Kornimate/medical-research-clean huggingface dataset:
comparison study of psoriasis severity assessment tools

Conditions: Psoriasis

Summary: this study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine a or methotrexate treatment.

patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine a (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). the primary outcome was to compare the difference between the conventional subjective psoriasis area and severity index (pasi) and the objective pasi by using colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. the secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.

Eligibility criteria:
inclusion criteria: * present with chronic plaque psoriasis based on a clinical diagnosis * have \> 5% body surface area involvement at screening * are a candidate for systemic therapy * are male or female patients 18 years or older * have given written informed consent approved by the institutional review board exclusion criteria: * have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis * have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline * have had etanercept within 4 weeks prior to baseline * have had adalimumab and infliximab within 8 weeks prior to baseline * have had ustekinumab within 16 weeks prior to baseline * presence of significant hepatic or renal disorders * have uncontrolled arterial hypertension * are women who are lactating, breastfeeding or planning pregnancy * have any other condition that precludes from following and completing the protocol

Keywords: cyclosporine methotrexate
quantitative diagnosis of fatty liver by dual energy ct technique

Conditions: Liver Disease

Summary: this study is proposed to explore the correlation between fatty content of fatty liver and the difference of ct attenuation value in men using dual-energy ct, and to set up a threshold for diagnosis of fatty liver.

this study is proposed to explore the correlation between fatty content of fatty liver and the difference of ct attenuation value in men using dual-energy ct, and to set up a threshold for diagnosis of fatty liver.

Eligibility criteria:
inclusion criteria: * hepatic tumor * living liver donor exclusion criteria: * pregnancy
study to evaluate potential predictors of relapse in participants with major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to identify if there are self-reported or objective measures related to mood parameters that can predict near-term relapse (within 1 month or at another identified time point before meeting the criteria for relapse) or early symptomatic changes indicative of relapse prodrome in major depressive disorder (mdd).

this is a prospective, multicenter, longitudinal, single-cohort, observational study in participants with mdd who have responded to, and are continuing to respond to and receive, an oral antidepressant treatment regimen. the study will consist of 2 parts: a screening phase of up to 2 weeks, and an observational phase of variable duration.

Eligibility criteria:
inclusion criteria: * participants must have met diagnostic and statistical manual of mental disorders-5th edition (dsm-v) criteria for diagnosis of nonpsychotic mdd within the past 2 years (that is, the start of the most recent major depressive episode (mde) must be less than or equal to 24 months before screening), as confirmed using the mini international neuropsychiatric interview (mini - dsm-v). mdd must be recurrent, rather than a single episode * during the most recent mde, participant must have responded to, and must be continuing to receive and respond to, an oral antidepressant treatment regimen (given at an adequate dosage and duration based on the massachusetts general hospital antidepressant treatment response questionnaire), within the past 3 months. a change in the oral antidepressant treatment regimen since the time of achieving response in the most recent episode will be allowed * participants must have a montgomery asberg depression rating scale total score less than or equal to 14 * participant must be willing and able to complete self-reported assessments via a study-specific smartphone, and must be willing to wear an wrist actigraphy device for the duration of the study exclusion criteria: * participant has any of the following dsm-v psychiatric diagnoses: mdd with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), schizophrenia, or schizoaffective disorder * participant has a history of drug or alcohol use, with a severity of at least moderate or severe, according to dsm-v criteria, within 6 months before screening * participant is currently receiving or has received vagal nerve stimulation (vns), electroconvulsive therapy (ect), or transcranial magnetic stimulation (tms) or deep brain stimulation (dbs) for the most recent mde * participant is currently receiving stimulants, anticonvulsants, or mood stabilizers for treatment of his or her mdd * participant is a woman who is pregnant, or planning to become pregnant, while enrolled in this study

Keywords: depressive disorder, major depression anti-depressant observational
enterobius vermicularis and bruxism in children

Conditions: Bruxism, Sleep

Summary: background. bruxism is an involuntary, non-functional activity of the masticatory system, and is frequently seen in childhood. bruxism has many aetiologies, like malocclusion, psychological factors, allergies and gastrointestinal disorders. aim. to investigate the relationship between enterobius vermicularis infection and bruxism in children.

bruxism has many aetiologies, like occlusal interferences, malocclusion, malnutrition, psychological factors, allergies and gastrointestinal disorders. among these gastrointestinal disorders, are various intestinal parasitic infections. given the controversy surrounding the potential association between bruxism and intestinal parasitic infestations, both important health issues, this study sought to evaluate the relationship between e. vermicularis infection and bruxism in e. vermicularis-positive and e. vermicularis-negative 3-10-year-olds children with bruxism.

Eligibility criteria:
inclusion criteria: * teeth-grinding at least once a week in the last 3 months before recruitment according to the criteria established by the american academy of sleep medicine (aasm) * angle class i occlusion * mesial step occlusion according to flush terminal plane. exclusion criteria: * treated with anti-helminthic drugs in the last 2 months before recruitment * drugs used that could affect the central nervous system and prevent sleep (sedatives, anti-depressants, neuroleptics, anti-muscarinics, selective serotonin re-uptake inhibitors) * sleep disorders (snoring, insomnia, obstructive sleep apnoea, restless leg syndrome, sleep-related epilepsy) * psychiatric or neurological disorders * upper respiratory system obstruction (last 15 days), * any systemic disease; * teeth erosion due to internal (reflux) or external (acidic drinks) factors * dermatological problems, associated with the use of bitestrip (up2dent, inc., pulheim, germany); * unsuitable skin structure; * previously diagnosed and treated for bruxism; * angle class ii or class iii occlusion
a telehealth advance care planning intervention

Conditions: Myeloid Malignancy; Acute Myeloid Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm; Myelofibrosis

Summary: the objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered serious illness care program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically molst and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.

the serious illness care program (sicp) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. it consists of the serious illness conversation guide as well as training and system-level support for clinicians to conduct serious illness conversations. the investigators have previously adapted the sicp to be delivered via telehealth for older adults with myeloid malignancies. in this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered serious illness care program compared to an education control.

Eligibility criteria:
inclusion and exclusion criteria for patients inclusion criteria: * age ≥60 years * a diagnosis of aml, mds, and similar myeloid malignancies (including but not limited to mds/mpn overlap syndrome, myelofibrosis) * being managed in the outpatient settings * able to provide informed consent * english-speaking exclusion criteria: - none inclusion and exclusion criteria for caregivers inclusion criteria: * age ≥18 years * selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters" * able to provide informed consent * english-speaking exclusion criteria: - none inclusion and exclusion criteria for oncology providers inclusion criteria: - oncologists and/or apps who will be conducting the telehealth-delivered acp visit exclusion criteria: - none

Keywords: older adults myeloid malignancies geriatric hematology serious illness conversations
ces1 carriers in the papi study

Conditions: Heart Diseases; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Myocardial Ischemia; Artery Occlusion; Aspirin Sensitivity; Clopidogrel, Poor Metabolism of; Platelet Dysfunction; Platelet Thrombus

Summary: this study builds, in part, upon preliminary results generated as part of the pharmacogenomics anti-platelet intervention (papi) study (nct00799396). the purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (ces1) on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and aspirin), as assessed by ex vivo platelet aggregometry, in healthy amish individuals. the investigators hypothesize that participants who carry alleles that modify the activity or expression of ces1 will have altered response to clopidogrel as well as dual antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * age 20 years or older * of old order amish descent exclusion criteria: * currently pregnant or less than 6 months have passed since delivery * currently breast feeding * has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed * has severe hypertension, defined by a blood pressure above 160/95 mm hg * takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation * is taking vitamins or other supplements and is unwilling to discontinue use for at least 1 week prior to study * has a coexisting malignancy * has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (ast) or alanine transaminase (alt) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (tsh) less than 0.4 or greater than 5.5 miu/l * has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode * is currently taking aspirin, clopidogrel, or anti-coagulants, such as warfarin, heparin, or gpiib/iiia antagonists, and have conditions that might place the participant at increased risk from withdrawal of these medications 14 days prior to protocol initiation * history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis * has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000 * has thrombocytopenia, defined by a platelet count less than 75,000 * has had surgery within the last 6 months * has an aspirin or clopidogrel allergy

Keywords: pharmacogenetics carboxylesterase personalized medicine
quadratus lumborum block iii versus peritubal local infiltration

Conditions: Postoperative Pain

Summary: investigators compare post operative analgesic efficacy of peritubal local infiltration versus quadratus lumborum block iii . in patients undergoing percutaneous nephrolithotomy operation


Eligibility criteria:
inclusion criteria: * patient with pelvic renal stone less than 2 cm * americans society of anesthesiologists physical status i, ii * bmi\<35 exclusion criteria: * patient refusal to participate in the study * americans society of anesthesiologists physical status iii or above * major hepatic, renal or cardiovascular disease * bmi \> 35 * coagulopathy * psychological disorders.
endoscopic resection of large colorectal polyps: an observational cohort study

Conditions: Colonic Polyp; Colonoscopy; Complication; Recurrence; Duodenal Polyp

Summary: this protocol describes a prospective cohort study. it addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.

over recent years, a number of studies have been published that have highlighted factors associated with improved efficacy and safety of large polyp resection. almost all of these studies originate from one large australian cohort. it is unclear, whether the results are generalizable to other populations. it is important to understand if these findings can be duplicated, to further build on the gained knowledge. at the same time the technology of endoscopic resection is evolving. established in 2012, the large polyp study group aims to prospectively examine outcomes related to endoscopic large polyp removal. enrollment of an ongoing randomized trial of 920 patients has just been completed and a second trial is planned. the primary aim of both trials is to understand whether a specific intervention will reduce the risk of adverse events. the added observational study will complement the trials in different ways: it will enroll patients who might not have been eligible for the trials and allow the application of other resection techniques. the observational study will therefore better represent the average patient who undergoes resection of a large polyp. furthermore, it will add sample size to examine secondary outcomes with greater power. this is a continuation of nct01936948 (safety of endoscopic resection of large colorectal polyps: a randomized trial) as a observational cohort. the continuation was approved by the institutional irb as part of the initial rct. at this point the investigators document the observational arm as its own study in this registry.

Eligibility criteria:
inclusion criteria: * any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion * patients with a ≥20mm colon polyp * patients with a ≥10mm duodenal polyp exclusion criteria: * patients who are receiving an emergency endoscopy * patients with coagulopathy with an elevated inr ≥1.5, or platelets \<50 * poor bowel preparation * pregnancy
family intervention for suicidal youth: emergency care

Conditions: Suicide, Attempted

Summary: this project evaluates a brief intervention in the emergency department (ed) for adolescents presenting with suicide attempts. the intervention aims to capitalize on the opportunity offered by the ed visit to deliver an effective intervention, improve adherence to follow-up care, decrease the risk of repeat suicide attempts, and improve clinical and functioning outcomes.


Eligibility criteria:
inclusion criteria: * 10-18 years * suicidal patient presenting to emergency department exclusion criteria: * acute psychosis/symptoms that impede consent/assessment * no parent/guardian to consent (youth \<18) * youth not english-speaking * parents/guardians not english or spanish-speaking.
hydrogen sulfide detoxification and butyrate metabolism in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls.


Eligibility criteria:
inclusion criteria: - ulcerative colitis patients: patients diagnosed with ulcerative colitis exclusion criteria: * healthy controls: no diagnosis of inflammatory bowel diseases * intake of antibiotics in the last month before the study
real-life assessment of the safety and performance of the synovium hcs device

Conditions: Gonarthrosis

Summary: patients who are to benefit from an injection of synovium hcs as part of their care will be offered to participate in this study. patients will need to sign a consent form to participate. prior to synovium hcs injection, patients will be asked a series of questions regarding their pain and disability. data collected during follow-up visits can be compared to pre-injection data.

inclusion period: 6 months follow-up period: * 6-month follow-up, after intra-articular injection with extension * 1 single syringe of synovium hcs (3 ml), * controls scheduled at 1 week, 1, 3, 6 months and up to 1 year * additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons * duration of the study: overall time estimated at 18 months * in this open-label ci, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.

Eligibility criteria:
inclusion criteria: * adult patient * patient with radiologically characterized gonarthrosis (stages kellgren \& lawrence grades i to iii) * patient with walking pain (womac a1) at least equal to 2 on the likert scale 0-4 * patient to benefit from an injection of synovium hcs as part of his treatment * patient agreeing to participate in the study * patient affiliated to a social security scheme or benefiting from such a scheme exclusion criteria: * viscosupplementation less than 6 months old * intra-articular corticosteroid injection less than 2 months old * inflammatory arthritis or active infectious of the knee studied * history of surgery of the lower limb concerned * kellgren \& lawrence grades not defined * known hypersensitivity to hyaluronic acid or chondroitin sulfate * pregnant or breastfeeding women * patient under guardianship, curatorship or judicial safeguard * patient participating in another clinical investigation, at the time of inclusion

Keywords: hyaluronic acid
prevention of sagopilone-induced neurotoxicity with acetyl-l-carnitine (alc)

Conditions: Prostate Cancer; Ovarian Cancer

Summary: this study investigates the safety and efficacy of acetyl-l-carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of sagopilone-induced peripheral neuropathy. patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. treatment with sagopilone will be given as long as the patient is benefitting. in addition patients will receive alc or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. safety will be determined by laboratory and other evaluations. efficacy of alc will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. efficacy of the combination of alc and sagopilone will be determined by the tumor response.


Eligibility criteria:
inclusion criteria: * males or females aged \>/= 18 years * epithelial ovarian, peritoneal cavity or fallopian tube cancer (except mucinous or clear cell tumors) or adenocarcinoma of the prostate * at least 1 unidimensional measurable lesion (suitable for recist evaluation) or for patients without measurable disease, ca 125 levels \>/= 2 times the upper limit of normal (uln) within 3 months and confirmed within 2 weeks prior to first infusion (ovarian cancer) or psa value \>/= 5 ng/ml (hrpc). * progression of disease (hrpc) despite adequate androgen-inhibiting hormone therapy. * progression of disease (ovarian cancer) or symptomatic relapse after previous therapy (elevated ca125 levels alone are insufficient for inclusion) who performance status 0 to 1 * no clinical residual neuropathy (ctcae grade 0 at baseline) * adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia) * adequate function of major organs and systems. * survival expectation =3 months * histologically or cytologically proven: 1. epithelial ovarian, peritoneal cavity or fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of \>33%) exclusion criteria: * symptomatic brain metastases requiring whole- brain irradiation * any concomitant malignancy: the following exceptions are allowed: non-melanoma skin cancer, carcinoma in situ of the cervix, malignancy with definitive treatment \>/= 5 years ago without relapse. * diabetes mellitus (even if controlled only by special diet) * history of chronic hepatitis b or c, or known hiv infection * seizure disorder requiring medication (such as steroids or anti-epileptics) * inability to swallow oral medications * prior treatment with epothilones * concomitant use of neurotoxic drugs * concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy

Keywords: peripheral neuropathy prostate carcinoma ovarian carcinoma
effectiveness of port site bupivacaine injection in postoperative pain reduction after lap. chole

Conditions: Pain, Postoperative

Summary: to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

the study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: 1. patients of both the gender of age \>18 years and \<45years 2. patients undergoing elective laparoscopic cholecystectomy under general anesthesia. 3. patients with a.s.a grade i and ii. exclusion criteria: 1. patients with known allergic reactions to local anesthetics. 2. patients converted to open procedure. 3. patients developing intra-operative complications. 4. patients undergoing for laparoscopic cholecystectomy for acute cholecystitis. 5. patients with obesity and chronic illness. 6. patients with history of opioids, steroids, nsaids and alcohol use.

Keywords: #post operative pain #laparoscopic cholecystectomy