Kornimate/medical-research-clean huggingface dataset:
feasibility and effects of an enhanced recovery vs conventional care after emergency colon surgery for patients with left colon perforation.

Conditions: Colon Perforation

Summary: a study was designed with a prospective cohort of all patients undergoing urgent surgery for left colon perforation between march 2014 and june 2017 who were treated according to a specific eras programme (eras group/29 patients). this group was compared with a historic case-matched control group with conventional care (cc group/21 patients). the main endpoints were postoperative 30-day morbidity, length of postoperative hospital stay, rate of readmission within 30 days, and mortality. the inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a peritonitis severity score (pss) between 6-11 points.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a peritonitis severity score (pss), between 6-11 points. exclusion criteria: * the exclusion criteria were patients under 18 years old and patients with a high risk of mortality according to a pss equal to or greater than 12 points.

Keywords: colon perforation surgery
two contrasting interventions for sleep management

Conditions: Primary Insomnia; Secondary Insomnia

Summary: this study will determine whether mind-body bridging (mbb), a mindfulness training program is more effective than a common sleep medication, zolpidem, in treating insomnia. it will also investigate whether mbb is additionally beneficial for co-morbid conditions such as stress, ptsd, depression, etc, compared with that of zolpidem.

sleep disturbance in active duty military personnel is highly prevalent and contributes to reduced performance of military duties. under extreme conditions, army personnel could endanger themselves and their comrades. increasingly, non-pharmacological treatments for insomnia are showing promise as complementary and alternative medicine treatments. many of these awareness training programs (atps) perform as well as, or even better than, medications. this study will determine whether mind-body bridging (mbb), an atp that teaches awareness/mindfulness and cognitive skills, is more effective than a common sleep medication, zolpidem. the study will also determine whether mbb exhibits additional benefits in co-morbid mental health conditions, including, stress, ptsd, depression, etc, compared with that of zolpidem. this will offer soldiers additional treatment options for insomnia in the hope that it will improve both sleep and other common comorbidities.

Eligibility criteria:
inclusion criteria: * primary insomnia * secondary insomnia * requiring sleep medication (zolpidem) for a three-week trial. * active duty military service member stationed at fort carson. exclusion criteria: * secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication. * treated for sleep problems using sleep medications which include lunesta, ambien, ambien controlled release (cr), seroquel, trazodone or remeron * major psychopathology (i.e., schizophrenia) * severe depression within the past 90 days * suicidal ideation within the past 90 days * psychiatrically hospitalized within the past 90 days * uncontrolled hypertension or diabetes * pregnancy * previous use of zolpidem proved to be ineffective or to cause other unwanted side effects * actively abusing controlled substances * enrolled in another study
optimal dose of propofol for induction of deep sedation for brain mri scanning in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: the children with cp has been shown different drug responses from the normal population of children and it may related with a various oral medications such as baclofen, tizanidine, diazepam, dantrolene, or anticonvulsant drugs. the aim of this study is to establish the optimal induction dose of propofol for deep sedation to start mri for \< 30 min in children with cp.


Eligibility criteria:
inclusion criteria: * children with cerebral palsy with patient agreement exclusion criteria: * sleep apnea, difficult airway, cardiorespiratory disease, allergic history to propofol
a comparative study of kinesiology taping versus taping in the treatment of plantar fasciitis

Conditions: Plantar Fasciitis

Summary: plantar fasciitis is a very studied pathology and treated with taping. there are studies that assess the effectiveness of kinesio taping, as well as taping or low-dye taping, few studies that compare the two treatments and assess which is more effective. in the present work the effectiveness of kinesio taping and taping will be assessed, as well as whether possible differences among intervention effects exist in terms of pain improvement, comfort and durability of the bandage.


Eligibility criteria:
inclusion criteria: * people with plantar fasciitis. * people of legal age. exclusion criteria: * healthy people * minors. * people with pathologies other than plantar fasciitis in the foot. * people who have treatment for fasciitis at the time of starting the study
osa homemonitoring

Conditions: Obstructive Sleep Apnea

Summary: up to now, no studies are available where a comparison has been made between the accuracy of, on the one hand, the gold standard psg and, on the other hand, a home monitoring sleep apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for snoring analysis, and a mattress for ballistocardiographic (bcg) recordings. the purpose of this study is twofold. on the one hand, a comparison between the predictive performance of an automated home monitoring system and the gold standard psg in sleep apnea diagnosis will be performed. the home monitoring system consists of a pulse oximeter, an accelerometer, a smartphone to record ambient sound, and a mattress to record the bcg signal. this system will be provided by ku leuven and equilli, two partners that work together with the sleep laboratory at uz leuven and the group stadius of the ku leuven in the osa+ project. the system performs automated signal processing and classification in order to determine the presence of sleep apnea events. on the other hand, this study aims to improve the phenotyping of patients suffering from sleep apnea. this task will be first developed using the classical psg and later an evaluation will be performed on the less obtrusive system.


Eligibility criteria:
inclusion criteria: * patients referred to the sleep lab for a diagnostic polysomnography because of suspicion of sleep apnea will be considered to participate in the trial upon signature of the informed consent. exclusion criteria: * patients younger than 18 years
study of sequential administration of oral 6-thioguanine after methotrexate in patients with lch

Conditions: Langerhans Cell Histiocytosis

Summary: the objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with langerhans cell histiocytosis (lch) treated with sequential administration of oral 6-thioguanine (6-tg) after methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * patients with histologic proof of lch who have multifocal or multisystem disease involvement. * patients must have a life expectancy of at least 8 weeks. * all patients must have ecog performance level rating of-\< 2. * patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study, using commercially available drugs. * patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of chemotherapy. * patients must have adequate liver function (bilirubin _\ _ 60 ml/min/1.73 m2) and normal electrolytes. * patients should have a granulocyte count \> 500/ul and a platelet count \>_ 100,000/ul (unless due to disease involvement of the bone marrow). * male and female patients of child-bearing age should use effective methods of contraception, if sexually active. exclusion criteria: * patients with active infections or significant medical conditions other than their disease (lch) shall be excluded.

Keywords: langerhans cell histiocytosis lch 6-thioguanine 6-tg methotrexate mtx 94-132
efficacy & safety of dronedarone versus amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation exclusion criteria: * contraindication to oral anticoagulation * patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous) * patients known to have chronic af, patients with atrial flutter or paroxysmal atrial fibrillation * severe congestive heart failure with new-york heart association (nyha) class iii or iv, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in af such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted * history of torsades de pointes or long qt syndrome or qt- or qtc-interval ≥500 msecs before randomization * treatment with other class i or iii antiarrhythmic drugs which cannot be discontinued * dysthyroidism or other contraindication to amiodarone the above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.

Keywords: atrial fibrillation sinus rhythm amiodarone
impact of long alimentary limb or long biliary limb roux-en-y gastric bypass on type 2 diabetes remission in severely obese patients.

Conditions: Diabetes Mellitus Type 2 in Obese

Summary: in patients with type 2 diabetes, roux-en-y gastric bypass (rygb), which excludes a portion of the stomach and the proximal intestine from the alimentary circuit, improves glucose metabolism more rapidly and more extensively than is expected from weight loss. the mechanisms of this unique effect of gastrointestinal exclusion appear to be complex and have not yet been clarified. a recent study unveil that intestinal uptake of ingested glucose is diminished by rygb and restricted to the common limb, where food meets bile and other digestive fluids, resulting in an overall decrease of post prandial blood glucose excursion. the hypothesize that reducing the length of the common limb, which is rarely measured and highly variable in clinical practice, may significantly affect the metabolic outcome of gastrointestinal surgical procedures. the aim of the present study is to compare the impact of two variants of roux-en-y gastric bypass with a short common limb, the long alimentary limb or the long biliary limb roux-en-y gastric bypass, on type 2 diabetes remission in severely obese patients.


Eligibility criteria:
inclusion criteria: * bmi ≥ 35 kg/m2 * all patient with type 2 diabetes * patients who were candidates for obesity surgery in accordance with french recommendation exclusion criteria: * severe cognitive or mental disorders * patient who have already undergone obesity surgery * severe and non-stabilised eating disorders * the likely inability of the patient to participate in lifelong medical follow-up * alcohol or psychoactive substances dependence * the absence of identified prior medical management of obesity * diseases that are life-threatening in the short and medium term; * contraindications to general anaesthesia.

Keywords: obesity diabetes mellitus type 2 bariatric surgery roux-en-y gastric bypass
gingival crevicular fluid of adiponectin and resistin as predictable implement in staging and grading system of periodontitis

Conditions: Periodontal Diseases; Obesity, Morbid

Summary: the goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using elisa in obese individuals. researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity


Eligibility criteria:
inclusion criteria: * obese persons with body mass index (bmi) more than 40 and suffering from periodontitis exclusion criteria: * patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection. * patients subjected to previous periodontal therapy 6 months before sampling. patients with systemic or local inflammatory conditions other than periodontal disease. * neither lactating nor pregnant.

Keywords: resistin, adiponectin, periodontitis grading, periodontal therapy
adverse event data collection from external registries on nonacog beta pegol

Conditions: Haemophilia B

Summary: the purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia b treated with nonacog beta pegol. the third party registries include pednet haemophilia registry (pednet) and the european haemophilia safety surveillance system (euhass). data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.


Eligibility criteria:
inclusion criteria: - participation in the pednet registry and/or the european haemophilia safety surveillance system (euhass), or other national and international registries exclusion criteria: - not applicable as this is a study collecting third-party data from registries
relationship between dosage of clopidogrel and platelet aggregation in chinese with different genotype

Conditions: Coronary Heart Disease

Summary: this study is a prospective, observational study to estimate the relationship between dosage of clopidogrel and platelet aggregation in chinese with different genotype. the investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention (pci) and cyp2c19 genotype may effect the platelet aggregation as well as clinical outcome.


Eligibility criteria:
inclusion criteria: * accept pci in chinese chd patients * expected dual antiplatelet therapy (dapt) at least 6 months exclusion criteria: * another planned pci within 6 months
study comparing effectiveness of intraperitoneal insulin administration to subcutaneous insulin administration

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in type 1 diabetics.

implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in type 1 dm subjects, as demonstrated in numerous european studies. glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. this study is aimed at comparing the efficacy of intraperitoneal (ip) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Eligibility criteria:
* type 1 diabetes mellitus (american diabetes association definition) * hba1c greater than or equal to 7.5% * intensive insulin treatment for at least 3 months * physical and intellectual ability to operate mip system * subject has been under the routine care of the investigator for at least two months prior to enrollment * subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency). * capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study * physical and intellectual ability to operate the mip system and to comply with the data reporting requirements of the study. * subject is willing to sign the informed consent form (approved by local institutional review board and medtronic minimed) exclusion criteria: * the subject's insulin usage exceeds 66 units per day. * severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months * reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable) * subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive * the subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data * the subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks * the subject has any condition that precludes him/her from completing the study requirements * has plans for activities which require them to go 25 feet below sea level

Keywords: diabetes implantable insulin pump intraperitoneal insulin delivery
artificial neural network directed therapy of severe obstructive sleep apnea

Conditions: Sleep Apnea

Summary: the investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (cdss) not only to detect the presence of sleep apnea but also to predict its severity. the cdss is based on deploying an artificial neural network (ann) derived from anthropomorphic and clinical characteristics. the investigators hypothesize that patients with severe osa defined as ahi≥30 can be diagnosed with the use of ann without undergoing a sleep study, and that empiric management with auto-cpap has similar outcomes to those who undergo a formal sleep study.


Eligibility criteria:
inclusion criteria: * must be an adult (≥18 years old) * must have symptoms suggestive of osa, and be considered for sleep study by the sleep specialist provider. exclusion criteria: * pregnancy or breast feeding * patients with severe congestive heart failure (eg, nyha class iv, ejection fraction \< 35%). * patients with end-stage renal disease on hemodialysis * patients with cva, parkinson, neuromuscular degenerative disease. * patient on narcotics. * patients with severe lung disease requiring oxygen at night and/or during the day. * patient with predominant insomnia or sleep hygiene problems, and who are not considered for psg by the sleep specialist.

Keywords: artificial neural network
does muscle wasting always mean muscle weakness? a prevalence study in copd

Conditions: COPD

Summary: peripheral muscle mass and strength are relevant indicators of copd survival. current guidelines recommend to assess muscle strength only in muscle wasted patients. however, a recent study reported quadriceps weakness without muscle wasting (menon, m et al. resp. res.2012, 13:119). thus, these guidelines raise the risk to miss out some weak patients. in clinical settings, fat-free-mass index (ffmi) is indicated as a simple index to assess muscle wasting. we aimed at determining the prevalence of patients entering in pulmonary rehabilitation (pr) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


Eligibility criteria:
inclusion criteria: * patients who have got ffmi (bioimpedance) * patients who have done quadriceps muscle strenght evaluation exclusion criteria: * patients without ffmi * patients without quadriceps muscle strenght

Keywords: experimental approaches peripheral muscle keyword rehabilitation
clinical study of the heartlight x3 endoscopic ablation system with excalibur balloon

Conditions: Atrial Fibrillation

Summary: the objective of the study is to demonstrate the improved ablation and procedure times of the heartlight x3 compared to the current heartlight catheter in the treatment of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation failure of at least one aad others exclusion criteria: * overall good health as established by multiple criteria
gene expression in renal transplant patients with field actinic keratosis undergoing metvix® photodynamic therapy (pdt)

Conditions: Actinic Keratosis

Summary: the aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with metvix photodynamic therapy (pdt) of actinic keratoses (ak) and cancerised field in renal transplant recipients.

in this study, the whole target area defined by the investigator will be treated by metvix pdt: this means that both lesions and sub-clinical lesions will be exposed to metvix pdt. biopsies will be performed in both regions: lesional and peri-lesional ones. this will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if metvix pdt acts on the sub-clinical lesions.

Eligibility criteria:
inclusion criteria: * renal transplant with an history of immunosuppression from 5 to 15 years, * presenting at least 4 discrete ak lesions, mild or moderate, either on the face, the scalp, forearms or the chest. exclusion criteria: * at risk in terms of precautions, warnings, and contra-indication referred in the package insert of metvix®, * ak lesions clinically atypical or suspicious for malignancy on the target field, * any of the following topical treatments within the specified washout period at screening: * 5-fu, imiquimod, diclofenac sodium: 3 months, * cryotherapy: 3 months, * pdt: 3 months, * other less common ak treatments: 3 months. * systemic retinoids within the last month prior to screening visit.

Keywords: renal transplant patients actinic keratoses metvix pdt field cancerisation gene expression
a study of repotrectinib versus crizotinib in participants with locally advanced or metastatic tyrosine kinase inhibitor (tki)-naïve ros1-positive non-small cell lung cancer (nsclc) (trident-3)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic tki-naïve ros1-positive non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic nsclc * participant has a ros1 gene rearrangement/fusion as detected by a local test. * at least 1 measurable lesion according to recist v1.1, as assessed by the investigator. * participants must not be exposed previously with tkis that demonstrated activities in ros1-positive nsclc * up to 1 prior line of systemic treatment for nsclc is permitted * ecog performance status ≤ 2 exclusion criteria: * symptomatic brain metastases or symptomatic leptomeningeal involvement. * history of previous cancer requiring therapy within the previous 2 years, except for nsclc under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected. * known tumor targetable co-mutations or rearrangements * clinically significant cardiovascular disease (either active or within 6 months prior to enrollment) note: other protocol-defined inclusion/exclusion criteria apply

Keywords: tki-naïve ros1 nsclc ros1-positive non-small cell lung cancer