Kornimate/medical-research-clean huggingface dataset:
modal day analysis of self monitoring blood glucose versus continuous glucose monitoring

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effectiveness of self monitoring of blood glucose (smbg) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using continuous glucose monitoring (cgm) for clinical diabetes management.


Eligibility criteria:
inclusion criteria: * male or female subjects ≥18 and ≤75 years of age * clinical diagnosis of diabetes * diabetes duration ≥ 1 year * hba1c ≥7.2% * diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy exclusion criteria: * taken prednisone or cortisone medications in the previous 30 days * currently pregnant or planning pregnancy during the study period * presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the subject's safety or successful participation in the study * unable to follow the study protocol * unable to speak, read and write in english

Keywords: type 2 diabetes a1c continuous glucose monitoring blood glucose
dosing of lt4 in older individuals

Conditions: Hypothyroidism

Summary: our overall goal is to determine the clinical consequences of allowing greater flexibility in lt4 dosing in older individuals who take lt4.

investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (lt4) in patients aged 65 years and older who are already taking a stable dose of at least 1.2 mcg/kg/day of lt4 therapy, one to maintain a target thyroid stimulating hormone (tsh) level of 0.5-2.0 mu/l (lower tsh group) and another of a lower levothyroxine dose to achieve a target tsh of 5.5-7.0 mu/l (higher tsh group). investigators will assess the effects of levothyroxine therapy at two different tsh targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, community dwelling, aged 65 years or older 4. diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day lt4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last tsh test. 5. ability to take oral medication and be willing to adhere to the medication regimen exclusion criteria: 1. hypopituitarism 2. history of thyroid cancer requiring suppression of tsh secretion 3. current use of liothyronine (lt3), thyroid extracts, tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests 4. gfr \<30 ml/min/1.73 m2 within the prior 12 months 5. unable to understand and comply with study requirements, as assessed by study staff and the pi, will be excluded. 6. other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.

Keywords: levothyroxine dosing
masitinib combined with isoquercetin and best supportive care in hospitalized patients with moderate and severe covid-19

Conditions: SARS-CoV 2; COVID-19; Coronavirus Disease 2019

Summary: study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe covid-19.

covid-19 is a respiratory disease caused by a novel coronavirus (sars-cov-2) that is associated with substantial morbidity and mortality. there is currently no vaccine to prevent covid-19 or infection with sars-cov-2 or therapeutic agent to treat covid-19. many patients with moderate and severe covid-19, develop a "cytokine storm" that leads to severe pulmonary inflammation and various thrombotic events associated with acute respiratory distress syndrome (ards) and potentially death. the combination of masitinib and isoquercetin may prevent the development of these two complications. masitinib is a potent blocker of mast cells and macrophages that are contributors to the cytokine storm. isoquercetin inhibits disulfide isomerase (pdi), an enzyme directly involved in the formation of clots, and also decreases d-dimer, a predictor of covid-19 thrombosis severity. the primary objective of this study is to evaluate efficacy of the masitinib and isoquercetin combination in moderate and severe covid-19 patients. the primary endpoint is subject clinical status at day 15, using a 7-point ordinal scale that is defined as follows: 1. not hospitalized, no limitations on activities; 2.not hospitalized, limitation on activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. hospitalized, on invasive mechanical ventilation or ecmo; 7. death.

Eligibility criteria:
inclusion criteria: * has laboratory-confirmed sars-cov-2 infection * hospitalized patients for the treatment of covid pneumopathy * patients not requiring icu at admission with moderate and severe pneumopathy according to the oms criteria of severity of covid pneumopathy.
gp2013 in the treatment of patients with previously untreated, advanced stage follicular lymphoma (assist_fl)

Conditions: Follicular Lymphoma

Summary: the purpose of this study is to demonstrate comparability of the orr in patients with previously untreated, advanced stage fl who receive gp2013-treatment to patients who receive mabthera-treatment.


Eligibility criteria:
inclusion criteria: * patient with previously untreated advanced stage, cd20-positive fl * patient with ecog performance status 0, 1 or 2. exclusion criteria: * patient with grade 3b (aggressive) fl or any histology other than fl grade 1, 2 or 3a * patient who has previously received any prior therapy for lymphoma * patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). * patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. other protocol-defined inclusion/exclusion criteria may apply

Keywords: follicular lymphoma biosimilar gp13-301 rituximab antibodies cd20
vaginal ecosystem and network in the united states study

Conditions: Bacterial Vaginosis; Candidiasis; Urinary Tract Infections; Genitourinary Syndrome of Menopause; Lichen Sclerosus; Lichen Planus; Vulvodynia; Endometriosis; Ureaplasma Infections; Cancer; Desquamative Inflammatory Vaginitis

Summary: the central premise of this study is that the intricate balance and diversity of the vaginal microbiome plays a pivotal role in the onset, progression, and severity of various gynecological conditions. specifically, the research aims to investigate how imbalances in microbial communities, such as the overgrowth of pathogenic bacteria or the depletion of beneficial ones, are linked to conditions like bacterial vaginosis, candidiasis, urinary tract infections, vaginal atrophy, and others. by employing pcr testing and the outcomes of next-generation sequencing (ngs) of the microbiome, the study seeks to identify distinct microbial profiles and patterns that are characteristic of each condition. this nuanced understanding is expected to lead to more accurate and early diagnosis, facilitating personalized and effective treatment strategies that go beyond the conventional, often indiscriminate use of antibiotics.

this study protocol is developed to analyze the vaginal microbiome of women using a 56-panel pcr test and ngs test. the aim is to collect vaginal swab samples from a wide range of participants, including both healthy individuals and those with diagnosed gynecological conditions, to identify different microbiome profiles. a key aspect of this study is the creation of a registry that will compile the data obtained from the pcr/ngs test results and participant information. this registry will serve as a valuable resource for ongoing research and will support the development of personalized approaches in women's health care. by systematically collecting and analyzing data, the registry will facilitate a better understanding of the vaginal microbiome's role in health and disease, aiding in the advancement of diagnostic and therapeutic strategies. additionally, the registry will provide a foundation for future studies, allowing for the exploration of long-term trends and relationships within the vaginal microbiome. this could lead to new insights into how the microbiome influences gynecological health and the development of targeted treatments. the combination of validating a precise diagnostic tool and establishing a comprehensive registry is aimed at enhancing patient care and supporting the broader research community in women's health.

Eligibility criteria:
inclusion criteria: * healthy cis-gender women between ages 18 and 89 exclusion criteria: * immunosuppressed or otherwise immunocompromised * pregnant or trying to conceive (i.e. ivf, iui)
obesity: prospective evaluation of upper airway obstruction and compliance in obese patients in pre and post bariatric surgery

Conditions: Obesity; Bariatric Surgery

Summary: this clinical trial is a monocentric, prospective, observational and controlled trial (historical cohort control group of healthy non-obese subjects who had nasal functional exploration for snoring) as part of current care. this study concerns the prevalence of obstructive sleep apnea syndrome (osas). osas is elevated in subjects with morbid obesity (bmi≥40) (on average 70%). international recommendations agree on the need to seek osas before bariatric surgery because of the high risk of complications. increased nasal resistance could also be related to a limitation of inspiratory flow due to an abnormality of the elasticity of the nasal mucosa or "nasal compliance". adipose infiltration of the nasal mucosa may occur during obesity. these tissue changes (decreased vaso-erectile tissue and increased adipose tissue) could modify the nasal compliance, which the decrease would be a possible factor of severity of osas in obese patients. screening for an abnormality of compliance could also anticipate a difficulty of equipment for continuous positive airway pressure (cpap) in the case of associated osas. all patients who must have bariatric surgery and get in the criteria are included. they will have to do a medical checkup pre and post-operative (polygraphy + ear/nose/throat assessment (ent) + nasal functional exploration). they will be followed for 13 to 24 months. the main objective of this research is to demonstrate a reduction of at least 30% of nasal compliance in a group of obese subjects (bmi\> 35) compared to a control group of healthy subjects. the secondary objectives are to is to demonstrate an increase of 30% in resistance in patients with bmi\> 35 compared to control group and a normalization of nasal compliance 1 year after surgery when their weight is normalized (bmi \<30). a study period of 4 years is planned.


Eligibility criteria:
inclusion criteria: * voluntary patient * patients aged 18 years or older. * bmi \> 35 * patient included in the bariatric surgery protocol * medical checkup :polygraphy and respiratory functional exploration (rfe) exclusion criteria: * impossible to obtain a consent or age less than 18 years * heart / kidney failure * absence of affiliation to a social security scheme * history of rhinological surgery * pregnancy, breastfeeding * subject presenting a congenital or acquired obstructive nasal obstructive physical obstacle (obstructive deviation, craniofacial malformation)

Keywords: obstructive sleep apnea syndrome (osas)
diaphragmatic paralysis in arthroscopic shoulder surgery

Conditions: Dyspnea; Hypoxia; Analgesia

Summary: this study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with bmi ≥ 30 kg/m².

this prospective observational study will screen patients with body mass index (bmi) ≥30 kg/m² undergoing acromioplasty or supraspinatus tendon repair. occurrence of post-operative hemidiaphragmatic paralysis will be observed using m-mode ultrasonography and its consequences on patient ventilation: arterial oxygen saturation, dyspnea, success of ambulatory procedure. causes of diaphragmatic paralysis will be analyzed.

Eligibility criteria:
inclusion criteria: * all patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened. exclusion criteria: age \<18 years, brachial plexus neuropathies, severe bronchopulmonary disease, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medications of the study protocol and diabetes.
comparison of blood products required using two different rotem cut-offs before invasive procedures in cirrhosis and acute on chronic liver failure (aclf) patients with severe coagulopathy

Conditions: Acute-On-Chronic Liver Failure

Summary: coagulation system in cirrhotics patients is a fragile state , which is rebalanced hemostasis. standard tests (inr/aptt) stop measuring at first stage of coagulation ,when the clot first form. vets measure the whole process such as rotem, teg and comparing these two tests to assess for transfusion of blood products for invasive procedures. . rotem provides information both on anti coagulant and procoagulant status where as conventional tests provide only anti coagulant status invasive procedures can be low risk or high risk or non surgical vs surgical, procedure related bleed occurs in 7% of patients with cirrhosis and associated with higher 28 day mortality. meld, ctp ,aki , sepsis increase the risk of procedure related bleed. hence for invasive procedures investigator is using relaxing threshold for blood product transfusion in cirrhosis, aclf patients. as use of rotem when compared to conventional tests reduces the need for blood transfusion. investigator want to proceed with further relaxation of cutoff values of coagulation parameters and use high cutoff vs low cut off for blood transfusion need.

aim and objective - to evaluate the efficacy and safety of relaxed threshold (compared to threshold) for blood product transfusion for invasive procedures in cirrhosis and aclf patients. hypothesis - relaxing the threshold ( as compared to conventional threshold ) for blood product transfusion will decrease the need for blood products without increase the bleeding complications for invasive procedures in cirrhosis and acute on chronic liver failure patients( aclf) sample size with justification: assuming the prevalence rate is 50% (tushar thesis -yet to be published), that is need of transfusion of blood produtcs in standard cutoff and relaxed cutoff , as according to this study the need in relaxed cut off has been reduced,investigator assumed the need in high cut off group is reduced to 40%, with alpha-5%, power-80%, investigator need to enroll 417 in each group with defaulter of 10% , it decided to have cases that is 934 total monitoring and assessment: all patients would undergo vital and baseline parameter screening before randomization. based on randomization investigator will assess the need for transfusion , and complications post procedure , post transfusion if any for a duration of 1month. intervention: patient after screening for all exclusion criteria will be randomized to procedure after or before transfusion of blood products and will be assessed the safety of procedure related bleed and need of intervention post procedure if any

Eligibility criteria:
inclusion criteria: 1. cirrhosis and aclf ( as per definition) 2. planned to undergo invasive procedures 3. severe coagulopathy- inr\>2.0 or platelets \<30k or fibrinogen\<100mg/dl . exclusion criteria: 1. ongoing bleeding 2. bleeding in past 48 hours before procedure 3. antiplatelet or anticoagulant therapy ( stopped \< 7 days before)
the use of q-collar to increase csf drainage in low-pressure hydrocephalus patients

Conditions: Low Pressure Hydrocephalus

Summary: the investigators hypothesize that the q-collar compression on bilateral internal jugular veins of patients with low pressure hydrocephalus will decrease venous drainage from the intracranial space, therefore increasing intracranial volume, decreasing brain compliance, and increasing csf drainage through the shunt. this should improve persistent hydrocephalus symptoms and demonstrate improved ventricular drainage on imaging with decompressed ventricles.

low-pressure hydrocephalus is an entity that is rare and difficult to manage. at this institution, dr. paul camarata uses a method of "neck-wrapping" in those low-pressure hydrocephalus patients that were admitted for complications with their shunt, hypothesized to decrease venous outflow from the intracranial space, increase venous pressure within the cranium and therefore increase the turgor in the brain tissue allowing for csf to more easily be pushed out of the ventricular space and through the drain. this would relieve the hydrocephalus symptoms and reduce ventricular size on imaging. the advent of the q-collar for reducing tbi in contact sports functions in a similar way to the "neck-wrapping" used at this institution, but via the simplified tool of the collar. it functions by compressing the internal jugular veins bilaterally to increase intracranial volume and prevent "brain slosh" that can occur in contact sports that leads to brain injury. the collar in contrast to the neck wrap occupies a smaller surface area, which the investigators hypothesize will reduce the discomfort that is commonly associated with neck wrap. furthermore, applying this q-collar to low pressure hydrocephalus patients that struggle with symptom management while inpatient, the investigators hypothesize that csf drainage will improve with wearing the collar via increased intracranial volume and lower brain compliance, therefore improving persistent hydrocephalus symptoms that are limiting on patient quality of life.

Eligibility criteria:
inclusion criteria: * adult with low-pressure hydrocephalus, able to cranial imaging, able to provide consent or have surrogate decision maker that is able to provide it for them exclusion criteria: * pediatric patients, patients that can't consent or don't have a surrogate decision maker, patients that can't get cranial imaging
dynamic hyperinflation during maximal voluntary ventilation in healthy subjects

Conditions: Dynamic Hyperinflation

Summary: maximal voluntary ventilation (mvv) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in copd (chronic obstructive pulmonary disease) patients. dynamic hyperinflation (dh) often occurs during mvv in copd and is believed to be due to expiratory flow limitation. the present study is intended to assess whether dh can also occur during mvv in normal subjects without expiratory flow limitation.

maximal voluntary ventilation (mvv) correlates well with maximal exercise capacity and is used to assess the ventilatory function during exercise in copd (chronic obstructive pulmonary disease) patients. dynamic hyperinflation (dh) often occurs during mvv in copd and is believed to be due to expiratory flow limitation. the present study is intended to assess whether dh can also occur during mvv in normal subjects without expiratory flow limitation. study design: healthy subjects with normal lung function will perform mvv at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. inspiratory capacity (ic) will be measured at rest and after each 12 seconds of mvv in order to detect dh. from the moment dh appeares at a given frequency, only one additional mvv at a higher breathing frequency will be conducted to confirm dh.

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * history of asthma, obstructive syndrome on basic lung function

Keywords: dynamic hyperinflation maximal voluntary ventilation inspiratory capacity healthy subjects
post-operative myocardial incident & atrial fibrillation

Conditions: Valve Heart Disease; Coronary Artery Disease

Summary: to explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.


Eligibility criteria:
inclusion criteria: * patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation exclusion criteria: * pregnant woman * urgent surgery or intervention * not able to consent to the protocol

Keywords: prognosis translational research
weaicor: wearables to investigate the long term cardiovascular and behavioral impacts of covid-19

Conditions: Covid19; Cardiovascular Complication; Behavioral Changes

Summary: this is an observational covid-19 study that uses wearable health monitoring technology to follow covid-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.

participants will wear a biostrap wristband device that captures high-fidelity, raw photoplethysmography (ppg) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. biometric data will be collected and participants will be alerted if any measurements are outside their normal range. researchers are recruiting 200 participants who were diagnosed with covid-19.

Eligibility criteria:
inclusion criteria: * positive covid-19 diagnosis * ages 18 to 120 * access to wifi exclusion criteria: * negative covid-19 diagnosis * age younger than 18 and older than 120 * lack of access to wifi

Keywords: digital health