Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of 3 doses of s47445 versus placebo in patients with alzheimer's disease at mild to moderate stages with depressive symptoms

Conditions: Alzheimer's Disease

Summary: the purpose of this trial is to assess the efficacy and safety of s47445 versus placebo in patients with alzheimer's disease at mild to moderate stages with depressive symptoms. an optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of s47445 in co-administration with donepezil.


Eligibility criteria:
inclusion criteria: * out-patients * able to perform neuropsychological tests * have a responsible informant * dsm-iv-tr criteria for dementia of the alzheimer's disease type * mini mental state examination (mmse) = 15-24 both inclusive * national institute of mental health (nimh) provisional criteria for depression in ad (nimh-dad) * cornell scale for depression in dementia total score \> or = 8 * patients who have never been treated with ad treatments or patients who have stopped ad treatment whatever the reason * patients either not currently treated with an antidepressant or patients being treated with an antidepressant at the recommended dose for at least 8 weeks without clinical efficacy, who can stop this treatment according to the investigator's opinion. exclusion criteria: * patients not able to read or write * patients having participated in a study testing disease modifying therapy for ad, or in another study with administration of investigational drug or device within the previous 3 months prior to selection visit * depressive symptoms that, in investigator's judgment, are clearly due to a medical condition other than ad, or are a direct result of non-mood related dementia symptoms * history of epilepsy or solitary seizure * medical history of major depressive disorder more than 3 years before onset of the disease, treated with antidepressive drugs or electroconvulsive therapy * severe or unstable disease of any type that could interfere with safety and efficacy assessments * alcohol abuse or drug abuse or addiction, as judged by the clinician (excluding nicotine) * clinically relevant lactose intolerance * antidepressant treatment not stopped for at least 3 weeks before inclusion * significant worsening of depressive symptoms or high suicidal risk according to investigator's judgment * for optional extension phase: medically instable chronic obstructive pulmonary disease and asthma, known hypersensitivity to donepezil hydrochloride or piperidine derivatives
effects of vitamin d, epigallocatechin gallate, vitamin b6, and d-chiro-inositol combination on uterine fibroids

Conditions: Leiomyoma, Uterine

Summary: randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with epigallocatechin gallate, vitamin d, d-chiro-inositol, and vitamin b6 on symptoms related to uterine fibroids

a randomized controlled trial aimed to evaluate the efficacy of a combination of epigallocatechin gallate, vitamin d3, d-chiro-inositol, and vitamin b6 as a treatment for uterine fibroids. the clinical study is double-blind, neither patients nor investigators know whether the subject receives the combination of epigallocatechin gallate, vitamin d, d-chiro-inositol, and vitamin b6 or the placebo. after 3 months of treatment, changes in symptoms associated with uterine fibroids, quality of life, and ultrasounds characteristics are compared between the two treatment arms.

Eligibility criteria:
inclusion criteria: * women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for hysterectomy. * women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for myomectomy / uterine arterial embolization. * women with multiple fibroids or single fibroma with a diameter ≥ 4 cm who are candidates for treatment with magnetic resonance (mr)-guided focused ultra-sound (mrgfus). exclusion criteria: * pregnancy. * breastfeeding. * smoking. * suspected malignancy. * patients who have undergone medical treatment for uterine fibroids within the previous three months. * patients allergic to the components of the product or placebo under study. * patients who refuse to provide informed consent to participate in the study.

Keywords: leiomyoma, uterine epigallocatechin gallate vitamin d d-chiro-inositol vitamin b6
a study of immune cells in patients with rheumatoid arthritis during different types of anti-tnf alpha treatments (study p05521)

Conditions: Rheumatoid Arthritis

Summary: this 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. patients at the national institute of rheumatology and physiotherapy, budapest, who are already scheduled to receive an anti-tnf agent will be asked to participate in this study. patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. patient's response to their treatment will also be studied based on x-rays and other examinations.

only patients who - regardless of this study - are scheduled and permitted to receive anti-tnf-alpha treatment because of their ra will be asked to participate. no patient will be recruited only for the sake of the study. the prescribing physicians will not be influenced by the study as to what form of anti-tnf-alpha therapy they should select.

Eligibility criteria:
inclusion criteria: * must have active ra (das28 \>5.1) * must have x-ray evidence of an erosive disease, * must be eligible for but have never received any anti-tnf treatment, * must fulfill the 1987 criteria of the american college of rheumatology classification criteria for a diagnosis of ra, for at least 3 months, * must have failed standard therapy (methotrexate or leflunomide). exclusion criteria: * must not be a women who is pregnant or breastfeeding, * must not have a history of any malignancy, * must not have an active infection, * must not be prone to infection, * must not have tuberculosis, hepatitis b, hepatitis c, or hiv, * must not have septic arthritis of a native prosthetic joint within the last 12 months, * must not have nyha grade 3 or 4 heart failure, * must not have a history of demyelinating disease or systemic lupus erythematosis.
cell-free dna in hereditary and high-risk malignancies

Conditions: Hereditary Cancer Syndrome

Summary: the goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (hcs). if this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. the study will also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care, and the perceptions of the medical value of test results.

the objective of this protocol is to develop a method to detect early signs of cancer in 'previvors' (people with hcs that do not yet have a cancer diagnosis). this will enable prediction of cancer onset so that patients and their doctors can make decisions to treat or prevent the cancers. hcs patients will be recruited from across canada to provide blood samples before and after cancer diagnosis. in parallel, there will be development of a circulating tumour dna (ctdna) -based test to detect early stage cancer and evaluation on the cost-effectiveness and feasibility of integrating such screening protocols into routine clinical care. in concert, consultation with patients and health care providers will occur to create recommendations for use within clinical care.

Eligibility criteria:
inclusion criteria: 1. individual with any known or suspected hereditary cancer predisposition (i.e. individuals with an identified pathogenic or likely pathogenic variant in a cancer predisposition gene and/or a family history of cancer without an identified gene mutation) at any stage in their cancer journey (ie: cancer survivor, unaffected with cancer, current cancer patient). 2. individual must be greater than 18 years of age 3. individual must speak english or french to participate in the qualitative interview and/or survey exclusion criteria: 1. individuals that do not meet the outlined inclusion criteria.

Keywords: circulating tumour dna cell-free dna (cfdna) hereditary cancer syndrome cancer brca1 lynch syndrome hereditary breast and ovarian cancer liquid biopsies brca2
evaluation of immersive audiovisual distraction impact on peroperative opioid consumption.

Conditions: Surgical Procedure, Unspecified; Analgesia; Outpatient

Summary: this study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with remifentanil added to local anesthesia. half of patients will receive an audiovisual distraction device while the other half not.

early recovery for patients undergoing surgery is the key factor for an outpatient procedure. the technique of adding remifentanil to a local anesthesia is used in 22% of the procedures realized in the chu de caen outpatient unit. decreasing opioid dose, whose side effects are numerous and widely described, as well as reducing anxiety are daily challenges to ensure comfort and successful care. we propose a prospective, randomized, monocentric, open label study to evaluate the impact of the use of an audiovisual distraction device on the intraoperative consumption of opioids, on the patient's pain and peroperative anxiety. ani (analgesia nociception index) will be used for peroperative overall comfort measurement. we will analyze if audiovisual distraction can integrate existing techniques such as hypnosis. finally, we will also assess the medico-economic impact of this technique in order to establish a benefit / cost ratio.

Eligibility criteria:
inclusion criteria: * adult patient * signed consent * outpatient surgery eligibility * patient covered by social security exclusion criteria: * unsigned consent * study participation refusal * deafness, blindness * claustrophobia * ani contraindication (atrial fibrillation, pace maker, severe autonomic system dysfunction) * contraindication or impossibility to use the audiovisual distraction device

Keywords: audiovisual distraction device peroperative opioid analgesia ambulatory care outpatient analgesia nociception index anxiety remifentanil remifentanil added to local anesthesia
awaits: a web-based e-health application for active illicit opioid users

Conditions: Opioid-use Disorder; IV Drug Usage; Overdose; Drug Addiction; Substance Use Disorders

Summary: the purpose of this research study is to: 1. assess how participants like the awaits e-health application as measured by their feedback on the intervention 2. test the impact of awaits on knowledge about opioid overdose and risk-reduction strategies. 3. assess the proportion of participants who accept a list of local treatment providers 4. test the impact of awaits on interest in being tested for hcv/hiv.

the pre-post study of awaits will: 1) assess the acceptability of awaits as measured by participant feedback about the intervention; 2) test the impact of awaits on knowledge about opioid overdose, as measured by the ootas; 3) assess the proportion of participants who accept a list of local mat treatment providers; and 4) test the impact of awaits on interest in being tested for hcv/hiv. the acceptability of awaits will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. the average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. pre-/post-changes in the percent of correct knowledge assessment items (i.e., about overdose and mat) and interest in hcv/hiv testing will be analyzed using a wilcoxon signed-rank test. the proportion of participants accepting a list of local mat treatment providers will be calculated.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. not enrolled in mat per self-report 3. self-reports illicit opioid use exclusion criteria: 3. does not acknowledge reviewing "information sheet for research" within redcap
surgery for locally advanced colon cancer: is it worth it? a multicenter retrospective analysis.

Conditions: Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4

Summary: the aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (lacc) with the necessity of a multivisceral resection (mvr).

all patients that meet the inclusion criteria will be registered in a retrospective database from 2014 to 2019 (5 years) data will be reported for every patients with colon cancer to have had either a resection of another organ or structure in addition to resection of the primary tumor, or to have had a t4 (a or b) tumour on postoperative histopathology. data included are patient demographics, asa score, tumor localization, preoperative imaging, neoadjuvant treatments, type of bowel resection and adjacent organs resected, tecnique (laparoscopic/laparotomic), postoperative complications and 30-day mortality, histopathology data including tnm scoring, completeness of surgical procedure (r0 to r2) and infiltration of tumor cells in resected tissues, adjuvant oncological treatments, and long term follow-up data on local and distant recurrence and survival.

Eligibility criteria:
inclusion criteria * \> 18 aa * patients with a locally advanced colon cancer (lacc) with the necessity of a multivisceral resection (mvr). exclusion criteria * stage iv * rectal cancer * emergency surgery (\<48 hours from admission) * asa \> iii
nasal mucin oral supplementation treatment respiratory inflammation using pufa in cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis; Dietary Modification

Summary: background : cystic fibrosis (cf) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. long chain polyunsaturated fatty acids have been shown to influence survival and muc5b expression in mice model of chronic pulmonary infection. method : to study the impact of lcpufa n-3 on muc5b expression (mrna level by rt-pcr) collected in airway epithelial cells obtained by nasal brushing. the secondary aim is to assess : muc1, muc2, muc4, muc5ac, muc7 expression (mrna level) in airway epithelial cells obtained by nasal brushing; lund-kennedy score; tnk-alpha, il-6, il-8 in blood plasma. this study is a double parallel, controlled double blind, randomized clinical trial : lcpufa n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment. statistical analysis : treatment group and placebo will be compared using u-mann-whitney, intention to treat and per protocol.

primary outcome measure : mucin muc5b (mrna level) in native airway epithelial cells obtained by nasal brushing secondary outcome measures : mucin muc1, muc2, muc4, muc5ac, muc7 (mrna level) in native airway epithelial cells obtained by nasal brushing. lund-kennedy score tnf-alpha, il-6, il-8 in plasma

Eligibility criteria:
inclusion criteria : * cystic fibrosis patient * aged 18 to 30 year * no modification of long term therapy (corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization exclusion criteria: * awaiting transplantation * patients on anticoagulants * contraindication to supplementation with polyunsaturated fatty acids * taking antibiotics in progress ( less than 15 days) * taking anti- inflammatory ongoing (more than one week per month , steroids , or nonsteroidal )

Keywords: pufa cystic fibrosis nasal brushing mucins mucin production
aidma: a psycho-educational program designed to support and train carers of alzheimer's disease (ad) patients

Conditions: Alzheimer's Disease

Summary: the aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of alzheimer's disease (ad) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. this training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.

context: research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of alzheimer's disease patients is still lacking. we venture the hypothesis that combined treatment including a specific antidementia drug for the ad patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters. main objective: to demonstrate that a psycho-educational programme designed to support and train carers of alzheimer's disease (ad) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters). methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial. evaluation criteria: primary criteria for the patient: dad scale (disability assessment for dementia). secondary evaluation criteria - for the patient: npi and adas-cog; for the caregiver: zarit scale, questionnaire of feeling of competency, montgomery and asberg depression rating scale (madrs), geriatric depression scale (gds). statistical analysis by the department of biostatistics and medical computing of the hospital cochin will be performed.

Eligibility criteria:
inclusion criteria: patients: * ad outpatients * stable pharmacological treatment * mini-mental state examination (mmse) \[10 -28\] * age \[60-90\] * informed consent caregivers: * reliability * motivation * psychological disorder related to patient's disease * need for information or help * informed consent exclusion criteria: patients: * other dementia * severe general disease * no reliable caregiver caregivers: * physical or mental disease incompatible with patient's management * impossibility to participate in the educational program * absence of anxiety-depression * psychotherapy

Keywords: alzheimer's disease training programme educational programme caregivers carers dementia treatment dementia cognitive disorder
effect and safety of electroacupuncture for symptoms of menopausal transition

Conditions: Menopausal Syndrome

Summary: the primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .

menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect. our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. we are going to conduct a phase ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.

Eligibility criteria:
inclusion criteria: 1. cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition). 2. menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems. 3. 40 to 55 years old. 4. volunteer to join in the trial and sign the informed consent. patients conformed with the 4 items at the same time will be included. - exclusion criteria: 1. regular cycles during the past 3 months before enrollment. 2. use of estrogen, ssris, soybean isoflavone, progestin, vitamin e or black sesame in the past 4 weeks. 3. patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy. 4. patients with radiochemotherapy history or undergoing radiochemotherapy. 5. cryptogenic vaginal bleeding 6. coagulation disorder or use of anticoagulants like warfarin and heparin sodium. 7. existing skin diseases like eczema or psoriasis. 8. severe hepatic/renal insufficiency. 9. insufficiently controlled hypertension, diabetes or thyroid diseases. 10. existing diabetic neuropathy, malignant tumor and psychiatric disorders. 11. wish to become pregnant or is pregnant or breast-feeding. 12. regular use of sedative or anxiolytic. 13. smoking or alcohol intake. 14. subjects with mandatory indication for ht (e.g. postsurgical menopause or active osteoporosis). 15. with cardiac pacemaker or artificial joint.
database of data collection

Conditions: Surgery of Breast Cancer

Summary: for several years, the paoli-calmettes institute has been centralizing the retrospective collection of clinical data of patients operated on for histologically proven breast cancer.

the current cohort (g3s) fed by more than 20 centers has more than 25,000 patient records. the collection centralizes the main characteristics of the patients, the tumor and the treatments. also included are the date of first recurrence, the localization (local, regional or distant) as well as the death or the date of the latest news. the current database is also updated regularly.

Eligibility criteria:
inclusion criteria: * patients operated for histologically proven breast cancer. exclusion criteria: * patient below age of 18 years

Keywords: surgery breast cancer