Kornimate/medical-research-clean huggingface dataset:
ibp-9414 for the prevention of necrotizing enterocolitis - the connection study

Conditions: Necrotizing Enterocolitis

Summary: ibp-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.


Eligibility criteria:
inclusion criteria: * gestational age at birth of 23 weeks+0 days to 32 weeks+0 days * birth weight 500-1500g * ≤ 48 hours of age * written informed consent from the subject´s legally authorized representative (lar) exclusion criteria: * participation in any other interventional clinical trial * infants in extremis to whom no further intensive care is offered by attending neonatologist * infants with, or at a high probability for, early onset sepsis * infants with recognized chromosomal anomalies * congenital or acquired gastrointestinal disease * earlier or planned administration of formulas, foods or supplements that contain added live bacteria * infants with known positive maternal hiv status
retinal effects after combined photodynamic therapy (pdt) with intravitreal triamcinolone

Conditions: Neovascular Age Related Macular Degeneration

Summary: background: to identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (pdt) and intravitreal triamcinolone (ivta). methods: in this retrospective study, 40 patients (40 eyes) were treated with pdt and same day ivta. optical coherence tomography (oct), fluorescein angiography (fa) and evaluation of distance visual acuity (va) were performed. main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.


Eligibility criteria:
inclusion criteria: * cnv secondary to age related macular degeneration exclusion criteria: * glaucoma, diabetic retinopathy

Keywords: ivta; cnv; age-related macular degeneration; pdt
the effects of beclomethasone upper the endotracheal cuff on the occurrence of sore throat at extubation

Conditions: Anesthesia, Endotracheal

Summary: the aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly instilled through the supraglottic line of the endotracheal tube on post-extubation airway disturbances related to tracheal intubation. the primary endpoint will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after extubation. secondary endpoints will regard the effects on hoarseness and cough.

the study will be prospective, randomized, controlled. patients will be premedicated with diazepam, 0.1 mg/kg and scopolamine, 0.05 mg/kg, i.m. one hour prior to their arrival in the operatory theatre. anesthesia will be induced by fentanyl, 0.1 mg, and propofol, 1.5-2 mg/kg. after obtaining muscle relaxation with cis-atracurium, 0.15 mg/kg, a taper guard evac murphy eye oral tracheal tube (mallinkrodt, mirandola, italy) with an internal diameter of 9 in men and 8 in women, will be positioned. these tubes have a line for suctioning above the cuff. the cuff pressure will be set to 20-30 cmh2o and checked every 6 hours with a proper inflating device. patients will be connected to a mechanical ventilator and anesthesia will be maintained with sevoflurane 1-2.5% and remifentanil, 0.05-0.15 mcg/kg/min. at the end of surgery, patients will be moved to the cardiac surgical intensive care, connected to a mechanical ventilator, and sedated with propofol and remifentanil until the conditions needed for weaning from the ventilator (control of bleeding, cardiovascular stability, thermal equilibrium) are achieved. then, propofol infusion will be stopped and remifentanil dosage decreased to 0.02-0.05 mcg/kg/min. after a successful t-tube trial of spontaneous breathing, tracheal tubes will be removed. remifentanil infusion will be continued and dosage titrated on patient pain evaluated with a vas scale; paracetamol 1 g will be given if need be.

Eligibility criteria:
inclusion criteria: * intensive care postoperative admission * tracheal intubation for a total lapse of time between 10 and 18 hours exclusion criteria: * age \< 18, * hypersensitivity to fans and/or corticosteroids, * a medical history positive for diseases affecting upper airways or trachea or causing cough, hoarseness, or voice disorders; * intubation after more than two attempts or with aids (i.e. stylets, airtraq, glidescope, fibroscopy).

Keywords: intubation intensive care cardiac surgery sore throat
clinical study of ingrezza (valbenazine) for the treatment of cervical dystonia

Conditions: Cervical Dystonia

Summary: study of ingrezza (valbenazine) for the treatment of cervical dystonia.

the study will be an open-label, prospective study. patients with a diagnosis of cervical dystonia will undergo 4 weeks of baseline evaluation, followed by a 12-week treatment period. subjects will be evaluated in-clinic every 4 weeks. standardized assessments will be performed at these visits. data will also be collected from wearable imus (inertial measurement units) and analyzed for improvements in involuntary, repetitive movements and postures.

Eligibility criteria:
inclusion criteria: * male or female patients between 18 and 85 years of age (inclusive) * a clinical diagnosis of cervical dystonia (ie, spasmodic torticollis) by investigator for at least six months * moderate to severe head tremor and/or dystonic posturing as judged by the investigator * stable botulinum toxin (botox, dysport, xeomin, or myobloc) therapy dosage for at least 3 months prior to baseline visit exclusion criteria * tardive dyskinesia * predominant anterocollis * concomitant use of strong cyp3a4 inhibitors (i.e. itraconazole, ketoconazole, clarithromycin), digoxin, strong cyp2d6 inhibitors (i.e. paroxetine, fluoxetine, quinidine), monoamine oxidase inhibitors (i.e. isocarboxazid, phenelzine, selegiline) * myotomy or denervation surgery in the affected muscles (eg, peripheral denervation and/or spinal cord stimulation) * diagnosis of myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial * moderate to severe hepatic impartment as determined by a child-hugh score ≥7 * marked limitation on passive range of motion that suggests contractures or other structural abnormality, eg, cervical contractures or cervical spine syndrome * any conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study * participation in another interventional study during participation in this study * pregnant or lactating females, or females of child-bearing potential not willing to use an acceptable method of contraception * history of hypersensitivity to valbenazine or any components of ingrezza. * is suicidal at screening as defined by below: 1. according to the c-ssrs, he or she must not be actively suicidal at visit 1 (screening) or visit 2 (baseline) (including, an answer of "yes" to c-ssrs questions 4 or 5 \[current or over the last 6 months\]) and must not have attempted suicide in the 1 year prior to visit 1 (screening); or 2. the subject is actively suicidal in the investigator's judgment
gabapentin versus transdermal fentanyl matrix for chronic neuropathic pain

Conditions: Neuropathic Pain; Spinal Stenosis

Summary: gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. but, there is no head to head study on the efficacy of those medication in neuropathic pain. the hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.


Eligibility criteria:
inclusion criteria: * patients are 20 years of age or older * patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (nrs) * neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change * positive mri finding or radiculopathy was confirmed by the emg/ncs or not less than 12 points in the s-lanss score assessment * patients who can make out the questionnaire * patients have agreed with the informed consent exclusion criteria: * patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (cr oxycodone, sr morphine) * patients who have other causes of neuropathy such as hypothyroidism, vit b12 deficiency, connective tissue disease, etc. * patients who have other disease which causes more pain compared with neuropathic pain * patients with a history of drug or alcohol abuse * patients who are pregnant or have the possibility of pregnancy * patients who are unable to use a transdermal system due to skin disease * patients with a serious mental disease * patients with a history of hypersensitivity to opioid analgesics * patients with a chronic pulmonary disease or respiratory depression * patients combined with industrial accidents or traffic accidents * at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure

Keywords: neuropathic pain gabapentin transdermal fentanyl matrix multicenter non-inferiority trial
i-care: a pilot study of cognitive behavioural therapy(cbt) for mood and anxiety disorders

Conditions: Mood Disorders; Anxiety Disorders

Summary: the goal of this clinical trial is to learn if cbt(cognitive behavioural therapy)-myowl(optimizing wellness through literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. the main questions it aims to answer are: primary objective (feasibility): to determine whether a clinically meaningful proportion of youth complete a full course of cbt-myowl / cbt-as-usual. primary objective (acceptability): to determine whether the cbt-myowl and cbt-as-usual interventions delivered are acceptable to youth participants. secondary objectives: 1. to determine whether cbt-myowl enhances time of retention compared to cbt-as-usual. 2. to determine whether youth who receive cbt-myowl have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive cbt-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency. participants will: participate in 12 sessions of either cbt-myowl or cbt-as-usual (active control) completes 4-5 questionnaires at sessions 3,6,9,12 complete the acceptability and exit interview at session 12


Eligibility criteria:
inclusion criteria: * aged 14-19 * primary diagnosis of a mood disorder or an anxiety disorder * ability to understand written and spoken english and to read a novel * treating physician considers cbt as indicated for the patient exclusion criteria: * patients already participating in active cbt therapy or recently completed cbt treatment (within the past 3 months) * active psychosis or mania
right ventricular function in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. however, there is no substantial that about the influence of obstructive sleep apnea on the right ventricular function. objective: to analyse the right ventricular function in patients with obstructive sleep apnea by means of real-time three dimensional echocardiography.

Eligibility criteria:
inclusion criteria: * individuals \> 18 years old and \< 70. exclusion criteria: * body mass index greater than 35 * past of clinically significant cardiac conditions

Keywords: obstructive sleep apnea right ventricular function pulmonary hypertension
application of elbow manipulation in archers

Conditions: Health

Summary: the aim of this study was to: (i) assess the impact of maximal muscle strength and stiffness on emg and myoton parameters for selected upper limb muscles; and (ii) assess how manipulation of the initial 2-s tension phase, in particular involving muscle stretching, affects these emg and myoton parameters during karting training.

emg and myoton measurements will be performed on selected muscles of the shoulder joint and forearm during karting drivers' training, initially at the beginning, after the athletes perform their first 8-minute run, after manipulation and after another 8-minute run.

Eligibility criteria:
inclusion criteria: * healthy persons aged 18, * a license to drive a kart, * a competitor who regularly competes in the league, * expressing informed consent to participate in the study and undertakes to comply with the regulations on the track and wear a helmet. exclusion criteria: * lack of volunteer consent, * previous upper, lower limb and spine surgeries, * other upper limb injuries in the last 6 months, * pain limiting participation in the study, * neurological diseases, * connective tissue diseases.

Keywords: go-kart drivers muscle fatigue recovery manipulation
a nutritional intervention to decrease breast density among female brca (breast cancer susceptibility gene) carriers

Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation

Summary: the purpose of this study is to determine whether adding dim supplement will decrease breast density among female brca mutation carriers in two years.

the research question: in female brca mutation carriers, will adding dim (100mg\*1/d, a nutritional supplement), decrease breast density in two years? study design: a single center single arm prospective interventional study of the use of dim to decrease risk of breast cancer among female brca carriers. study population: subjects will be female carriers of a brca mutation and have more than 10% mammographic breast density at baseline. intervention: dim supplement (100mg\*1/d). study time line: this will be a 2 years study. at initiation a breast mammography will be performed and eligibility assessed. follow-up visits will occur every 4 months and quality of life questionnaires as well as adherence to dim supplementation will be assessed. at the initiation and every 4 months blood and urine samples will be collected for estrogen profile. at 12 and 24 months a mammography will be performed to verify changes in breast density. primary endpoint: a decrease of more than 10% in breast density compared to baseline, following dim supplementation intervention among female brca carriers. study impact: decrease in mammographic breast density was shown to be a good marker for lower risk of breast cancer. this study has the potential to dramatically impact the management of female brca carriers. if we prove that by adding a food supplement breast density is decreased, we will change standard of care in these woman. in addition, the urine and blood samples collected during the study will be used for future translational research on the pathogenesis of breast cancer.

Eligibility criteria:
inclusion criteria: * women who carrier the brca 1\\2 mutation. * no history of breast or ovarian malignancy. * i. baseline mammographic breast density is more than 10% or ii. baseline breast mri with density or enhancement ≤ 2. * age 18-70. * absence of any psychological, familial, sociological or geographical situation potentially hampering adherence to the study protocol and follow-up schedule. * informed written consent must be signed according to ich/eu gcp, before subject registration. exclusion criteria: * women who have undergone preventive breast reduction. * breast imaging demonstrating a lesion suspected to be cancerous. * breast feeding or pregnancy or planning to get pregnant. * known allergy to dim and its ingredients.

Keywords: brca mutation breast cancer estrogen metabolism 3,3-diindolylmethane breast density
an exploratory clinical trial to evaluate the efficacy and safety of a novel antibacterial bone traction needle

Conditions: Wound Infection

Summary: the goal of this clinical trial is to test in wound infection. the main question it aims to answer is: whether this antibacterial bone traction needle is safe and has a good effect on wound infection. participants will be implanted with an antibacterial bone traction needles and the infection grade of wound after surgery will be observed. if there is a comparison group: researchers will compare the control group without antibacterial ability to see if the experimental group can effectively inhibit wound infection.


Eligibility criteria:
inclusion criteria: 1. limb fractures, infections, defects and deformities caused by various congenital or acquired factors, such as multiple fractures of tibia and fibula, infectious bone defects of tibia, knee varus, horseshoe varus foot, etc.; 2. the subject understands the significance of this project, voluntarily acts as the subject and signs the informed consent. exclusion criteria: 1. the subjects are pregnant or lactating women; 2. pathological fractures (such as primary or metastatic tumors); 3. the patient is allergic to iodine and its compounds; 4. the patient is allergic to metal implants; 5. patients with coagulopathy (such as hemophilia, vitamin k deficiency, severe liver disease, etc.); 6. the patient had participated in other clinical trials in the past 3 months; 7. the patient had contraindications to anesthesia and surgery; 8. the patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid use (continuous use for more than 3 months); 9. the patient had poor compliance and was judged by the researchers to be unable to complete the experiment according to the research plan, such as alcohol addiction, drug abuse, schizophrenia, dementia, and did not provide consent for voluntary participation in the clinical study.

Keywords: external fixation, implant
variation of glucose values at early stages of diabetes - continuous glucose monitoring

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. in addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling conditions. the onset of type 2 diabetes is a gradual shift from normal to abnormal, giving rarely noticeable symptoms at its early stages or even in later stages when damage has already been caused. due to the gradual onset, the diagnosis is often delayed, and as much as half of the asymptomatic patients remain undetected. the diagnostic criteria for diabetes are based on artificial boundaries reflecting the risk of complications related to diabetes. the golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is both time consuming and costly. this study aims at improving the prediction of type 2 diabetes among high-risk individuals by examining glucose excursion patterns in subjects with impaired glucose tolerance. in addition, this study will show whether the currently used diagnostic test could be replaced by an easier and less expensive method.

Eligibility criteria:
inclusion criteria: * individuals with impaired glucose tolerance (2h plasma glucose during oral glucose tolerance test \>7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose \> 7.0 mmol/l and/or 2h plasma glucose \> 11.1 mmol/l on two occasions, or both criteria fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short duration (\<3 years); 40 from padova university hospital, 60 from the botnia study or the ppp (prevalence, prediction, prevention)-botnia study in finland. * age 40-75 years exclusion criteria: * medication with: insulin, glucagon-like peptide-1 (glp-1)-analogues, sulphonylureas, oral corticosteroids, thyreostatic agents or thyroid hormone, luteinizing-hormone-releasing hormone (lhrh) analogues * pregnancy * known changes in retinal fundus photographs * known, microalbuminuria * hba1c \>8% * fasting plasma glucose \>10 mmol/l * medication with metformin, glitazones, gliptins (or acarbose) is allowed but gliptins and acarbose need to be stopped 2 days before testing and during the study

Keywords: type 2 diabetes continuous glucose monitoring
5 fractions of pelvic sabr with intra prostatic sabr boost:

Conditions: Prostate Cancer

Summary: stereotactic ablative body radiotherapy (sabr) given in 5 weekly fractions. simultaneously treating the pelvic lymph nodes, prostate and mri-nodule to a total dose of 25 gy, 35 gy and up to 50 gy, respectively. the radiation will be given with 6-18 months of adt. 5-fraction sabr is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.


Eligibility criteria:
inclusion criteria * histologically confirmed prostate adenocarcinoma (centrally reviewed) * high-intermediate risk defined as two or more of: t2c, gleason 7 or psa 10-20ng/ml, * high-risk prostate cancer, defined as at least one of: t3, gleason 8-10, or psa \> 20 ng/ml * willing to give informed consent to participate in this clinical trial * able and willing to complete epic, porpus and eq-5d questionnaires exclusion criteria * prior pelvic radiotherapy * contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * anticoagulation medication (if unsafe to discontinue for fiducial insertion) * diagnosis of bleeding diathesis * poor baseline urinary function defined as international prostate symptom score (ipss) \>20 * evidence of castrate resistance (defined as psa \< 3 ng/ml while testosterone is \< 0.7nmol/l. patients could have been on combined androgen blockade but are excluded if this was started due to psa progression. * definitive extrapelvic nodal or distant metastatic disease on staging investigations. * hip prosthesis