Kornimate/medical-research-clean huggingface dataset:
ffp in traumatic brain injury (fit-brain) trial

Conditions: Moderate to Severe Traumatic Brain Injury

Summary: the goal of this clinical trial is to learn about treatment with fresh frozen plasma (ffp) in individuals with moderate to severe traumatic brain injury. the two main question\[s\]it aims to answer are: * is the ffp treatment safe? * does the ffp treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. patients with moderate to severe tbi will randomly receive either: * standard of care treatment * standard of care treatment + 2 units of ffp. researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (ffp) treatment to see if the ffp is safe and beneficial to participant outcomes.

the two units of fresh frozen plasma will consist of 400-500 ml. the 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (hpc) measured on 24-hour follow-up ct scan, the disability rating score (drs), 24-hour glasgow coma scale (gcs) and the 3-month and 6-month extended glasgow outcome score (gos-e). a third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.

Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 18 and 65 years 2. moderate to severe tbi: gcs 3-12 3. cerebral contusion confirmed on the initial ct scan with brain injury guidelines (big) = 3 (corresponding to lesion ≥ 8 mm ) exclusion criteria: 1. persons with a known history of adverse reaction to plasma products. 2. persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen. 3. persons who are currently incarcerated. 4. persons with inadequate venous access. 5. treatment cannot start within 1 hour of arrival at the hospital. 6. the time of injury is unknown. 7. non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon. 8. interfacility transfers 9. class 3 hemorrhagic shock 10. persons with known "do not resuscitate" orders prior to randomization 11. persons who refuse the administration of blood products 12. persons with a research "opt out" bracelet 13. persons who require ffp for any other indication (e.g., reversal of coagulopathy)

Keywords: tbi traumatic brain injury
application of virtual mandibular position in temporomandibular jont reconstruction with costochondral graft in children jaw deformity

Conditions: Temporomandibular Joint Ankylosis; Facial Asymmetry

Summary: hypothesis：computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (tmja) or condyle absence with jaw deformity. methods: the inclusion criteria is children patients younger than 12 years old with unilateral tmja or condyle absence. a virtual mandibular position is designed preoperatively according to the ct data of jaw and dentition. 3d printed templates and occlusal splints are used to guide the costochondral graft and mandibular position. during surgery, the affected ramus is reconstructed with costochondral grafting under the virtual mandibular position. after surgery, the occlusal splint is fixed to maxilla at least one month, and then, replaced by orthodontic functional appliance to promote downward growth of the maxilla. occlusion, facial symmetry, costochondral graft growing would be evaluated and analysed until adulthood.


Eligibility criteria:
inclusion criteria: * \<12 years old * unilateral temporomandibular joint ankylosis or condyle absence； * temporomandibular joint reconstructed with costochondral graft； exclusion criteria: * bilateral temporomandibular joint ankylosis or condyle absence * combined with systematic disease

Keywords: virtual mandibular position; temporomandibular joint reconstruction; jaw deformity;costochondral graft
eus guided portal-systemic pressure gradient measurement to predict treatment response and outcomes of varices to endoscopic variceal ligation in patients with chronic hepatitis.

Conditions: Cirrhosis Portal

Summary: the aim of the current study is to assess if eus-ppgm could predict the treatment response and outcomes of varices to endoscopic variceal ligation (evl) in patients with chronic hepatitis. the hypothesis is that a high eus-ppgm value at 3 months correlates with the presence of varices requiring evl in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.


Eligibility criteria:
inclusion criteria: * age between 18 to 75 years old * informed consent available * suffering from chronic hepatitis induced cirrhosis * suffering from oesophageal varices and received evl as a result of 1. primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (ogd) or 2. secondary variceal prophylaxis after evl in patients with active oesophageal variceal bleeding * or bleeding gastric varices that have received endoscopic canoacrylate injection exclusion criteria: * medical child-pugh class c uncorrected platelet count \ 1.5 (natural) history of hepatic encephalopathy current or history of hepatocellular carcinoma * anatomical main portal vein thrombosis anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure). previous history of spontaneous bacterial peritonitis within the previous three months portopulmonary hypertension cardiac decompensation - endoscopically confirmed exclusion criteria presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver. presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
perforated appendicitis with delayed presentation

Conditions: Appendicitis

Summary: there is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. with the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. however, there is little evidence to determine which children are most likely to benefit from this approach. prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.

the ability of clinical practice guidelines to improve clinical practice and optimize resource utilization continues to be substantiated in the literature. to be effective, clinical practice guidelines must be developed from reliable and reproducible data. this trial prospectively compares expectant management versus immediate laparoscopic or open appendectomy for perforated appendicitis in children with a delayed diagnosis. the primary outcome measure is length of hospital stay.

Eligibility criteria:
inclusion criteria: * all children with a delayed diagnosis of perforated appendicitis. delayed diagnosis will be defined as symptoms for 4 or more days. duration of symptoms will be defined as the time pain started. * confirmed diagnosis of perforated appendicitis. the diagnosis of perforated appendicitis will be based on diagnostic imaging (ct scan or ultrasound), showing an established appendiceal abscess or phlegmon. * consent to participate exclusion criteria: * uncertainty about the diagnosis. * the need for laparotomy for another reason. * free intraperitoneal air on imaging. * perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis. * children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.

Keywords: laparoscopic appendectomy open appendectomy expectant management paediatric
in-office and domiciliary use of a new ozonized gel for the management of periodontal disease

Conditions: Periodontal Diseases

Summary: the aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease. patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (piezon ems with perioslim inserts) followed by manual instrumentation with gracey curettes and application of erythritol airflow powders. then, patients will be randomly divided into two groups according to a split-mouth design: the control group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the trial group ozoral pro for quadrants 2/4 (or 1/3) will be used. patients will use the products at home with one daily application for the following 14 days after the visits. the trial group will use ozoral gel for home applications. the following indexes will be assessed at baseline, t1 (1 month), t2 (3 months) and t3 (6 months): recession, ppd, bop %, cal, pcr %. contextually, the application of the two gels will be performed.

the aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of periodontal disease comparing chlorhexidine and ozone gels. patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (piezon ems with perioslim inserts) followed by manual instrumentation with gracey curettes and application of erythritol airflow powders. then, patients will be randomly divided into two groups according to a split-mouth design: * control group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4) * trial group: administration of ozoral pro for quadrants 2/4 (or 1/3). patients will use the products at home with one daily application for the following 14 days after the visits. the trial group will use ozoral gel for home applications. the following indexes will be assessed at baseline, t1 (1 month), t2 (3 months) and t3 (6 months): recession, ppd, bop %, cal, pcr %. contextually, the application of the two gels will be performed.

Eligibility criteria:
inclusion criteria: * presence of bilateral periodontal sites according to the new classification of periodontal and peri-implant diseases (severity: staging i; complexity: staging ii). * no systemic disease; * compliant patients. exclusion criteria: * absence of dental implants; * neurological and psychiatric diseases; * patients taking bisphosphonates during the previous 12 months from the beginning of the study; * pregnant and/or breastfeeding women; * patients undergoing anticancer therapy. * patients with poor compliance.

Keywords: ozone chlorhexidine split-mouth
oct measures predicting ffr

Conditions: Coronary Disease

Summary: background: the decision-making process of patients with angiographically-intermediate coronary lesions (icl) is clinically challenging and may benefit from adjunctive invasive techniques. fractional-flow-reserve (ffr) represents the gold standard to evaluate icl but optical-coherence-tomography (oct) is a novel, promising, high resolution coronary imaging technique. objectives: 1. investigate the relation between oct and ffr parameters in icl and understand if oct measures may predict ffr. 2. understand if oct parameters may predict clinical outcome of patients with icl not underwent revascularization on the bases of negative ffr. study design: multicentre, international, individual patient's level data pooled analysis.

principal investigators that enrolled stable or unstable patients with icl who underwent both ffr and oct assessment of the same lesion, will be contacted to participate the study. agreeing investigators will be asked to complete a structured database by providing a series of key baseline clinical and angiographic data, oct and ffr parameters. collected dataset will include: sex, age, hypertension, diabetes, hypercholesterolemia, current smoking, family history of cad, clinical presentation, previous pci, previous mi, previous cabg, non-invasive ischemia, angina, n° of diseased vessels, diseased vessel, percentage diameter stenosis at quantitative coronary angiography (qca% stenosis), length of stenosis at quantitative coronary angiography, presence of thrombus or ulceration, mla, area stenosis at oct, ffr protocol (intracoronary adenosine, endovenous adenosine, contrast) results and long term clinical follow-up.

Eligibility criteria:
inclusion criteria: * patients with angiographically-intermediate coronary lesion * patients who underwent both ffr and oct assessment of the same lesion

Keywords: intermediate coronary lesions fractional flow reserve optical coherence tomography
is less more? dosing and sequencing effect

Conditions: Depression/Anxiety

Summary: the investigators want to evaluate core components from cognitive behavioral psychotherapies (cbts) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.

in the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment. 1. it is hypothesized that both component a (cognitive restructuring) and component b (external attention allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. the difference between components as well as between the number of sessions on primary and secondary outcomes will be explored. 2. the combinatory effects, comparing the effect of receiving component a subsequent to component b and vice versa will be explored. 3. the process of change in both components will be explored. 4. group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored. 5. the moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored. 6. potential harmful effects will be explored in each group.

Eligibility criteria:
inclusion criteria: (i) age ≥ 18 years, (ii) clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to gad-7≥10, sias ≥37, phq-9 ≥10, or pdss ≥9, (iii) danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera. exclusion criteria: (i) severe depression deemed to require more intense psychotherapy or medication (phq-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.

Keywords: cbt combinatory effects most optimizing dosing sequencing effects
personalized diabetic kidney disease risk info to initiate and maintain health behavior changes

Conditions: Diabetic Kidney Disease

Summary: we propose to pilot a telehealth approach to evaluate components of risk communication by: 1. providing personalized tailored patient feedback to help initiate and maintain specific diabetic kidney disease (dkd)-related behaviors (e.g., medication adherence, weight, exercise, diet, smoking cessation) to reduce their risks. 2. evaluating how this feedback can be incorporated into clinical care by examining 6 month patient outcomes. specific aims are: 1. to evaluate the feasibility and acceptability of providing both patients and their provider feedback on individuals' dkd risk via the telehealth intervention and incorporating it into regular clinical practice. 2. if improvements in outcomes are found, to estimate the cost of the program in terms of the patient, provider, and overall costs of implementing the program.

we propose an innovative telehealth approach that has reduced antecedents of kidney disease, including poor blood pressure and glucose control, but has never been used to treat dkd. to mitigate the growing burden of dkd, these studies are designed to determine whether a potentially scalable, telehealth intervention effectively slows progression of dkd in a diverse us population and whether it is also cost-effective. the intervention simultaneously addresses medication management and behavioral therapies and education that seek to optimize adherence and self-efficacy. this proposed pilot trial will begin to evaluate if a multifactorial telehealth intervention may be effective in reducing progression of dkd.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes with progressive kidney disease exclusion criteria: * metastatic cancer * dementia * psychosis * no access to phone * diagnosis of non-diabetic kidney disease

Keywords: dkd
neurostimulation applied to fibromyalgia

Conditions: Fibromyalgia

Summary: neurofibro is a double-blind, randomized, placebo-controlled clinical trial, using neurostimulation in women with fibromyalgia.


Eligibility criteria:
inclusion criteria: * (1) diagnosis of fibromyalgia, according to the american college of rheumatology criteria; * (2) been diagnosed for at least three months; * (3) be female; * (4) be in the age group between 25 and 60 years of age; and * (5) sign the consent form. exclusion criteria: * (1) cognitive deficit, evaluated through the mini mental state examination (mmse); * (2) illiterate; * (3) people with metallic implants located on the head, cochlear implants and cardiac pacemaker; * (4) history of convulsion; * (5) severe depression, measured by score greater than 36 on beck depression inventory; and * (6) be pregnant.

Keywords: fibromyalgia, neurostimulation, tdcs
clinical study to examine the effects of erythropoietin on left ventricular function after acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the primary objective of this study is to establish the effects of a single bolus of epo, administered within three hours after a primary pci for a first acute myocardial infarction, on left ventricular function.

erythropoetin (epo) is commonly known as an effective treatment for anemia. however, several important extra-hematopoeitic effects of epo are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by epo administration. however, clinical studies with epo in non-anemic patients are scarce. we performed a safety study in our department on the effects of a single bolus of epo in patients with an acute myocardial infarction. serum epo levels increased a 200-fold and epo administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events. in conclusion, experimental data clearly showed that a single bolus of epo after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. in our safety study, epo administration in patients with an acute myocardial infarction was safe and well tolerated. this will be a probe (prospective, randomised, open label study with blinded endpoint) designed study, in wich one group will receive one bolus of epo 60.000 iu) intravenously within 3 hours after the primary pci procedure and the other group will receive standard therapy. after 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.

Eligibility criteria:
inclusion criteria: successful primary pci (timi 2/3) for a first acute myocardial infarction, diagnosed by: * chest pain suggestive for acute myocardial infarction * symptom onset \< 12 hour before hospital admission, or \< 24 hour in case ongoing ischemia * ecg with st-t segment elevation \> 1 mv in 2 or more leads * timi flow 0/1 before primary pci on diagnostic coronary angiography; exclusion criteria: * hemoglobin levels \> 10.6 mmol/l; * anticipated additional revascularisation within 4 months; * cardiogenic shock; * presence of other serious medical conditions * pregnancy/breast feeding * malignant hypertension * end stage renal failure (creatinin \> 220 micromol/l) * previous treatment with rh-epo * blood transfusion \<12 weeks prior to randomisation * polycythemia vera * previous acute myocardial infarction * concomitant inflammatory or malignant disease * recent trauma or major surgery * unwilling to sign informed consent * atrial fibrillation

Keywords: erythropoietin myocardial infarction pci left ventricular function