Kornimate/medical-research-clean huggingface dataset:
dietary fiber intake in alcohol-dependent patients

Conditions: Alcoholism

Summary: the alcohol problem affects 7.5% of the population in europe and represents a major public health problem. alcoholism is also a major cause of undernutrition. diet is a major factor influencing the composition of the intestinal microbiota and previous studies, carried out at saint-luc clinics and catholic university of louvain, show that alcoholic patients suffer from dysbiosis, that is a significant alteration of the gut microbiota. the investigator's preliminary studies, carried out at the integrated unit of hepatology of saint-luc clinics, have shown that alcohol represents more than 40% of total caloric intake in alcohol-dependent patients. in addition, alcoholic patients have an insufficient intake of dietary fiber, that is to say a contribution lower than the belgian nutritional recommendations. indeed, the conseil supérieur de la santé recommends a total amount of dietary fiber equal to or greater than 25 grams per day to ensure correct intestinal function. fructan-type dietary fiber (inulin and fructo-oligosaccharides) is found naturally in many fruits and vegetables (jerusalem artichokes, asparagus, artichokes, onions, garlic, chicory roots, bananas). they are neither absorbed nor digested by human enzymes but fermented selectively by intestinal bacteria. a good digestive tolerance to dietary fiber supplementation has been observed in healthy subjects as well as in obese patients, in previous studies conducted at catholic university of louvain and saint-luc clinics. however, a nutritional rebalance via fiber supplementation and digestive fiber tolerance have never been tested in an alcohol-dependent population. the primary objectives of this academic research project in nutrition, carried out in alcohol-dependent patients, are as follows: 1. restore a nutritional balance as recommended by the conseil supérieur de la santé via a dietary fiber intake 2. to study digestive tolerance to fibers 3. to study the intestinal and psychological well-being related to a fiber intake depending on the results obtained during the achievement of the primary objectives, the biological samples (blood, stool) collected during the study will be used to analyze the composition of the intestinal microbiota and the plasma markers associated with intestinal function.


Eligibility criteria:
inclusion criteria: * male or female * aged between 18 and 65 * caucasian * french speaking * alcohol drunk less than 48h before day 1 exclusion criteria: * another addiction, except smoking * psychiatric comorbidity on axe 1 of diagnostic and statistical manual-iv * antibiotic, probiotic or fibers recent (\<2 months) treatment (or other molecule modifying intestinal transit) * non-steroidial anti-inflammatory drug or glucocorticoids recently taken (\<1 month) * obesity: body mass index\<30 * bariatric surgery * type 1 or 2 diabetes * chronic inflammatory diseases (crohn disease, coeliac disease, rheumatoid arthritis) * cirrhosis or advanced hepatic fibrosis (fibroscan \> or = f3) * pregnancy

Keywords: dietary fibers alcohol-dependent
real-time detection of ctdna and/or hpv dna in high-risk locally-advanced head and neck squamous cell carcinoma

Conditions: Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer

Summary: this research study will include patients with high risk locally advanced head and neck squamous cell carcinoma (la-hnscc) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment. patients with both stage iii hpv positive and stage iii hpv negative will be included. in this study, we aim to evaluate feasibility of ctdna and/or hpv dna detection in real time in high-risk la-hnscc.

pre-meridian aims to study the kinetics of ctdna and hpv dna after standard treatment in high-risk la-hnscc patients. this is an important study to understand their role in detecting mrd and determine optimal timing for ctdna and hpv dna quantification for future studies in immunotherapy. we hypothesize that hpv dna (in hpv+) +/- ctdna detection in plasma after standard therapy may be quantified and monitored as mrd in high risk la-hnscc patients. we further hypothesize that detection of mrd in high risk la-hnscc after standard therapy may predict recurrence. finally, we hypothesize that ctdna time-to-clearance will be longer than 4-6 weeks after the end of treatment in some la-hnscc patients and therefore mrd may be further tested at 8-10 weeks after the end of standard therapy

Eligibility criteria:
inclusion criteria: * histologically or cytological confirmed la-hnscc of the oral cavity, oropharynx, hypopharynx, or larynx. * stage iii hpv positive or stage iii-iv hpv negative. * availability of tumor sample * patients who are candidates for standard definitive treatment defined as: * surgery followed by radiotherapy +/- chemotherapy or * definite radiotherapy or * definite chemoradiotherapy. exclusion criteria: * early stage hnscc (i and ii) * distant metastatic hnscc

Keywords: kinetics of ctdna kinetics of hpv dna high-risk la-hnscc liquid biopsy head and neck molecular profiling advanced cancer
neuronal integrity in bipolar depression

Conditions: Bipolar I Disorder, Most Recent Episode Depressed

Summary: the aim of this study is to examine the neurological unity in bipolar depression and to investigate white matter abnormalities that may contribute to etiology

bipolar disorder is a chronic mood disorder which is characterized by repetitive episodes, usually manifests through adolescence or early adulthood. it has a prevalence of approximately 2,5% with a 1:1 ratio of male and female. it is a disorder that may disrupt central nervous system functions such as cognition, thought, perception, affect, judgement, adaptation to the environment and behavioural regulation. it may manifest with various clinical onsets. although etiology of bipolar disorder is still unknown, some biological factors such as bdnf, oxidative stress and structural changes of brain are proven to have a role in etiology. diffusion tensor magnetic resonance imaging (dti) is a neuroimaging technique that elucidates abnormalities of brain white matter (wm), based on structural investigation of a tissue via measurement of diffusion rate and direction of water molecules. this method lets imaging of white matter tracts, whole anatomical extent and structural integrity of the brain tissue. so, it can provide data about anatomical connectivity of brain. there are some parameters used for indicating microstructural integrity of white mat-ter such as fractional anisotropy (fa) and apparent diffusion coefficient (adc) in dti. fa is a measure which reflects directional coherence of water diffusion, and it is sen¬sitive to microstructural wm differences. it is defined on a scale ranging from mostly isotro¬pic (when approaching to zero) indicating poor integrity of the axons to mostly anisotropic (when approaching to 1) indicating intact wm integrity. adc is a scalar index of the rate of water diffusion among different dif¬fusion directions under a gaussian distribution. a higher value of adc indicates lesser restricted diffusion, and it implies fewer organized structures in wm which supports presence of abnormalities in the structural in¬tegrity of white matter. as it has a complicated literature, in this study, we aimed to investigate neuronal integrity and its abnormalities by dti, which may contribute to the etiology of bipolar depression.

Eligibility criteria:
inclusion criteria: patients; * aged between 18 and 65 * having a diagnosis of bipolar type i disorder depressive episode by structured clinical interview for dsm-iv axis i disorders (scid-i) * having no other general medical, neurological or psychiatric condition healthy controls; * matched with bipolar depressive patients by age and sex * having no other general medical, neurological and psychiatric condition exclusion criteria: * bipolar depressive patients and healthy control subjects with any other general medical, neurological or psychiatric condition, metal implant, severe head injury or pregnancy
effects of type of delivery mode and gestational age on maternal bonding

Conditions: Mother-Infant Interaction; Postnatal Depression; Postpartum Anxiety

Summary: to evaluate the effects of gestational age and other factors on maternal attachment relationship. there are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. the aim of this study was to evaluate factors which affected mother-infant bond (mib) using maternal attachment inventory (mai).

the maternal attachment inventory (mai) measure maternal love attachment (9). muller tested the mai questions in two phases; maternal adaptation and maternal attachmenteach item is evaluated by a 4-way to 26-point likert-type scale ranging from "always" to "never". always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. the lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).

Eligibility criteria:
inclusion criteria: * natural pregnancy (without any assisted reproductive technology (art) method) * aged 18 to 45 years * no adverse obstetric history exclusion criteria: * psychiatric diagnosis * history of psychiatric drug use * postpartum blues * known complications during pregnancy

Keywords: the maternal attachment inventory postnatal depression postpartum anxiety
effectiveness of budesonide nasal instillation in a vertex-to-floor position

Conditions: Chronic Frontal Rhinosinusitis; Vertex to Floor Position

Summary: o chronic rhinosinusitis is one of the most common health issue affected american population. surgery plays an important role in the patients who failed the medical treatment. the most difficult location to be operated endoscopically is the frontal sinus. frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. the topical therapy can be delivered by many approaches. according to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. the technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. the head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is vertex-to-floor position.


Eligibility criteria:
inclusion criteria: * chronic rhinosinusitis with frontal sinusitis patient * age ≥12 * post-frontal sinus surgery with frontal sinus opening\>3mm * satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique exclusion criteria: * isolated frontal sinus surgery * history of previous head and neck radiation * previous nasal or sinus operation * clinically significant deviated nasal septum * history of paranasal sinus tumor * known immunocompromised host * history of budesonide allergy * cannot provide full flexion of the neck (cannot perform vertex-to-floor position) * post-randomization exclusion: pathologic invasive fungal infection

Keywords: post-frontal sinus operation chronic rhinosinusitis patients budesonide nasal instillation vertex to floor position
crux biomedical vena cava filter study - united states

Conditions: Pulmonary Embolism

Summary: the purpose of this study is to determine if the crux vena cava filter system is safe and effective in preventing pulmonary embolism.


Eligibility criteria:
inclusion criteria: * patient has a permanent or temporary risk of pulmonary embolism * patient or legal guardian must provide written informed consent * at least one of the following conditions * proven pe * recurrent pe despite adequate anticoagulation * contraindication to anticoagulation * inability to achieve/maintain therapeutic anticoagulation * iliocaval dvt * large, free-floating proximal dvt * massive pe treated with thrombolysis/thrombectomy * chronic pe treated with thrombectomy * procetion during thrombolysis for iliocaval dvt * pe with limited cardiopulmonary reserve * poor compliance with anticoagulation medication * high risk of injury worsend by anticoagulation * multi-trauma patient with high risk of pe * surgical patients at high risk of pe * medical condition with high risk of pe * patient has documented vena cava diameter of 17-28mm * patient has ivc anatomy suitable for infra-renal placement * patient willing to be available for the appropriate follow up. exclusion criteria: * age \<18 years old * patient has any one of the following conditions * renal vein thrombosis * ivc thrombosis extending to te renal veins * duplicate ivc * gonadal vein thrombosis * requires supra-renal placement * uncontrolled infectious disease * risk of aseptic pe * uncontrolled coagulopathy * existing inferior vena cava filter implant * life expectancy less than 6 months * pregnant or planning a pregnancy in the next 6 months * condition that inhibits radiographic visualization of the ivc * known allergy or intolerance to polytetrafluoroethylene (ptfe) or nitinol * known hypersensitivity to contract which cannot be pretreated * access vessels preclude safe insertion of delivery system * participation in another drug or device trial * unable or unwilling to cooperate with study procedures or required follow-up visits

Keywords: vena cava vena cava filter pulmonary embolism venous thromboembolism risk of pulmonary embolism
evaluation of the use of the atalante system in patients presenting a non-traumatic hemiplegia in acute-subacute phase (15 days to 6 months).

Conditions: Stroke; Stroke, Acute; Stroke, Subacute; Robotics

Summary: the spirit study is interventional, national, prospective, open, multicentric each patient being his/her own control. it is conducted to assess the safety and performance of the atalante exoskeleton system in patients presenting a non-traumatic acute-subacute hemiplegia. the primary endpoint is defined by the patient's ability to perform the 10 mwt with the atalante system. the study will include at least 12 patients and takes place in three french rehabilitation centers.


Eligibility criteria:
inclusion criteria: * patient with non-traumatic vascular hemiplegia in acute subacute phase (15 days to 6 months) hospitalized in rehabilitation center, * patients presenting a fac score of 0, 1 or 2, * patient with ischemic or hemorrhagic stroke of which etiological evaluation is complete, * adult patient ≥18 years old, * patient able to verticalize on a daily basis and having a stabilized blood pressure, * patient with stable medical condition at the time of inclusion in the study (absence of infectious and cardiorespiratory events), * patient's height is at least 1m55, * lengths of patient's lower limb are in the following intervals: * thigh (distance gluteus maximus - patella): 56.8 and 64.8 cm, * distance between the ground and the joint space of the knee (to be measured while wearing the shoes the patient intends to wear with atalante): * 45.7-60.7 cm for patient with an ankle dorsiflexion ≥ 16° * 45.7-57.7 cm for patient with an ankle dorsiflexion \&gt; 13° et \&lt; 16° * 45.7-56.7 cm for patient with an ankle dorsiflexion \&gt; 10° et ≤ 13° * 45.7-55.7 cm for patient with an ankle dorsiflexion ≥ 0° et ≤ 10° * intertrochanteric distance lower or equal to 46.0 cm when seated, * maximum weight: 90 kg, * patient able to read and write french and who have signed an informed consent form. exclusion criteria: * ranges of motion below: * hip: 90° flexion, 5° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation * knee: 5° extension, 110° flexion * ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion * patient whose joint centers cannot be aligned atalante's system, * severe spasticity (greater than 3 on the modified ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae * pregnant or lactating women, * medical history of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis, * patient with a cardiac contraindication to physical exertion, * evolutive intercurrent disease: venous thrombosis, hypotension, * patient unable to deliver his/her consent, * patient under legal protection, * patient participating at the same time in another study.

Keywords: stroke acute stroke subacute stroke robotics physiotherapy rehabilitation powered exoskeleton walking exercises ambulation
high flow oxygen during spontaneous breathing trial in patients with high weaning risk failure: impact on the weaning course at d7 from the first spontaneous breathing trial.

Conditions: Mechanical Ventilation; Mechanical Ventilator Weaning; Endotracheal Extubation

Summary: in intensive care unit (icu), mechanical ventilation (mv) is part of routine care. weaning phase is a daily preoccupation for the caregivers. prolonged mv can lead to many complications. failing the weaning phase expose the patient to the need for reintubation, that improves the mortality. the caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation. in order to help the clinician making the good choice, the spontaneous breathing trial (sbt) is a key tool. the international literature provides the investigators many ways to perform the sbt. the most common is the t-piece; the patient is disconnected from the ventilator and connected to a t-piece that can provide supplemental oxygen. another one is the support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the t-piece conditions. in many french icu's, the sbt is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need. in high risk for reintubation patients, the sbt can create physical stress, that lead to prolonged mv. in our icu, for those patients, the investigators perform the sbt by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy. the investigators hypothesis that high flow oxygen sbt, will allow the high risk for reintubation patients to succeed the sbt.

the investigators proposed to compare 2 strategies for sbt in high risk for reintubation patients: 1. classic sbt (c-sbt) 2. high flow oxygen sbt (hfo-sbt) this prospective randomized study had 2 conjoint primary outcome: 1. the hfo-sbt shows a better actuarial rate for extubation at day 7 from the begin of the weaning phase 2. compare the reintubation rate at d7 from the extubation

Eligibility criteria:
inclusion criteria: * age \> 18 yrs. * admission in icu * mechanically ventilated \> 24 hours * mechanically ventilated using support ventilation mode * patient with one of these criterion: * cardiac disease (left ventricular dysfunction lvef \<46%, antecedent of ischemic heart disease, antecedent of acute pulmonary edema) * respiratory disease (copd, emphysema, bronchectiasis, asthma, obesity-hypoventilation syndrome, restrictive pulmonary disease) * informed and signed consent from the patient or next of kin. exclusion criteria: * head trauma as a cause for icu admission * neuromuscular disease prior icu admission * tracheotomized patient * pregnancy * decision not to forgo life sustaining therapy * patient not affiliated with a social security organism * adult private from his liberty with judicial decision * patient that have already been included in the study

Keywords: spontaneous breathing trial high flow oxygen
prospective evaluation of heart failure patients with central sleep apnea

Conditions: Central Sleep Apnea; Heart Failure

Summary: central sleep apnea (csa) has been associated with increased mortality and primarily occurs in patients with heart failure (hf). the primary purpose of this study is to document the natural progression of moderate to severe csa in heart failure patients.

this trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (csa).

Eligibility criteria:
inclusion criteria: * subject is willing and able to comply with this protocol and has signed an irb/mec approved informed consent (as well as privacy protection authorization in the united states) * age is greater than or equal to 18 years * known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight psg with eeg and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics: * ahi greater than or equal to 20 * greater than or equal to 50% of classified events of a central nature * less than 20% of the total ahi comprised of obstructive apnea events * diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening psg, or since the date of the earliest test used for baseline, whichever is longer. optimal medications include: beta blockade, ace-i or arb and diuretics unless contraindicated or not considered medically necessary. exclusion criteria: * current or intended use of any mask-based therapy for central sleep apnea * baseline oxygen saturation less than or equal to 90% on a stable fio2 * severe chronic obstructive pulmonary disease (copd) (per gold classification system) * history of cerebrovascular accident (cva), myocardial infarction (mi), coronary artery bypass grafting (cabg) surgery, or percutaneous coronary intervention (pci), or any cardiac ablation procedure within the 3 months prior to the study * unstable angina * history of primary pulmonary hypertension * currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study * if subject has an implanted cardiac resynchronization device (crt), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment * life expectancy of less than 6 months

Keywords: heart failure central sleep apnea sleep disordered breathing cardiac dysfunction
physiotouch for treatment of radiation fibrosis

Conditions: Radiation Fibrosis

Summary: a quarter of a million women will develop breast cancer (bc) in this year alone. many of these women will have side effects as a result of their breast cancer treatment. radiation fibrosis syndrome (rfs) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. the physiotouch is a hand held device that can be used to treat rfs and may improve the treatment of fibrotic tissue. this pilot randomized controlled trial aims to determine the efficacy of using the physiotouch in addition to current standard of care for treatment of bc-related rfs.


Eligibility criteria:
inclusion criteria: * history of radiation therapy for breast cancer * clinical or suspected rfs * reported functional impairments exclusion criteria: * metastatic disease of soft tissue * history of bilateral radiation therapy * previously diagnosed shoulder impairments not related to rfs * prior treatment with physiotouch * current or recent pregnancy * current breastfeeding * other contraindications to safe and meaningful participation at discretion of study team
pressurized ppv 23ga vitrectomy in complicated diabetic tractional retinal detachment

Conditions: Retinal Detachment

Summary: to investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (pcl) perfusion to remove vitreous during suction-cutting 23 ga vitrectomy using a dual, dynamic drive (3d)technology, in complicated retinal detachment surgeries.


Eligibility criteria:
inclusion criteria: * complicated retinal detachment with no more than 6months of evolution exclusion criteria: * retinal detachments of more than 6 months of evolution no light perception