Kornimate/medical-research-clean huggingface dataset:
dynamic aspects of internal pre-activation of effects sensors of voluntary action in parkinson's disease

Conditions: Parkinson's Disease

Summary: the ability to predict sensory effects of people's own motor actions is a key component of human action realization. recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the parkinson's disease, remains unclear. the current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with parkinson's disease and in matched control participants. indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * adults age 18 years and older * parkinson's disease exclusion criteria: * other pathology or neurological or psychiatric history * known pregnancy or breastfeeding * absence of affiliation to social security or universal health coverage (cmu) * person under legal protection * patient's opposition to participate

Keywords: parkinson's disease voluntary action action-effect preactivation action-effect prediction
efficacy and safety study of canagliflozin (ta-7284) in combination with insulin in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of canagliflozin (ta-7284) in combination with insulin in patients with type 2 diabetes for 16 weeks administration.

this is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of canagliflozin (ta-7284) in japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. the patients will receive either ta-7284 100mg or placebo orally for 16 weeks.

Eligibility criteria:
inclusion criteria: * patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational dug * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients with hba1c of ≥7.5% and \<10.5% * patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug exclusion criteria: * patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (cushing's syndrome, acromegaly, etc.) * patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) * patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * patients with systolic blood pressure of ≥160 mmhg or diastolic blood pressure of ≥100 mmhg * patients with serious renal or hepatic disease * patients with egfr of \<45 ml/min/1.73 m2 * patients who are the excessive alcohol addicts * patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Keywords: insulin resistance
the role of platelet rich plasma injections in cases of stress incontinence

Conditions: Stress Urinary Incontinence; Urinary Incontinence

Summary: urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation stress urinary incontinence (sui) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). it is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall. current sui treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation. stress urinary incontinence (sui) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). it is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall. current sui treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure. the mid-urethral sling (mus) has become the preferred procedure, as it is less invasive than the burch colposuspension. however, the mus procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion. hence, there is a need for alternative efficacious, outpatient sui treatments. platelet-derived therapies are a growing trend across multiple medical and surgical specialties. evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines. these biologically active proteins include transforming growth factor-β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin-like growth factor, vascular endothelial growth factor. these growth factors are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation. the key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing. one of the most well-described platelet-based therapies is autologous platelet-rich plasma (prp). prp is derived from the centrifugation of whole blood with a separator gel to remove the red and white blood cells. the resulting supernatant has a greater than four-fold increase in platelets and other plasma proteins. this concentrate is then administered via injection.

Eligibility criteria:
inclusion criteria: * female patient with mild to moderate sui exclusion criteria: * under anti-platelet agent treatment * platelet dysfunction syndrome * critical thrombocytopenia * acute and chronic infections * anti-coagulation therapy * history of malignancy
impact of oocytes with clcg on icsi outcomes and their potential relation to pesticide exposure

Conditions: Pesticide Poisoning

Summary: oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. centrally located cytoplasm granulation (clcg) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased icsi outcomes. this retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (icsi) program between 2009 and 2011. the participants lived in the picardy region of france and had been exposed to pesticides. the participants were divided in two groups based on prevalence of oocytes with clcg (lclcg \[n= 83\]: low prevalence of oocytes with clcg under 25%. hclcg \[ n= 68\]: high prevalence of clcg over 75%). the embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values.

oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. centrally located cytoplasm granulation (clcg) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased icsi outcomes. this retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (icsi) program between 2009 and 2011. the participants lived in the picardy region of france and had been exposed to pesticides. the participants were divided in two groups based on prevalence of oocytes with clcg (lclcg \[n= 83\]: low prevalence of oocytes with clcg under 25%. hclcg \[ n= 68\]: high prevalence of clcg over 75%). the embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values. the included population in the investigator's retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an icsi program between 2009 and 2011.

Eligibility criteria:
inclusion criteria: * couples who attendes a reproductive medical center * couples that were part of a icsi program between 2009 and 2011 * women were normo-responders * female \> 18 years \<35 yeas old exclusion criteria: * female \ 35 yeas old * couple with severe male infertility factors on oocyte activation and subsequent embryo development

Keywords: oocyte ovarian stimulation dysmorphic cytoplasm
a study to evaluate the safety and therapeutic effects of transplantation of mnv-bm-bld in pediatric patients with pearson syndrome

Conditions: Mitochondrial Diseases; Pearson Syndrome

Summary: mitochondrial diseases are a genetically heterogeneous group of disorders caused by mutations or deletions in mitochondrial dna (mtdna) displaying a wide range of severity and phenotypes. these diseases may be inherited from the mother (mitochondrial inheritance) or non-inherited. the latter are ultra-rare pediatric diseases caused by a mutation or deletion of mtdna, which develop into a systemic multi organ disease and eventually death. mnv-bm-bld is a therapeutic process for enrichment of patient's peripheral hematopoietic stem cells with normal and healthy mitochondria derived from donor blood cells. the process, called mitochondria augmentation therapy, aims to reduce the symptoms of mitochondrial diseases.


Eligibility criteria:
inclusion criteria 1. patient diagnosed with pearson syndrome, as verified by molecular identification of a defect in the mitochondrial dna. 2. normal maternal mitochondria as verified by mtdna sequencing. 3. males and females between 3 years or older and up to 18th birthday. 4. patient is transfusion independent. 5. patient has at least one of the following systematic involvements: 1. high baseline lactate levels 2. episodes of metabolic crisis in the last year before pre-screening 3. renal failure (not dependent on dialysis) or evidence of proximal tubulopathy 4. growth retardation or failure to thrive exclusion criteria 1. absence of detectable mitochondria mutation or deletion. 2. patient or patient's mother have a positive test for microbiologic 3. patient is unable to undergo leukapheresis. 4. patient suffers from chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the ability to interpret the study results. 5. patient has been treated previously with any cell or gene therapy. 6. patient has participated in another clinical treatment trial or received other experimental medications outside of a clinical trial within 1 month prior to start of this study.

Keywords: autologous stem cell transplantation mitochondrial diseases pearson syndrome rare diseases
swim up and gradient methods used in assisted reproduction techniques on dna fragmentation of spermatozoa

Conditions: Male Infertility; Unexplained Infertility

Summary: sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. most commonly used sperm preparation methods are the swim up and the density gradient. recent studies shows that the dna integrity status of the spermatozoa is related to the success in assisted reproduction techniques. sperm preparation methods may theoretically cause damage to sperm dna. therefore it is important to select the optimum method of sperm preparation causing least sperm dna damage. aim of our study is to investigate and compare the effect two different sperm preparation techniques on dna fragmentation.


Eligibility criteria:
inclusion criteria: male factor subfertile group: couples of having at least two abnormal sperm analysis according to who criteria. unexplained subfertile group: couples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy. no previous ivf or iui attempts before the study exclusion criteria: severe oligospermia (sperm count \< 5 millions/ per ml) systemic diseases or therapies influencing dna integrity for male partner

Keywords: spermatozoa dna fragmentation swim-up density gradient
the role of pro-angiogenic immune cells in human pregnancies

Conditions: Fetal Growth Retardation; Preeclampsia

Summary: identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.


Eligibility criteria:
inclusion criteria: * placentas that have been delivered in the medical center exclusion criteria: * none
using mobile technology to reduce stereotypy

Conditions: Child Development Disorders, Pervasive

Summary: nearly all children with autism spectrum disorders engage in non-functional repetitive vocal and motor behaviours commonly referred to as stereotypy. these repetitive behaviours may considerably interfere with the child's daily functioning, learning, and social inclusion. as such, stereotypy generally has a negative impact on the child and family's health and quality of life. several behavioural interventions have been developed to reduce engagement in stereotypy in children with autism spectrum disorders, but the limited number of specialists available, the long waiting lists associated with public health services in canada, and the high costs of private services have considerably restricted accessibility. one potential solution to the limited availability and high costs of services is using a mobile application to recommend, teach, and monitor interventions designed to reduce engagement in stereotypy. to this end, the purpose of the study is to evaluate the effects of the istim (i.e., individualized stereotypy treatment integrated modules), a mobile application designed to assist parents in reducing stereotypy in children with autism spectrum disorders. specifically, we will assess whether the istim correctly estimates the frequency or duration of stereotypy, offers suggestions consistent with recommended clinical practices, effectively reduces engagement in stereotypy, and is socially acceptable, safe, and easy to use for parents of children with autism spectrum disorders. the results of the study will allow us to determine whether the mobile application may be used to treat this core symptom in children with autism spectrum disorders, which could potentially reduce waiting times and costs of providing health services to this population. by reducing engagement in stereotypy, the istim may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism spectrum disorders * must engage in at least one form of stereotypy exclusion criteria: * stereotypy occurs less than 12 times per hour (or less than 20% of time) * the form of stereotypy is potentially dangerous for the person (e.g., head banging, self-biting) * the form of stereotypy is maintained by social consequences (e.g., attention, task avoidance)

Keywords: autism spectrum disorders stereotypy repetitive behavior
pharmo institute seroquel safety study

Conditions: Schizophrenia; Major Depressive Disorder; Bipolar Disorder; Generalized Anxiety Disorder

Summary: the purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. the outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. this retrospective cohort study is based on population-based record linkage system (pharmo rls) capturing about 2.5 millions residents in the netherlands.


Eligibility criteria:
inclusion criteria: * episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics. exclusion criteria: * less than a year of recorded history before the cohort entry date * use of multiple antipsychotics concomitantly * duration and dose of the antipsychotic drug cannot be determined

Keywords: atypical antipsychotics quetiapine
confocal microscopy evaluation of margin clearance in basal cell carcinomas in mohs surgery

Conditions: Basal Cell Carcinoma

Summary: this study is comparing the accuracy and speed of the vivascope 2500 ex-vivo fluorescent confocal microscope with frozen section mohs histology in evaluating clear margins in basal cell carcinoma in mohs surgery.

patients with basal cell carcinomas in the head and neck area, being considered for mohs surgery with frozen sections will be invited to participate in this trial by the investigators when they attend for their pre-surgical consultation. they will be given sufficient time to review the information sheet and ask questions. when they attend for their mohs surgery, they will be recruited if they wish to participate in this trial, at which point, the investigator, or an authorized member of their team, will obtain written informed consent for patients. the patient will then undergo mohs surgery. the processing and interpretation with frozen sections will be conducted in the same way, the only difference being immediately after the bcc is excised with a mohs bevelled edge (45o incision), the tissue is immersed in acridine orange (nuclear dna stain) and placed upside down with the deep margin of the tissue face up. with a glass slide placed on top, we would place the fcm (vivascope 2500) over this, scan the tissue and obtain mosaic images of the tissue which would be stitched together. the penetration of the fcm scan is approximately 0.25mm. this is approximately the distance between 2-3 mohs wafers. the investigators would usually consider a margin of 3 mohs wafers (300 microns) clear. when the scanning is completed (5 minutes), the mohs layer would be sent for frozen section (stained with haematoxylin and eosin) for confirmation in the usual way. the mohs surgeon can interpret the fcm mosaic images later. acridine orange does not interfere with frozen sections or paraffin histopathological quality. no medicines will be used in this study. the information is collected on only 1 patient visit. there is no follow up period. the main objectives would (1) compare the accuracy in detection of bcc margins with fcm compared with fsm and (2) evaluate the time taken for processing and interpretation of fcm (acridine orange inking and rinsing, image acquisition and mosaic stitching, and image interpretation) compared with the time taken for processing and interpretation of fsm (sample flattening, freezing and cutting with the cryostat, h\&e staining, slide cover slipping and slide interpretation).

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. patient with basal cell carcinoma on the head and neck undergoing mohs surgery with frozen sections 3. patient willing and able to give informed consent 4. patient treated not previously or currently treated with a hedgehog inhibitor medication (vismodegib) 5. patient suitable for mohs surgery 6. excised lesion suitable for scanning with fcm as determined by investigator - exclusion criteria: -

Keywords: basal cell carcinoma mohs surgery vivascope 2500 ex-vivo fluorescent confocal microscope frozen section mohs histology
molecular studies on hereditary haemorrhagic telangiectasia families

Conditions: Telangiectasia, Hereditary Hemorrhagic

Summary: this study will examine genes involved in the vascular dysplasia hereditary haemorrhagic telangiectasia i(hht)

hereditary haemorrhagic telangiectasia (hht) is a condition inherited as an autosomal dominant trait. sequencing dna from affected and unaffected family members allows us to identify disease-causal genes. sequencing these genes allows us to identify what the precise dna variants are which are causing disease, particularly if linked to functional assays in separate studies.

Eligibility criteria:
inclusion criteria: * member of family affected by hht exclusion criteria: * unable or unwilling to provide informed consent for dna sample
capecitabine in women with operable breast cancer

Conditions: Invasive Breast Carcinoma; Primary Invasive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Summary: the purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.

* prior to the start of treatment, patients will have a small metal clip inserted into the tumor bed to identify the tumor site to the surgeon. at that time, a needle biopsy of the breast tumor or a sentinel (underarm) lymph node biopsy will also be performed. * patients will take capecitabine orally twice daily for 14 days. this treatment will repeat every 21 days (1 cycle). patients will receive 4 cycles of this treatment. * a physical exam and blood work will be done every three weeks after starting therapy to monitor side effects. * after two weeks of capecitabine a biopsy from the tumor will be done to generate information about the characteristics of the tumor that may respond to capecitabine. * after completing 4 cycles (12 weeks) of capecitabine, patients will then undergo surgery to remove any remaining breast cancer (lumpectomy or mastectomy). post-surgical treatment (radiation, chemotherapy, and hormonal therapy) is at the discretion of the patients physician.

Eligibility criteria:
inclusion criteria: * histological confirmation of primary invasive breast cancer * stage i-iii operable breast cancer. * primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation * women greater than 18 years of age * ecog performance status 0-1 * wbc \> 4000/mm3 * platelet count \> 100,000/mm3 * sgot \< 2x uln * calculated creatinine clearance \> 50ml/min exclusion criteria: * evidence of metastatic (stage iv) cancer on physical exam or any diagnostic study. * pregnant or breast-feeding women * inflammatory breast cancer * her2 positive disease * history of hypersensitivity to a 5-fu or known dihydropyrimidine dehydrogenase (dpd) deficiency * uncontrolled intercurrent illness * prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant. * excisional biopsy performed prior to enrollment * uncontrolled coagulopathy * lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

Keywords: invasive breast cancer operable breast cancer capecitabine