Kornimate/medical-research-clean huggingface dataset:
letrozole as early adjuvant treatment of postmenopausal patients with primary breast cancer

Conditions: Breast Cancer

Summary: this is a prospective open-label one-arm phase iii trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer. this trial is not recruiting patients in the united states.


Eligibility criteria:
inclusion criteria: * compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment * nodal status negative or positive * good health status 0-2 (eastern cooperative oncology group) * estrogen- and/or progesterone-receptor positive * adequate marrow, kidney and liver function exclusion criteria: * metastatic or inflammatory breast cancer * patients with previous or concomitant cancers (not breast cancer) within the past 5 years except adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. patients with other previous cancers must have been disease-free for at least 5 years and patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases. * current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures. * recent (within 6 weeks) or planned dental or jaw surgery * patients with primary overactive parathyroid * patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.

Keywords: postive breast cancer postmenopausal disease free survival letrozole early adjuvant treatment primary hormone receptor
study of mdx-1411 in patients with relapsed/refractory chronic lymphocytic leukemia or mantle cell lymphoma

Conditions: Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Summary: to determine if mdx-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.

dose-escalation, multidose study of mdx-1411, a fully human nonfucosylated monoclonal antibody (mab) targeting the cd70 transmembrane cell-surface protein, which is highly expressed in b-cell malignancies such as cll and mcl.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of relapsed/refractory mcl or hematologically/bone marrow confirmed relapsed/refractory cll that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy; * subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy * for mcl, must have measurable disease * at least 4 weeks since the last systemic therapy, including rt, for the treatment of mcl/cll; * at least 4 weeks since taking any corticosteroids prior to the first dose of mdx-1411 * ecog performance status 0 to 2; * no known positivity for human immunodeficiency virus (hiv) and no active infection with hepatitis b or hepatitis c; exclusion criteria: * history of severe hypersensitivity reactions to other monoclonal antibodies; * use of other investigational drugs within 30 days before study drug administration * prior treatment with any other anti-cd70 antibody; * active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of mdx-1411; * evidence of bleeding diathesis or coagulopathy; * active autoimmune disease requiring immunosuppressive therapy; * known current drug or alcohol abuse; * underlying medical conditions that will make the administration of mdx-1411 hazardous

Keywords: medarex inc.
dexmedetomidine versus sevoflurane in children with anticipated difficult intubation

Conditions: Craniofacial Abnormalities; Mandibular Hypoplasia

Summary: difficult problem in the paediatric age group because of their small mouth opening and un-cooperativeness.currently used methods of sedation for fibreoptic intubation such as benzodiazepines, propofol or opioids may cause respiratory depression, especially when used in high doses

dexmedetomidine, an a2-agonist, has none-to-minimal respiratory depressant effects, which is clearly a great advantage in handling a critical (unstable, difficult) airway while inducing sedation in both adult and infants. the aim is to compare intubation conditions between dexmedetomidine and sevoflurane inhalation during fibreoptic intubation in pediatric patients with an anticipated difficult intubation

Eligibility criteria:
inclusion criteria: * asa physical status i and ii * aged 1 year to 3 years * require general anaesthesia with tracheal intubation for surgical correction of the congenital or acquired pathology that created the difficult airway exclusion criteria: * parents refusal * allergy to drugs
enbrel-juvenile idiopathic arthritis (jia) use results survey [all-case surveillance]

Conditions: Juvenile Idiopathic Arthritis

Summary: this surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated enbrel as a treatment for active polyarticular jia. 1. primary occurrence status of adverse events; incidence of all adverse events, serious adverse events 2. secondary factors affecting safety and to confirm the efficacy such as das28.

all patients who administrated enbrel for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Eligibility criteria:
inclusion criteria: * patients in active polyarticular jia (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years). * patients receiving enbrel for jia as diagnosed by a qualified physician. * age 5 - 16 years exclusion criteria: * patients not administered enbrel

Keywords: enbrel-jia
an observational quality of life study in participants with rheumatoid arthritis treated with rituximab

Conditions: Rheumatoid Arthritis

Summary: this multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (ra) who are initiated with rituximab (mabthera/rituxan). participants will be followed for 6 months from initiation of treatment.


Eligibility criteria:
inclusion criteria: * adult participants of both genders who are 18 years or older * diagnosis of ra for at least 6 months according to the criteria of the american college of rheumatology (acr) of 1987 for the ra classification * participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label * ability to meet the program's requirements and to voluntarily sign the informed consent term. exclusion criteria: * participants who have received any investigational medication within less than or equal to (\<=) 1 year before the first dose of the currently indicated treatment * participants with an active infection * participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements * functional class iv defined based on the acr functionality criteria for ra * participants who can not or who do not want, for any reason, to answer the questionnaires.
effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass

Conditions: Heart Valve Disease

Summary: the purpose of this study is to study the effect of remote ischemic preconditioning on acute kidney injury in patients undergoing heart valve replacement surgery with cardiopulmonary bypass.

hypothesis : ripc using tourniquet might be a simple technique with the benefit to provide renal protection without disturbing operating procedure and prolongation of total operating time.

Eligibility criteria:
inclusion criteria: * patients undergoing complex valve surgery. exclusion criteria: * older than 80 years * those with left main disease \>50%, or hepatic or pulmonary disease * active infective endocarditis * left ventricular ejection fraction \<30% * myocardial infarction (mi) within 3 weeks * pre-existing renal dysfunction (serum creatinine (cr) level \>1.4 mg/dl), and those with peripheral vascular disease affecting the lower limbs.
prevalence of pharyngolaryngeal reflux in patients treated for obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea; Reflux, Laryngopharyngeal

Summary: the aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome. it is proposed to carry out simultaneously, at the sleep center of the polyclinique of poitiers (cspp), a polysomnography, a 24-hour restech pharyngeal ph-metry (day and night), a peptest (in the evening and in the morning of the polysomnography), with the rss-12 questionnaire and the rsa score.


Eligibility criteria:
inclusion criteria: * adults (\> 18 ans) * polysomnography planned for osa assessment * rpl known or not, suspected or not * affiliation to a social security scheme or beneficiary of such a scheme * patient having signed the free and informed consent exclusion criteria: * minors * smoking, alcoholism, chronic or serious disabling pathology * medical history of upper aerodigestive tract cancer, radiotherapy * recent infection of upper aerodigestive tract, chronic rhinosinusitis * permanent nasal obstruction * active allergy * non-obstructive sas (central) * patient under anti-secretory treatment (ipp) during the 8 days preceding the restech associated with the psg * refusal to participate in the study * protected patients: adults under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, breastfeeding or parturient * hospitalized without consent
pharmacotherapy and psychotherapy in the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. the study was randomized controlled trial with four arms involving a control group.


Eligibility criteria:
inclusion criteria: * men diagnosed with erectile dysfunction * must be in the age range of 18 to 40 years * must be in a stable heterosexual relationship * must not be suffering from any medical or psychiatric illness exclusion criteria: * men not meeting criteria of diagnosis of erectile dysfunction * men not in a heterosexual relationship * men above the age of 40 years * men diagnosed with any medical or psychiatric illness
validation of the breathe asthma intervention trial

Conditions: Asthma

Summary: the overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (pcps) to their black adult patients with uncontrolled asthma in federally qualified health centers (fqhcs).

nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. however, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. while inhaled corticosteroids (ics) are a safe and effective treatment for uncontrolled asthma, relative to whites, blacks have lower rates of ics adherence. black adults with uncontrolled asthma experience profound health disparities. despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below healthy people 2020 targets, particularly among vulnerable populations. this brief evaluation of asthma therapy (breathe) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ics adherence.

Eligibility criteria:
provider recruitment inclusion criteria: * pcps (mds and nurse practitioners (nps)/physician assistants (pas)) working in family, primary or internal medicine care services * who have at least 40 adult patients with persistent asthma (defined as having been prescribed ics) on their patient panel exclusion criteria: * pcps whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and obstetrics and gynaecology (ob-gyn) patient recruitment inclusion criteria: patients must be 1. adults (\> or = 18 years of age) who self-report race as black or african american 2. with pcp-diagnosed persistent asthma 3. prescribed ics 4. receiving asthma care at participating fqhcs 5. who have uncontrolled asthma 6. have erroneous personal health and/or negative ics beliefs exclusion criteria: 1. participation in phase 1 (part 1) of the breathe trial (focus groups) 2. non-english speaking 3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses
a study of neoantigen mrna personalised cancer in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of sw1115c3, a neoantigen mrna personalised cancer vaccine, in patients with advanced malignant solid tumours.


Eligibility criteria:
inclusion criteria: * are 18 to 80 years old (including boundary values), without limitation of sex at time of consent. * based on the recist 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration. exclusion criteria: * have used a live attenuated vaccine within 4 weeks before the first use of sw1115c3 with the following exceptions: * adverse reactions induced by previous anti-tumour treatments have not yet recovered to grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the pi \[or designee\], such as hair loss, grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on nci ctcae version 5.0.
the impact of yoga on endometriosis-related pain

Conditions: Endometriosis

Summary: the central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

yoga has been demonstrated to improve menstrual pain associated with primary dysmenorrhea through use of physical exercises, mental meditation, and breathing techniques. still, there has been limited studies assessing potential benefits of yoga on pain symptoms of endometriosis. it is important to further assess yoga as a complementary therapy for women with endometriosis.

Eligibility criteria:
inclusion criteria: 1. reproductive aged women 18-45 2. self-reported prior surgery with pathology confirming a diagnosis of endometriosis 3. no current use of yoga 4. baseline moderate pain, score greater than or equal to 5 on vas scoring 5. access to internet with wifi capability for zoom platform and completion of weekly surveys 6. access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water) 7. ability to commit to duration of 12-week yoga course exclusion criteria: 1. pregnant patients 2. established yoga participation or moderate exercise regimen 3. physical trauma or disability 4. planned surgery or hormonal medication change during study 5. non-english speaking patients

Keywords: pelvic pain
audiological benefit and improved quality of life with two bone conduction systems: adhear vs. bonebridge in experienced users

Conditions: Bone Conduction Deafness; Hearing Loss, Conductive

Summary: patients implanted with a bonebridge will be asked to be part of the study. the study subjects are enrolled into the study according to inclusion criteria. patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. after this time period patients will be asked to use the adhesive device instead of the bonebridge for 3 weeks. audiologic tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.

phase 1 patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. they will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. phase 2 patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. after three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire. no patients will be implanted with a bonebridge as part of the study. audiologic testing consists of sound field audiometry, freiburg monosyllables test and oldenburg sentence test. questionnaires consist of the aqol-8d and the ssq-12

Eligibility criteria:
inclusion criteria: * patients implanted with a bonebridge device and are active users * unilateral and/or bilateral conductive hearing loss (chl) * subjects aged 13 years or older * capable of the german language * willingness and ability to perform all tests required for the study * signed, and dated informed consent before the start of any study specific procedure exclusion criteria: * pregnancy or breastfeeding * patient is intolerant of the materials as described by manufacturer's ifu * patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter. * patient cannot perform the audiological tests or is unable to fill out the questionnaires. * patient presents with retrocochlear, or central auditory disorder. * any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures

Keywords: hearing aid
groups for regaining our wellbeing

Conditions: Gulf War; Fatigue; Pain; Depression

Summary: this study is a randomized clinical trial measuring outcomes up to 6-months post-intervention. the objective of this study is to evaluate outcomes of two different group interventions for veterans with chronic multisymptom illness (cmi). the interventions to be compared are mindfulness-based stress reduction and an adapted version of the chronic disease self-management program (acdsmp) for veterans experiencing symptoms of chronic multi-symptom illness (cmi) - musculoskeletal pain, fatigue, and cognitive failures - especially those who were deployed to gulf war i. hypothesis one (re: outcomes): participants randomized to the adapted chronic disease self-management program (acdsmp) will derive benefit for the primary outcomes, but with smaller effects than the participants randomized to mindfulness-based stress reduction (mbsr). the investigators hypothesize that veterans randomized to mbsr will report greater reductions in each of the three primary outcome measures (pain, fatigue, and cognitive failures) at 6-month follow-up as compared to acdsmp. hypothesis two (re: acceptability): mbsr will be an acceptable and satisfactory program for veterans with cmi, as measured by attendance rates, a self-report measure of satisfaction, and qualitative interviews. the investigators hypothesize that veterans with cmi randomized to mbsr will report greater satisfaction with care than their peers randomized to acdsmp.

the investigators will enroll 308 participants. half of these will be gulf war veterans who meet criteria for cmi, and the other half will be veterans from other periods of service who also meet criteria for cmi. each participant will be randomized to either participate in mbsr or acdsmp (stratified by gulf war deployment status so there are \~7-8 gulf war veterans in each group for every cohort). measures to collect primary outcome data (pain, fatigue, cognitive failures, patient satisfaction), secondary outcomes, and potential mediators will be administered at four assessments: (1) baseline; (2) post-intervention; (3) at 3-months after the group ended; and (4) at 6-months after the group ended. sample demographic data (age, gender, race, income, education, etc.) will be collected at baseline only. all study procedures will take place at va puget sound health care system in seattle, wa.

Eligibility criteria:
inclusion criteria: * self-report all the criteria for chronic multi-symptom illness * fluent in english and able to provide informed consent exclusion criteria: * currently drinking with past-year history of alcohol-related seizures or delirium tremens * current dms-v substance use disorder other than cannabis or nicotine * moderate or high risk of suicide as assessed with mini * current psychotic disorder * current manic episode * diagnosis of borderline personality disorder or antisocial personality disorder * inpatient admittance for psychiatric reasons in the past month * prior participation in mbsr or cdsmp (attended at least one session)

Keywords: pain management fatigue mindfulness gulf war
feasibility of adapted physical activity based on a walking platform in hospitalized old patients for cancer

Conditions: Oncology; Adapted Physical Activity

Summary: the investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.


Eligibility criteria:
inclusion criteria: * patient with cancer * patient over 70 years old hospitalized 48 hours or more * patient identified as eligible for medical prescription of adapted physical activity * mastery of the french language ; * patient affiliated to a social security scheme * patient giving written consent exclusion criteria: * patient totally unable to communicate * patient in terminal palliative care * patient with a size \ 2m and / or a weight\> 130kg * patient unable to perform adapted physical activity sessions * patient unable to wear a restraint harness. * patient deprived of liberty or under guardianship * patient unable to comply with protocol requirements for geographical, social or psychopathological reasons