Kornimate/medical-research-clean huggingface dataset:
effects of eszopiclone on sleep-dependent learning in schizophrenia

Conditions: Schizophrenia

Summary: this study will determine whether eszopiclone will normalize sleep patterns and restore sleep-dependent enhancement of motor skill learning in patients with schizophrenia. the investigators will compare subjects taking a placebo to those taking 3 mg of eszopiclone with regard to: sleep architecture and sleep latency as measured by actigraphy and polysomnography and sleep-dependent motor skill learning.


Eligibility criteria:
inclusion criteria: * clinically stable outpatients with dsm-iv diagnoses of schizophrenia exclusion criteria: * history of neurologic or psychiatric disease other than schizophrenia * substance abuse or dependence within the past six months * other chronic medical conditions that affect sleep * pregnancy/breast feeding * hepatic impairment * treatment with metabolic inhibitors or inducers

Keywords: sleep schizophrenia procedural learning motor skill
evaluation of changes in the immunological microenvironment surrounding subcutaneous breast cancer metastases after liquid nitrogen cryotherapy

Conditions: Breast Cancer

Summary: cryotherapy is a cold ablation technique used in many tumor locations. the destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. studies describe complex responses with elevated levels of activating nk cells, circulating and anti-tumor t cells, and pro-inflammatory and nf-kb dependent cytokines. in breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells the university hospital of nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with argon. this technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. the aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy. the study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. a better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent * the patient must be a member or beneficiary of a health insurance plan * patient with metastatic breast cancer with painful subcutaneous metastases. * patient eligible for cryotherapy. * therapeutic decision of antalgic and palliative treatment by cryotherapy taken in pluridisciplinary consultation meeting. * patient available for 15-day follow-up. exclusion criteria: * the subject is in a period of exclusion determined by a previous study * the subject us unable to express their consent or refuses to sign the consent form * the patient is under safeguard of justice or state guardianship

Keywords: cryotherapy cytotoxicity
mobility and attention capacity in former premature children

Conditions: Attention Concentration Difficulty; Mobility Limitation

Summary: attention functions have a major impact on children's social and school behavior. they are an important issue for prematurely born children often seen as having learning difficulties and being restless, when it could be an adaptative answer to attention disorders. the aim of this study is to evaluate attention capacity in former premature children aged 6-7 years old with regards to different postures or mobility, for the attention functions of orienting, alerting and executive control. the attention network test using reaction time and accuracy to visual stimuli will be used to evaluate attention functions in each posture and mobility.

attention functions have a major impact on children's social, school and emotional adjustment. they are one of the most common issues for prematurely born children with implications in academic and social-behavioral functioning. prematurely born infants are often seen as having excessive mobility or being restless when it could be an adaptative answer to attention disorders leading to learning difficulties. respecting spontaneous mobility could improve attention performance in vulnerable children. the aim of the study is to evaluate global attention performance of former premature children at the preschool age of 6 to 7 years. this evaluation will be done in three usual postures or mobility, and for the 3 attentional functions of orienting, alerting or executive control. they will be compared within the prematurely born children group and to term born controls of the same age. the attention network test adapted to children by rueda et al (neuropsychologia 2004) using reaction time and accuracy to visual stimuli will be used to evaluate attention functions. presentation of stimuli through virtual video glasses and collection of answers will be done thanks to a specific software.

Eligibility criteria:
main inclusion criteria: * children born before 35 weeks gestation and routinely followed for their prematurity in the follow-up clinic of the maternite regionale universitaire healthy term born children recruited after information leaflet displayed in the university but not the hospital main exclusion criteria: * children with a visual or motor disability preventing the realization of the test

Keywords: prematurely born children attention function posture mobility
promotion of weight management

Conditions: Overweight

Summary: the identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.

the research will examine the impact of intermittent fasting to promote long term body weight maintenance following successful weight loss in overweight and obese veterans. this research is especially relevant to the majority of veterans who struggle with obesity and maintaining weight loss. obesity increases the risk for storing excess calories in ectopic depots, including skeletal muscle. intramuscular fat is related to altered substrate utilization (metabolic inflexibility) and defects in insulin sensitivity, ultimately leading to type 2 diabetes mellitus and cardiovascular disease. the objective of this proposal is to test in a randomized clinical trial the effectiveness of an intensive weight management program with and without intermittent fasting (if) to combat weight regain and the obesity crisis in our veterans. further, this application proposes to examine the role of several enzymes involved in skeletal muscle fatty acid oxidation as a mechanism for efficacious long term weight management.

Eligibility criteria:
inclusion criteria: * veteran * 50-75 years of age * bmi: 25-40 kg/m2 * postmenopausal status for women exclusion criteria: * uncontrolled diabetes (hba1c \>10% or the current use of insulin) * neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments * active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease * weight change within the past month of \>5 kg * self-reported alcohol or drug abuse * anti-coagulant medication for muscle biopsies only impaired renal function (creatinine \> 1.5 mg/dl) history or evidence of serious liver disease (lfts \> 2.5 x wnl)

Keywords: exercise diet obesity
pelvic inflammatory disease in covid-19 era

Conditions: Pelvic Inflammatory Disease

Summary: the goal of this retrospective cohort study is to to scrutinize the impact of coronavirus disease 2019 (covid-19) on incidence, demography and patient characteristics in pelvic inflammatory disease comparing with the equal time duration, before and after lockdown was initiated in the country. the main aim of this study was to compare the demographic and clinical parameters between two cohorts before the onset of lockdown and within the pandemic.


Eligibility criteria:
inclusion criteria: pelvic inflammatory disease exclusion criteria: pregnancy oncologic disease
sensory integration for infants with cortical visual impairment

Conditions: Sensory Integration Disorder

Summary: our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .

cortical vision impairment (cvi) and cerebral palsy (cp) lead to decrement in sensory and motor functions of infants. the current study examined the effectiveness of sensory integration interventions on sensory, motor, and oculomotor skills in infants with cortical vision impairment. thirty-four infants with cvi and cp aged 12-18 months were enrolled to the study. the infants were randomly divided into 2 groups as the control and intervention groups. the intervention group took sensory integration intervention 2 days a week for 8 weeks in addition to conventional physiotherapy two days a week for eight weeks. the control group only received the conventional physiotherapy program 2 days a week for 8 weeks. the duration of the treatment sessions were 45 minutes for both interventions. before and after the intervention, sensory processing functions were evaluated with the test of sensory functions in infants (tsfi) and motor functions were evaluated with the alberta infant motor scale (aims).

Eligibility criteria:
inclusion criteria * cerepral palsy * cortical visual impairment * 12-18 months exclusion criteria * not participating in treatment regularly

Keywords: cerebral palsy cortical visual impairment sensory integration motor function early intervention.
real life study in myopic neovascularization

Conditions: Myopic Choroidal Neovascularisation

Summary: this is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. the patients will be treated with intravitreal injections of aflibercept following a real life protocol. this sudy aims to evaluate the visual acuity during a 36 months period of time.


Eligibility criteria:
inclusion criteria: * man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices). * high myopy defined by refractive error ≤ -6 d or history of high myopia among pseudophakic patient or patient treated with refractive surgery * patient with active cnvm * • patients naïve or patients pretreated with previous history of laser photocoagulation or pdt or by other anti-vegf treatments who did not receive injection since the last 3 month * with oct or angiography examination exclusion criteria: * treatment with an anti vegf administrated by intravitreal injection within 1 months prior to baseline in the study eye. * treatment with pdt or laser administrated within 6 months prior to baseline in the study eye. * history of vitrectomy in the study eye * history of any other retinal disease * va less than 20/250
curcumin in treating patients with familial adenomatous polyposis

Conditions: Familial Adenomatous Polyposis

Summary: this randomized phase ii trial studies curcumin in treating patients with familial adenomatous polyposis. curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

specific aims: i. to determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery. ii. to measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (odc), polyamines, mucosal deoxyribonucleic acid (dna) methylation, proliferative index (ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa b (nfkb), and v-akt murine thymoma viral oncogene homolog 1 (akt) survival pathways. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive curcumin orally (po) twice daily (bid) for 12 months. arm ii: patients receive placebo po bid for 12 months. after completion of study treatment, patients are followed up at 4 months.

Eligibility criteria:
inclusion criteria: * patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir * patients with familial adenomatous polyposis (fap) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy exclusion criteria: * female patients of childbearing age not on effective birth control * pregnant women * white blood cell count (wbc) \< 3500/ml * platelet count \< 100,000/ml * blood urea nitrogen (bun) \> 25mg% * creatinine \> 1.5mg% * patients unable to stop non-steroidal anti-inflammatory drugs (nsaids), aspirin, curcumin, tumeric, calcium, vitamin d, green tea, or polyphenol e supplements for the duration of the trial * malignancy other than nonmelanoma skin cancer * active bacterial infection * patients with symptoms of active gastroesophageal reflux disease (gerd) (symptomatic despite medication or current erosive esophagitis on endoscopy) * patients with a history of peptic ulcer disease * patients on warfarin or plavix
a study to evaluate the efficacy and safety of obinutuzumab in patients with isn/rps 2003 class iii or iv lupus nephritis

Conditions: Lupus Nephritis

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with international society of nephrology/renal pathology society (isn/rps) class iii or iv lupus nephritis (ln) when added on to standard-of-care therapy consisting of mycophenolate mofetil (mmf) and corticosteroids.


Eligibility criteria:
key inclusion criteria: * diagnosis of active or active/chronic isn/rps 2003 class iii or iv proliferative ln as evidenced by renal biopsy performed within 6 months. participants may co-exhibit class v disease in addition to either class iii or class iv disease * urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection * other inclusion criteria may apply key exclusion criteria: * pregnancy or breastfeeding * severe renal impairment or the need for dialysis or renal transplantation * receipt of an excluded therapy, including any anti-cd20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening * significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation * known active infection of any kind or recent major episode of infection * intolerance or contraindication to study therapies * other exclusion criteria may apply
brain blood vessel responses to changes in blood flow

Conditions: Magnetic Resonance Imaging; Cerebrovascular Circulation

Summary: brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

global cerebral blood flow (cbf) decreases with advancing age; however, some adults have accelerated declines in cbf, placing them at a greater risk of cognitive impairment. however, there is a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain. this study will systematically address this gap in knowledge by examining cerebrovascular control in adults during acute physiological challenges (simulated postural change test and breathing increased carbon dioxide) that stimulate a change in cbf.

Eligibility criteria:
inclusion criteria: * between the ages of 55-69 years * have a bmi ≤34.5 kg/m2 * nonsmoker * females must be postmenopausal exclusion criteria: * diagnosis of mild cognitive impairment (mci) or alzheimer's disease (ad) * history or evidence of hepatic disease, hematological disease, or peripheral vascular disease; severe kidney injury requiring hemodialysis * history of cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia * uncontrolled hypertension * history of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease * severe untreated obstructive sleep apnea * history of diabetes with hba1c greater than 9.5% * major neurologic disorders other than dementia (e.g., ms, als, brain surgery, etc.) * current or recent (\&lt;1 year) major psychiatric condition (axis i) or addictive disorders * significant surgical history * other significant medical conditions at investigators' discretion * contraindications to mri * prescribed medications that interfere with prazosin * lactose allergy

Keywords: magnetic resonance imaging brain blood flow lower body negative pressure carbon dioxide
use of topotecan in patients with refractory acute leukemia

Conditions: Non-Hodgkin's Lymphoma; Leukemia

Summary: the purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. the drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

the purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. the drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Eligibility criteria:
inclusion criteria: patients in the following disease categories will be considered eligible for this study: * any acute leukemia beyond an initial attempt to induce a remission or after relapse * chronic myelogenous leukemia in blast phase * refractory multiple myeloma * refractory non-hodgkin's and hodgkin's lymphoma * patients must be more than 14 days beyond prior myelotoxic chemotherapy * several other eligibility criteria apply. exclusion criteria: * none

Keywords: multiple myeloma lymphoma leukemia etoposide drug therapy clinical trials
continuous infusion of fu combined with epirubicin and oxaliplatin in patients with a/mgc

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (eof5 regimen) in patients with unresectable advanced or metastatic gastric cancer (a/mgc). since mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of pet scan evaluation with routine ct scan evaluation, the other was to search for predictor factors of clinical results ( orr,pfs and os) with pharmacogenomics methods. this modification was approved by the ethic committee of fudan university cancer hospital, and the approval number was irb50-15-1101a.

ecf regimen is considered as a reference regimen for gastric cancer in europe. now, no regimen has been proved to be more effective while less toxicity than ecf regimen. oxaliplatin has demonstrated synergy with 5-fu in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. it presents a better toxicity profile than cisplatin. recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-fu for about 44 hours (e.g folfox4 ) to treat a/mgc, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. therefore, it is logical to modify ecf regimen with oxaliplatin replacing cisplatin and a short-term fu infusion replacing 21-day fu infusion. our objective is to evaluate whether the eof5 regimen is less toxicity while is comparable effective as ecf regimen.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ecog performance scale ≤2 * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * adequate hepatic, renal, heart, and hematologic functions (platelets \>80×109/l, neutrophil\>2.0×109/l, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(uln), and serum transaminase≤2.5×the uln) exclusion criteria: * pregnant or lactating women * concurrent cancer * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * neuropathy, brain, or leptomeningeal involvement * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia * uncontrolled significant comorbid conditions and previous radiotherapy

Keywords: time to progression overall survival response rate quality of live toxicities