Kornimate/medical-research-clean huggingface dataset:
primary care intervention for ptsd in ethiopia

Conditions: PTSD

Summary: mixed methods (qualitative and quantitative) cluster randomized pilot feasibility trial (n=40) to refine the the brief relaxation, education and trauma healing (breathe) ethiopia intervention and explore effectiveness and implementation. fifty patients will be enrolled across the pre-pilot and the pilot to account for potential treatment dropout. eight health care centers will be randomized to treatment or waitlist conditions. 1. primary outcomes: change in hypothesized treatment mechanisms: (1) increased knowledge about ptsd; reductions in (2) ptsd-related stigma; (3) trauma-related cognitions; and (4) self-reported arousal; (5) increased use of stress management strategies; and (6) reductions in physiological arousal as measured by increased heart rate variability. 2. secondary outcomes: change in symptoms and functional impairment. reductions in (1) ptsd (2) depression and anxiety symptoms, and (3) functional impairment. 3. process evaluation: mixed methods multi-stakeholder process evaluation of the implementation of the intervention as measured by the re-aim framework (reach, effectiveness, adoption, implementation, maintenance). we will collect qualitative data on adoption and implementation (e.g. facilitators and barriers to intervention delivery) and quantitative assessment of patient and provider participation and retention (reach), satisfaction (adoption) and fidelity (implementation).


Eligibility criteria:
inclusion criteria: 1. for all participants: being 18 years of age or older 2. for all participants: being able and willing to provide informed consent to participate in the study 3. for all participants: being able to complete procedures in amharic or english. 4. for patients: treatment at a sodo district primary care clinic for severe mental illness (smi) 5. for patients: identified as having: 1. experienced a traumatic event, 2. associated ptsd symptoms defined as scores on the ptsd checklist dsm-5 (pcl-5), and 3. any associated functional impairment on the whodas-2. 6. for health care providers: providers working at the target health centers who administer, provider care for, or supervise the care of patients with mental health concerns. 7. for caregivers: being identified by the patient as a close family member or friend whom the patient gives permission to be involved in the study exclusion criteria: 1. current high risk of suicide as measured by the composite international diagnostic interview (cidi) suicide module 2. inability to participate in the treatment, as determined by the psychiatric nurse.

Keywords: post traumatic stress disorder severe mental illness psychotherapy global mental health ethiopia
korean medicine patient registry of postoperative therapy for musculoskeletal disorders (kpop-md): a study protocol

Conditions: Musculoskeletal Disorders; Korean Medicine Patient Registry; Post-operative Therapy

Summary: to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for patients with musculoskeletal disorders after musculoskeletal operations


Eligibility criteria:
inclusion criteria: * aged 19 and over * those who have undergone musculoskeletal related surgery (corresponding to the disease classification code m00-99, s00-99) within 3 years * voluntary applicant who has no problem with communicate with study associates or a mild cognitive impairment patient who scored higher than 23 points in korean version of the montreal rating questionnaire with voluntary participation exclusion criteria: * participants in other clinical trials * those who are unlikely to be adhered to the schedule of clinical studies * those who are expected to have difficulty understanding and responding to research questionnaires such as illiteracy, mental and physical weakness

Keywords: korean medicine patient registry post-operative therapy musculoskeletal disorders
nfc changes in sle patients and its correlation with anti-u1rnpantibodies and disease activity

Conditions: System Lupus Erythematosus

Summary: 1. detection of different pattern of nail fold capillary changes in sle patient. 2. correlation of nail fold capillary changes in sle patients and anti-u1rnp antibodies. 3. correlation of nail fold capillary changes with sle disease activity. 4. frequency of nail fold capillary changes in sle patients

systemic lupus erythematosus is a complex, multi-organ autoimmune disease . the presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions .the clinical manifestations of sle include muco cutaneous, musculoskeletal system, cardiac, neurological, renal, hematologic, and vascular system involvement . nail fold capillaroscopy (nfc) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nail fold area . nail fold capillary changes are very common in patients with sle. the major nfc pattern that has been reported in sle patients was non-specific sub-types, followed by normal pattern and scleroderma pattern. in (sle) patients are reported a large spectrum of antibodies, including the anti-ribonucleoproteins (rnp) antibodies these antibodies were linked to several clinical manifestations and prognostic in patients with sle. anti-u1-rnp antibodies are involved in both innate and adaptive immune responses during pathogenesis of connective tissue diseases 12. u1-rnp complex is an intra nuclear protein that converts pre-mrna to mature rna and constitutes three specific proteins a, c, and 70 kda. high titer rnp antibodies are detected in mctd patients and correlated with clinical disease activity index and the frequent complication of pulmonary artery hypertension in those patients . it also has been found that nfc may detect subclinical microvascular changes in sle in the presence of anti-u1-rnp antibodies and may facilitate early preventive therapy for major organ vasculopathy .

Eligibility criteria:
inclusion criteria: * adult sle patients who fulfilled the 2012 systemic lupus international collaborating clinics (slicc) criteria exclusion criteria: 1. sle patient aged less than 18 yeares old. 2. individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease). 3. congestive cardic failure and presence of clupping. 4. coexisting diabetes mellitus. 5. history of smoking. 6. patients unable to co-operate for nailfold capillaroscopic examination

Keywords: nailfold capillaroscopy anti-u1rnp antibodies disease activity
role of epoxy-eicosatrienoic acids in post-occlusive hyperemia and thermal hyperemia

Conditions: Healthy Volunteers

Summary: the objective of this proof of concept study is to assess the involvement of epoxy-eicosatrienoic acids (eets) in post-occlusive hyperemic and thermal hyperemia responses, and the interaction between nitric oxide (no) and eets, using the latest methods for the study of functional microcirculation.

the eety study is a single-center proof of concept study in healthy volunteers. the main objective is to study the involvement of epoxy-eicosatrienoic acids (eets) in the reactivity of cutaneous microcirculation during post-occlusive hyperemia and thermal hyperemia, by studying the response to microdialysis of fluconazole (an inhibitor of eets) versus control, on the forearm. response is measured by the amplitude of the post-occlusive hyperemia and thermal hyperemia peaks (maximum amplitude as a percentage of maximal vasodilation and areas under the curve: auc) during the injection of fluconazole compared to an intradermal injection of solvent (nacl 9 ‰). the subjects are healthy volunteers of both sexes, aged between 18 and 35, non-smokers and in good health. over two years, 30 subjects will be included in the study for 6 to 13 weeks.

Eligibility criteria:
inclusion criteria: * age between 18 and 35 years * affiliated to the french social security system or beneficiary a similar regime * in good health exclusion criteria: * active smoker * pregnant, parturient, breast-feeding * person deprived of civil liberties by judicial or administrative measure; person under legal protection, * minor less than 18 years * within period exclusion for other clinical research studies * person has exceeded the annual compensation for participation in trials * person with active disease or with prolonged treatment, excluding oral contraceptives and paracetamol * asthma, urticaria, angioedema, known drug allergy

Keywords: epoxy-eicosatrienoic acid laser doppler endothelium derived hyperpolarizing factor cutaneous microcirculation post-occlusive hyperaemia thermal hyperemia intradermal microdialysis fluconazole
effect of kava on anxiety and stress in cancer survivors

Conditions: Kava; Anxiety; Stress; Cancer; Depression; Sleep

Summary: this is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment. participants will be randomized to take either kava first or placebo first. kava 75 mg or placebo will be taken three time daily (tid) for 14 days (period 1), followed by a washout period of 14-28 days. thereafter, the participant will take either placebo or kava tid for 14 days (period 2), whichever he/she did not take in period 1.


Eligibility criteria:
inclusion criteria: * completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up * score of ≥ 5 on the gad-7 questionnaire, considered to be mild anxiety * ecog performance status 0-1 * normal kidney and liver function within 28 days prior to the first dose of kava or placebo * willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion * ability to provide written, informed consent exclusion criteria: * regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration * anti-cancer therapy within 28 days prior to registration, and/or during study participation, except for aromatase inhibitors * known liver disease such as cirrhosis (any child-pugh class), active infectious hepatitis, immune-mediated hepatitis, hemochromatosis, non-alcoholic steatohepatitis (nash), or wilson's disease * use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention * chronic use of high-intensity statin therapy * significant uncontrolled conditions or situations, which in the judgment of the enrolling investigator, could affect safety and/or ability to adhere to study requirements * adjustments in anti-depressants and/or anxiolytic medications within 8 weeks prior to study registration * known allergy to kava * women who are pregnant, intend to become pregnant, or are nursing * regular use of alcohol, defined as ≥ 3 times per week, regardless of amount, within 14 days prior to study registration * parkinson's disease * history of or current substance use disorder by self-report
a trial comparing the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: - type 2 diabetes mellitus - hba1c 7.0-10.0% \[53-86 mmol/mol\] (both inclusive) by central laboratory analysis - current treatment with insulin glargine for at least 90 days prior to screening - stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - body mass index (bmi) below or equal to 40 kg/m\^2 exclusion criteria: - any use of oral antidiabetic agents (oads) (except for metformin) within 90 days prior to visit 1 (screening) - current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - previous and/or current treatment with glucagon-like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide) - impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal range (unr) - impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (1.4 mg/dl) for females, or as allowed according to local contraindications for metformin - screening calcitonin above or equal to 50 ng/l - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2) - history of chronic pancreatitis or idiopathic acute pancreatitis
trial evaluating modified folfirinox and modified folfox in the treatment of locally advanced or metastatic small bowel adenocarcinoma

Conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma

Summary: randomized, non-comparative, open-label, multi-centre phase ii study to evaluate modified folfirinox and modified folfox in the locally advenced or metastatic small bowel adenocarcinoma. the primary objective is to assess the percentage of patients alive without prograssion at 8 months.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the small intestine (duodenum, jejunum, ileum) * metastatic or locally advanced unresectable tumour with curative intent * patient who never received first-line chemotherapy * measurable lesion according to recist 1.1 criteria * ecog status \< or = 2 for patients under 70 years, or 0 or 1 for patients over 70 years * life expectancy estimated at over 3 months * patient over 18 years of age * patient able to understand and sign the information and informed consent note * women of childbearing age and men who have sex with women of childbearing age must agree to use contraception during the trial treatment and for at least 9 months after stopping the experimental treatments. exclusion criteria: * msi/dmmr tumor * adenocarcinoma of the ampulla of vater * neutrophils \< 1500/mm3, platelets \< 100 000/mm3 * hemoglobin \ 1.5x normal, alkaline phosphatase \> 2.5x normal (or \>5x normal if liver metastases), creatinine clearance \> or = 40 ml/min. according to mdrd * hypokalaemia, hypomagnesaemia and hypocalcaemia below normal, and for calcaemia, it must be corrected before enrolment. * adjuvant chemotherapy completed less than 6 months ago * history of myocardial infarction within the last 6 months, severe coronary artery disease or severe heart failure * severe renal failure * peripheral sensory neuropathy with functional discomfort * active and/or potentially severe infection or other uncontrolled conditions * treatment with a cytochrome p450 inhibitor within 4 weeks prior to the administration of the protocol treatment (refer to paragraph 8.3 "contraindicated treatments" of the protocol) * patients currently undergoing treatment using st john's wort * treatment with brivudine within 4 weeks prior to the administration of protocol
effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy

Conditions: Hyperalgesia

Summary: the purpose of this study is to study the effect of intraoperative magnesium on remifentanil-induced postoperative hyperalgesia after thyroidectomy


Eligibility criteria:
inclusion criteria: * patients undergoing thyroidectomy, * age 20-65, * american society of anesthesiologists physical status classification i or ii. exclusion criteria: * history of chronic pain, regular use of analgesic, antiepileptic or antidepressive drugs, * history of drug \& alcohol abuse, * psychiatric disorder, * use of opioids within 24hrs, * renal disease with decreased gfr, * neuromuscular disease, severe cardiac disease.

Keywords: remifentanil induced postoperative hyperalgesia
evaluation of safety and efficacy of nasea(r)/ramosetron inj. in patients undergoing facial bone fracture operations

Conditions: Facial Bones Fracture

Summary: postoperative nausea and vomiting (ponv) is one of the most common and distressing complications after anaesthesia and surgery, and may lead to serious postoperative complications this prospective, randomized study designed to evaluate the best injection time to get the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-ht(3) antagonist in patients undergoing facial bone surgery.

1. participants * 100 patients with undergoing facial bone surgery are going to be randomly allocated to one of the 3 groups 2. randomization * g1(n=33) - ramosetron 0.3mg i.v. just before the beginning of the surgery * g2(n=33) - ramosetron 0.3mg i.v. just after the end of the surgery and moving into the recovery room * g3(n=33) - no medication but regular antiemetics i.v. if the patient wants 3. the primary endpoint * the incidence of nausea and vomiting for 24 h after surgery at 0-6h, 6-12 h and 12-24 h 4. the secondary endpoints * the severity of nausea, need for rescue medication * patient satisfaction with efficacy

Eligibility criteria:
inclusion criteria: * patient who sign informed consent form for the study * patient who are considered as surgical candidates with facial bones fracture exclusion criteria: * patient who have had nausea/vomiting episodes

Keywords: facial bones post operative nasea vomiting fractures reduction
long-term clinical outcomes of intravascular ultrasound-guided vs angiography-guided primary percutaneous intervention in patients with acute st segment elevated myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: to examine the impact of ivus guidance on clinical outcomes in the patient with acute st segment elevated myocardial infarction.

intravascular ultrasound (ivus) has been increasingly used as a guide for percutaneous coronary intervention (pci) during elective as well as emergent clinical scenario. recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of ivus-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization. there are sparse data available on the clinical impact of ivus-guided pci in the setting of acute myocardial infarction (ami) and its use remains a matter of controversy as shown by previous studies. this study is to examine the impact of ivus guidance on clinical outcomes in the patient with acute st segment elevated myocardial infarction (stemi).

Eligibility criteria:
inclusion criteria: * clinical inclusion criteria: 1. age \> 18 years 2. onset of stemi \> 30 minutes, but \< 12 hours 3. st segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed lbbb on ecg 4. willing and able to provide informed consent * angiographic inclusion criteria: 1. having at least one infarct-related coronary artery, of which (1) the culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the timi flow is ≤ 1 in culprit lesion segment prior to guide wire crossing 2. no excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation exclusion criteria: * clinical exclusion criteria: 1. contraindicating to any concomitant study medications 2. having cardiogenic shock with hemodynamic instability 3. a history of bleeding diathesis or known coagulopathy 4. a history of cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (gi) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or hb \< 10 g/dl 5. planned surgery which may cause discontinuation of adp-receptor antagonist 6. other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year 7. repeated mi within 7 days of hospitalization for acute mi * anigographic exclusion criteria: 1. bifurcated lesion unable to identify the culprit lesion 2. the culprit lesion is located in the left main artery 3. diffusive lesions without distinguishable culprit lesion 4. previous stent implantation in the culprit lesion segment or stemi caused by stent thrombosis 5. likely cabg procedure within 30 days 6. renal failure requiring or during dialysis

Keywords: stemi intravascular ultrasound angiography primary percutaneous intervention
pilot safety study of injectable sis for critical limb ischemia

Conditions: Critical Limb Ischemia; Peripheral Arterial Disease; Peripheral Vascular Disease

Summary: this study is intended to collect safety and effectiveness data on the cook injectable small intestinal submucosa (sis)


Eligibility criteria:
inclusion criteria: * diagnosis of critical limb ischemia * rutherford 4-5 or leriche-fontaine iiib * patient unable to be treated by endovascular or surgical means exclusion criteria: * patient's age is \<21 * patient is pregnant or breast-feeding (or is planning to become pregnant within the next year) * patient has had a previous surgery, within 30 days of the study procedure * patient has any planned surgical or interventional procedure within 30 days after the study procedure * patient has a life expectancy less than 1 year * patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue * additional restrictions as specified in the clinical investigation plan

Keywords: critical limb ischemia wound healing amputation