Kornimate/medical-research-clean huggingface dataset:
randomized controlled and prospective trial of a cohort of people who made a suicide attempt

Conditions: Suicide, Attempted

Summary: the prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. it is estimated that 10-15 % of people who made a suicide attempt die by suicide. recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. a one month recurrence rate is 5 %, 12-25 % at one year. most people who made a suicide attempt receive ambulatory monitoring. on this population, there is a low adherence to care. the main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt. the secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.

this is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). all participants are evaluated after one year of monitoring. the search duration is 2 years (one inclusion year and one year of follow-up). it is planned to include 330 patients, 165 patients in each group. the program (experimental group) includes three interventions: * a series of three telephone calls ( the second week , one month and three months after discharge from hospital ) * a systematic telephone contact with the referring physician * a telephone helpline for people who made a suicide attempt and referring physicians.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years. * patients admitted to the emergency department for a suicide attempt. * patients referred to outpatient care. * patients who have given their written consent. exclusion criteria: * patients not affiliated to social security. * patients do not have the faculties needed to be evaluated (cognitive or delusional disorder). * patients hospitalized for longer than 72 hours. * patients can not be recalled by phone (no phone, homeless, incarcerated) * patients who do not speak french.

Keywords: suicide, attempted prevention suicidal act telephone contact professional coordination
study of kn026 in combination with docetaxel as neoadjuvant therapy in her2-positive breast cancer

Conditions: Breast Cancer

Summary: this is an open-lable, multicenter, and single arm phase ii trial to evaluate treatment with kn026 plus docetaxel as neoadjuvant therapy in patients with early-stage (t1c or 2, n1, m0; t2 or 3, n0, m0) or locally advanced (t1c or 2 or 3, n2, m0; t3n1m0; t1c or 2 or 3, n3a or 3b, m0) her2-positive breast cancer. the subjects will receive kn026 30 mg/kg iv + docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

kn026 is an anti-her2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of her2, leading to a dual her2 signal blockade.

Eligibility criteria:
inclusion criteria: * male or female subject \>= 18 years; * histologically or cytologically confirmed her2-positive breast cancer defined as 3+ determined by validated ihc or positive by in situ hybridization (ish); * early-stage (t1c or 2, n1, m0; t2 or 3, n0, m0) or locally advanced (t1c or 2 or 3, n2, m0; t3n1m0; t1c or 2 or 3, n3a or 3b, m0) breast cancer; * adequate organ function assessed within 7 days prior to first trial treatment; * ecog score 0 or 1; * left ventricular ejection fraction (lvef) ≥ 55% at baseline; exclusion criteria: * stage iv (metastatic) breast cancer; * inflammatory breast cancer; * previous anti-cancer therapy or radiotherapy for any malignancy; * major surgery for any reason within 28 days; * history of uncontrolled intercurrent illness; * other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
compression and cold therapy on the post-operative shoulder

Conditions: Postoperative Pain; Shoulder Pain

Summary: the purpose of this study is to evaluate and compare clinical post-operative outcomes for patients using active cooling and compression device and those using ice bags and elastic wrap after acromioplasty or arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: * patient has undergone unilateral rotator cuff repair or acromioplasty * willing to sign a consent form * able to follow study procedures exclusion criteria: * non-ambulatory * participation in concurrent investigational protocol * any bleeding coagulopathies * raynaud's disease or other vasospastic hypersensitivity or circulatory syndromes * hypertension (due to secondary vasoconstriction) * compromised local circulation (including localized compromise due to multiple surgical procedures) * a history of vascular impairment (such as frostbite or arterial sclerosis) * cold allergy (cold urticaria) or prior adverse reactions to cold application * rheumatoid arthritis * local limb ischemia * paroxysmal cold hemoglobinuria * cryoglobulinemia or any disease that produces a marked cold pressor response * inflammatory phlebitis * acute inflammations of the veins (thrombophlebitis) * decompensated cardiac insufficiency * arterial dysregulation * erysipelas * deep acute venal thrombosis (phlebothrombosis) * carcinoma and carcinoma metastasis in the affected extremity * decompensated hypertonia * pulmonary embolisms * congestive heart failure * pulmonary edema * suspected deep vein thrombosis * acute inflammatory skin diseases * infection * venous or arterial occlusive disease
prophylactic transfer of leukemia-reactive t cells after allogeneic transplantation

Conditions: Chronic Myeloid Leukemia

Summary: efforts to decrease the risk of gvhd by depleting t cells from the graft in cml patients have been complicated by an increased incidence of leukemia-relapse. newer protocols using cd34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of t cells in incremental doses to treat or avoid relapse of disease seem to be more promising. in this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic t cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.

the conditioning protocol contains: total body irradiation 8-12 gy (4-6 x 2 gy, a 2 x/die) day -9 to-7 thiotepa 10 mg/kg (2 x 5 mg/kg) day -5 fludarabine 200 mg/m2 (5 x 40 mg/m2) day -6 to-2 atg fresenius 25 mg/kg (5 x 5 mg/kg) day -6 to-2 cyclosporine a 1 mg/kg day -10 to-3 on day 0 cd34+ cells after immunomagnetic selection are infused. \> 4 x 10e6/kg cd34 cells/kg are required. on days 28, 56 and 112 after transplantation, cytotoxic t cells generated in-vitro are infused in patients who do not have signs of acute gvhd. regular follow-up compromises immune monitoring including tetramer analyses of peptide-reactive t cells

Eligibility criteria:
inclusion criteria: * age 18-60 * ph+ cml * hla a0201, 0301, 1101, b0801 * bcr-abl b3a2 positive * no significant comorbidities * resistance or intolerance of imatinib exclusion criteria: * hiv positive * blast crisis

Keywords: adoptive immunotherapy bcr-abl reactive t cells allogeneic transplantation
car-t immunotherapy targeting cd19- all

Conditions: B-cell Leukemia

Summary: this study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified t cells targeting cd19 negative all that express cd22, cd123, cd38, cd10, cd20 and tslpr, as many patients developed cd19-negative disease after cd19 cart immunotherapy. clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. this is a phase i/ii trial enrolling patients from multiple clinical centers.

anti-cd19 chimeric antigen receptor t cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory b-cell acute lymphoblastic leukemia (r/r b-all). however, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of cd19 surface antigen. patients with cd19-negative relapse after cd19 car-t-cell therapy usually have a poor prognosis. the mechanisms underlying cd19-negative relapses are not fully understood and it is important to develop solutions to supplement post-cd19 immunotherapies. potential markers for recurrent leukemic blasts in an emerging cd19-negative blast population include many known b-cell lineage antigens. to prevent further target escape and improve the therapeutic effects, car gene-modified t cells targeting cd22, cd123, cd38, cd10, cd20 or tslpr have been considered in post cd19 car-t immunotherapy. this study aims to evaluate safety and efficacy of administrating one or multiple non-cd19 targeting car-t cells to patients with cd19-negative b cell malignancies.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. native cd19 negative b cell malignancies or relapse after cd19-car-t immunotherapy. 3. malignant b cells expressing one or more of the following surface molecules: cd22/cd123/cd38/cd10/cd20/tslpr. 4. the kps score over 80 points, and survival time is more than 1 month. 5. greater than hgb 80 g/l. 6. no contraindications to blood cell collection. exclusion criteria: 1. complications with other active diseases, and difficult to assess patient response. 2. bacteria, fungus, or virus infection, and unable to control. 3. living with hiv. 4. active hbv and hcv infection. 5. pregnant and nursing mothers. 6. under systemic steroid use within a week of the treatment.

Keywords: cd19- b-all cart cd22, cd123, cd38, cd10, cd20, tslpr
kenya hiv self-testing in prep delivery

Conditions: HIV-1-infection

Summary: in a three-arm, randomized trial, the investigators will test the use of hiv-1 self-testing to decrease the frequency and burden of clinic visits for prep while resulting in equivalent prep adherence and hiv testing.

guidelines recommend hiv-1 testing quarterly for individuals on prep. clinic-based hiv testing every three months is costly for both clinics and participants. the investigators propose using hiv self-testing to replace quarterly clinic-based hiv testing for participants on prep, eliminating half of clinic visits and saving staffing and participant costs. the investigators want to understand the effect that reduced clinic contact frequency (resulting from hiv self-testing) has on prep adherence or completion of hiv-1 testing, overall and in subgroups. the investigators will enroll roughly 495 eligible individuals on prep: 165 men and 165 women in hiv-1 serodiscordant couples and 165 women at risk of hiv-1 infection (priority populations for prep delivery in kenya and more generally in africa). in this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. participants randomized to six-monthly clinic visits will receive a 6-month supply of prep and either two blood-based hiv self-tests (blood-based hiv self-testing arm) or two oral fluid hiv self-tests (oral fluid hiv self-testing arm). participants randomized to quarterly clinic visits will receive a 3-month supply of prep and get tested for hiv by a healthcare professional at the clinic (standard of care arm) study outcomes, measured at months 6 and 12, include prep adherence (defined as the detection of prep in dried blood spots as well as persistence in refilling prep), hiv-1 testing, and safety (including side effects and social harm).

Eligibility criteria:
inclusion criteria: * age ≥18 years hiv-1 uninfected based on negative hiv-1 rapid testing * not currently enrolled in an hiv-1 prevention clinical trial * taking prep and planning to continue * willing to be randomized to either clinic based hiv-1 testing or hiv-1 self-testing * note: women who are pregnant at screening/enrollment are still eligible exclusion criteria: * unable to provide written informed consent * contraindication to use tenofovir (tdf)+/- emtricitabine (ftc)/ lamivudine (3tc) for the hiv-1 serodiscordant couples, hiv-1 infected members of the couple will be enrolled for a single visit at baseline, if: * age ≥18 * able and willing to provide written informed consent

Keywords: hiv aids prep truvada public health global health infectious disease self-testing kenya africa low and/or middle income countries (lmic) cost-effectiveness
the effect of morning versus evening administration on the pharmacokinetics and pharmacodynamics of empagliflozin

Conditions: Diabetes Mellitus; Pharmacokinetics; Pharmacodynamics

Summary: an open-label, one way, two period comparative study to determine the effect of morning versus evening administration of empagliflozin 10mg on its pharmacokinetics and pharmacodynamics in healthy adults

sixteen(16) healthy subjects will receive a single oral dose of empagliflozin at the evening(period i) and after a seven days washout period, the same 16 subjects will receive a single oral dose of empagliflozin at the morning(period ii). in both periods(i and ii), blood samples will be collected from each volunteer ethylene diamine tetra-acetic acid(kedta) containing tubes prior to drug administration then samples will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours(h) after drug administration. these samples will be centrifuged and the plasma harvested and stored at -80°c until assay. urine samples will be collected over the first 24h after oral administration of the drug with sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.

Eligibility criteria:
inclusion criteria: * subject is at least 18-45 years at screening. * subject has a body mass index of 18 to 35 kg/m2. * subject are non smokers or moderate smokers(not more than 5 cigarettes per day) * subject is willing to participate and give their final written consent prior to the commencement of the study procedures * subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study. * subject has a normal blood pressure and pulse rate, according to the reference normal ranges exclusion criteria: * treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study. * subjects who have taken any medication two weeks preceding of the trial starting date. * documented history of sensitivity/idiosyncrasy to medicinal products or excipients. * any prior surgery of the gastrointestinal tract that may interfere with drug absorption. * gastrointestinal diseases. * renal diseases. * cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia . * pancreatic disease including diabetes. * hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases * hematological disease or pulmonary disease * abnormal laboratory values. * subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study. * positive hiv test. * history of or current abuse of drugs, alcohol or solvents. * endocrine disorders as pheochromocytoma, addison disease, glucagon deficiency, carcinomas, extra-hepatic tumors * autoimmune disorders as graves disease * (central nervous system (cns) disorders

Keywords: diabetes empagliflozin circadian rythm
intestinal microbiota and visceral pain in chronic intestinal pseudo-obstruction syndrome (cipo)

Conditions: Intestinal Obstruction

Summary: chronic intestinal pseudo-obstruction syndrome (cipo) is a rare gastrointestinal motility disorder. cipo evolves through iterative flare-ups that can be triggered by viral or bacterial infections, psychological stress, or malnutrition. all of these factors are associated with dysbiosis of the intestinal microbiota (im). many studies have associated visceral pain with dysbiosis of the im, particularly in the context of irritable bowel syndrome (ibs), a painful pathology associated with transit disorders. the team in dr. cénac's laboratory has demonstrated the analgesic effect of a bacterial lipid produced by an intestinal bacterium in the context of ibs. the study hypothesize that cipo patients have a taxonomic and functional dysbiosis of the im responsible for hyperactivation of sensory neurons inducing visceral pain.

the aim of the study is to identify metabolites differentially produced by the gut microbiota of cipo patients with visceral pain to determine their effect on the host with a focus on intestinal homeostasis. for that, 3 samples of digestive effluent will be collected in paediatric cipo patients. then, the study will: 1. characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric cipo patients. 2. quantify bacterial lipids in digestive effluents from painful and non-painful paediatric cipo patients. in ileal effluents, we will perform absolute quantification of the bacterial lipidome. we will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and, long-chain beta-hydroxylated fatty acids, gaba-lipopeptides, lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry. 3. test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia. the effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia. we will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above. in a second step, in order to determine their inhibitory potential, the same experiments will be performed on neurons activated by a calcium channel receptor agonist, trpv1 (capsaicin) or by a mix of agonists (histamine, serotonin and bradykinin) of g protein-coupled receptors involved in visceral hypersensitivity

Eligibility criteria:
inclusion criteria: * patient aged 1 to 21 years * patient diagnosed with cipo for at least 12 months (= patients meeting at least 2 of the following 4 criteria: 1. recurrent episodes of intestinal dilatation, 2. inability to maintain nutrition, 3. intestinal neuromuscular alteration and 4. genetic variants.) * patient with an ileal or colonic digestive diversion * signature of informed consent by both holders of parental authority and agreement in principle given orally by the subject; * patients affiliated to a social security scheme exclusion criteria: -

Keywords: microbiota
mindfulness mediation intervention in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with copd.

chronic obstructive pulmonary disease is a progressive multi-dimensional disease with a complex network of somatic and affective components. anxiety is a common experience for persons with copd both as a reaction to dyspnea (48) and as a separate co-morbid condition (10, 26). the presence of anxiety magnifies copd symptoms and further impairs physical functioning (53). both anxiety and copd alter breathing patterns similarly causing irregular rapid shallow breathing at rest, which is inefficient and cannot adequately respond to increases in ventilatory demands from physical or emotional activity (121). both copd and anxiety are also associated with changes in neurological functioning. whereas anxiety tends to be associated with increased amygdala activity (54), copd is associated with a decrease in frontal cortex functioning (25, 28, 122). persons with copd who experience anxiety are less able to correctly process the level of physical and emotional demand for any given situation and their ability to meet that demand (46, 123). pulmonary rehabilitation addresses both the physical and emotional symptoms of copd, however gains in function are quickly lost over time (4). evidence suggests that mindfulness based meditation can alter neural pathways to facilitate processing of emotions and increase quality of life for persons with copd. the overall objective of this study is to assess the ability of persons with copd to participate in a mindfulness meditation intervention and to examine the impact of mindfulness meditation on their anxiety levels and global sense of coherence. a modified version of antonovsky's sense of coherence model will be used as the framework for this study. we will address the specific aims: 1) to determine the effects of mindfulness meditation on breathing patterns; 2) to determine the effects of mindfulness meditation on anxiety levels; 3) to determine self-reported adherence rates following an eight-week small group instructional course on mindfulness meditation, and 4) to determine the effects of mindfulness meditation on global sense of coherence levels in persons with copd. the national center for complementary and alternative medicine identifies meditation as a form of cam that focuses on the interaction among the brain, body, mind and behavior that is already practiced by 8% of persons who participate in cam therapy. meditation is rated a special priority research area by nccam.

Eligibility criteria:
inclusion criteria: * any stage of chronic obstructive pulmonary disease * able to read and write english exclusion criteria: * severe mental disability * inability to attend

Keywords: meditation chronic obstructive pulmonary disease mindfulness anxiety breathing patterns
dose-response of cannabis and driving

Conditions: Driving Impaired; Cognitive Impairment; Abuse Cannabis

Summary: epidemiological studies have established a link between collisions while driving and cannabis use. with the changing legal landscape around cannabis, there is much interest in determining per se limits of cannabis while driving. the present study will evaluate driving on a driving simulator after smoking placebo or cannabis with 3 different levels of thc. thc is the active component in cannabis and blood, urine and oral fluid levels of thc will be correlated with driving impairment.

participants will attend the laboratory for 4 separate sessions, separated by about a week. in each session, participants will receive one of 3 doses of smoked cannabis or a placebo. participants will not know which dose they are receiving. participants will complete questionnaires, do cognitive tests and drive on a driving simulator before and after smoking the cannabis or placebo cigarette. blood, urine and oral fluid will be collected throughout the 7-8 hour session to determine levels of thc and its metabolites. these values will be correlated with measures of driving impairment.

Eligibility criteria:
inclusion criteria: * near daily use of cannabis (1-5 days/week) confirmed by self-report and urine screening * has held a class g2 or g licence (or equivalent from another jurisdiction) for at least 12 months * willing to abstain from using cannabis for 72 hours prior to each practice or test session * willing to abstain from alcohol for 48 hours prior to each session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session) * provides written and informed consent exclusion criteria: * diagnosis of severe medical or psychiatric condition * meets criteria for current or lifetime alcohol or other substance use disorder, except tobacco use disorder and caffeine use disorder * regular user of medication that may affect cognitive functioning and/or driver performance * family history of schizophrenia or other psychotic disorder * pregnant, looking to become pregnant, or breastfeeding