Kornimate/medical-research-clean huggingface dataset:
study of xaliproden (sr57746a) in patients with mild-to-moderate dementia of the alzheimer's type

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate alzheimer's disease. the patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease using nincds-adrda criteria * mild to moderate degree of severity of dementia as assessed by the mini-mental status examination score of 16 to 26 (inclusive) * potential participant may be treated with conventional alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period * potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility * mother tongue is english, spanish or french (oral and written fluency) * signed informed consent from potential participant or legal representative and identified caregiver exclusion criteria: * potential participant with any other cause of dementia. * potential participant with serious health problems other than alzheimer's disease * use of an investigational drug within two months prior to randomization or during this study
apatinib for inoperable advanced chondrosarcoma

Conditions: Efficacy; Toxicity, Drug

Summary: anti-angiogenesis tyrosine kinase inhibitors (tkis) have been proved to show promising effects on prolonging progression-free survival (pfs) for advanced chondrosarcoma after failure of standard multimodal therapy. methylsulfonic apatinib is one of those tkis which specifically inhibits vegfr-2. this study summarizes the experience of two peking university affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.


Eligibility criteria:
inclusion criteria: * 1) histologically confirmed high-grade sarcoma; * 2) initial treatment in the orthopedic oncology departments of the two affiliated hospitals of peking university; * 3) tumors not amenable to curative treatment or inclusion in clinical trials; * 4) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy; * 5) measurable lesions according to response evaluation criteria for solid tumors (recist1.1) ; * 6) eastern cooperative oncology group performance status 0 or 1; * 7) acceptable hematologic, hepatic, and renal function. exclusion criteria: * had central nervous system metastasis; * had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia; * had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on; * had pleural or peritoneal effusion that needs to be handled by surgical treatment; * combined with other infections or wounds; * pregnant or breastfeeding.

Keywords: chondrosarcoma apatinib inoperable toxicity prognosis
randomized study versus placebo for the prevention of neurotoxicity induced by weekly paclitaxel

Conditions: Breast Cancer

Summary: this study recommends the use of onlife dietary supplement, which will be followed by a few day before the initiation of paclitaxel, for the prevention of paclitaxel induced neuropathy. onlife will be continued one month after stopping chemotherapy. this would limit the number of paclitaxel dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly paclitaxel.

this study recommends the use of onlife dietary supplement which will be followed by a few day before the initiation of paclitaxel for the prevention of paclitaxel induced neuropathy. onlife will be continued one month after stopping chemotherapy. this would limit the number of paclitaxel dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly paclitaxel. two treatment arms : - arm a : 20 patients included in the placebo arm (standard chemotherapy with paclitaxel + placebo dietary supplement) arm b : 40 patients included in the experimental arm (standard paclitaxel chemotherapy + onlife® food supplement)

Eligibility criteria:
inclusion criteria: * breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly paclitaxel 80 mg/m² for 12 courses. * age ≥ 18 years * performans status ≤ 3 according to karnofsky and life expectancy greater than 6 months * for patients of childbearing age, effective contraception while taking onlife®/placebo. * patient able to swallow onlife/placebo® tablets easily * patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol * patient has understood, signed and dated the consent form * patient affiliated to the social security system exclusion criteria: * patient previously started on paclitaxel * known allergy to any of the substances in the study product onlife®/placebo (fish oil product) * diabetes * exogenous (alcoholism) * history of peripheral neuropathy at inclusion and/or presence of sensory and/or motor disorders due to other neurological diseases * pregnant or breastfeeding woman * other uncontrolled progressive pathologies * impossible or random follow-up * persons deprived of liberty or under guardianship (including curatorship) * inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

Keywords: breast neuropathy onlife dietary supplement paclitaxel
trial comparing hcg triggering versus gnrh agonist triggering in pcos patients

Conditions: Infertility; PCOS

Summary: in this study the investigators compare the traditional way of triggering with a new way in patients with poly cystic ovary syndrome (pcos). this to reduce the risque of ovary hyper stimulation syndrome (ohss) in in vitro fertilization/ intracytoplastic sperm injection (ivf/ icsi) treatment. the investigators also compare the number of mature oocytes, embryo's and pregnancy rate.


Eligibility criteria:
inclusion criteria: * icsi patients below 38 years * 1, 2 and 3e ivf cycle * body mass index (bmi) less than 32 * pcos patients exclusion criteria: * endocrinal diseases or problems

Keywords: ohss mataphase ii oocytes (mii) good quality embryo's pregnancy
the impact of botulinum toxin treatment in quality of life of cervical dystonia patients

Conditions: Botulinum Toxin; Quality of Life; Cervical Dystonia

Summary: the purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(qol) in cervical dystonia patients


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years to 75 years * subjects requiring treatment for a clinical diagnosis of cervical dystonia * willing to provide written informed consent before any study-related procedures. exclusion criteria: * patients with pure anterocollis * patients with an anaphlyactic response history to botulinum toxin type a. * patients who have been treated with botulinum toxin type a within 3 month. * females who are pregnant, planning pregnancy, unable to use contraception or lactating. * any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.
a 26-week extension study of evp-6124 (alpha-7 nachr) as an adjunctive pro-cognitive treatment in schizophrenia subjects on chronic stable atypical antipsychotic therapy

Conditions: Schizophrenia; Impaired Cognition

Summary: this study is being conducted to further investigate the safety of prolonged exposure to evp-6124 in subjects with schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies evp-6124-015 and evp-6124-016.


Eligibility criteria:
inclusion criteria: * completion of the day 182 visit in a previous 26-week double-blind study (evp-6124-015 or evp-6124-016). * subject has signed informed consent for this extension study, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any extension study specific procedures. subjects who are unable to provide informed consent will not be included in the study * no clinically significant changes in the subject's medical status during the participation in evp-6124-015 or evp-6124-016. any significant changes in health care status and their impact on subject eligibility will be reviewed by the investigator and sponsor on a case-by-case basis. * in the opinion of the investigator, the extension treatment is in the best interest of the subject. * fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. females and the female partners of male must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 year, willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception \[including at least one barrier method\]). female subjects must have a negative urine pregnancy test predose on day 1. exclusion criteria: * significant risk for suicidal or violent behavior, as determined by the investigator. significant risk for suicidal behavior is defined as 1) suicidal ideation as endorsed on items 4 and 5 of the columbia-suicide severity rating scale (c-ssrs); 2) suicidal behaviors detected by the c-ssrs; or 3) psychiatric interview and examination. * adverse events from the previous study (evp-6124-015 or evp-6124-016) that have not resolved, are of moderate or greater severity and judged to be possibly related or related to study drug and are thought by the investigator to be contraindications to study participation. * any condition which would make the subject, in the opinion of the investigator, unsuitable for the study. * female subjects who are pregnant. * subjects who received any other investigational treatment during participation in either evp-6124-015 or evp-6124-016 other than assigned study medication.

Keywords: schizophrenia cognition cognition impairment alpha-7 nachr
the effect of a phospholipid drink on cognitive performance under acute stress

Conditions: Cognitive Performance (Focus)

Summary: the study will explore the effects of a 6-week phospholipid drink intervention on the cognitive performance and physiological and subjective stress parameters of males following a repeated psychosocial/physical stressor.

the study conforms to a randomised, double-blind, placebo controlled, parallel groups design examining cognitive performance and physiological/subjective stress responses after a psychosocial/physical stressor before and after a six week daily intake of an phospholipid containing drink vs. placebo. the study will examine: cognitive performance following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue. physiological and subjective stress responses following acute stress prior to, and following 6-weeks intake of a phospholipid containing drink or a placebo analogue

Eligibility criteria:
inclusion criteria: * male ≥18 years old * healthy (self-report health questionnaire) * bmi \<30 kg/m² * free from medication (prescribed and 'over-the-counter') exclusion criteria: * current psychological affective/mood disorders * self-reported physical disorder/disease (significant cardiovascular, autoimmune, endocrine, gastrointestinal or neurological conditions, chronic pain, or sleep disorders) * high chronic stress * smokers * recreational drug use (within the last month) * night shift work * hypertension (resting blood pressure exceeding 160/95 mmhg) * skin conditions (e.g. eczema) on hands * food allergies * participation in a clinical study within a month prior to screening or during participation * participation in any of our previous stress induction studies

Keywords: memory attention
follow-up study of transcranial direct current stimulation to treat major depressive disorder

Conditions: Major Depressive Disorder

Summary: the investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tdcs); as to verify whether this treatment prevents relapse.

our first ongoing study (efficacy study of transcranial direct current stimulation (tdcs) to treat major depressive disorder) addresses whether tdcs is an effective treatment for depression treatment. the purpose of the present study is to determine whether tdcs is also an effective strategy for sustaining remission. we will enroll patients who presented remission using tdcs from our previous study and offer them to tdcs every other week for three months, than once a month for another three months. we will address whether tdcs prevents relapse by assessing depression scores once a month, using a time-to-event analysis. the importance of the present study is to determine whether tdcs is able to sustain remission during long-term follow-up of depressed patients.

Eligibility criteria:
inclusion criteria: patients from previous studies (id:usp-hu-001 and id:usp-hu-002) who: * received tdcs and responded. * received tdcs + sertraline and responded. * received sertraline or placebo and did not respond, and thereafter received tdcs during the cross-over phase and responded. exclusion criteria: patients from previous studies who: * received tdcs and did not respond. * received tdcs + sertraline and did not respond. * received sertraline or placebo and responded. * did not respond during the crossover phase. * do not wish to participate in the present study.

Keywords: major depressive disorder follow-up relapse remission transcranial direct current stimulation
analysis of foxp3 and vimentin expression in renal transplant recipient

Conditions: Function of Renal Transplant

Summary: this observational study is designed to analyse the urinary mrna expression of foxp3 and vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in france and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.

this observational study is designed to analyse the urinary mrna expression of foxp3 and vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in france and to determine the predictive value of these gene expression on the one year graft outcome including graft function,

Eligibility criteria:
inclusion criteria: * all renal transplant recipients aged \>18 years with informed consent * kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the agency of biomedicine * supported by a conventional procedure * informed consent signed. * no pregnancy or lactation in progress. * serology hiv and (hcv negative suppressed by amendment n°2) * no contraindication for a biopsy at 1 year post transplant exclusion criteria: * positive crossmatch, focal segmental glomerulosclerosis (fsgs) as primary nephropathy, hiv positive population * absence of registration on the waiting list for transplantation with the agency of biomedicine * hiv-positive serology * chronic renal failure secondary to focal segmental hyalinosis * cross-match historical or cross match of the day positive t or b awareness * patient included in a memorandum of industry (suppressed by amendment n°1) * no affiliation to a social security scheme * patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis

Keywords: tolerance renal transplantation chronic allograft nephropathy
safety and efficacy study of a dual pi3k delta/gamma inhibitor in hematological malignancies

Conditions: Lymphoma, B-Cell; T-Cell Lymphoma

Summary: the objective of this study is to evaluate the safety and efficacy of rp6530, a dual pi3k delta/gamma inhibitor in patients with hematologic malignancies.

the maximum tolerated dose (mtd) will be determined based on the safety, pharmacokinetic (pk) and efficacy data. safety analyses include ae's, ae's related to the drug, sae's, laboratory values, vitals/ ecg and dose limiting toxicity (dlt). pk include measurement of peak plasma concentration (cmax), area under the plasma concentration versus the time curve (auc), time of maximum concentration observed (tmax). efficacy analyses include overall response rate (orr) and duration of response (dor).

Eligibility criteria:
inclusion criteria: * refractory to or relapsed after at least 1 prior treatment line. * ecog performance status ≤2 * patients must be ≥18 years of age * able to give a written informed consent. exclusion criteria: * any cancer therapy in the last 4 weeks or limited palliative radiation \<2 weeks * patients with hbv, hcv or hiv infection * autologous hematologic stem cell transplant within 3 months of study entry. allogeneic hematologic stem cell transplant within 12 months. * previous therapy with gs-1101 (cal-101, idelalisib), ipi-145, tgr-1202 or any drug that specifically inhibits pi3k/ mtor (including temsirolimus, everolimus), akt or btk inhibitor (including ibrutinib). * patients on immunosuppressive therapy including systemic corticosteroids. * patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.). * patients with known history of liver disorders. * patients with uncontrolled diabetes type i or type ii * any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * women who are pregnant or lactating.

Keywords: cll, sll, nhl, sll, ptcl, ctcl, mm, aml
comparative effectiveness trial for diagnosis of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: the overall objective of our study is to determine the clinical usefulness of bus for nec evaluation in diverse nicu settings.

bowel ultrasound (bus) for nec evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. advantages of bus is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. bus is already being used in centers that have sufficient bus expertise as an alternative standard of care approach for evaluating nec, but in a highly variable manner. standard ultrasound equipment is all that is needed for bus. pre-study training will be conducted for sonographers to acquire the study bus images using standardized technique. pre-study training of radiologists will also be conducted to standardize the interpretation of bus findings for nec. all bus for nec ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. all bus performed as part of the study will not be charged to patients.

Eligibility criteria:
inclusion criteria * admitted to the nicu at cmkc or kumc * with clinical suspicion for nec for which further imaging evaluation was decided by treating neonatologist exclusion criteria • infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent bus from being performed
efficacy and safety of probiotics in neonatal hyperbilirubinemia

Conditions: Hyperbilirubinemia, Neonatal

Summary: neonatal jaundice occurs in 60% of term infants and 80% of premature infants. although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. neonatal jaundice can cause neurological complications and kernicterus. considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (nec) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in bandar abbas.


Eligibility criteria:
inclusion criteria: * between 2 and 28 days old * having jaundice * gestational age between 35-42 weeks exclusion criteria: * less than 2 days or more than 28 days old * gestational age out of the range of 35-42 weeks * infants whose parents refused to cooperate * patients with sepsis and other comorbid conditions
trugraf® testing in high-risk kidney transplant recipients

Conditions: Kidney Transplant Rejection

Summary: this is an observational study to evaluate trugraf® testing in high immune risk kidney transplant recipients. trugraf is the first and only non-invasive test approved by medicare to rule out silent rejection in stable kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * high immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (hla) antibody, or a pre-transplant panel reactive antibody \>75%. * recipient of a primary or subsequent deceased-donor or living donor kidney transplantation. * stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels). * kidney transplant patients who are at least 30 days post-transplant. exclusion criteria: * need for combined organ transplantation with an extra-renal organ and/or islet cell transplant. * recipients who do not meet criteria of high-immune risk. * recipients of previous non-renal solid organ and/or islet cell transplantation. * infection with hiv. * infection with bk. * patients that have nephrotic proteinuria (urine protein \>3 gm/day).
outcome of tucidinostat-based therapy in hr+ metastatic breast cancer patients previously treated with cdk4/6 inhibitor

Conditions: Breast Cancer

Summary: to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with cdk4/6 inhibitor therapy in the real world.

cyclin-dependent kinase (cdk) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive her2-negative advanced breast cancer significantly prolongling patients'pfs and os,but there is no optimal therapy after its progression.tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ace trial demonstrated that tucidinostat plus exemestane improved pfs compared with placebo plus exemestane in hr+,mbc patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received cdk4/6 inhibitors.the aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with cdk4/6 inhibitor therapy in the real world.

Eligibility criteria:
inclusion criteria: * 1.woman, age \> 18 years old 2.diagnosed with hr+/her2- metastatic breast cancer 3.patients received tucidinostat-based therapy after progression on cdk4/6 inhibitor 4.complete medical history was available exclusion criteria: * 1.medical history was incomplete