Kornimate/medical-research-clean huggingface dataset:
phase 3, randomized study of apremilast in japanese participants with palmoplantar pustulosis (ppp)

Conditions: Palmoplantar Pustulosis

Summary: the primary objective of the study is to evaluate the efficacy of apremilast (amg 407) twice daily (bid) compared with placebo in participants with palmoplantar pustulosis (ppp).


Eligibility criteria:
* key inclusion criteria * japanese participants ≥ 18 years of age upon entry into initial screening * palmoplantar pustulosis diagnosis with or without pustulotic arthro-osteitis (pao) for no less than 24 weeks * pppasi total score of ≥12 at screening and at baseline * moderate or severe pustules/vesicles on palms or soles (pppasi severity score ≥2) at screening and at baseline * inadequate response (defined as repeated relapsing-remitting in the same location for a 24-week period) to topical treatments prior to or at screening * key exclusion criteria * changes in disease severity during screening (pppasi total score change ≥ 5 improvement, from screening to baseline) * periodontitis requiring treatment * chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment * has a diagnosis of plaque-type psoriasis at baseline * has the presence of pustular psoriasis on any part of the body other than the palms and soles * has evidence of skin conditions of hand and feet at baseline that would interfere with evaluations of the effect of investigational product * has unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within 12 weeks prior to screening * malignancy or history of malignancy * participant has received any procedures for focal infection within 24 weeks of baseline * female participants who are breastfeeding or who plan to breastfeed while on study * female participants of childbearing potential with a positive pregnancy test * had prior treatment with apremilast * has a prior medical history of suicide attempt at any time in the participant's lifetime prior to signing of informed consent or randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing of informed consent

Keywords: palmoplantar pustulosis ppp amg 407 apremilast otezla
dash diet, quality of life and cardiac parameters of patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; Hypertension

Summary: the clinical trail study aimed to determine effect of dash eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome. the main questions it aims to answer are: 1. dash diet improve quality of life? 2. dash diet improve cardiac parameters? the researchers assessed the results of 12 weeks of the dash diet. patients will apply the dash diet prepared individually by the researchers for 12 weeks.

the study period was 12 weeks. patients' food consumption (3 day), anthropometric measurements, blood pressure measurements, physical activity levels, biochemical and cardiac parameters, adherence to dash eating plan and the macnew heart health-related quality of life scale were recorded at the beginning of the study and at the end of 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed with acute coronary syndrome within the last month * with a measured blood pressure above 140/90 mmhg or using antihypertensive drugs * not obese (body mass index \< 30) * not diagnosed with a disease requiring a different medical nutrition therapy (chronic renal failure, diabetes, cancer, etc.) * volunteered to participate in the study exclusion criteria: * acute coronary syndrome diagnosed more than 1 month ago * obese (body mass index \> 30 ) * without hypertension * receiving different medical nutrition therapy

Keywords: acute coronary syndrome hypertension dash diet quality of life cardiac parameters
transversalis fascia plane block versus erector spinae plane block for analgesia in inguinal hernia repair

Conditions: Post Operative Pain

Summary: uncontrolled postoperative pain after inguinal hernia repair increases the incidence of postoperative complications.

inguinal hernia repair is one of the most common surgical procedures in the world. annually, more than 20 million inguinal hernia repairs are conducted worldwide. uncontrolled postoperative pain increases the incidence of postoperative complications. regional blocks, as a part of multimodal analgesia, can improve pain control in the postoperative period and reduce complications that may arise from using a single mode of analgesia. for example, reliance on opioid analgesia increases the incidence of pruritus, nausea, and vomiting, as well as respiratory depression. hebbard first described the ultrasound (us)-guided transversalis fascia plane (tfp) block in 2009. a local anesthetic (la) injected between the transversus abdominis muscle and its deep investing fascia will block the anterior and the lateral branches of the t12 and l1 nerves. erector spinae plane block (espb) is a type of facial plane block in which local anesthetic is administered in the plane located between the erector spinae muscle and thoracic transverse process. espb blocks the transmission of nociceptive stimuli through the dorsal/ventral rami of the spinal nerve roots, prevents afferent stimuli transmission, and inhibits efferent activation of the sympathetic nervous system and can thus provide both somatic and visceral sensory blockade, which would make it an ideal regional anesthetic technique for abdominal surgery.the effect of espb is also achieved through the block of the lateral, posterior, and anterior thoracic wall resulting in multiple levels sensory blocks. additional proposed mechanism of action could be explained by the epidural spread of the anesthetics.

Eligibility criteria:
inclusion criteria: * male patients undergoing elective open unilateral inguinal hernia repair under general anesthesia, asa status i-ii, aged from 20 to 65 years old exclusion criteria: * contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis) * altered cognitive function * body mass index (bmi \> 35 kg/m2) * patients who have difficulty understanding the study protocol * patients who have any known allergy to study medications * advanced hepatic or renal failure * chronic opioid consumption * patient refusal
effects of rtms and tdcs treatment on brain function, craving and relapse prevention

Conditions: Addiction

Summary: addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rtms) and trans-cranial direct current stimulation (tdcs) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. there is some evidence that rtms applied to the left prefrontal cortex results in significantly lowered craving. to date, no studies have investigated the effects of a course of either rtms or tdcs treatment on opioid craving, brain function, and relapse prevention in opioid addicts. individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. the present study aims to examine the effects of a course of daily prefrontal rtms and tdcs on brain function, desire and craving and help to relapse prevention in abstinence phase.

the investigators plan to compare and contrast tms and tdcs alone or in combination to treat opioid abuse. we will use a 4 cell randomised parallel controlled trial, consisting of active or sham tms, and active or sham tdcs \[a-tdcs, a-tms; s-tdcs, a-tms; a-tdcs, s-tms; s-tdcs, s-tms). the investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. moreover, the investigators hypothesise that combining the two active treatments will be synergistic and will produce the largest reductions in craving and use.

Eligibility criteria:
inclusion criteria: * 40 treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study. exclusion criteria includes: * history of seizures, * receiving any medications known to lower seizure threshold, * pregnancy, * metal implants above the waist, * brain lesions or tumors, * a history of negative reactions to tms, and * a positive opioid urine screen (except methadone and suboxone

Keywords: brain stimulation
relationship of periodontitis and cardiovascular risk in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Periodontitis

Summary: rheumatoid arthritis (ra) is one of the most common autoimmune inflammatory arthritis affecting 0.5 to 1% population worldwide characterized by synovitis, increased inflammatory markers and progressive bone and cartilage erosion. ra is associated with an increased cardiovascular morbidity and mortality compared with the general population.

although inflammation has been shown to contribute substantially to the development of cardiovascular diseases (cvds) in patients with ra, there is also a high prevalence of traditional cvd-risk factors among these patients. the elevated risk has been shown to be attributable to combination of both traditional risk factors hypertension, smoking, dyslipidemia and obesity and ra-specific factors rheumatoid factor (rf) positivity, rheumatoid factor (rf) positivity and disease activity score including 28 joints (das28). periodontitis, a chronic inflammatory disease characterized by loss of the periodontal ligament and alveolar bone, is a major cause of tooth loss. periodontal diseases are highly prevalent and can affect up to 90% of the world population with varying degree of disease severity. the prevalence of periodontitis is higher in ra population compared to the healthy individuals. studies have reported increased periodontal tissue breakdown in ra patients, certain clinical and pathological similarities exist between both diseases. pathogenic processes in ra, which is characterized by synovial inflammation and progressive destruction of cartilage and bone, are similar to those in periodontitis. periodontitis also has been linked to other diseases known to be associated (higher) with ra as diabetes, cvd, metabolic syndrome, some types of cancer. periodontitis is one of the major modifiable risk factor of cvd. both periodontitis and cvd share common risk factors as smoking, diabetes mellitus, age, socioeconomic status, stress and obesity, which could result in confounding any association between them. studies revealed that periodontal treatment improves endothelial function and there was a longitudinal study evaluating the impact of periodontal treatment on c-imt in people with mild/moderate periodontitis. 6 and 12 months following periodontal treatment, a statistically significant reduction in c-imt compared to baseline measurements was reported. these associations emphasize the importance of oral health as a common under-recognized factor increasing cv risk.

Eligibility criteria:
inclusion criteria: * the study participants' will be diagnosed according to 2010 acr/ eular classification criteria of rheumatoid arthritis exclusion criteria: * participants with history of cvd event (myocardial infarction, coronary artery disease/reperfusion therapy, stroke, transient ischemic attack) in past or any patient experiencing cardiovascular revascularization surgery or the onset of cerebrovascular disorder within past 6 months or those with serious liver disease or renal disease will be excluded, as well. patients with overlap diseases will be excluded
robotic resection for patients with gastric gastrointestinal stromal tumors: a single-center study

Conditions: Gastrointestinal Stromal Tumor of Stomach

Summary: patients with gastric gastrointestinal stromal tumors will receive robotic resection.

gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract. approximately 60% of tumors develop in the stomach.before, patients with gastric gastrointestinal stromal tumors would receive open or laparoscopic surgery. however, gastrointestinal stromal tumors located at special sites, such as cardia, were hardly treated. recently, the robot was used to remove gastric gastrointestinal stromal tumors. in this study, the robot will be used to remove gastric gastrointestinal stromal tumors. then, we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.

Eligibility criteria:
inclusion criteria: 1. requirements of informed consent and assent of participant, parent or legal guardian as applicable. 2. patients with gastric gastrointestinal stromal tumors scheduled for robotic resection and between the age of 18 and 80 years old without considering sex. 3. american society of anesthesiologists (asa) physical status i-iii. 4. participants can follow the visit plan. exclusion criteria: 1. patients certified by a doctor that doesn't fit to participate in this study. 2. patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function \> ii (nyha) patients, patients received coronary artery bypass grafting (cabg) recently, and patients with severe hypertension (systolic pressure≥180mmhg or diastolic pressure≥110mmhg). 3. patients with gastrointestinal stromal tumor with distant metastasis. 4. patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (child - pugh≥ 10; creatinine clearance \< 25 ml/min). 5. patients with gastrointestinal operations and complicated abdominal operations. 6. patients with severe malnutrition (albumin≤30g/l, weight loss in half a year\>10%, subjective global assessment (sga) classification c, body mass index \<18, hb\<70g/l). 7. pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). 8. patients participated other subjects 3 months before this subject. 9. sponsors or researchers directly involved in the testing or their family members.

Keywords: gastrointestinal stromal tumors robot manual suture
influence of preload dependence on the effect of phenylephrine on cardiac output

Conditions: Hypotension

Summary: the perioperative hemodynamic management aims to ensure organ perfusion pressure and an oxygen arterial transport adapted to oxygen consumption. phenylephrine is the α-adrenergic agonist widely used during anesthesia for arterial pressure control. several questions on phenylephrine global and regional hemodynamics effects remain unresolved. the investigators assume that phenylephrine may decrease cardiac output by increasing the afterload, while most likely could also make an increase or a stability of cardiac output by action on the venous return. the investigators propose an observational study assessing the influence of preload dependence, defined by the values of pulse pressure variation, on the effect of phenylephrine on cardiac output, measured beat by beat by esophageal doppler. the aim of the investigators work is to improve the understanding of phenylephrine action, a daily use therapeutic action, to improve the patients care.


Eligibility criteria:
inclusion criteria: * hypotension (sbp \<90 mm hg and / or map \<60 mm hg) * injection of a bolus of phenylephrine at the discretion of the anesthesiologist physician in charge of the patient. exclusion criteria: * minor or major patient under guardianship * esophageal diseases * supra ventricular rhythm trouble * severe valvular * shunt intracardiac * vt \<7ml/kg theoretical weight * heart rate / respiratory rate \<3.6 * clinical hypepression of intra-abdominal * compliance \<30 ml/cmh2o * pulmonary hypertension, right ventricular failure * spontaneous ventilation * thorax open * vg severe dysfunction (lvef \<40%) * prior injection of ephedrine prior
evaluation of dosing interval of higher doses of ranibizumab

Conditions: Macular Degeneration; Choroidal Neovascularization

Summary: evaluation of dosing interval of higher doses of ranibizumab for patients with wet age-related macular degeneration (amd).

phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. an additional purpose is to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.

Eligibility criteria:
inclusion criteria: * treatment naive macular degeneration patients with choroidal neovascularization * \>50 years old * visual acuity 20/40 to 20/320 exclusion criteria: * pregnancy * previous history of thromboembolic event including myocardial infarction or stroke
malignant myoepithelioma of bone and soft tissues: diagnostic imaging and histology in relation to prognosis

Conditions: Myoepithelioma

Summary: the purpose of the study is to assess whether there is a correlation between imaging and histology with prognosis in patients with soft tissue and bone mc from the archives of the rizzoli orthopaedic institute all the patients with a histological diagnosis of soft tissue or bone malignant myoepithelioma treated from 1998 to 2021


Eligibility criteria:
inclusion criteria: * male and female patients treated at rizzoli orthopaedic institute between 01 jan 1998 and 31 dec 2021 * age ≥ 2 years old * diagnosis of soft tissue or bone malignant myoepithelioma (mc-sb) * patients with available clinical and imaging data exclusion criteria: * at least one inclusion criterion not met
use of remote monitoring for covid-19 patient

Conditions: COVID

Summary: the central hypothesis motivating this study is that remote patient monitoring (rpm) of infectious disease patients can efficiently facilitate self-isolation. additionally, rpm can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

aim-i to develop and test a clinical care pathway that can be utilized in similar epidemic conditions in the future. to study this aim, the investigators will be using the covid-19 medical surge as a condition to evaluate the framework of delivering care through remote patient monitoring. the success of this care delivery model will be evaluated on ease of model implementation, patient satisfaction, clinical outcomes, and the utilization of shared decision making. aim-ii to evaluate remote patient monitoring for appropriate resource utilization in epidemic and pandemic conditions. to evaluate this aim, the investigators plan to compare the emergency department (ed) visits and in-patient admission of patients with and without wearable remote patient monitoring devices. additionally, the investigators will compare the number of patients that required critical interventions (mechanical ventilation and ecmo) during the hospital stay. aim iii to evaluate the utilization of wearable technology for upfront predictions of patients that would require in-patient admissions. to evaluate this aim, patients who are diagnosed with covid-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary. the comparison group will be patients undergoing routine standard of care at the hospital. ed visits, in-patient hospital admissions, and patient satisfaction will be the outcome measures compared between the two groups. aim iv to evaluate the association between early identification of critical, abnormal vital signs and the prevention of serious adverse events. to evaluate this aim, patients in the monitored group and non-monitored group will be compared for ed visits, in-patient admissions, length of hospital stay, and serious adverse events.

Eligibility criteria:
inclusion criteria: * covid-19 positive patient * does not require in-patient admission exclusion criteria: * allergic to sensor patch * has implanted pacemaker * has excessive sweating
detection of sln in patients with endometrial cancer undergoing robotic assisted staging: comparison of isb and icg

Conditions: Endometrial Cancer

Summary: the investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with technesium-99 and isb colorimetric dye, sln biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. sln biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine h\&e pathologic analysis.

the study objective is to compare two sentinel lymph node detection technologies \[fluorescence imaging and indocyanine green (icg) dye verses standard laparoscopic colorimetric analysis using isosulfan blue (isb) dye\] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. the following three specific aims would be addressed in this research proposal: specific aim 1: to determine the ability of mapping bilaterally pelvic sln in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-isb dye + fluorescence imaging-icg dye vs. colorimetric analysis-isb dye alone). specific aim 2: to estimate the negative predictive value (npv) of pelvic sln in endometrial cancer with respect to predicting nodal metastasis. specific aim 3: to evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (ihc) staining by comparing ihc results and standard hematoxylin and eosin (h\&e) results.

Eligibility criteria:
inclusion criteria: 1. the patient must be ≥18 and ≤85 years of age. 2. the patient must be female. 3. the patient must be willing and able to provide informed consent. 4. the patient is willing and able to comply with the study protocol. 5. the patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy. 6. the patient agrees to follow-up examinations out to 6-weeks post-treatment exclusion criteria: 1. the patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy. 2. the patient has known or suspected allergies to iodine, icg or isb. 3. the patient has hepatic dysfunction confirmed by elevated liver function studies (i.e., hepatic enzyme sgot, sgpt or bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)

Keywords: sentinel lymph nodes da vinci firefly sentinel lymph node mapping fluorescence imaging sln sln mapping