. each course of treatment will include daily infusions for 12 days. the total study duration for each participant will be up to 86 weeks. the primary objective is to determine whether two courses of teplizumab administered 6 months apart slows the loss of β cells and preserves β cell function over 18 months (78 weeks) in children and adolescents 8-17 years old who have been diagnosed with t1d in the previous 6 weeks. the secondary objectives are to evaluate improvements in key clinical parameters of diabetes management, to determine the safety and tolerability of teplizumab, and to evaluate the pharmacokinetics (pk) and immunogenicity of teplizumab

Eligibility criteria:
inclusion criteria: 1. is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration. 2. has received a diagnosis of type 1 diabetes (t1d) according to the criteria from the american diabetes association. 3. is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal t1d diagnosis. 4. has a peak stimulated c-peptide of ≥0.2 pmol/ml from a mixed meal tolerance test (mmtt) at screening. 5. has a positive result on testing for t1d-related autoantibodies. exclusion criteria: 1. has any autoimmune disease other than t1d with the exception of stable thyroid or celiac disease. 2. has an active infection and/or fever. 3. has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv). 4. an individual who has a medical, psychological or social condition that, in the opinion of the principal investigator, would interfere with safe and proper completion of the trial.

Keywords: t1d, type 1 diabetes, recent-onset t1d
dose escalation study in acute myeloid or b-cell acute lymphoblastic leukemia

Conditions: Relapsed or Refractory Acute Myeloid Leukemia; Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Summary: the main purpose of this study is to test the safety and efficacy of vs-4718 in two types of leukemia patients and to find the right dose of vs-4718 for future clinical trials. other purposes of this study include: * testing for study drug vs-4718 levels in blood over time and what happens to the study drug in patients. * to find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * pathologic confirmation of aml or b-all * must have relapsed or refractory aml or b-all with no alternate therapy of proven benefit * ecog status of 0 or 1 * adequate renal function \[creatinine less than or equal to 1.5x uln\] or gfr of at least 60ml/min * adequate hepatic function via total bilirubin, ast, and alt * corrected qt interval of less than 470 ms (via fridericia correction formula) * negative pregnancy test for women of child bearing potential * willingness to use adequate birth control throughout participation for both men and women exclusion criteria: * diagnosis of acute promyelocytic leukemia * active grade 2 or higher acute gvhd at time of study entry or active chronic gvhd (moderate or severe) * gastrointestinal conditions which could interfere with the swallowing or absorption of study medication * diagnosis of currently active cns leukemia * known infection with hiv or aids (testing not required) * known active hepatitis a, b or c (testing not required) * patients being actively treated for a secondary malignancy * cancer-directed therapy within 14 days of the first dose of study drug or 5 half-lives, whichever is longer * major surgery within 28 days prior to the first dose of study drug * use of an investigational drug within 28 days or 5 half-lives whichever is longer * women who are pregnant or breastfeeding * evidence of uncontrolled infections requiring antibiotic therapy; potential subjects with known or suspected infections on stable antibiotic therapy for 72 hours may be enrolled * uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: leukemia acute leukemia relapsed leukemia refractory leukemia acute myeloid leukemia b-cell acute lymphoblastic leukemia
a study of ixekizumab (ly2439821) in chinese participants with radiographic axial spondyloarthritis

Conditions: Spondyloarthritis

Summary: the main purpose of this study is to evaluate the efficacy and safety of ixekizumab in chinese participants with radiographic axial spondyloarthritis (r-axspa).


Eligibility criteria:
inclusion criteria: * have an established diagnosis of radiographic axial spondyloarthritis (r-xspa) with sacroiliitis defined radiographically according to the modified new york criteria. * participants have a history of back pain ≥3 months with age at onset \<45 years. * biologic naïve or have had prior treatment with 1 tumor necrosis factor (tnf) inhibitor. * must have had an inadequate response to 2 or more nsaids at the therapeutic dose range for a total duration of at least 4 weeks or have a history of intolerance to nsaids. * have a history of prior therapy for axspa for at least 12 weeks prior to screening. exclusion criteria: * have total ankylosis of the spine. * have recently received a live vaccine within 12 weeks or have had a vaccination with bacillus calmette-guerin (bcg) within the past year. * have an ongoing or serious infection within the last 12 weeks. * have a compromised immune system. * have any other serious and/or uncontrolled diseases. * have either a current diagnosis or a recent history of malignant disease. * have had major surgery within 8 weeks of baseline, or will require surgery during the study. * are pregnant or breastfeeding.

Keywords: ankylosing spondylitis
memantine treatment for improving rehabilitation outcomes and preventing depression in older adults

Conditions: Depression

Summary: this study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

depression is a serious medical illness that is often difficult to diagnose and treat. it occurs in people of all ages, but is often overlooked in older adults. depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. however, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. in turn, depression may hinder a patient's recovery from an illness. this study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition. this double-blind study will last for 12 months. participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat alzheimer's disease. both memantine and placebo will be administered to participants for 12 weeks. all participants will be followed for an additional 40 weeks. outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. in addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. all measurements will be taken at week 12 and month 12.

Eligibility criteria:
inclusion criteria: * admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture) * medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure) exclusion criteria: * aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the mini mental state examination) * current major depressive episode * history of or current psychosis or mania * current substance or alcohol abuse or dependence (within 3 months of study entry) * current use of memantine * sensitivity or contraindication to memantine * end-stage kidney, liver, heart, or lung disease * recent hemorrhagic stroke * a fim score of greater than 70 (on a 91 point scale)

Keywords: major depressive disorder rehabilitating elderly apathy
arm motor control on bi and uni adls

Conditions: Stroke; Peripheral Neuropathy; Spinal Cord Injuries; Cerebral Palsy

Summary: this study is being performed to assess how certain chronic disabilities - stroke, upper extremity (ue) amputation, spinal cord injuries (sci), cerebral palsy (cp) - differ from healthy subjects in their ability to perform adls. by studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (adls), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect adls in patients with differing long-term disabilities.

cross-sectional study comparing bilateral adl activities for stroke survivors, sci paraplegics, ue amputees, adults with cp, and healthy controls. the study participants will perform 4 adl tasks with the bias passive robots. from these tasks, the bias robots will provide information regarding position, velocity, distance, displacement, etc. this, along with video information provided by the 3d kinect and eeg neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on adl tasks. participation in the study will include the following steps: 1. informed consent: after arrival, subjects will review and sign the consent form with study personnel present. 2. pre-assessments: a member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. subjects will be evaluated using a battery of assessments such as, but not limited to, the box and block, pin and prick, and grip strength using a dynamometer. 3. break: subjects will be given a 15 minute break. 4. bias passive robot system: subjects will be introduced to the device and each wrist will be placed on to the end of each robot. as common therapy tasks are performed by the subject, the bias devices will collect the data along with the video from 3d kinect, ecg gelled electrodes, and the eeg neuroheadset. after each of the 4 adl activities, subjects will be asked about their level of exercise and discomfort, if any. after subjects finish all exercises with the bias, they will be thanked for their participation in the study. 5. video and photos may be collected to determine subject quality of adl movement.

Eligibility criteria:
inclusion criteria: study will include subjects 18 years of age or older from any of the below groups: * stroke survivors, 3 months post event * upper extremity amputees, 3 months post event * cervical sci (c-5 to c-7), 3 months post event * cerebral palsy participants * healthy participants exclusion criteria: * the inability to perform at least some aspects of adl tasks such as drinking, pouring, pinching, and grasping. * severe spasticity

Keywords: stroke amputees spinal cord injuries cerebral palsy robotics rehabilitation
nutritional management of children with chronic diarrhea

Conditions: Growth and Tolerance Infant Study

Summary: the study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.


Eligibility criteria:
inclusion criteria: * less than or equal to 9 months of age at enrollment * candidates for an elemental formula * chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, hiv-advanced disease or other underlying gi disease with chronic diarrhea controlled by a semi-elemental or elemental formula * parents agree to feed infant with experimental formula for least 50% of total calories during study period exclusion criteria: - any non-approved concomitant study
cohorte nationale vih-2

Conditions: HIV-2 Infection

Summary: the hiv2 study is an open cohort of prospective, multicentric, national observation. the main objective is to study hiv-2 infection in adult patients followed in france.

the secondary objectives are : * describe the epidemiological and clinical characteristics of participants infected with hiv-2, and the immuno-virological characteristics of the infection. * to study the clinical and immunological progression of hiv-2 infection and the prognostic factors of this evolution. * study the response to antiretroviral treatment (clinical, immuno-virological) and contribute to the identification of the antiretroviral strategies and combinations most suited to the particularities of the infection. * allow an evaluation of the care practices of participants followed in french hospitals * provide a bank of clinical-biological data and samples allowing the performance of virological and / or immunological studies on hiv-2 infection. the follow-up of the participants is different according to the therapeutic status of the participants, naive of antiretroviral treatment or already treated with antiretrovirals.

Eligibility criteria:
inclusion criteria: * hiv-2 infection only, diagnosed by elisa, confirmed by western-blot test, * follow-up in consultation or hospitalization in one of the investigating centers, * age greater than or equal to 18 years, * prolonged follow-up possible, residence in france planned for at least one year, * consent to participate, * long-term medical care possible for the participant, or by medical aid (ame), or declaration of obtaining ame at the time of inclusion. exclusion criteria: * hiv-1 infection * double hiv-1 + hiv-2 seropositivity

Keywords: virus hiv cohort
spatax: clinical and genetic analysis of cerebellar ataxias and spastic paraplegias

Conditions: Cerebellar Ataxias; Spastic Paraplegias

Summary: cerebellar ataxias (ca) and spastic paraplegias (sp) are genetically and clinically very heterogeneous. more than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. these progressive disorders are often severe and fatal, due to the absence of specific therapy. the spatax network combines the experience of european clinicians and scientists working on these groups of diseases. over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of dna to participating laboratories, mapping of three new loci, and refinement of several loci). in addition to clinicians from europe and mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the spatax members, the group includes major european laboratories devoted to the elucidation of the molecular basis of these disorders. each laboratory will centralize all families with a subtype of autosomal recessive (ar) ca (n=116) or sp (n=207) in order to efficiently map and identify the responsible gene(s). genome-wide scans are already underway in 61 families. given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. the spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. the knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. in the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. the series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.


Eligibility criteria:
inclusion criteria: * progressive ataxia or paraplegia exclusion criteria: * lack of signed informed consent

Keywords: cerebellar ataxias spastic paraplegias mutations spectrum linkage studies genetic counselling
the efficacy of spsipb on postoperative pain in patients undergoing shoulder surgery

Conditions: Post Operative Pain

Summary: aim is to assess the postoperative analgesic efficacy of spsipb and its effect on opioid consumption in patients undergoing shoulder surgery.

there were three randomized groups: group 1 (no block-control group, n=12) group 2 (spsipb-2nd rib targetted, n=12), group 3 (spsipb-3rd rib targetted, n=12). all patients had standard general anesthesia. group 2 and group 3 had serratus posterior superior intercostal plane block (spsipb) with 0.25% bupivacaine (total volume of 30 ml) before the surgery. local anesthetic was injected between 2nd rib an serratus posterior superior muscle in group 2 and it was injected between 3rd rib and same muscle in group 3. all patients had 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. all patients had ibuprofen 3x400 mg in postoperative 24 hours. numerical rating scale (nrs) was used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol was administered as a rescue analgesic in all patients.total tramadol consumption was calculated.

Eligibility criteria:
inclusion criteria: * adult patients older than 18 years of age who underwent open or arthroscopic shoulder surgery under general anesthesia and were american society of anesthesiologists (asa) i-ii-iii according to the asa risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: serratus posterior superior intercostal plane block postoperative pain shoulder surgery regional anesthesia