Kornimate/medical-research-clean huggingface dataset:
procedure for duodenum to ileal diversion to treat type 2 diabetes

Conditions: Type 2 Diabetes; Obesity

Summary: study will monitor changes in hba1c for subjects in intervention arm vs control arm.

randomized, single-center, parallel-group, open-label pilot study to evaluate the safety and effectiveness of the gi windows magnet anastomosis system (mas) when used to create a dual-path enteral diversion compared with medical therapy alone to effect glycemic control in obese patients with type 2 diabetes mellitus (t2dm)

Eligibility criteria:
inclusion criteria: * body mass index (bmi) 30 to 50. * subject type 2 diabetes criteria: 1. t2dm diagnosis ≥6 months but \< 10 years 2. on 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose) 3. hemoglobin a1c (hba1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable hba1c over a 3-month period (i.e., \<0.3% reduction) 4. stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to screening visit. * if subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled. * able to understand and sign informed consent document * has primary care physician and/or endocrinologist who follows patient for all comorbid conditions exclusion criteria: * known or suspected allergy to nickel or titanium or nitinol * type 1 diabetes * use of injectable insulin * uncontrolled t2dm fasting glucose ≥ 200 mg/dl (11.1 mmol/l) * probable insulin production failure, defined as fasting serum c peptide \<1 ng/ml (0.3 nmol/l) * any documented conditions for which endoscopy/colonoscopy would be contraindicated. * contraindication to general anesthesia * congenital or acquired anomalies of the gi tract, including atresias, stenosis or malrotation. * any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon. * previous technically difficult or failed colonoscopy or endoscopy * if on metformin, history of polycystic ovarian syndrome (pcos) * unable or unwilling to perform home blood glucose monitoring * history of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease) * diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin * previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves. * specific genetic or hormonal cause of obesity (e.g. prader-willi syndrome)
clinical characteristics of infantile hemangioma

Conditions: Hemangioma

Summary: the primary purpose of this study is to identify the clinical characteristics of infantile hemangioma (ih) in our single center in china. the second objective of the study is to identify the clinical features of infantile hepatic hemangioma (ihh) and ulceration in patients with ihs.

infantile hemangioma (ih) is the most common benign tumor of infancy with an estimated prevalence of 4%-5%. ihs may be presented in any part of body including the visceral organs, but are preferentially located on the face, head and neck area. ihs exhibit a characteristic life cycle consisting of a rapid proliferating phase within the first year of life followed by a slowly involuted phase lasting for up to five years. although most resolve over time without major sequelae, a significant subset can result in severe complications including disfiguring and ulceration, some even could impair organ functions and threaten patients' life. risk factors of ihs have been identified including multiple gestation, low birth weight, prematurity, white race, eclampsia and placental abnormalities. however, the exact occurrence, clinical features and risk factors of ihs is still unknown in chinese patients because of the lack of large scale of prospective studies. in addition, characteristics of ulceration of ihs and infantile hepatic hemangiomas (ihhs) are also not well documented. therefore, it's important to perform this prospective study to determine the clinical features of chinese patients with ihs, and this study will also make contributions to the prevents, diagnoses and treatments of ihs.

Eligibility criteria:
inclusion criteria: * age ≤6 years old * diagnose of ihs * consent of both parents (or the person having parental authority in families) exclusion criteria: * congenital hemangioma, kaposiform hemangioendothelioma, or other vascular anomalies * age\>6 years * hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments * patients with an inability to participate or to follow the study treatment and assessment plan

Keywords: infantile hemangioma infantile hepatic hemangioma ulcerated infantile hemangioma clinical characteristics demographic characteristics
bluewind medical system for the treatment of patients with oab

Conditions: Over Active Bladder

Summary: bluewind system safety and performance in treatment of patients diagnosed with overactive bladder (oab)

bluewind medical system safety and performance in treatment of patients diagnosed with overactive bladder (oab)

Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female aged 18 - 80. * patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests. * patients with overactive bladder symptoms: * urinary frequency greater than 8 times/24 hours and/or urinary urgency leaks of at least 2 leaks on 3 day voiding diary * patient who has failed conservative treatment after at least 6 months of treatment * patients with normally functioning upper urinary tract. * patients with no clinical evidence of a neurological s2-s4 motor sensory deficit. * prior ptns group: patients who have had successful ptns treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency \[\<8 voids/day\], based on retrospective diary review). * de novo patient group: patient who passes the bluewind compatibility test. exclusion criteria: * any metal implant in the area of bluewind medical implantation site. * patients who have not had stable oab medications for at least 30 days. * patients who have received botulinum toxin injections within the past 6 months. * previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months. * any spinal or genitourinary surgery within the last 6 months. pelvic pain disorders * obvious clinically demonstrated genuine stress incontinence. * any neurological disease or disorder including neuropathy or injury resulting in neuropathy. * current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.) * pelvic radiotherapy and chemotherapy. * severe uncontrolled diabetes. * patients anticipating magnetic resonance imaging (mri) exams. * presence of cystocele, enterocele or rectocele of grade 3 or 4. * prior ptns group: patients who are receiving concomitant nerve stimulation therapies for oab treatment, except for ptns maintenance therapy. * de novo patient group: patients who have received or are receiving nerve stimulation therapies for oab treatment, including ptns.
nebulized hypertonic saline for mechanically ventilated children

Conditions: Respiratory Failure

Summary: children who need to be on a ventilator often have thick secretions/mucus in their lungs. these secretions can obstruct the breathing tube and their windpipe, which can worsen lung function and prolong the need for the ventilator. hypertonic saline is a medicine that is used to thin out secretions in patients with cystic fibrosis (and other conditions). we hypothesize that having children on a ventilator inhale this medication will shorten the amount of time that they need to be on the ventilator.

recent pediatric data shows that less than 80% of children mechanically ventilated for ≥ 96 hours survived to picu discharge, while 100% of children mechanically ventilated for \< 96 hours survived to picu discharge. interventions that decrease duration of mechanical ventilation may improve outcome by limiting ventilator-induced lung injury, sedative medication usage and ventilator-associated pneumonia. obstructive airway secretions may prolong mechanical ventilation by causing atelectasis and endotracheal tube obstruction, with resultant cardio-respiratory instability. nebulized hypertonic saline (hts) is used to decrease mucus viscosity and increase mucociliary clearance in patients with diseases such as cystic fibrosis and bronchiolitis, and has been used to enhance airway clearance in mechanically ventilated children. administering nebulized hts to mechanically ventilated children may facilitate airway clearance and shorten mechanical ventilation. in a randomized study of children \< 2 years old following cardiac surgery, patients given dornase, another mucolytic agent, had a significantly decreased duration of mechanical ventilation versus those given saline placebo (52 hrs vs. 82 hrs). hts may be even more effective, as mechanically ventilated newborns with persistent atelectasis had more improvement in radiographic findings and oxygen saturation when randomized to receive hypertonic saline compared to those randomized to receive dornase. this may be because dornase may only be effective in patients with leukocytes or bacterial present in tracheal aspirates, while hts may be effective in all ventilated patients. further study of the impact of prophylactic mucolytic therapy on the duration of mechanical ventilation in children is warranted.

Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation of \< 12 hrs duration prior to enrollment * expected duration of mechanical ventilation of \> 48hrs from enrollment * age \< 18yo exclusion criteria: * inclusion in another clinical study * cystic fibrosis * status asthmaticus * pulmonary hemorrhage/contusion * home o2 use * home non-invasive positive pressure (cpap/bipap) ventilation use * pre-existing tracheostomy * prescription of mucolytic medication by primary clinical team * allergy to inhaled saline/hypertonic saline or albuterol

Keywords: pediatric mucolytic respiratory failure atelectasis hypertonic saline
effect of md1003 in chronic visual loss related to optic neuritis in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to demonstrate the superiority of md1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.


Eligibility criteria:
inclusion criteria: 1. diagnosis criteria of ms fulfilling revised mc donald criteria (2010) 2. uni-or bilateral optic neuropathy with worst eye va≤ 5/10 confirmed at 6 months 3. worsening of visual acuity during the last three years 4. informed consent prior to any study procedure 5. patient aged 18-75 years exclusion criteria: 1. optic neuritis relapse within the three months before inclusion 2. normal rnfl at oct 3. presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia\>7 dioptrics, intraocular pressure\>20 mm hg, amblyopia, retinal or optic head abnormalities (drusen, tilted disc) 4. bilateral visual acuity \<1/20 5. visual impairment caused by ocular flutter or nystagmus 6. pregnancy or childbearing potential woman without contraception 7. any general chronic handicapping disease other than ms 8. new treatment introduced less than 3 months prior to inclusion or less than 1 month for fampridine

Keywords: multiple sclerosis (ms) optic neuritis visual defect visual loss relapsing remitting multiple sclerosis (rrms) primary progressive multiple sclerosis (ppms) secondary progressive multiple sclerosis (spms)
multi-omics studies of host-microbiome interaction in chronic obstructive pulmonary disease and bronchiectasis

Conditions: COPD Exacerbation; Bronchiectasis With Acute Exacerbation

Summary: chronic obstructive pulmonary disease (copd) and bronchiectasis are common chronic respiratory diseases in china. copd is characterized by irreversible lung function decline due to airway inflammation, emphysema and alveolar destruction. bronchiectasis is characterized by permanent bronchiectasis, its main clinical symptoms are cough, dyspnea, hemoptysis and recurrent respiratory tract infections. the incidence and prevalence of bronchiectasis have assumed continuously grows in global. airway microbiota, whose alterations play an important role in the occurrence and development of bronchiectasis, form a complex ecosystem interacted with host cells and various biotic and abiotic factors in the microenvironment. additionally, mounting evidence suggests that the airway microbiome is associated with copd phenotypes and endotypes, and that dysbiosis contributes to airway inflammation. however, the mechanisms remain poorly understood, owing to limited knowledge of microbial functional properties, metabolic activities and cross-talk with the host immune system. the investigators aim to collect sputum specimen and perform multi-omic analysis on patients with copd and bronchiectasis in seven clinical centres in china.


Eligibility criteria:
inclusion criteria: * patients diagnosed with bronchiectasis (according to the chinese consensus, patient's previous chest ct examination must show bronchiectasis) or copd (according to gold 2022). * patients with age ≥18 years old. * written informed consent. exclusion criteria: * pregnancy or lactation, or those without taking effective contraceptive measures * subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders * subjects with a history of alcohol or illicit drug abuse * subjects with any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe copd * diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (gfr \< 30ml/min) or immunodeficiency * participated in any interventional clinical trial within 3 months before enrolment. * poor compliance or inability to cooperate as judged by the doctor

Keywords: chronic obstructive pulmonary disease bronchiectasis
epoprostenol for injection in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this is an open-label, nonrandomized extension to study ac-066a301. the study will assess safety and tolerability of act-385781a while providing a means for continuing treatment after ending participation in study ac-066a301.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study-mandated procedure 2. patients who completed participation in study ac-066a301 3. patients who have not obtained access for commercial efi at the time of ending participation in study ac-066a301 exclusion criteria: 1. patients who prematurely discontinued study drug in study ac-066a301 2. patients for whom continued treatment with efi is no longer considered appropriate
phase iii randomized, double-blind, placebo-controlled study of intravenous immune globulin for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: objectives: i. determine whether high-dose intravenous immune globulin (ivig) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis. ii. determine the time to recovery following ivig.

protocol outline: this is a randomized, double-blind study. patients are treated with intravenous immune globulin or placebo. in the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks. patients are followed at 3 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * clinically or laboratory-supported definite multiple sclerosis * disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive) * targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb severity -1 or greater on mayo clinic rating scale or between 3+/5 and 4-/5 on medical research clinic muscle power scale * documented by mayo clinic department of neurology as neither progressing nor improving for 4 to 18 months prior to entry no clinical evidence of spontaneous or corticosteroid-induced improvement * able to cooperate with isometric strength testing requirements --prior/concurrent therapy-- * no concurrent experimental drug therapy * no concurrent intravenous immune globulin at least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin * at least 3 months since plasma exchange --patient characteristics-- * hepatic: no coagulation defect, e.g., hyperviscosity syndrome * renal: creatinine no greater than 1.5 times normal * cardiovascular: no unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke * immunologic: no human gamma globulin or albumin sensitivity no hypergammaglobulinemia no known antibody deficiency syndrome, especially iga deficiency other: * no condition interfering with neurologic exam, e.g.: * major amputation * deforming arthritis * major psychiatric illness * superimposed lower motor neuron deficit * no intellectual impairment precluding study participation * no pregnant or nursing women * adequate contraception required of fertile patients

Keywords: multiple sclerosis neurologic and psychiatric disorders rare disease
impact of adjuvant chemotherapy in patients with colon cancer

Conditions: Colon Cancer; Adjuvant Chemotherapy

Summary: the present study aims to investigate the impact of adjuvant chemotherapy with 5-fu isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages ii and iii colon cancer. will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

cancer is a major public health problem. colorectal cancer is the third most common cancer in men and women around the world. despite advances in surgical and pharmacological treatment, this type of cancer remains a leading cause of cancer death in western countries. the adjuvant chemotherapy treatment based on the use of fluoropyrimidine, especially 5-fluorouracil (5-fu) is the mainstay of the pharmacological treatment of colorectal cancer. this treatment showed benefit in overall survival and progression-free survival in the adjuvant treatment of patients with stage ii and iii disease. in the last decade, the combination treatment with oxaliplatin has shown benefit in patients with either metastatic disease as with locoregional disease who underwent surgical treatment. however, the increased use of 5-fu and oxaliplatin, and increased patient survival have caused increased incidence of adverse events. 5-fu has cardiotoxic effects that may range from 1.2 to 18% depending upon the drug administration. another adverse event of chemotherapy for colon cancer is neurotoxicity. peripheral neuropathy is one of the toxicities associated with treatment with oxaliplatin and its characteristics to be dose-dependent and cumulative. thus, the adjuvant chemotherapy with 5-fu and oxaliplatin may cause cardiotoxicity, changes in vascular function and increased oxidative stress. what is not known are the effects of treatment of 5-fu and oxaliplatin in cardiac autonomic modulation and peripheral vascular function. therefore, the present study aims to investigate the impact of adjuvant chemotherapy with 5-fu isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages ii and iii colon cancer. will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Eligibility criteria:
inclusion criteria: * scale of performance status 0 - 1 * patients submitted to colectomy for adenocarcinoma of colon stages ii and iii. exclusion criteria: * severe pulmonary disease * decompensated cardiovascular disease * neurological disease * insulin-dependent diabetes mellitus * dialysis renal insufficiency

Keywords: colon cancer adjuvant chemotherapy sympathetic nerve activity peripheral vascular function
use of platelet-rich plasma (prp) and platelet-poor plasma (ppp) to prevent infection and delayed wound healing

Conditions: Elective Foot and Ankle Surgery.

Summary: the purpose of this study is to see if applying prp and ppp to surgical sites and the closing incision helps prevent infection and slow wound healing.

this will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (prp) and platelet-poor plasma (ppp) treatment or no treatment. we hypothesize that the antimicrobial properties of prp and barrier properties of ppp (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. thus, the incidence of infection and delayed wound healing will be lower in patients receiving prp and ppp compared to patients who do not receive prp and ppp. however, due to clinical equipoise, we do not know for certain that prp and ppp is truly effective. the cost of preparing prp and ppp is substantial, and involves a blood draw that would not otherwise be done. thus, it is important to know if this treatment is effective or not.

Eligibility criteria:
inclusion criteria: * elective foot and ankle surgery. exclusion criteria: * younger than 18 years, older than 80 years of age.

Keywords: infection delayed wound healing platelet-rich plasma