Kornimate/medical-research-clean huggingface dataset:
phase iii study of lenalidomide and dexamethasone with or without elotuzumab to treat relapsed or refractory multiple myeloma

Conditions: Lymphoma; Multiple Myeloma

Summary: the purpose of the study is to determine whether the addition of elotuzumab to lenalidomide/low-dose dexamethasone will increase the progression free survival (pfs).


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * documented progression from most recent line of therapy * 1-3 prior lines of therapy * measurable disease * life expectancy ≥3 months * prior treatment with lenalidomide permitted if: 1. best response achieved was ≥partial response (pr) 2. patient was not refractory 3. patient did not discontinue due to a grade ≥3 related adverse event 4. subject did not receive more than 9 cycles of lenalidomide and had at least 9 months between the last dose of lenalidomide and progression exclusion criteria: * subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma * active plasma cell leukemia * known human immunodeficiency virus (hiv) infection or active hepatitis a, b, or c
adenoidectomy for otitis media in 2-3 year old children

Conditions: Otitis Media With Effusion

Summary: the purpose of this study is to evaluate the efficacy of three different surgical treatments (1. bilateral myringotomy and tube insertion (m\&t); 2. adenoidectomy and bilateral myringotomy (a\&t); 3. adenoidectomy with myringotomy and tympanostomy tube insertion (a-m\&t)) in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in the middle ear in children aged 24-47 months. the fluid in the middle ear is of at least three months' duration and unresponsive to standardized, recent antimicrobial treatment. the children are assigned to one of the three surgical treatments. after surgery, they are followed with examinations monthly and at the time of intercurrent infections for three years.

the specific aim of this study is to compare, by means of a randomized clinical trial, the efficacy of three surgical treatment combinations: adenoidectomy with myringotomy (a-m), adenoidectomy with myringotomy and tympanostomy tube insertion (a-m\&t), and m\&t alone, in reducing subsequent middle ear disease in children aged 24-47 months with otitis media with effusion (ome) of at least 3 months' duration unresponsive to standardized, recent antimicrobial treatment. the children are randomly assigned to one of three treatment arms: 1. m\&t; 2. a-m; and 3. a-m\&t. subjects are be stratified according to: 1. age; 2. nasal obstruction; and 3. previous tubes. all subjects are scheduled for surgery according to assignment within 4 weeks after entry. the first post-operative visit takes place 2 weeks after surgery, and a complete examination of the ears, nose, and throat (ent exam) including pneumatic otoscopy, tympanometry and audiometry is performed. subjects are followed with monthly evaluations (ent-exam, pneumatic otoscopy, tympanometry) for three years. audiometry is performed every 6 months. all subjects are evaluated at any time while still enrolled in the study if signs and symptoms of uri, acute otitis media (aom, including otorrhea), or ome occur and are treated appropriately. subjects who develop ome for 4 months bilaterally or 6 months unilaterally have m\&t and continue to be followed in the study. the primary outcome measure will be percentage of time with middle ear effusion (mee). episodes of aom, otorrhea, and ome, time to first recurrence, and number of surgical procedures will be compared between the three treatment groups. treatment failures, complications and sequelae of treatments will also be recorded and compared among the three treatment groups.

Eligibility criteria:
* males and females between 24 and 47 months of age, in good general health. * asymptomatic otitis media with effusion bilaterally for a minimum of 3 consecutive months. * at least one 10-day course of a broad-spectrum antimicrobial agent in the last month.

Keywords: otitis media with effusion children tympanostomy tubes adenoidectomy
bronchoprovocation study to evaluate the pharmacodynamics of albuterol sulfate inhalation aerosol, eq 90 mcg base

Conditions: Asthma

Summary: this randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate hfa inhalation aerosol, eq 90 mcg base (amneal ireland limited) to proair® hfa (albuterol sulfate) inhalation aerosol, eq 90 mcg base (teva respiratory, llc) in patients with stable mild asthma.


Eligibility criteria:
inclusion criteria: * male and non-pregnant female subjects (18-65 years of age). * stable mild asthmatics based on national asthma education and prevention program (naepp) guidelines. * fev1 ≥ 80% of predicted. * airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) pc20 ≤ 8 mg/ml. * nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years). * written informed consent exclusion criteria: * evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study. * history of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season. * history of cystic fibrosis, bronchiectasis or other respiratory diseases. * history of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ecg with evidence of ischemic heart disease. * treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months. * known intolerance or hypersensitivity to any component of the albuterol mdi.
non-interventional study to evaluate safety and efficacy of novocart 3d in patients with cartilage defects

Conditions: Cartilage Diseases

Summary: non-interventional study to evaluate safety and efficacy of novocart 3d in adult and adolescent patients with full thickness cartilage defects after the treatment with novocart 3d.

a 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the international knee documentation committee (ikdc) score.

Eligibility criteria:
inclusion criteria: * male and female adult patients * children and adolescents with closed epiphysial plate * defect size ≥2.5 and ≤10 cm2 post-debridement * localized full thickness articular cartilage defect of the knee (grade 3 \& 4 international cartilage repair society (icrs) classification) exclusion criteria: * radiologically apparent degenerative joint disease in the target knee as determined by kellgren and lawrence grade \>2 * more than 2 defects or 2 corresponding lesions * ankylosis * arthrofibrosis * diffuse chondromalacia * total/subtotal resected meniscus * insufficient ligament guidance * patella malignement * inflammatory joint disease * general cartilage degeneration or increased joint deterioration * cancer, present or within the last 5 years * primary treatment in children and adolescents with open epiphysial plate * chronical infection diseases * untreated coagulation disorder * pregnancy and lactating * known history of allergies against ingredients of novocart® 3d

Keywords: cartilage defect in the knee mact
high dose iv iron plus esa in chemotherapy-induced anemia

Conditions: Anemia

Summary: this study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of esa and high-dose iv iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with esa monotherapy (darbepoietin alfa alone) in cia patients with functional iron deficiency.


Eligibility criteria:
inclusion criteria: * patient who has signed a written consent * age ≥ 19 ③ histologically diagnosed advanced/metastatic solid cancer * patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study * anemia with functional iron deficiency 1. hemoglobin \<10g/dl 2. functional iron deficiency: transferrin saturation \<50% and serum ferritin 30-800ng/ml ⑤ ecog performance status 0-2 ⑥ life expectancy ≥ 24weeks exclusion criteria: * absolute iron deficiency (serum ferritin \<30 ng/ml and transferrin saturation \<20%) or no iron deficiency (serum ferritin ≥800 ng/ml or transferrin saturation ≥50%) * if there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin b12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.) * ongoing bleeding at the time of study registration * patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia) * presence of bone marrow tumor invasion * receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration * history of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration * past or family history of hemochromatosis ⑨ history of hypersensitivity to iron treatment or erythropoiesis stimulating agents ⑩ uncontrolled acute or chronic infection ⑪ renal dysfunction (serum creatinine ≥2.0 mg/dl, or glomerular filtration rate \<30 ml/min/1.73 m2) or liver dysfuction (ast or alt 3 times or more the upper limit of normal) ⑫ pregnant or lactating women
international t1 multicentre cmr outcome study

Conditions: Cardiomyopathy; Heart Failure; Coronary Artery Disease; Chronic Kidney Diseases; Inflammation; Fibrosis

Summary: myocardial fibrosis is the fundamental substrate for the development of heart failure. cardiovascular magnetic resonance (cmr) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (lge) and t1 mapping. patients: prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy. imaging: non-invasive measures of myocardial fibrosis: native t1, extracellular volume fraction (ecv) and lge. primary endpoints: all cause and cardiovascular mortality. secondary endpoints: arrhythmic composite and hf composite endpoints.


Eligibility criteria:
inclusion criteria: 1. adults \> 18 years of age 2. clinical indication for cmr 3. able to provide informed consent exclusion criteria: contraindications for cardiac magnetic resonance imaging due to mr unsafe devices or objects

Keywords: t1 mapping cmr outcome multicenter
temperature-dependent changes in cardiovascular parameters during warm water footbaths in healthy women

Conditions: Warm Footbath; Cardiovascular System; Autonomic Nervous System

Summary: a study to explore whether different temperatures of warm water footbaths have different effects on the cardiovascular system, the autonomic nervous system and the general well-being of healthy women.

this is a blinded, four-arm randomized controlled trial with crossover design to explore the effects of warm water footbaths with different water temperatures on cardiovascular stress, reaction of the autonomic nervous system and a feeling of comfort and warmth in healthy female volunteers. cardiovascular and ans measurements are performed continuously throughout the interventions and the participants rate their feelings of warmth, general well-being and the footbath-related comfort with questionnaires.

Eligibility criteria:
inclusion criteria: * written informed consent * age between 18 and 55 years exclusion criteria: * male sex * chronic skin lesions at the lower legs or feet * varicose veins grade 3 and grade 4 (marshall stage classification), chronic venous insufficiency * cardiac arrhythmia * cardiac pacemaker * asthma bronchiale * consumption of hrv-modulating medication (especially tricyclic antidepressants, beta blockers) * pregnancy * insufficient knowledge of the german language

Keywords: warm water footbath temperature-dependent effects cardiovascular system autonomic nervous system heart rate variability healthy female volunteers
quantification of gluten peptides in feces

Conditions: Celiac Disease

Summary: treatment for celiac disease (cd) is a lifelong strict gluten-free diet (gfd). patients should be followed-up with dietary interviews and serologic tests for cd markers to ensure adherence to the diet. however, none of these methods offer an accurate measure of dietary compliance. our aim was to evaluate the measurement of gluten immunogenic peptides (gip) in stools as a marker of gfd adherence in cd patients and compare it with traditional methods of gfd monitoring. we performed a prospective, non-randomized, multicentre study including 188 cd patients on a gfd and 73 healthy controls on a gluten-containing diet. subjects were given a dietary questionnaire and fecal gip quantified by elisa (ivylisa gip-s kit). serological anti-tissue transglutaminase (anti-ttg) iga and anti-deamidated gliadin peptide (anti-dgp) iga antibodies were measured simultaneously.


Eligibility criteria:
inclusion criteria: * the study group consisted of celiac patients following a gfd for at least one year prior to the inclusion in the study and they were required to have an hla-dq2 or hla-dq8 haplotype and an histologically abnormal duodenal biopsy (grade marsh iiib or iiic) at the time of diagnosis, supported by positive serum anti-endomysium iga antibodies and/or anti-tissue transglutaminase (anti-ttg) iga antibodies. * the positive and negative control groups was comprised of healthy asymptomatic subjects in whom cd had been ruled out and who were not suspected of having any other gastrointestinal condition exclusion criteria: * all study patients included history of kidney or liver disease, and history of severe psychiatric disease or seizure disorder.
a prospective study of axillary hair loss in patients treated with the miradry system

Conditions: Underarm Hair

Summary: the purpose of this study is to evaluate hair reduction in the underarms in patients treated with the miradry system.

this study is designed to quantify the amount of hair reduction in patients treated with the miradry system in the axilla. hair counts will be assessed before and after treatments including at follow up visits.

Eligibility criteria:
inclusion criteria: * 18 years of age * visible underarm hair (prefer light colored hair; blonde, red, gray) exclusion criteria: * secondary axillary hyperhidrosis * prior surgery and/or botox injections in axillae * pacemaker or requires supplemental oxygen * pregnant

Keywords: underarm hair underarm hair reduction axillary hair axillary hair reduction underarm odor axillary odor
pain, psychological, and endocannabinoid responses to yoga in breast cancer survivors with chemotherapy-induced neuropathic pain

Conditions: Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Neuropathic Pain

Summary: this study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). participants will complete three separate sessions on different days. the first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. during the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga.


Eligibility criteria:
inclusion criteria: * a diagnosis of breast cancer (stage 0-iii), * no evidence of active disease (i.e., recurrence, bone metastases, etc), * presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms, * at least six months since last active cancer treatment, with no further planned treatment (note. active treatment is defined as surgery, chemotherapy, or radiation), * the participant agrees to use the safety stop feature on the treadmill if needed, * at least 18 years of age, * and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions. exclusion criteria: * undergoing current chemotherapy or radiation treatment for cancer, * taking anticoagulant therapy, * uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc), * stroke or myocardial infarction in the past 6 months, * being pregnant or planning to become pregnant, * severe mobility constraints (e.g., confined to a wheelchair), * having a history of light headedness or fainting during blood draws or physical activity.
silicone hydrogel contact lens clinical and comfort benefits with a multi-purpose disinfecting solution

Conditions: Refractive Error; Myopia; Hyperopia; Astigmatism; Presbyopia

Summary: the purpose of this study was to compare lens comfort on day 30 for air optix® lenses cared for with opti-free® puremoist® (ofpm) multi purpose disinfecting solution (mpds) compared to acuvue® oasys® lenses cared for with habitual mpds.

prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

Eligibility criteria:
inclusion criteria: * sign informed consent. * currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol. * willing to wear contact lenses on a daily wear basis for the duration of the study. * currently using a multi-purpose solution, as specified in protocol. * vision correctable to 20/30 (snellen) or better in each eye at distance at visit 1. * willing to follow the study procedures and visit schedule. * other protocol-defined inclusion criteria may apply. exclusion criteria: * currently wearing air optix, acuvue oasys, or acuvue advance brand of lenses. * currently using any opti-free brand of multi-purpose solution. * must wear contact lenses on an extended wear (overnight) basis during the study. * known sensitivity or intolerance to polyquad® or aldox preserved lens care products. * monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear. * use of additional lens care products other than a multi-purpose solution within 7 days prior to visit 1. * use of topical ocular over-the-counter (otc) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to visit 1. * any abnormal ocular condition observed during the visit 1 slit-lamp examination. * current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to visit 1. * ocular surgery within the 12 months prior to visit 1. * any systemic diseases at visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions. * participation in any clinical study within 30 days of visit 1. * other protocol-defined exclusion criteria may apply.

Keywords: refractive error myopia hyperopia astigmatism presbyopia contact lenses contact lens solution comfort
deep vs moderate neuromuscular blocks on remifentanil for laparoscopic gastrectomy

Conditions: Gastric Cancer

Summary: the primary purpose is to compare the remifentanil requirements in deep vs moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gastric cancer scheduled laparoscopic gastrectomy exclusion criteria: * patients refusal to consent hyperbilirubinemia chronic pain opioid abuse incurrent infective status peripheral vascular disease
portuguese inguinal hernia cohort (pine) study

Conditions: Inguinal Hernia; Chronic Pain

Summary: prospective national cohort study of patients submitted to elective inguinal hernia repair. the primary outcome is the prevalence of chronic postoperative inguinal pain, according to the eurahs qol questionnaire at 3 months postoperatively. the study will be delivered in all portuguese regions through a collaborative research network. four 2-week inclusion periods will be open for recruitment. a site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.


Eligibility criteria:
inclusion criteria: * elective inguinal hernia repair in a portuguese hospital * willing and able to consent and comply with the follow up protocol exclusion criteria: * urgent/emergent inguinal hernia repair
the application of a biphasic calcium sulfate graft material in sinus floor elevation

Conditions: Alveolar Bone Loss; Edentulism Nos

Summary: pneumatization of the maxillary sinus may lead to insufficient bone volume for dental implant placement in the edentulous posterior maxilla. sinus floor elevation (sfe) surgery with the lateral window technique is a safe and predictable surgical intervention to restore bone height in the maxillary premolar and molar areas. according to the literature, several bone graft materials may be successfully applied for sfe surgery. there is a lack of evidence regarding the application of biphasic calcium sulfate (bcs) for sfe. the healing period following staged sfe is 2-9 months. the aim of this study is: * to evaluate the success of sfe surgery using bcs as graft material, * to compare the microarchitecture of the augmented bone depending on the healing period, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 years, * patients who need dental implant-borne prostheses, * patients with insufficient bone height in the posterior maxilla due to sinus pneumatization. exclusion criteria: .• patients who had major systemic diseases as classified by the american society of anesthesiologists (asa grades iii-iv), * psychiatric contraindications, * patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication, * radiation to the head or neck region within the previous five years, * localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis, * evidence of uncontrolled periodontal disease, * alcohol use disorder defined by the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5), * recreational drug abuse, * heavy smoking (\>10 cigarettes/day), * diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. leukoplakia, erythroplakia, precancerous lesions, oral squamous cell carcinoma and malign tumors of the soft and hard tissues, oral candidiasis, oral lichen planus, psoriasis, pemphigus, and pemphigoid. * pregnancy or nursing, * poor oral hygiene

Keywords: bone graft material biphasic calcium sulfate sinus floor elevation sinus lift maxillary sinus augmentation microcomputed tomography cone beam computed tomography histology histomorphometry dental implant