Kornimate/medical-research-clean huggingface dataset:
a phase ii study of continuous versus syncopated dosing of cc-5013 for the treatment of refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: to evaluate the response rate, response duration, and survival of patients treated with cc-5013 in a chronic dosing schedule versus a syncopated dosing schedule.


Eligibility criteria:
* history of histologically documented multiple myeloma with relapsed or resistant disease * pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. * signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Keywords: multiple myeloma revimid cc5013 cc-5013
restorative treatment of severe tooth wear; direct vs indirect

Conditions: Tooth Wear; Dental Restoration Failure; Dental Restoration Wear

Summary: this study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive. this study compares two different treatment techniques for severe tooth wear. the first technique is regarded as the 'standard' technique. this is a full rehabilitation using only direct composite restorations (ap-x, kuraray, japan). the second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (estenia c\&b, kuraray, japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. other elements are restored conform the direct protocol. an important benefit for the patients is the rehabilitation of their worn dentitions. functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. indirect techniques have the advantage of a superior control over form of restorations.

Eligibility criteria:
inclusion criteria: * patients age of at least 18 years old. * generalized moderate to severe tooth wear (tooth wear index (twi) ≥ 2) with a patient demand for treatment (smith 1984) * full dental arches, but one diastema due to one missing tooth in the posterior area was allowed. * an estimated need for increase of vertical dimension of occlusion (vdo) of ≥3mm at the location of the first molars. exclusion criteria: * limited mouth opening (\<3.5cm). * (history of) temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems. * local or systemic conditions that would contra-indicate dental procedures. patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with gord (gastro oesophageal reflex disease), were not excluded.
life story book with mentally alert residents of nursing homes

Conditions: Depressive Symptoms; Quality of Life

Summary: the objective of this study is to study the effects of the life story book intervention on depressive symptoms and meaning in life for mentally alert residents of nursing homes.

two nursing homes were recruited to participate. one nursing home will receive the life story book intervention while the other half receives usual care intervention. the interventions were then switched, and the participants who received usual care intervention received the life story book intervention while the home that received life story book intervention received usual care intervention. the study consisted of two treatment periods of 3 weeks separated by a washout period of 1 week. life story book provides a person with the opportunity to chronologically share their life experiences and memories. this three-1 hour reminiscence intervention is designed to provide a person with the opportunity to review their past and capture their life story into something tangible. the life story book includes a combination of written information, photographs of significant people, places or events, and personal narratives from the stages of life that the person would like to include.

Eligibility criteria:
inclusion criteria: * ability to speak english * a resident of the nursing home * a score of 4 or higher on the six-item screener exclusion criteria: * a score of 4 or higher on the six-item screener
the safety and efficacy of neramexane in patients with moderate to severe alzheimer's disease

Conditions: Alzheimer's Disease

Summary: memory loss and difficulties with thinking associated with alzheimer's disease may be due to chronic release of a brain chemical called glutamate. glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (n-methyl-d-aspartate, nmda) on the cell. neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (nmda receptor antagonist).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of moderate to severe alzheimer's disease; * ambulatory patients exclusion criteria: * folate deficiency; * clinically significant central nervous system disease other than alzheimer's disease; * clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Keywords: neramexane nmda receptor antagonist memory loss alzheimer disease
endoscopic sinus surgery in recurrent acute rhinosinusitis

Conditions: Maxillary Sinusitis; Sinusitis, Acute; Sinusitis

Summary: the aim of this study is to find out if endoscopic sinus surgery improves the quality of life in patients suffering from recurrent acute rhinosinusitis. our main outcome is the difference between the average change in disease-specific snot-22 quality of life questionnaire scores (from baseline to 5-6 months follow-up) between the intervention and the control groups.

this is a randomized controlled trial. patients suffering from recurrent acute sinusitis episodes will be randomly allocated to two groups: intervention group, where they will receive endoscopic sinus surgery in addition to medical treatment and control group, where they will receive mere medical treatment. both groups will be followed-up for 5 to 6 months. at baseline and after 5 to 6 months, patients will answer the life quality questionnaires snot-22 and rand 36-item health survey. the numbers of sinusitis episodes, medical appointments for respiratory symptoms, use of medications, numbers of days lost from work or studies and numbers of days with various respiratory and adverse symptoms will be recorded with patient diaries. the potential serious adverse events (e.g. cerebrospinal fluid leak, orbital complications) related to surgery will be collected from the medical records.

Eligibility criteria:
inclusion criteria: * at least 3 acute sinusitis episodes during previous 6 months or 4 acute sinusitis episodes during previous 12 months or at least 2 episodes per year for 3 consecutive years * episodes must last less than 4 weeks and be diagnosed and treated as acute rhinosinusitis by a physician * episode symptoms include nasal discharge, nasal congestion, hyposmia and facial pressure or pain and the episodes have to be severe enough for the patient to seek medical help and for daily life to be significantly disturbed * patients must have failed a three-month conservative therapy (medication for possible allergies, nasal corticosteroids and douching and courses of antibiotics as necessary) exclusion criteria: * age under 18 years, * immunodeficiency or immunosuppression * pregnancy, * previous illness making same-day surgery unfeasible * ongoing antibiotic treatment for other reasons, * primary complaint of nasal septal deviation and * chronic rhinosinusitis with or without nasal polyposis * symptoms for over 12 weeks and/or lund-mackay score over 8 in paranasal sinus cbct scanning

Keywords: adult endoscopic sinus surgery
sensorimotor training for injury prevention in collegiate soccer players ii

Conditions: Concussion, Mild; Sport Injury

Summary: the purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. the hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.


Eligibility criteria:
inclusion criteria: * male and female athletes * 18 years of age or older * on the soccer roster who are eligible to play in the fall 2019 season at the participating institutions. exclusion criteria: * current diagnosis of concussion (i.e. a non-medically cleared concussion) * current lower-extremity musculoskeletal injury, * seizure disorder with photo sensitivity * other medical diagnosis that will prevent participation in the intervention.

Keywords: concussion injury prevention
study of tj003234 (anti-gm-csf monoclonal antibody) in subjects with severe coronavirus disease 2019 (covid-19)

Conditions: Coronavirus Disease 2019 COVID-19

Summary: this is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of tj003234 administered as an intravenous (iv) infusion in subjects with severe covid-19 under supportive care, and to assess the effect of tj003234 on the levels of cytokines.


Eligibility criteria:
inclusion criteria: * age: 18 years or older (including 18 years); male or female * laboratory-confirmed sars-cov-2 or covid-19 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay. * bilateral lung infection confirmed by imaging. * severe disease that meets one of the following conditions: (i) at rest, finger blood oxygen saturation ≤ 93% or pao2/fio2 ≤ 300 mmhg; (ii) requiring non-invasive or invasive mechanical ventilation; or (iii) requiring high flow oxygen ≥ 15l/min * hospitalized for no more than 5 calendar days at the time of screening exclusion criteria: * any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. * chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). * pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. * cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. * blood system disorders or routine blood analysis test abnormalities: hemoglobin \< 8 g/dl; absolute neutrophil count (anc) \<1500 × 109/l; platelets \< 50 × 109/l. * dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. * subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing * subjects that require ecmo. * pregnant or breastfeeding females.
safety study of p28gst treatment in crohn's disease patients

Conditions: Crohn's Ileocolitis

Summary: this multicenter phase 2 clinical trial is designed to assess safety of p28gst (protein 28 kd glutathion s transferrase), aiming to control inflammation in moderate crohn's disease (cd), before or after intestinal resection surgery. p28gst is a parasite enzyme molecule from schistosoma with potent immunogenic and anti-oxidant properties. based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of p28gst could protect against recurrence after intestinal resection surgery in cd.

to carry out this study, 24 moderate cd patients will be enrolled in a safety phase 2a study. cd patients will be included after intestinal resection surgery or in moderate crohn's disease (cd). drug therapy will consisted in 3 injections of 100 µg of p28gst within 3 months (one injection per month). the main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by cdai (crohn disease activity index).

Eligibility criteria:
inclusion criteria: * subjects between the ages of ≥18 years at inclusion. * subjects with ileal or ileo-colic cd without fistula * subjects operated or not * cdai score \< 220 * no concomitant treatment excepted salicylates * women of child bearing potential must be negative for pregnancy prior to study enrolment * contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection . * no tobacco consumption (end date of tobacco consumption 8 days before surgery). * signed consent form * french social security coverage. exclusion criteria: * subject who use of azathioprine, anti-tnf (tumor necrosis factor), methotrexate, vedolizumab, ustekinumab and other immunosuppressors for 8 weeks before first injection of p28gst * subject who use of corticosteroids for 15 days before first injection of p28gst * subject with history of vaccine hyper sensitivity or allergy. * subject with any other clinical manifestation determined by the investigator * subject wih aids, b or c hepatitis.

Keywords: crohn disease immunotherapy helminth antigen
a study of elacestrant versus standard endocrine therapy in women and men with er+,her2-, early breast cancer with high risk of recurrence

Conditions: Breast Cancer

Summary: the primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, estrogen receptor-positive (er+), human epidermal growth factor-2 negative (her2-) early breast cancer with high risk of recurrence.


Eligibility criteria:
key inclusion criteria: * histopathologically or cytologically confirmed er-positive (≥ 10% by immunohistochemistry \[ihc\]), her2-negative \[ihc = 0 or 1, or (ihc = 2 and in situ hybridization \[ish\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the american society of clinical oncology (asco)/college of american pathologists (cap) guidelines * participants considered at high risk of recurrence at initial staging * participants who have received at least 24 months but not more than 60 months of endocrine therapy (ais or tamoxifen) with or without a cdk 4 and ckd 6 inhibitor (cdk4/6i) * participants who received prior cdk4/6i or a poly adenosine diphosphate-ribose polymerase (parp) inhibitor must have already completed or discontinued these treatments. key exclusion criteria: * participants with inflammatory breast cancer * history of any prior (ipsilateral and/or contralateral) invasive breast cancer * participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix * participants who have had more than a 6-month continuous interruption of prior soc adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: elegant breast cancer stage ii breast cancer stage iii breast cancer female breast cancer, male high-risk breast cancer high risk breast carcinoma er-positive breast cancer er-positive her-2 negative breast cancer er positive/her2 low breast cancer breast cancer, er+, her2- adjuvant adjuvant therapy
a study of once monthly subcutaneous mircera in patients with chronic renal anemia not on dialysis

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.patients will receive sc mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of esa previously administered. subsequent doses will be adjusted to maintain hemoglobin levels within the target range. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * continuous maintenance esa therapy with the same dosing interval during the previous month, and no change in totally weekly dose. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension; * significant acute or chronic bleeding; * active malignant disease (except non-melanoma skin cancer).
head and neck cancer survivorship ototoxicity screening (sos)

Conditions: Head and Neck Cancer Survivors; Cancer of the Head and Neck Surviors

Summary: to evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (h\&n) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (crt).


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years old) * h\&n cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based crt or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation. exclusion criteria: * patient has been evaluated by an audiologist within the past 12 months * use of a hearing aid * received a cochlear implant * cannot complete simple forms in english

Keywords: survivorship quality of life cisplatin radiation head and neck cancer hearing loss ototoxicity
safeboosc iii two-year follow-up

Conditions: Deficits, Neurologic; Extreme Prematurity; Brain Damage

Summary: the safeboosc-iii 2 year follow up study will follow up on all patients randomised in the safeboosc-iii clinical trial (nct03770741). the investigators will collect data when the patients are two years of corrected age from routine standardised follow up assessments, parental questionnaires as well as informal assessments. the study will commence in september 2021, and will expect to include all 72 sites across 18 countries, which take part of the safeboosc-iii clinical trial.

in the safeboosc-iii trial, the objective is to investigate the effect of treatment based on cerebral near-infrared spectroscopy (nirs) monitoring of brain oxygenation compared with treatment as usual in extremely preterm infants. the primary outcome of the trial is death or survival with severe brain injury at 36 weeks' postmenstrual age. despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. therefore, if treatment based on cerebral nirs monitoring decreases the risks of death or survival with severe brain injury, it is important to document if the beneficial effect persists into early childhood, in the form of better neurodevelopmental outcome. furthermore, it is also important to identify evidence of unexpected harms. it would be unfortunate if cerebral nirs monitoring became standard practice without good evidence that long-term patient-relevant benefits outweigh possible harms. as the safeboosc-iii trial intends to randomise 1600 infants, there is potential to achieve sufficient power for a meaningful assessment of the experimental intervention's effect on long-term neurodevelopment, as well as an evaluation of unexpected harms. the objective of the safeboosc iii follow-up study is to investigate the benefits and harms of treatment guided by cerebral nirs monitoring of brain oxygenation in extremely preterm infants during the first 72 hours of life, assessed at two years' corrected age. the hypothesis is that the intervention will decrease a composite of death or moderate-or-severe neurodevelopmental disability at two years' corrected age, and/or increase cognitive function in survivors assessed by the bayley iii/iv test, with insignificant harms. the investigators aim to collect data on as many children as possible and will do this by collecting clinical data from health care records as well as answers from parental questionnaires.

Eligibility criteria:
inclusion criteria: participation in the safeboosc-iii trial and enrollment in a neonatal intensive care unit (nicu) taking part in the follow-up study, with parental consent according to local regulations. exclusion criteria: parental objection to the use of their child's data in the follow-up study.

Keywords: neurodevelopmental disability cerebral palsy neurosensory deficits cognitive disability follow up study extremely preterm birth near infrared spectroscopy (nirs) cerebral oximetry
joint ultrasound evaluation of asymptomatic rheumatic feet

Conditions: Rheumatoid Arthritis

Summary: objectives: the aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (ra) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with ra and determine the correlation between ultrasound and radiography in the detection of bone erosion. methods: the foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal \[mtp\] joints) of 50 healthy subjects and 50 patients with ra (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative power doppler (pd) signals and erosion using ultrasound. statistical significance was set to 5%.


Eligibility criteria:
inclusion criteria: rheumatoid arthritis group: * ra with at least one year since diagnosis * asymptomatic feet * age between 18 and 65 years control group * absence of known osteoarticular disease exclusion criteria for both groups: * peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis * previous surgical intervention and/or fracture in feet/ankles * intra-articular corticosteroid injection in previous three months in any of the joints evaluated * foot neuropathy * pain and swelling in feet or ankles

Keywords: rheumatoid arthritis ultrasonography synovitis foot joints