Kornimate/medical-research-clean huggingface dataset:
a study to assess the immune response following administration of influenza and pneumococcal vaccines to subjects with rheumatoid arthritis receiving cp-690,550 or placebo

Conditions: Rheumatoid Arthritis

Summary: a randomized, double blind, placebo controlled phase 2 study to assess the immune response following administration of influenza and pneumococcal vaccines to subjects with rheumatoid arthritis receiving cp-690,550 with and without background methotrexate


Eligibility criteria:
inclusion criteria: * the subject must meet the american college of rheumatology (acr) classification criteria for the diagnosis of ra by satisfying at least four of the seven criteria. * the subject must have active disease at both screening and baseline exclusion criteria: * history of any documented influenza or pneumococcal infection within the last 3 months. * receipt of any vaccine within 1 month prior to the initial study drug administration (cp-690,550 or placebo cp-690,550). * if a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.
spinal manipulation for treatment of chronic headaches

Conditions: Headache Disorders

Summary: this study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. this study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.

spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. however, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. this study will determine the feasibility of conducting a large spinal manipulation clinical trial. this study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits. participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. assessments will occur at study entry, at the end of each week, and at the end of the study.

Eligibility criteria:
inclusion criteria: * history of cervicogenic headaches exclusion criteria: * contraindications to spinal manipulation or massage * use of chiropractic or therapeutic massage care prior to study entry * use of any prophylactic prescription medication * involved in any type of lawsuit prior to study entry * headaches with several different causes

Keywords: headaches spinal manipulation massage chiropractic
systemic fluoride bioavailability from toothpastes containing calcium carbonate or silica as abrasives

Conditions: Dental Fluorosis

Summary: the risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. however, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. to test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.


Eligibility criteria:
inclusion criteria: * good general health * good oral health * normal salivary flow rate exclusion criteria: * gastric disorders * renal disorders

Keywords: toothpastes dental fluorosis fluoride bioavailability
nipple-areola complex sensitivity after the section of periareolar dermis in breast reduction

Conditions: Sensitivity of Nipple-areolar Complex

Summary: the purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (nac) prospectively due to the section of the dermis after decortication (schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.

preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons. in patients whose cap should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the nac. in clinical practice, there is a greater mobilization of nac when making a careful section of the dermis after decortication. in contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed. given the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the nac in these cases. to evaluate the sensitivity of the nac will be used semmes-weisnstein's monofilament. each point will be obtained five measurements. the largest will be scorned and the lowest value. the final value of each point corresponds to an arithmetic mean of the three remaining values.

Eligibility criteria:
inclusion criteria: * patients who willingly seek the service requesting breast reduction or mastopexy; * patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery; * patients who undertake to comply with the protocol previously presented and discussed with them; exclusion criteria: * patients with prior breast surgery; * patients with body mass index (bmi) greater than 34.9; * patients with severe anemia; * patients with neurological disease; * patients with impairment cardiovascular; * metabolic diseases - diabetes; * patients with autoimmune disease; * menopausal patients * patients with collagen disease; * patients with psychiatric disorders.

Keywords: sensitivity section of periareolar dermis breast reduction
thrombin generation and platelet activation in crs/hipec

Conditions: Mesothelioma; Peritoneum; Pseudomyxoma Peritonei; Peritoneal Carcinomatosis

Summary: cytoreductive surgery (crs) with hyperthermic intraperitoneal peroperative chemotherapy (hipec), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. the potential hemostatic interference in crs and hipec is phase dependent. this study demonstrates the combined use of rotem (rotational thromboelastometry), pact (platelet activation test) and cat (thrombin generation test) assays during crs and hipec with a follow-up of 7 days postoperative.

the purpose of this study was to quantitatively assess the impact of crs and hipec, on various components of hemostasis. routine laboratory assays such as activated clotting time, activated partial thromboplastin time, prothrombin time, or platelet count might, as demonstrated previously, insufficiently provide specificity and/or sensitivity to assess coagulation and platelet disorders. therefore, additionally thrombin generation (tg) was analyzed by the calibrated automated thrombogram assay (cat). also, platelet function was quantitatively assessed by the pac-t-ub assay and rotational thromboelastometry (rotem) was used to elucidate the contribution of platelets, intrinsic and extrinsic coagulation pathways in peri-operative bleeding. the hypothesis of this study was that the procedure exposed an increased thrombotic risk, resulting in a faster and increased tg and hyper platelet function?

Eligibility criteria:
inclusion criteria: * a confirmed histological diagnosis of peritoneal disease (e.g., mesothelioma; pseudomyxoma peritonei; colorectal, ovarian, or gastric peritoneal carcinomatosis of colorectal, ovarian, or gastric cancer origin; or abdominal sarcomatosis); and * age \<80 years; and * a cardiac, renal, hepatic, and bone marrow function compatible with surgery; and * informed written consent to participate in the study exclusion criteria:(or) * inherited coagulation abnormalities, * active systemic infections, * interstitial lung disease, * serious cardiac dysrhythmia or condition, new york heart association classification of iii or iv, congestive cardiac failure, uncontrolled hypertension (diastolic blood pressure constantly \>100 mm hg, systolic blood pressure constantly \> 180 mm hg). * inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 gpt/l or neutrophil granulocyte count less than \<1.5 gpt/l. * inadequate renal function at the beginning of the trial, defined as gfr less than \<60 ml/min, * inadequate liver function at the beginning of the trial, defined as bilirubin \>1.5 times uln (upper limit of normal), active hepatitis b or c infection, * female patients who are pregnant or breast feeding * participation in another therapeutic clinical trial.

Keywords: cytoreductive surgery hyperthermic intraperitoneal peroperative chemotherapy platelet function thrombin generation thromboelastometry
french adaptation of the aida (assessment of identity development in adolescence) and lopf-q (levels of personality functioning questionnaire) scales.

Conditions: Personality Disorders; Borderline Personality Disorder

Summary: the main objective of this study is to develop the french version of the two questionnaires aida and lopf-q. the secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology. to participate in the study, patients will have to complete online or paper versions of the questionnaires aida-lopf and other assessments of personality and general psychopathology (bb5, sdq). parents will have to answer complete the parent version of the sdq questionnaire. the bpfsc-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. the investigators will also add the clinical diagnoses according to icd-10 found in the medical record.

a personality disorder is a lasting mode of behavior and lived experience that deviates significantly from what is expected in the culture of the individual is invasive and rigid, appears in early adolescence or adulthood, is stable over time and is a source of distress or impaired functioning. most of the tools for assessing high-risk personality disorders and traits have been developed in adults.yet it is important to have effective tools to distinguish personality disorders from other mental disorders as early as possible. the identification of young people at high risk of personality disorders allows their rapid referral to appropriate psychotherapies. the aida and lopf-q, screening questionnaires, were recently developed to include an assessment of personality functioning in the process of diagnosing emotional and behavioral disorders in adolescence. they have been tested in several countries such as germany, usa, mexico, croatia... the results of the studies show that aida and lopf questionnaires are reliable and valid instruments for assessing normal and disturbed identity in adolescents and distinguishes well between patients with psychiatric illnesses and healthy controls.

Eligibility criteria:
inclusion criteria: * the adolescent must be between 12 and 18 years old * be able (see non-inclusion criteria below) and agree to complete the various evaluations proposed, and not present a psychotic episode at the time. time of the questionnaires. * the adolescent does not have to have any risky personality traits to participate in this study. exclusion criteria: * insufficient levels of french and / or reading * presence of an intellectual development disorder or a clinically proven current psychotic disorder, * active or passive opposition of the patient and / or its legal representatives to participate in the study.

Keywords: adolescents questionnaires
exploring the psycho-traumatic impact of a violent act commited at the bordeaux-gradignan penitentiary center

Conditions: Post Traumatic Stress Disorder; Offensive Aggression; Violent Behavior

Summary: the study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the bordeaux-gradignan penitentiary center.

the overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue. recent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed. the study will thus seek to explore the development of a post-traumatic stress disorder following a violent act committed using the pcl-5 questionnaire study design :observational, descriptive, monocentric study with completion of an anonymous self-questionnaire. participation in the study is voluntary and anonymous with signature of a non-opposition form. expected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. more specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.

Eligibility criteria:
inclusion criteria * aged over 18 * have as a reason for imprisonment one of the following: homicide and willful violence resulting in death, rape or sexual assault, violence and other personal injury. * having signed and duly completed the non-objection form for participation in the study * mastery of the french language
effects of open-label placebos on covid-related psychological health

Conditions: Stress; Anxiety; Depression

Summary: this project aimed to test the efficacy of a telehealth-administered placebo without deception intervention on stress, anxiety, and depression related to the covid-19 pandemic. participants were randomized into two groups (open-label placebo vs. no-treatment control). all participants received information on the impact of covid-19 on psychological health. participants in the open-label placebo group were instructed to watch an informational video on the beneficial effects of placebos without deception, remotely interact with an experimenter, and take open-label placebo pills twice a day for two weeks. participants in the no-treatment control group did not receive any intervention. instead, participants met with an experimenter and reported on their psychological and physical health. the investigators predicted that the placebo without deception group would exhibit substantially reduced stress, depression, and anxiety compared to a no-treatment control group.


Eligibility criteria:
inclusion criteria: * individuals who have experienced moderate covid-19 stress, as assessed by a score of ≥ 35 on the covid-19 stress scale (taylor et al., 2020). exclusion criteria: * non-michigan residents; self-reported diagnosis of anxiety, depression, adhd, schizophrenia, bipolar disorder, substance use disorder; currently taking psychotropic medication including antidepressants, anti-anxiety medication or stimulants; allergies or concerns with the placebo pill ingredients; or active diagnosis of covid-19 at the time of eligibility or enrollment.

Keywords: covid-19 non-deceptive placebos intervention telehealth stress anxiety depression
molecular and microbiota signatures underlying colonic diverticular disease

Conditions: Diverticular Disease of Colon

Summary: the pathogenesis of diverticular disease is likely multifactorial in origin. this project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

the pathogenesis of diverticular disease is likely multifactorial in origin. some studies have demonstrated the role of genetic factors, while others have highlighted the role of environmental factors. the present project aims to study the involvement of environmental factors in the pathophysiology of diverticular disease, the underlying molecular mechanisms, and alterations in the microbiota.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years. * belonging to one of the following groups: 1. patients with diverticula of the colon without symptoms. 2. patients symptomatic for diverticular disease. 3. subjects undergoing colonoscopy for colorectal cancer prevention or follow-up of previous polypectomies, asymptomatic for digestive symptoms. * obtaining informed consent. exclusion criteria: * acute complicated diverticulitis (bleeding, perforation) * previous colon surgery * antibiotics or laxatives within the past 90 days * pregnancy and/or lactation * systemic and psychiatric disorders * asthma, food allergies and other allergic-type disorders * possible diseases leading to intestinal bacterial contamination (diabetes, blind loop syndrome, rheumatologic diseases).
transplantation with ybritumomab tiuxetan (zevalin) plus beam regimen in patients with refractory large b-cell difusse lymphom

Conditions: Non-Hodgkin's Lymphoma

Summary: to evaluate the efficacy (complete response rate) of ybritumomab tiuxetan (zevalin) administration in the conditioning treatment of patients with refractory large b-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.


Eligibility criteria:
inclusion criteria: 1. give their written informed consent. 2. abide by at least one of the following conditions: * obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (r-chop, r-megachop, r-epoch or the like), or else * absence of partial response after having received salvage (post-induction) chemotherapy including r-ife, r-eshap, r-ice or the like. * patients on first recidivation who do not attain partial remission after salvage chemotherapy. * patients with transformed lymphoma, on first partial remission (no cr). 3. stable disease at the time of transplantation. 4. age ≥ 18 but ≤ 70. 5. life expectancy of greater than three months. additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.: 1. performance status (ecog) \< 3. 2. fev1, dlco and fvc ≥ 50% of the normal theoretical values. 3. ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%. 4. total bilirubin and transaminases \< 3 times the normal maximum value, except if attributable to the underlying disease. 5. creatinine \ 40 ml/min, except if attributable to the underlying disease. 6. absence of symptomatic heart disease, cirrhosis or active b or c virus hepatitis. 7. hiv negative. exclusion criteria: 1. impossibility of collecting, via apheresis, a number of cd34+ cells ≥ 2 x 106/kg. 2. known hypersensitivity to mouse proteins. 3. involvement of cns by lymphoma. 4. progressive lymphoma during the month prior to the date of transplantation. 5. previous radioimmunotherapy. 6. previous autologous transplantation of haematopoietic stem cells. 7. pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method. 8. being submitted to treatment in a clinical trial for 30 days prior to entry in this trial. 9. active psychiatric disease, including addiction disorders. 10. existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.

Keywords: z-beam autologous lymphoma geltamo
efficacy and safety of aprotinin on transfusion requirements in patients undergoing radical or total cystectomy

Conditions: Blood Loss, Surgical; Postoperative Hemorrhage

Summary: the purpose of this study is to assess if aprotinin (baya0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.


Eligibility criteria:
inclusion criteria: * subjects 18 years of age and older * subjects requiring elective radical or total cystectomy for bladder cancer * documented, signed, dated informed consent obtained prior to any study specific procedures being performed exclusion criteria: * subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin * subjects with sepsis or undergoing laparoscopic surgery * subjects with impaired renal function (serum creatinine \>2.5 mg/dl or 221 micromoles/liter) * subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. based on the investigator's opinion of any active significant medical illness the subject may have * subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of \<24% or hemoglobin of \<8 g/dl) * subjects who have participated in an investigational drug study within the past 30 days * subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception * planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid * subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)

Keywords: prevention of blood loss blood loss, surgical blood loss, postoperative