Kornimate/medical-research-clean huggingface dataset:
feasibility and preliminary efficacy of hatha yoga in head and neck cancer survivors

Conditions: Head Neck Cancer

Summary: treatment for head and neck cancer can result in marked musculo-skeletal impairment (msi). this study will examine the effects of hatha yoga as a therapeutic modality to address msi.

the use of aggressive treatment for head and neck cancer (hnc) particularly combined modality treatment regimens has resulted in an increase in survival. unfortunately, this improvement has come with a marked increase in acute and late-effects. acute hnc treatment-related toxicities have been clearly and extensively documented; however, data pertaining to adverse late-effects, those most likely to impact the survivor's long term symptom burden, functionality, and overall quality of life (qol), are limited. this pilot study will be conducted to examine the feasibility of tailored hatha yoga as a therapeutic modality to address msi in patients who have survived hnc.

Eligibility criteria:
inclusion criteria: * \>/= 18 years of age * \>3 months post-treatment of hnc * no active cancer * ability to understand english in order to complete questionnaires * willing to participate in the guided and home yoga practice * willing to drive to the study site * willing and able to provide informed consent * completed medically indicated physical therapy * medical clearance by study medical oncologist exclusion criteria: * a prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation) * have received radiation therapy or chemotherapy for any condition other than primary hnc * medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, dementia) * active yoga practice within the past 6 months
impact of cold air exposure on croup symptoms

Conditions: Croup

Summary: the goal of the present randomised controlled clinical trial is to compare the efficacy of a 30-minute exposition to cold, atmospheric, outdoor air on the severity of croup symptoms with exposition to indoor room air in children with mild to moderate croup receiving a single dose of dexamethasone during winter croup outbreaks.

croup is a viral laryngitis that represents the most common cause of acute upper airway obstruction in children. it is therefore a frequent reason for emergency department visits. the benefit of dexamethasone on croup symptoms is well established with an onset of action of at least 30 minutes. various non-pharmacological measures, including exposition to cold air, are also thought to be effective in reducing the severity of symptoms, although this has not been demonstrated yet in the current scientific literature. the aim of the present study is to evaluate the efficacy of exposition to cold air on the symptoms of croup in children. the investigators designed a prospective, open-label, single centre randomised controlled trial to evaluate the effect of exposition to cold air on the symptoms of croup in children. the study was performed during autumn and winter croup outbreaks when outdoor air temperature was \ or=2 (to permit a clinically relevant reduction in the westley croup score of at least 2 points from baseline at 30 minutes), diagnosed by a triage nurse and confirmed by a senior attending pediatric emergency physician. exclusion criteria were history or physical examination suggesting any other diagnosis, severe croup requiring immediate nebulised epinephrine, chronic respiratory disease (except asthma), underlying airway abnormalities, immunodeficiency; and contraindication to steroids. according to the recommended standards of care, all children with croup were administered a standard 0·6 mg/kg/dose oral dexamethasone at triage. participants were randomly allocated either to the outdoor cold air exposition group or to the indoor group allocation using a single, constant 1:1 allocation ratio. demographic data, previous exposition to cold air before presentation at pediatric emergency department, as well as vital signs and westley croup score on arrival, and after 30 and 60 minutes, were recorded. parents were reached by phone 7 days after the initial visit to assess the child's clinical outcome and the final diagnosis, as well as the need for further consultation or hospitalization in the meantime.

Eligibility criteria:
inclusion criteria: - children from 3 months to 10 years with clinical signs of croup and westley croup score \> or =2 exclusion criteria: * need for close monitoring * need for nebulized epinephrine * history or physical examination suggesting any other diagnosis * chronic respiratory disease (except asthma) * underlying airway abnormalities * immunodeficiency * contraindication to steroids

Keywords: croup laryngitis laryngotracheitis laryngotracheobronchitis pediatrics children infant cold air
flexible composite next generation tissue separating mesh in laparoscopic incisional/ventral hernia repair

Conditions: Incisional Hernia; Ventral Hernia

Summary: this is a multi-center, observational study of incisional/ventral hernia repair with ng-tsm laparoscopically. the study is not randomized and has a single treatment design assessing ng-tsm intra-operatively, its ease of use and handling characteristics.

the objectives of the study are to evaluate the ease of use of ng-tsm intra-operatively in laparoscopic incisional/ventral hernia repair, and assessing early outcomes post-operatively following mesh implantation, including seroma formation, hematoma, wound complications, infections, early recurrences, adverse events, and subject comfort, as well as health economic data to include quality of life, subject satisfaction data, time of procedure, length of stay, re-hospitalization, and extended hospitalization.

Eligibility criteria:
inclusion criteria: * subject must be able to provide written informed consent * male or female subjects that are ≥ 18 years of age * female subjects must be using adequate contraception, or be surgically sterile, postmenopausal or practicing abstinence, and not planning to become pregnant * planned laparoscopic procedure to repair an abdominal incisional/ventral hernia that requires the addition of reinforcing or bridging material to obtain the desired surgical result exclusion criteria: * subjects with a potential growth as ngtsm will not stretch significantly * female subjects who are pregnant on the day of implantation * surgical site (mesh implantation site) that is classified as contaminated (acute, non purulent, inflamed) or dirty/infected (containing retained devitalized tissue and those that involve existing clinical infection or perforated viscera) * subjects who have received investigational articles less than 30 days prior to enrollment or who are currently receiving investigational products or devices * employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
impact of covid-19 on the benefit of cardiac rehabilitation

Conditions: Heart Failure; Covid19

Summary: the covid-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity \[\> 70 years old, cardiovascular history in particular arterial hypertension (hypertension ), heart disease...\]. this polymorphism is linked to vasculitis and the immune response. patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities. on the cardiovascular level, two sides can be considered. on the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. on the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form. cardiovascular involvement is particularly high in hospitalized and deceased patients. the odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 \[1.9; 3.1\], for cardiovascular pathologies of 2.93 \[1.73; 4.96\]. recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation. cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.). it consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. the physical exercises can be endurance or resistance type. capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement. the hypothesis is that patients who contracted covid-19 would have lower cardiac capacities after recovery from the infection than patients without covid-19 or that their capacity for recovery would be less. there could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by covid-19 or was pre-existing.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * patient referred for outpatient cardiovascular rehabilitation in one of the participating centers between 02/01/2020 and 12/31/2020 * french-speaking patient exclusion criteria: * patient under guardianship or curatorship * patient deprived of liberty * patient under legal protection * patient objecting to the use of their data as part of this research
to compare the safety and pk/pd characteristics of subjects with between hepatic impairment and normal hepatic function

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of dwp16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.

the study design is an open-label, multi-center, parallel, single oral dose study.

Eligibility criteria:
inclusion criteria: 1. a person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial. 2. a person who is 19 years of age or more and under 80 years of age at the time of screening. 3. those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (bmi) of 18.0 kg/m2 or more and 30.0 kg/m2 or less. exclusion criteria: 1. a person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of dwp16001. 2. those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the sglt2 inhibitor family or who have a history of clinically significant hypersensitivity reaction. 3. serum cr \>1.5mg/dl or egfr (ckd-epi cr) \<60ml/min/1.73m2 4. those who have used sglt2 inhibitor family drugs within two weeks of the scheduled date of administration of dwp16001.
the relationship between preoperative anxiety and postoperative delirium in elderly chinese patients

Conditions: Cohort Studies

Summary: this study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the the relationship between preoperative anxiety and postoperative delirium in elderly chinese patients: a multicenter prospective cohort

this is a retrospective cohort study using prospective data from a multicenter database. 8000 elderly patients undergoing elective non-cardiac or non-neurosurgical surgery were included in this study. the generalized anxiety disorder scale (gad-7) was used to measure preoperative anxiety symptoms. the confusion assessment method (3d-cam) was used to assess postoperative delirium in elderly patients undergoing non-cardiac surgery. if the patient is discharged, follow up by phone or email. binary logistic regression analysis and propensity score matching (psm) and subgroup analysis were used to analyze the data.

Eligibility criteria:
inclusion criteria: * elderly patients (age ≥ 65 years) * non-cardiac surgery, non-neurosurgical surgery exclusion criteria: * history of neurological or psychiatric disorders or use of neuropsychiatric drugs; * impaired cognitive function or inability to cooperate with preoperative follow-up; * sent to icu after surgery; * deletional delirium outcome; * baseline missing \>5%

Keywords: preoperative anxiety aged postoperative delirium
improvement project to optimizing nutrition with higher protein and calorie pediatric tube feeding

Conditions: Critically Ill Children

Summary: this quality improvement project will include a practice change based on national guidelines for the nutritional management of picu patients.

this quality improvement project will include a practice change based on national guidelines for the nutritional management of picu patients. the primary aim of this quality improvement project is to better meet protein needs of icu critically ill children

Eligibility criteria:
inclusion criteria: * children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days exclusion criteria: -
inhaled bronchodilator association and quality of life in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of quality of life (qol) in chronic obstructive pulmonary disease (copd) patients treated with inhaled bronchodilators


Eligibility criteria:
inclusion criteria: * diagnosis of copd confirmed by pulmonary function test (pfts) * recent treatment with a free or fixed association of inhaled bronchodilators
compliance and tolerance to oral antibiotherapy in osteoarticular infections (otabio)

Conditions: Drug-Related Side Effects and Adverse Reactions; Treatment Adherence and Compliance

Summary: bone and joint infections (bji) are most often bacterial infections that can occur after surgery or de novo. they are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. treatment of bji is based on antibiotic therapy, often combined with surgery. antibiotic therapy, at high doses, lasts a minimum of 6 weeks. it can be responsible for severe adverse effects. these characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * diagnosis of osteoarticular infection * treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date * patient who was informed and did not object to participate in the study exclusion criteria: * treatment for bji with oral antibiotic without end of treatment date * treatment for bji with parenteral antibiotic only * patient who doesn't have a telephone number or who doesn't want to give it * adults subject to a legal protection measure * pregnant or breastfeeding women

Keywords: tolerance adherence antibiotic bji adverse effect
study of tranexamic acid for the reduction of blood loss in patients undergoing surgery for long bone fracture

Conditions: Femoral Fractures

Summary: tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. this study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.


Eligibility criteria:
inclusion criteria: * patient undergoing surgery for fracture shaft of femur exclusion criteria: * patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia * patients with known coagulopathy * patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%) * patients with documented dvt or pe at screening or in past three months * patients having known hypersensitivity to tranexamic acid or any other constituent of the product * patients with any associated major illness (e.g., severe cardiac or respiratory disease) * anticoagulants (other than lmwh or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

Keywords: tranexamic acid blood loss long bone fracture surgery
impact of smoking, benzodiazepine (bzd) use and obesity on severe obstructive sleep apnea (sosa)

Conditions: Obstructive Sleep Apnea; Obesity; Smoking

Summary: in this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe obstructive sleep apnea (sosa).

this study is a retrospective study. patients enrolled: all patients with a psg (polysomnography) between 1st january 2014 and 30th june 2015. first analysis: influence of smoking, benzodiazepine use, and obesity on the ahi (apnea hypopnea index: the number of apnea and hypopnea per hour of sleep). second analysis: only among patients with sosa: influence of smoking, benzodiazepine use, and obesity on sleep fragmentation and night oximetry.

Eligibility criteria:
inclusion criteria: * all patients registered for an overnight psg at clinique saint-luc of bouge exclusion criteria: * none

Keywords: all patients registered for a psg polysomnography
bologna ibd markers

Conditions: Crohn's Disease

Summary: individuate possible predictive factors of anti-tnfalfa-induced deep remission in crohn's disease.

this trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (caucasian, male/female,18-65 years old) with moderate-severe active crohns disease and with indication for anti-tnf therapy according to the normal clinical practice. simultaneously, 30 no-ibd controls with no gi disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.

Eligibility criteria:
main inclusion criteria for ibd patients: * adult patients (caucasian) * moderate-severe active crohns disease (220≤ cdai ≤450; blood crp ≥5 mg/l and/or fecal calprotectin ≥250mg/l) * indication for anti-tnf therapy according to the normal clinical practice * informed consent signed main exclusion criteria for ibd patients: * changes of crohns disease treatment gastrointestinal medication (including corticosteroids) within the previous 2 weeks prior to enrollment * pregnant or breast-feeding (at index date) female patients main inclusion criteria for no-ibd controls: * no-ibd adult controls (caucasian) with no gi disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic * informed consent signed main exclusion criteria for no-ibd controls: * medical history of digestive diseases * digestive, renal or metabolic disease, as determined by the medical visit and sa blood chemistry analysis
efficacy and safety of teneligliptin in combination with metformin in chinese patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of mp-513 (teneligliptin) in combination with metformin.


Eligibility criteria:
inclusion criteria: * a signed and dated informed consent form obtained from the subject, in accordance. * the subject is aged ≥18 years at signature of the informed consent form. * hospitalization status: outpatient. * the subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (day -28). * the subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (day -28). subjects who cannot do exercise due to complication are not limited to this criteria. * the subject's hba1c is ≥ 7.0% and \< 10.0% at the screening visit (day -28) and on day -14. exclusion criteria: * the subject has a history of type 1 diabetes mellitus or a secondary form of diabetes. * the subject has received insulin within 1 year prior to the screening visit (day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration). * the subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (day -28).
va111913 ts: first in human study

Conditions: Dysmenorrhea

Summary: this is a first-in-human study of va111913 ts, a new chemical entity being developed for the treatment of dysmenorrhea. this study is designed to investigate determine the safety, tolerability and pharmacokinetics of va111913 ts after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.

va111913 ts is a selective v1a-receptor antagonist. the hypothesised mechanism of action of a v1a receptor antagonist in dysmenorrhea has been described in literature. contractions of the uterine muscle are required for normal menstruation. women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. these abnormalities have been shown to lead to the pain experienced in dysmenorrhea. thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. in humans, vasopressin, via the v1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. thus, a v1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.

Eligibility criteria:
inclusion criteria: * healthy females 18 to 45 years of age. * subjects must have a negative pregnancy test at screening and admission. using acceptable form of contraceptive during and after study. exclusion criteria: * administration of any imp within 12 weeks before entry to the study or any prescribed medicine within 14days of the study. * any clinically important medical disease, condition or abnormal laboratory test results. other protocol-defined inclusion/exclusion criteria may apply

Keywords: healthy (dysmenorrhea)