Kornimate/medical-research-clean huggingface dataset:
pharyngeal sensitivity in diagnosis algorithm for sleep apnea syndrome

Conditions: Sleep Apnea Syndrome

Summary: pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. preliminary results have suggested that the use of this parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. pharyngeal sensitivity will be measured using the sensitest device which allows an automatic measurement of the pharyngeal sensation. the use of this parameter in diagnosis algorithm will be compared with polysomnographic results.


Eligibility criteria:
inclusion criteria: * consecutively included patients with suspicion of sleep apnea syndrome * patients who have signed the informed consent form * patients with body mass index less than or equal 30 kg/m2 exclusion criteria: * body mass index more than 30 kg/m2 * pharyngeal infection or allergic rhinitis less than 2 weeks before recordings * craniofacial anomalies and/or limited mouth opening and/or teeth position compromising mouthpiece installation and stability during measurement * instable dentures * exaggerated gag reflex preventing pharynx examination * no visibility of the soft palate * systemic or topical anti-inflammatory treatments * treatments that may increase the occurence of nocturnal respiratory events and/or leading to daytime sleepiness and cognitive impairment * cardiac failure, or symptoms suggesting cardiac failure * history of stroke * contraindication for using xylocaine spray * no affiliation to national insurance * patient participating in another research study involving drugs that may interfere with sleep recordings and/or measurement of pharyngeal sensation * patient subjected to exclusion period following participation in another research study

Keywords: sleep apnea pharyngeal sensitivity pharyngeal dilator reflex diagnosis algorithm patients with suspected sleep apnea syndrome
a study of monthly risedronate for osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

the comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Eligibility criteria:
inclusion criteria: * female: 50 years of age or older * \>5 years since last menses natural or surgical * have lumbar spine bmd (bone mineral density) more that 2.5 standard deviations (sd) below the young adult mean, or have 1-spine bmd more than 2.0 sd below the young adult female mean value and also have at least one prevalent vertebral body fracture exclusion criteria: * history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia * bmi (body mass index) \>32 kg/m\^2 * use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone * hypocalcemia or hypercalcemia of any cause * markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Keywords: randomized controlled trial, osteoporosis, risedronate
pa.ri.ge. study. the prognostic role of inflammatory circulating biomarkers in hnscc: a prospective multicentric trial

Conditions: Head and Neck Cancer

Summary: this is a clinical, observational, non-pharmacological, multicenter, prospective case-control no-profit study to assess the prognostic role of several circulating inflammatory biomarkers


Eligibility criteria:
inclusion criteria: 1. age \&gt; 18 years; 2. written informed consent; 3. squamous carcinoma of the hypopharynx, larynx and oral cavity; 4. clinical stage i-iva according to the viii edition of ajcc staging system 5. primary surgery as first line curative intent treatment, followed by ± adjuvant radiotherapy± chemotherapy based on the pathological findings following the nccn guidelines exclusion criteria: 1. relapsing or metastatic disease 2. locally advanced disease not amenable to curative intent treatment 3. previous local or systemic treatment for head and neck cancer 4. previous malignancies (exluding non-melanoma skin cancers) unless complete remission has been achieved at least 5 years before entering the study 5. psychiatric disorder or known substance abuse 6. concomitant immunosuppressive treatment 7. concomitant immunostimulant treatment 8. chronic inflammatory disease 9. autoimmune disease 10. major surgery in the previous year 11. history of recent onset of any condition which, in the investigator's opinion, could interfere with patient adherence for the entire duration of the protocol. 12. positive serum pregnancy test for women of childbearing age. women of childbearing potential (wocbp) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
the research registry for neonatal lupus

Conditions: Neonatal Lupus; Systemic Lupus Erythematosus; Sjogren's Syndrome; Congenital Heart Block

Summary: women with lupus and other related disorders produce certain antibodies in the blood. some women have these antibodies even if they have not yet developed symptoms of lupus or sjogren's syndrome. when these women become pregnant, they may pass the antibodies to their infants. the infants may then develop a disease called neonatal lupus. the symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. this registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.

neonatal lupus is a disease seen in babies born to mothers who have antibodies to ssa/ro and/or ssb/la proteins. the mother may have systemic lupus erythematosus, sjogren's syndrome, or be otherwise healthy. heart block and a characteristic skin rash are the primary manifestations of neonatal lupus. the research registry for neonatal lupus was initiated in 1994 to help basic scientists and clinicians better understand the cause of neonatal lupus and discover a cure. the research registry is a central repository of patient information, sera, and dna. the registry provides blood samples (kept anonymous) to scientists studying neonatal lupus. information from the registry forms the basis of family counseling and tracks important data such as recurrence rates in subsequent pregnancies and the effects of treatments. the research registry also serves as an educational resource for women who are eager to learn about this disease. women with a child affected by neonatal lupus may enroll in the registry. women can be self referred or referred by their doctors. siblings of women with a child affected by neonatal lupus, fathers and maternal grandparents of children with neonatal lupus, and unaffected siblings of a child with neonatal lupus are also invited to participate in this study. all information on the mother and her family is confidential; only nonidentifying information will be provided to researchers. women interested in the registry will be sent articles and educational materials about neonatal lupus, a consent form for the registry, and an enrollment questionnaire. participants will be asked to sign a medical records release form. participants will also be asked to donate a blood sample for antibody testing and dna isolation.

Eligibility criteria:
inclusion criteria: * mother with antibodies to ssa/ro, ssb/la, or ribonucleoproteins (rnp) or child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) or father of neonatal lupus-affected child or maternal grandparents of neonatal lupus-affected child or maternal aunts and uncles of neonatal lupus-affected or unaffected siblings of neonatal lupus-affected child

Keywords: anti-ssa/ro antibodies anti-ssb/la antibodies
pathological fracture in potentially unstable spinal metastases of breast cancer

Conditions: Spinal Metastases; Breast Cancer

Summary: the purpose of this study is to identify potential risk factors for and determine the rate of pathological fracture for patients which having spine metastases from breast cancer and be defined as potentially unstable (sins 7-12) according to the spinal instability neoplastic score (sins). the investigators' analysis will provide robust data about the development of spinal instability and help identify the optimal timing of local surgery treatment.

considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the spine oncology study group (sosg) devised an 18-point sins, which proved reliable and has been widely used in clinical practice. scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. lesions with a low sins (score 0-6) do not requires surgical interventions, whereas a high sins (score 13-18) predicts the need for surgical stabilization to restore spinal stability. however, treatment strategy of intermediate sins (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. with the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate sins (score 7-12) to explore the rate of pathological fracture and relevant risk factors. this study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.

Eligibility criteria:
inclusion criteria: * age 18-65 years, female * had a histological confirmation of breast cancer, including all pathological types * had a histological or radiological confirmation of spinal metastases from breast cancer * sins 7-12 exclusion criteria: * prior prophylactic stabilization surgery to the spine at current level of interest * patients with other malignancies except breast cancer * misdiagnosis of spinal metastases from breast cancer confirmed by pathological examination * patients without undergoing follow-up on schedule * withdraw from the study for any reason

Keywords: pathological fracture indeterminate instability spinal metastases breast cancer
pharmacokinetics, safety, tolerability and pharmacodynamics of bms-986189 in healthy subjects

Conditions: Severe Sepsis

Summary: the main purpose of this study is to measure the amount of study drug (bms-986189) in the blood and urine and to see if bms-986189 is safe and well-tolerated in healthy people after a single dose.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy, males and females, 18 to 55 years of age, inclusive * body mass index (bmi) of 18.0 to 30.0 kg/m2, inclusive * women of childbearing potential (wocbp) must have negative serum pregnancy test (performed for all females; minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 24 hours prior to start of study drug exclusion criteria: * any significant acute or chronic medical illness * history of diabetes mellitus, severe hypertriglyceridemia, acute or chronic pancreatitis, pancreatic exocrine disorder * history of autoimmune disease * any known skin condition that would affect subcutaneous dosing * positive blood screen for hepatitis c antibody (hcv ab), hepatitis b surface antigen (hbsag), or hiv -1 and hiv -2 antibody other protocol defined inclusion/exclusion criteria could apply
phase 3 study of tislelizumab versus sorafenib in participants with unresectable hcc

Conditions: Hepatocellular Carcinoma (HCC)

Summary: this is a phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. this study also includes a substudy investigating the safety, tolerability, pk, and preliminary efficacy in hcc in japanese participants. in japan, preliminary safety and tolerability will be evaluated (safety run-in substudy) before japanese participants are recruited in this phase 3 study.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed diagnosis of hcc 2. barcelona clinic liver cancer (bclc) stage b or c disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach 3. no prior systemic therapy for hcc (with the exception of hcc participants enrolled in the safety run-in substudy \[japan only\]) 4. measurable disease 5. child-pugh score a 6. easter cooperative oncology group (ecog) performance status ≤ 1 7. adequate organ function key exclusion criteria: 1. known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc histology 2. tumor thrombus involving main trunk of portal vein or inferior vena cava 3. loco-regional therapy to the liver within 28 days before randomization 4. clinical evidence of portal hypertension with bleeding esophageal or gastric varices at screening, or within 6 months before randomization 5. bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at screening, or within 6 months before randomization/enrollment 6. presence at screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse 7. participant with any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization 8. history of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy 9. qt interval corrected for heart rate (qtc) (corrected by fridericia's method) \> 450 msec at screening note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: advanced liver cancer rationale-301
study of cyclosporine in the treatment of dry eye syndrome (st-603-005)

Conditions: Dry Eye Syndromes

Summary: the purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe dry eye syndrome with or without sjogren's syndrome or other autoimmune disease exclusion criteria: * intraocular or refractive surgery in the study eye within 3 months prior to study start * unwilling to discontinue use of contact lenses during the run-in and duration of the study * pregnancy or lactation
the effect of surface acoustic waves on the prevention of colonization in longterm indwelling urinary caatheters

Conditions: Baacterial Colonization; Urinary Tract Infections

Summary: this is a double blinded rct to evaluate the effect of the uroshield saw transducer on preventing bacterial colonization in longterm indwelling catheters. the duration of the trial is 30 days. the investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.

this is a double blinded randomized controoled trial of 30 days duration. the trial device is the uroshield, saw device which is an externally applied device attached to the external portion of the urinary catheter. subjects will be randomized to a control group and the treatment group. the control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham uroshield device. the treatment group will receive the same standard of care treatment but will be attached to an active uroshield saw device. at baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. these numbers will be evaluated to see if there is a difference between the active and sham devices.

Eligibility criteria:
inclusion criteria: * currently being treated with an indwelling urinary catheter for at least 30 days. * ability to sign informed consent or have someone authorized to sign informed consent. exclusion criteria: * currently being treated for an active urinary tract infection. * previous treatment with surface acoustic waves.

Keywords: catheter uti's
cardiac autonomic dysfunction in childhood cancer survivors

Conditions: Autonomic Dysfunction; Childhood Cancer

Summary: this study is being done to evaluate heart rate activity and sleep patterns, among participants in the long-term follow-up (ltfu) study. primary objective using mobile health (mhealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions. secondary objectives among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.

potential participants will be recruited by email and phone. survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. this data collection will take place in datstat connect, which is the online consenting and data collection tool utilized for the ccss. consented/enrolled sjlife participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a whoop® strap prior kit prior to scheduling a device setup session with a team member. the kit will include the whoop® strap, brief instructions for setup, and prepaid return mailing materials. the whoop® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)

Eligibility criteria:
inclusion criteria: * enrollment on the ccss protocol. * 18 years or older. * has a smartphone and is willing to download the whoop® app for the duration of study participation. * reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables. exclusion criteria: * unable to independently provide informed consent. * visual impairment that prevents participant from engaging with study materials. * unable to read or understand study materials in english. * mailing address outside the united states.

Keywords: childhood cancer survivors cardiac
effect of different doses of budesonide on markers of bone metabolism in children with asthma

Conditions: Asthma

Summary: the purpose of the trial is to check if inhaled glucocorticosteroids (igcs) have influence on bone condition (if igcs increases risk of osteoporosis and bone fraction) in children with asthma.

asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. igcs are the basic group of drugs in asthma, because of inflammatory character of disease. all igcs are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. the purpose of trial is to check if igcs have influence on bone condition (if igcs increases risk of osteoporosis and bone fraction) in children with asthma.

Eligibility criteria:
inclusion criteria: * allergic only to house dust mites * never treated chronically (longer than at least 3 months) with anti-asthmatic drugs * newly-diagnosed or non-treated asthma * must be able to inhale drugs exclusion criteria: * other allergic diseases requiring treatment with glucocorticosteroids * other chronic diseases * asthma exacerbation * pregnancy

Keywords: asthma children inhaled glucocorticosteroids bone metabolism
feasibility & acceptability of a virtual sister circle intervention for black women with depressive symptoms

Conditions: Depressive Symptoms; Depression

Summary: the purpose of this study is to evaluate the feasibility and acceptability of a protocol for middle- and older-aged black women with depressive symptoms.


Eligibility criteria:
inclusion criteria: * identify as black or african american * identify as female * age 40 years and older * community-dwelling * self-report of experiencing depressive symptoms * ability to commit to the 8-week intervention * access to zoom * speak and read english exclusion criteria: * have a diagnosis of bipolar, but is not taking medication for the condition * experiencing psychosis

Keywords: sister circle black women
impact of handing to patients a copy of the consultation report on their medicine consumption

Conditions: Viral Gastro Enteritis; Pharyngitis

Summary: in france, patients with benign viral infections (ie: gastro enteritis and/or rhinopharyngitis, etc.) often receive several prescriptions from their doctors, although there is evidence that these medicines are not efficient. we hypothesize that patients could be reassured by health advices, especially if they are written. in addition, we believe that doctors would feel less guilty for not prescribing drugs if they could hand written consultation reports to patients, in these situations. we aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

in france, 90% of general practitioners' (gps) consultations end with prescription of drugs (versus only 43,2% in netherlands). a french medical thesis published in 2013 showed that drugs prescriptions were not a priority for patients. rather than medicine's prescription, patients preferred attentive listening associated with personalized advices from their gps. several studies also showed that a commercial relationship exists between doctors and patients. the prescription is like an exchange currency against the patient money. we aim to assess the impact of handing to patients with viral gastroenteritis or upper respiratory tract infections, a copy of the consultation report on their medicine consumption.

Eligibility criteria:
inclusion criteria: all consecutive patients with \>18 ans diagnosis of gastroenteritis or rhinopharyngitis by the physician written consent by patient exclusion criteria: patients who have already visited the doctor in the last 15 days a given patient can only be included once diagnostic uncertainty or need of laboratory tests cognitive impairment only one patient by family or visit

Keywords: general practice viral infections consultation reports drug prescription