Kornimate/medical-research-clean huggingface dataset:
probiotics in newly diagnosed t1d

Conditions: Type 1 Diabetes; Type1diabetes; Type 1 Diabetes Mellitus

Summary: the investigators aim to further the understanding of environmental factors that underlie the development of type 1 diabetes (t1d) and the post-onset disease trajectory. dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing t1d in those with genetic susceptibility. dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed western diet, or by widespread use of antibiotics. here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates t1d progression. the investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following criteria: 1. males and females 5-17 years of age with a clinical diagnosis of t1d within the past 90 days 2. positive for ≥ 1 diabetes-related autoantibodies (iaa, gad, ia-2, or znt8) 3. stimulated c-peptide area under the curve (auc) of ≥ 0.2 nmol/l during a mixed meal tolerance test 4. treatment naïve of any immunomodulatory agent exclusion criteria: * patients must not meet any of the following criteria: 1. probiotic use within 1 month of screening visit 2. presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism 3. diabetes other than t1d 4. female participants of child-bearing age with reproductive potential must not be knowingly pregnant 5. any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Keywords: newly diagnosed recent onset visbiome probiotic
effect of dexamethasone shortly before surgery on the intraoperative dose of remifentanil

Conditions: Perioperative Pain

Summary: this explorative post hoc analysis included patients randomized in the dex-2-tka trial (nct03506789) who were operated under general anesthesia with remifentanil and propofol. patients having general anesthesia with sevoflurane were excluded. as the two groups receiving preoperative dexamethasone were identical at the time of outcome assessment, they were merged to one and were compared with placebo.

the dex-2-tka was a randomized, blinded, placebo-controlled, multicenter trial in participants undergoing primary tka conducted to investigate the effects of dexamethasone on morphine consumption, levels of postoperative pain, and harm. the methodology has been described in detail in the primary publication (ref), the protocol article and in the statistical analysis plan. in short, the trial was conducted at one private and four public danish hospitals. patients were randomized into one of three groups receiving either: dexamethasone + placebo, dexamethasone + dexamethasone or placebo + placebo in a 1:1:1 ratio. the first dose of trial medication (intravenous dexamethasone 24 mg or placebo) was administered immediately after onset of anesthesia. twenty-four hours after end of surgery, the second dose (dexamethasone 24 mg or placebo) was administered. as the two groups receiving preoperative dexamethasone were identical at the time of outcome assessment for thi post-hoc analysis, they were merged to one and were compared with placebo yielding a ratio of 2:1 between the groups recieving dexamethsone and the placebo group. patients received either spinal anesthesia or general anesthesia (remifentanil and propofol were preferred). before end of surgery all patients received ondansetron iv 4 mg. for patients in general anesthesia, sufentanil (0.3 μg/kg) was administered. all participants were provided with a patient-controlled analgesia pump (morphine 1 mg/ml, bolus 2 mg, lock-out 6 minutes, no background infusion) for 24 hours postoperatively. additional boluses of 2 mg morphine on participant request were allowed the first hour after cessation of anesthesia. all participants received a protocolled non-opioid analgesic pain alleviation regime comprised of oral paracetamol 1 g and ibuprofen 400 mg given 1 hour before and every 6 hours after surgery and the surgeon administered local infiltration analgesia intraoperatively according to a standardized regimen. the present explorative post hoc analysis included patients randomized in the dex-2-tka trial who were operated under general anesthesia with remifentanil and propofol. patients having general anesthesia with sevoflurane were excluded.

Eligibility criteria:
inclusion criteria: * participation in dex-2-tka (nct03506789) * general anesthesia exclusion criteria: * spinal anestehesia * use of sevoflurane
outcome following semitubular plate vs. polyaxial locking plates

Conditions: Ankle Fractures

Summary: in this prospective study, all patients with distal fibula fractures (ao 44 b1.1, b1.2, b1.3), with indication for surgery were included. patients were randomized to either the depuy synthes® one-third semitubular plate (group i) or newclip technics, active ankle® polyaxial locking plate (group ii). in group ii early weight bearing was allowed after two weeks postoperatively. primary outcome parameter was function of the ankle joint, assessed by the olerud and molander ankle score (omas), foot and ankle outcome score (faos) and karlsson and peterson scoring system for ankle function (kpss). secondary outcome parameter were postoperative complications. superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * fracture of the distal fibula (ao 44 b1.1, b1.2, b1.3) * written informed consent exclusion criteria: * pregnancy * mental disorders * comprehensive legal support. * pathological and/or osteoporotic fracture * open fracture
night pain in patients with rotator cuff syndrome

Conditions: Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Tendinitis; Rotator Cuff Tear

Summary: the aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

patients who were diagnosed as rotator cuff syndrome by clinical examination and magnetic resonance imaging will be included in this prospective study. demographic data (gender, age, education level, occupation), shoulder pain duration, history of trauma to the shoulder, smoking, dominant arm and diabetes will be questioned and body mass indexes will be calculated. active shoulder range of motion of the patients will be measured by goniometer and recorded . specific tests, which are important for rotator cuff lesion, will be performed to determine whether they are positive or not. magnetic resonance imaging of the patients with shoulder pathology will be recorded. a visual analog scale will be used to determine the intensity of day and night pain. shoulder shoulder pain and disability index to assess shoulder disability of patients, sf-36 form will be filled by patient to evaluate the effect of shoulder pathology and kinesiophobia score to assess the avoidance of pain induced movement.

Eligibility criteria:
inclusion criteria: * to be diagnosed with rototor cuff pathology by magnetic resonance imaging * age range between 18-65 years old * to be literate and cooperative exclusion criteria: * having shoulder pathology other than rototor cuff pathology (glenohumeral instability, bisipital tendon lesions, glenohumeral joint osteoarthritis, acromioclavicular joint osteoarthritis, milwaukee shoulder) * having complete rotator cuff tear * patients with a history of shoulder or cervical surgery * the presence of cervical pathology * patients with a history of fracture in the shoulder with pain * local corticosteroid injection history for the shoulder (over the last 6 months) and using painkiller regularly * physical therapy history for the shoulder (in the last 3 months) * the presence of systemic inflammatory disease * malignancy * pregnancy * a history of any psychiatric disorders

Keywords: pain shoulder rotator cuff
infiltration of the vestibulum vaginae with botulin toxin in patients with localized provoked vulvodynia

Conditions: Localized Provoked Vulvodynia

Summary: in this study we will investigate the efficacy and safety of infiltration of the vestibulum vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. in literature covering this subject we find that the prevalence of this condition is between 10 and 15%. especially young, sexually active women suffer from this problem and some of them are not capable of having sexual relations with their partner because of this burning pain. the most probable explanation for the physiopathological mechanism is an increase of nerve endings in the epithelium of the vestibulum, with an increase and activation of pain receptors in the vestibular mucosa. it also seems that patients with vestibulodynia have a higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain and a lower capacity of relaxation. botulin toxin (botox) is a neurotoxin that causes a temporary paralysis of the muscle cells. that way it can decrease the increased tension of the pelvic floor muscles botox also inhibits the pain receptors in the vestibulum. patients will be recruited through the gynecology consultations. every patient with localized provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy, antidepressants, anti-epileptics, local anesthetics) will undergo q-tip testing. if positive and there are no underlying diseases, the patient will be invited to participate in the study and after oral and written informed consent, will be included in the study population. every 6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots in the vestibulum. 50 % of the subjects will receive physiological water instead of botox (control population). after 3 sessions, we will assess if there is any difference in provoked pain in treated patients vs. placebos through q-tip testing.


Eligibility criteria:
inclusion criteria: * +18 years, of sound mind * dutch speaking * previously treated for this condition with neuropathic pain medication (antidepressants and anti-epileptics) * in good health exclusion criteria: * systemic diseases * pregnancy
the evicel post-authorization surveillance study

Conditions: Peripheral Vascular Disease; Hemorrhage

Summary: the objective of this non-interventional post authorisation safety surveillance (pass) study is to observe the clinical safety performance of evicel when used as suture support for haemostasis in vascular surgery.


Eligibility criteria:
inclusion criteria: * subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery * evicel fibrin sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es * subjects must be willing to and capable of participating in the study, and provide written informed consent exclusion criteria: * subjects with known intolerance to blood products * subjects unwilling to receive blood products * subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding * subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

Keywords: hemostasis
study of women with severe diarrhea-predominant irritable bowel syndrome having failed conventional therapy

Conditions: Irritable Colon; Irritable Bowel Syndrome (IBS)

Summary: the purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have failed conventional therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with severe diarrhea-predominant irritable bowel syndrome (ibs). * failed conventional therapy. * willing to make daily calls on a touch-tone telephone. exclusion criteria: * history of or current chronic or severe constipation. * bloody diarrhea, abdominal pain with rectal bleeding. * thrombophlebitis. * abnormal thyroid stimulating hormone (tsh) value. * alcohol and/or substance abuse within past two years. * pregnant or lactating. * history/treatment of malignancy within past five years.

Keywords: dose-ranging diarrhea-predominant irritable bowel syndrome d-ibs ibs irritable bowel syndrome
navistar® thermocool® sf catheter: observational study

Conditions: Atrial Fibrillation; Paroxysmal Arrhythmia

Summary: this is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

this study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the navistar® thermocool® sf catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Eligibility criteria:
inclusion criteria: * drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation * age 18 years or older * patients must be able and willing to provide written informed consent to participate in the study exclusion criteria: * atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * previous ablation for atrial fibrillation * episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion * uncontrolled heart failure, or nyha class iii or iv heart failure * documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram * contraindication to anticoagulation * stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months * awaiting cardiac transplantation * heart disease in which corrective surgery is anticipated within 6 months * enrollment in investigational drug, biologic or device study * subjects unwilling to comply with protocol or follow-up requirements * patients who are pregnant

Keywords: symptomatic paroxysmal atrial fibrillation observational acute procedural outcomes ablation drug refractory arrhythmia recurrent symptomatic
effect of transcutaneous vagus nerve stimulation for pain control after cesarean delivery

Conditions: Postoperative Pain, Acute

Summary: this study investigates whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section, and explores its possible mechanisms of action through an exploratory study.

post-cesarean section pain, if improperly managed, may affect the prognosis of the mother and the health of the infant. there is an urgent need to explore safer, more effective, and more direct non-pharmacological, non-invasive adjunctive interventions to alleviate the pain associated with cesarean section. non-invasive transcutaneous auricular vagus nerve stimulation is a green neuromodulatory measure that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. this study aims to investigate whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section and to explore the possible mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: 1. patients are classified as american society of anesthesiologists (asa) physical status i to iii. 2. scheduled for elective cesarean delivery under spinal anesthesia. 3. patients are aged between 19 to 45 years old. 4. patients have provided written informed consent. exclusion criteria: 1. local skin infection occurs in the auricular area during transcutaneous auricular vagus nerve stimulation. 2. cases where spinal anesthesia fails and general anesthesia is required. 3. patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure. 4. patients who have used opioid medications at least 6 months prior to surgery. 5. patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments. 6. patients with a history of psychiatric illness.

Keywords: transcutaneous auricular vagus nerve stimulation (tavns) auricular acupoint cesarean section postoperative pain inflammatory response
evaluate efficacy, safety, tolerability and biodegradation of pa5346 ocular implant in patients with open-angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma (OAG); Ocular Hypertension (OH)

Summary: the goal of this clinical study is to learn how effective and safe is a single administration of pa5346 ocular implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. it will also assess how long it takes for pa5346 ocular implant to dissolve in the eye.

this is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of pa5346 ocular implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension. the study plans to recruit approximately 12 participants. eligible participants will receive a single pa5346 ocular implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.

Eligibility criteria:
key inclusion criteria: * ability to provide informed consent and follow study instructions * 18 years of age or older * diagnosis of open-angle glaucoma or ocular hypertension in both eyes * qualifying iops across 2 visits following washout of iop-lowering medication, if applicable * qualifying best-corrected visual acuity bcva using early treatment diabetic retinopathy study (etdrs) chart in study eye * qualifying corneal endothelial cell density (cedc) in the study eye key exclusion criteria: * pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye. * advanced or severe glaucoma * disqualifying central corneal thickness in either eye * significant other ocular conditions that could prevent accurate assessment of iop and corneal health * uncontrolled medical conditions * have previously received, any injectable glaucoma medication into the anterior chamber of the study eye * have received intravitreal injections in the study eye within the last 3 months of the screening visit and anticipated need for an intravitreal injection during the course of the study * unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
chronic myeloid leukemia (cml) real-life database

Conditions: Chronic Myeloid Leukemia (CML)

Summary: establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of cml patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.

observational study collecting real-life clinico-biological data from patients with cml. data are collected prospectively and retrospectively, from diagnosis and throughout the long-term follow-up of cml (follow up continues after treatment stopped).

Eligibility criteria:
inclusion criteria: * patient diagnosed for chronic myelocytic leukemia exclusion criteria: * cml allograft without tki treatment * refusal or inability to sign the consent

Keywords: leukemia leukemia, myeloid chronic myeloid leukemia chronic, bcr::abl positive hematologic malignancies tyrosine kinase inhibitor (tki) targeted therapy
b-mode ultrasound imaging in detecting early liver cancer

Conditions: Cirrhosis; Early Hepatocellular Carcinoma; Fibrosis; Stage I Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma

Summary: this pilot trial studies how well b-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. diagnostic procedures, such as b-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

primary objectives: i. to investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (hcc) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries. outline: patients undergo b-mode ultrasound imaging of the liver over 15 minutes.

Eligibility criteria:
inclusion criteria: for healthy volunteers 1. patients over 18 years of age. 2. must have no known medical problems and have had a full medical exam within 6 months of the study. if healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures. for hcc patients 1. patients over 18 years of age. 2. patient with confirmed diagnosis of hcc, and untreated or patients with suspected hcc (suspected hcc nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or patients at a higher risk of hcc undergoing a screening program by ultrasound. exclusion criteria: for healthy volunteers 1. patients who are not likely to comply with the protocol requirements. for hcc patients 1. patients should not be taking other investigational agents. 2. concomitant medications for treatment of the target lesion.