Kornimate/medical-research-clean huggingface dataset:
study to identify the impact of denosumab on the immune system in patients with her2 negative breast cancer

Conditions: Breast Neoplasms

Summary: the aim of this prospective, randomized, multicenter, open-label, explorative phase ii study is to identify the impact of (neo)adjuvant denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with her2 negative non-metastatic primary breast cancer.

in this study, postmenopausal patients with stage t1c + grade 3, stage ii or iii, her2-negative breast cancer, which are planned to undergo surgery followed by adjuvant ac-t chemotherapy, are randomized between no denosumab, denosumab low dosing and denosumab high dosing. denosumab administration will start one week before surgery and continue until the last chemotherapy cycle.

Eligibility criteria:
inclusion criteria: * postmenopausal, defined as 1 year without menstrual activity, previous bilateral oophorectomy, age older than 60 years or baseline fsh \>20 u/l and estradiol \<110 pmol/l. * clinical stage t1c + grade 3, stage ii or iii breast cancer amenable to adjuvant ac-t combination chemotherapy. * measurable disease (breast and/or lymph nodes). * histological proven her2-negative breast cancer in the core biopsy material. * who 0-2. * adequate bone marrow function (within 4 weeks prior to randomization): wbc≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l. * adequate liver function (within 4 weeks prior to randomization): bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl. * adequate renal function (within 4 weeks prior to randomization): the calculated creatinine clearance should be ≥50 ml/min. * albumin-adjusted serum calcium \> 2.0 mmol/l (8.0mg/dl) * accessible for treatment and follow-up. * written informed consent. exclusion criteria: * evidence of distant metastases (m1). * history of breast cancer. * prior chemotherapy or radiation therapy. * previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * prior or current bisphosphonate or denosumab usage. * serious other diseases as recent (last 6 months) myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias. * current active dental problems including dental abscess or infection of the jawbone (maxilla or mandible), non-healed dental or oral surgery, a current or prior diagnosis of osteonecrosis of the jaw or planned invasive dental procedures for the course of the study. * known hypersensitivity reaction to any of the components of the treatment. * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

Keywords: breast cancer denosumab chemotherapy immunity immune system perideno
prevalence of sleep-disordered breathing in patients with a newly diagnosed non small cell lung cancer

Conditions: Bronchial Cancer

Summary: there is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer. the aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.

there is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer. enrollment 1200 patients this wide sample is expected to respond to the main and secondary objectives of the study

Eligibility criteria:
inclusion criteria: * patients with nsclc undergoing diagnostic * performance status 0,1,2 exclusion criteria: * \>75 years * osa known and in the last 12 months treated ps \>2 * patients under a long-term oxygen therapy * persons deprived of liberty by judicial decision. * \<18 years
effect of noninvasive ventilation on physical activity and inflammation in copd patients

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic

Summary: parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with stable copd. main objective: to evaluate the effect of 12 months of noninvasive ventilation on c-reactive protein concentration and daily physical activity in hypercapnic patients with stable copd. secondary objectives: to compare the plasmatic concentration of other inflammatory biomarkers between copd patients with conventional treatment and wich noninvasive ventilation. to determine the response of breathlessness, health-related quality of life and lung function to noninvasive ventilation. to identify the copd patients with a higher gasometric and clinic response to noninvasive ventilation.


Eligibility criteria:
inclusion criteria: * age: 45-75 yrs. * copd diagnosis (postbronchodilator fev1/fvc \< 0.7) for at least 6 months. * fev1 \< 45% predicted * baseline ph 7.35-7.45 * baseline paco2\>45 mmhg breathing current air * smoking history (\>15 pack-year) * clinically stable for at least the last three months * pharmacological treatment optimized in the last two years. exclusion criteria: * previous diagnosis of asthma, other airway obstructive disease, sleep apnea syndrome, interstitial lung disease, chest wall disease or neuromuscular disease. * apnea-hypopnea index \> 10/h * morbid obesity (bmi \> 45 kg/m2) * previous diagnosis of ischaemic heart disease, cardiac failure, cirrhosis, chronic renal failure, rheumatoid arthritis or other inflammatory disease.
prevention of mucositis in patients with head and neck cancer treated with radiotherapy

Conditions: Radiation- Induced Mucositis; Adverse Effect of Radiation Therapy; Head and Neck Cancer

Summary: prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : a double-blind randomized controlled trial

to compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.

Eligibility criteria:
inclusion criteria: * aged 15 years old or older, * diagnosed with head and neck cancer * on treatment of external radiation therapy exclusion criteria: * pregnant * previously underwent external radiation therapy * illiterate

Keywords: radiation- induced mucositis head and neck cancer radiation therapy side effect
trapeziectomy vs. trapeziometacarpal limited excision for thumb base osteoarthritis

Conditions: Thumb Osteoarthritis

Summary: a randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.


Eligibility criteria:
inclusion criteria: * painful osteoarthritis in the thumb base and radiological arthritis (eaton littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test). * pain at rest. * conservative treatment \>6 months (activity modification, splinting, painkillers or thumb base steroid or prp injection) exclusion criteria: * rheumatoid arthritis. * ongoing infection in the hand or wrist. - * history of gout or pseudo gout. * inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * intra-articular injection in the affected joint within 6 months. * eaton littler class 4 (stt joint involved).
study on prevention and treatment of dry eye in patients using glaucoma drops

Conditions: Dry Eye; MGD-Meibomian Gland Dysfunction

Summary: a multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.

1. to compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. to evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.

Eligibility criteria:
inclusion criteria: * 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops. * a group: patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye: 1. subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort; 2. the instability of tear film (required): tear break up time (tbut); 3. lacrimal secretion: schirmer i test; 4. the ocular surface damage (strengthen diagnosis): fluorescein staining (fl); in the mentioned in ①+②（tbut≤5s) or ①+②（tbut≤10s)+③（\<10mm）/④（fl+）。 * the choice of study eyes: choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study. * voluntary participation in this clinical study, and signed informed consent. exclusion criteria: * with metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, sjogren's syndrome eat; * combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis. * using any artificial tears and except any clinical trials of dry eyes within two weeks. * with drug therapy, embolization and surgical treatment of dry eyes. * with other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.

Keywords: dug induced dry eye meibomian gland dysfunction, mgd sodium hyaluronate ophthalmic solution sodium bromide hydrate eye drops meibomian gland massage
investigating if a stronger tdcs intensity is more effective for improving naming ability in people living with alzheimer's disease

Conditions: Alzheimer Disease

Summary: there is currently little symptomatic therapy for alzheimer's disease (ad) and nothing effective for individuals with frontotemporal dementia (ftd). however, neuromodulation with transcranial direct current stimulation (tdcs) has the potential to be a clinically effective therapy for both ad and ftd. the challenge now is to specify the parameters and conditions under which tdcs is most effective to transition from the laboratory to clinical medicine. tdcs studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. these variable results may be related to the conventional stimulation intensity level of 2ma. the investigators predict that administering tdcs at 4.0 ma, a more significant number of participants would show a meaningful response, and those who improve at 2ma may improve even more from 4.0ma due to having a larger electric field produced. the investigators aim to test this hypothesis in people with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mild to moderate ad * score between 18 and 25 on the moca * score on the cambridge naming task during the pre-assessment exclusion criteria: * no history of stroke or tbi * no shunts or metal in the body * no history of significant heart disease, alcoholism and drug use
reproductive medicine network biologic specimen repository

Conditions: Infertility

Summary: the reproductive medicine network (rmn) is a nationwide cooperative network of 7 clinical sites and a data coordination center, and is sponsored in 5 year increments by the eunice kennedy shriver national institute for child health and human development (nichd). the rmn is charged with designing, implementing and publishing high quality clinical research in reproductive medicine. it has been in existence for over 15 years and has performed several seminal clinical trials that have fundamentally changed clinical practice in this field. in addition, many worthy ancillary protocols have been generated and published. it is this latter fact, as well as the continued interest by investigators both inside and outside the rmn for access to dna or serum samples from the previously performed trials, that has motivated the present investigators to proactively begin a biologic samples repository from the ongoing and pending rmn clinical trials. ideally, this repository would allow investigators to seamlessly access trial samples for many years into the future, and thus greatly amplify the use of resources and the impact of the rmn.


Eligibility criteria:
inclusion criteria: * any subject of an rmn clinical trial and consents to participate in the repository is eligible for inclusion. exclusion criteria: * n/a
umbilical cord length index for prediction of cord abnormalities before delivery

Conditions: Umbilical Cord Problem

Summary: the umbilical cord plays an essential role in intrauterine life. it is the pathway between mother, placenta and fetus during pregnancy and delivery. complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. compression and vasospasm in utero are important factors in fetal distress. nuchal umbilical cord can be diagnosed antepartum using ultrasound, but the complications are unpredictable and unpreventable


Eligibility criteria:
inclusion criteria: * singleton pregnancy. * pregnant ≥ 37 weeks gestation. * women who will accept to participate in the study exclusion criteria: * preterm deliveries. * amniotic fluid abnormalities (oligohydramnios, polyhydramnios). * intrauterine growth retardation * early membrane rupture * women need urgent cesarean section. * multifetal gestation. * placenta previa. * fetuses with major congenital anomalies. * women with chronic maternal illness as hypertension
sound perception study of hearing-impaired people with hearing aids

Conditions: Auditory Perception

Summary: the aim of the eternel project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. this will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. the more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. in this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.


Eligibility criteria:
inclusion criteria: for all participants: * age between 60 and 75 * native french speaker * have given their consent to take part in the study. * declare that they have an active social life or hobbies that stimulate their cognitive abilities * have a moca score above 26 * no tympano-ossicular dysfunction. * voice in noise audiometry results showing normal results. for participants with impaired hearing : * pure tone audiometry showing audiograms of type n3 or n4 and symmetrical between the two ears. * report having experienced problems with abnormally prominent sound. for participants with normal hearing: - pure tone audiometry showing audiograms with losses of less than 30 dbhl. exclusion criteria: * be under guardianship or curatorship, * be deprived of liberty by judicial or administrative decision, or be under legal protection. * bear the consequences of an ear infection and/or have a history of an ent disease that permanently affects hearing or balance (vestibular schwannoma, ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).
chiropractic management of chronic lower back pain in older adults

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine the effectiveness of chiropractic management for treatment of chronic lower back pain in older adults.

the identification of alternative safe and effective interventions for chronic lower back pain in the elderly is critical in view of its high prevalence, negative impact on quality of life and the treatment risks associated with chronic medication use. this is particularly germane to the veteran population, with a prevalence of lower back pain in excess of 40%. in 1998, published guidelines from the american geriatric society listed chiropractic management among the non-pharmacologic strategies for treating chronic pain symptoms in older adults. a recent study showed that a substantial number of older patients who received chiropractic care were less likely to be hospitalized, less likely to have used a nursing home, more likely to report a better health status, more likely to exercise vigorously and more likely to be mobile in the community. patients undergoing chiropractic care have also reported greater satisfaction as compared to standard medical care. despite the general clinical acceptance of chiropractic care and satisfaction with chiropractic services, evidence on the potential benefit and safety of chiropractic management of lower back pain in older adults is lacking. the purpose of this study is to evaluate the effectiveness of chiropractic management in older adults with chronic lower back pain, by comparing spinal manipulation to a sham intervention.

Eligibility criteria:
inclusion criteria: 1. pain greater than three months in duration 2. localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms 3. pain elicited upon deep palpation of the lumbar erector spinae musculature 4) pain that can be either exacerbated or relieved by varying body position exclusion criteria: 1. patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture 2. patient will be excluded if they have undergone a course of previous chiropractic care 3. severely demented patients, as indicated by their previous medical history and mini mental state scores of 22 or less, will not be selected. * the exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.

Keywords: older adults patient education randomized controlled trial sham procedure spinal manipulation veterans
a long term study of long-acting injectable risperidone in the treatment of patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to document the long term safety of a long-acting injectable formulation of risperidone in the treatment of patients with schizophrenia who have previously been treated with long-acting risperidone. efficacy will also be evaluated.

this is an open-label, long-term study of a flexible dose of a long-acting injectable formulation of risperidone (risperidone lai) injected into the muscle at 2 week intervals for at least 12 months in patients diagnosed with schizophrenia. it is an extension of an open label study of patients with schizophrenia (ris-usa-259) switching from treatment with an oral antipsychotic medication to long-acting injectable risperidone. safety evaluations include incidence of adverse events, physical examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis), electrocardiograms (ecgs), and extrapyramidal symptom rating scale (esrs), a scale for assessing muscle tone, gait, and abnormal movements. efficacy assessments include measurements using the positive and negative syndrome scale for schizophrenia (panss) and the clinical global impression-severity of illness scale (cgi-s). risperidone (25-50milligrams \[mg\]) injections, long-acting formulation, every 2 weeks for at least 1 year. dosages may be increased (50 mgs maximum) or decreased at discretion of the investigator. supplementary risperidone tablets (1mg) may be administered.

Eligibility criteria:
inclusion criteria: * completion of ris-usa-256 within 7 days exclusion criteria: * history of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness * significant and untreated or unstable medical illness such as diabetes, hypertension, angina * serious illness of the liver, kidney, or significant disturbances of the cardiac, pulmonary, gastrointestinal, endocrine, neurological system * pregnant or nursing females, or those lacking adequate contraception * known hypersensitivity or unresponsiveness to risperidone

Keywords: schizophrenia intramuscular injection antipsychotic agents long-acting risperidone
the association between gene polymorphisms and infectious complications after liver surgery

Conditions: Liver Disease

Summary: the purpose of the study is to test whether the presence of polymorphisms in genes encoding substances of the innate immune response in patients undergoing partial hepatic resection because of benign or malignant hepatobiliary disease is related to a higher incidence of infectious complications, post-resectional liver failure or mortality.

partial hepatic resection is a feasible and relatively safe procedure for selected patients with benign or malignant hepatobiliary disease. liver failure after partial hepatic resection, so-called post-resectional liver failure (plf), is a dreaded complication with high mortality rates. patients suffering from plf experience significantly more clinically significant infections (csi) when compared with patients without plf. the liver plays an important role in the body's innate immune defense. recently, polymorphisms in genes encoding key molecules in the innate immune response (e.g. nuclear factor kappa-b) have shown to be associated with a greater risk of csi. the presence of these polymorphisms combined with partial hepatic resection might render patients susceptible to the development of csi, plf and early mortality after liver resection.

Eligibility criteria:
inclusion criteria: * age \>18 years * benign or malignant liver disease requiring partial hepatic resection exclusion criteria: * inability to give informed consent * liver disease judged irresectable after intra-operative evaluation * use of immunosuppressive drugs * resection \< 1 segment * unable to comply with follow-up

Keywords: liver surgery gene polymorphisms innate immune response infectious complications post-resectional liver failure mortality