Kornimate/medical-research-clean huggingface dataset:
shared decision making for patients with first-admission schizophrenia

Conditions: Schizophrenia

Summary: to determine whether shared decision making (sdm) intervention improves patient satisfaction in patients with first-admission schizophrenia compared with usual care.


Eligibility criteria:
inclusion criteria: * admitted to an acute care psychiatric ward. * diagnosed with schizophrenia (icd-10 codes: f20-f29) * aged 16 to 65 years old at admission * no prior experience of psychiatric admission (first-admission) exclusion criteria: * diagnosed with moderate to severe mental retardation * diagnosed with organic mental disorders (icd10 codes: f00-f09) * having poor japanese language skill * severe conceptual disorganization as measured by brief psychiatric rating scale of 5 or more.

Keywords: first hospitalization
value of liquid potassium magnesium citrate in controlling hypertension

Conditions: Hypertension

Summary: in the dash (dietary approaches to stop hypertension) trials, a diet rich in fruits, vegetables, nuts and dairy products, and limited in fat content, was shown to be useful in controlling hypertension. key components of such a diet are potassium, magnesium and alkali, each of which has been implicated in lowering blood pressure. whether a liquid formulation of potassium-magnesium citrate will result in equivalent bp effect as the dash diet is unknown.

the dash diet is rich in potassium and magnesium. it is also high in alkali content, since the anions are provided mostly by citrate rather than chloride. considerable data are already available in the literature invoking a protective role on hypertension of potassium, magnesium and alkali. in this protocol, the investigators want to test the hypothesis that liquid potassium-magnesium citrate (kmgcit) as a pharmaceutical formulation could serve as a surrogate for the dash diet, and would lower blood pressure among patients with pre- or stage i hypertension on their customary diet. each subject will participate in all four phases, chosen in random order. the four phases will be: placebo phase (microcrystalline cellulose in water), potassium chloride phase (potassium chloride powder in water), potassium citrate phase (potassium citrate powder in water), kmgcit phase (kmgcit powder in water) during each phase, subjects will receive one of the test drugs for 4 weeks, followed by at least 1 week of withdrawal. change in 24 hr bp, office bp will be measured at baseline and after each phase. central aortic blood pressure and carotid-femoral pulse wave velocity, -terminal-telopeptide (ctx), 24 hr urine electrolytes will be measured at 4 weeks in each phase.

Eligibility criteria:
inclusion criteria: * patients with pre- or stage i hypertension, with systolic blood pressure of 120-159 mm and diastolic of 80-99 mm * age \> 21 years of age exclusion criteria: * diabetes mellitus, * renal impairment (serum creatinine \> 1.4 mg/dl), * any heart diseases such as congestive heart failure or sustained arrhythmia, * chronic nsaid use, * treatment with diuretics, * gastroesophageal reflux disease (gerd) requiring treatment with acid reducing agents or antacid more than once a week, * esophageal-gastric ulcer, * chronic diarrhea * hyperkalemia (serum \> 4.6 mmol/l for patients on angiotensin converting enzyme (ace) inhibitors or angiotensin receptor blockers (arb), serum k \> 5.0 for patient not on ace inhibitors or arbs) * liver function test above upper limit of normal range. * subjects who require any potassium supplement on a regular basis from any reasons * pregnancy * history of major depression, bipolar disorder, or schizophrenia * history of substance abuse.

Keywords: potassium magnesium citrate dash
ub-621, a new type of anti-herpes simplex virus (hsv) monoclonal antibody for the use in the treatment of adult recurrent hsv-2 infections of the genitals

Conditions: Recurrent Genital Herpes

Summary: a randomized, single-blind, dose-selected phase ii trial to evaluate the safety, efficacy and pk of ub-621 in adults with recurrent genital hsv-2 infection


Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age inclusive. * subject must be hsv-2 seropositive * subjects have a history of recurrent genital herpes in the past year * subjects have a negative result on the hiv ab/ag assay * subjects must agree to use contraception during study participation * subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks period after the administration of study drug. * subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area. * subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the hsv lesion score, and to record in the patient dairy * female subjects must have a negative serum β-hcg at screening and a negative urine pregnancy test prior to study drug administration. exclusion criteria: * serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except hsv) in the anogenital area, etc. that may interfere with the assessment of the efficacy of ub-621. * history or current evidence of malignancy except for a localized non-melanoma skin cancer * known immunosuppression * exposure to hsv vaccine * medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by igg or plasma administration) * any other conditions that in the judgment of the investigator would preclude successful completion of the clinical study * treatment with systemic steroids or other immunomodulating agents within 30 days prior to screening or planned treatment with systemic steroids or immunomodulators during the study period. * renal impairment and/or hepatic impairment * ecg abnormalities of clinical relevance or cardiovascular conditions * abnormal blood tests according to "toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trial "in the guidance for industry, 2007: 1. albumin\<3 g/dl 2. alp\>2.5\*uln 3. alt\>2.5\*uln 4. ast\>2.5\*uln 5. bilirubin\>1.5\*uln 6. cpk\>1.5\*uln 7. rggt\>2.5\*uln 8. hemoglobin: female\<11 g/dl; male\<12.5 g/dl 9. platelet\<125\*10e3/ul 10. wbc\<2.5\*10e3/ul or 11. anc\<1.5\*10e3/ul
cv-squish-ed: clinical validation study

Conditions: Sepsis; Infection

Summary: this is a study to evaluate the diagnostic performance of the investigational cytovale system \& intellisep test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection compared to retrospective physician adjudication, per the sepsis 3 definition, of those patients.

this is a multi-site prospective study to evaluate the diagnostic performance of the investigational cytovale system \& intellisep test for patients presenting to the emergency department with signs or suspicion of infection. the intellisep test is a microfluidic test that measures the biophysical properties of human leukocytes in conjunction with other laboratory findings and clinical assessments to aid in the early detection of sepsis with organ dysfunction occurring within the first three days after the blood sample collection.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old 2. the first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record 3. a 300µl blood sample originally collected in a k2 edta (hematology purple top) tube within 4 hours of the first recorded vital sign is available. 4. sign or suspicion of infection, defined as meeting either of criterion a-1 and a-2 (based on temperature, wbc, heart rate, respiratory rate and/or culture order criteria): exclusion criteria: 1. patients in whom a palliative care or hospice course is expected during ed visit 2. self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection 3. self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder 4. self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (appendix c) 5. self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant 6. patients transferred to the emergency department from another acute care facility 7. residents or patients of a hospital-based skilled nursing facility

Keywords: sepsis
selective internal radiation therapy (sirt) versus transarterial chemoembolisation (tace) for the treatment of hepatocellular carcinoma (hcc).

Conditions: Hepatocellular Carcinoma

Summary: selective internal radiation therapy is superior to transarterial chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * ≥18 years * hcc, proven by histology or according to easl criteria * intermediate stage hcc (stage b according to bclc) * at least one measurable lesion in magnetic resonance imaging (mri) * tumor load ≤ 50% * preserved liver function (child pugh a and b) exclusion criteria: * patients feasible for curative treatment (e.g. resection or local ablation) * previous tace or sirt * chemotherapy during the last 4 weeks * child pugh stage c * bclc stage d * ecog performance status \>0 * tumor involvement \>50% of the liver * extrahepatic tumor * serum bilirubin \>2.0 mg/dl; serum albumin 2.8 g/dl, serum creatinine \>2 mg/dl; leukocytes \<3000/ml; thrombocytes \<50000/ml * clinically apparent ascites (ascites only in ct/mri is no exclusion criteria) * esophageal bleeding during the last 3 months * hepatic encephalopathy * transjugular intrahepatic portosystemic shunt (tips) * infiltration or occlusion of the portal vein * hepatofugal blood flow in the portal vein * hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan * contraindications against angiography * gravidity
open-label safety extension study of avonex

Conditions: Multiple Sclerosis

Summary: to collect data on serious adverse events which occur during extended treatment with avonex in subjects at high risk for developing multiple sclerosis (ms) and in subjects with secondary progressive ms.


Eligibility criteria:
inclusion criteria: * must have completed (as defined below) one of the following biogen avonex® clinical studies and meet the other criteria indicated. * subjects enrolled from studies c95-812 and c97-830 must have completed their respective study within 12 months prior to enrollment in c98-838. subjects enrolled from study c96-823 must have completed the study within 24 months prior to enrollment in c98-838. * have not been diagnosed with any other disease that accounts for their neurologic symptoms. exclusion criteria: * history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta. * history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin. * history of seizure within the 3 months prior to enrollment. * abnormal laboratory results at the screening visit: * history of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study. other inclusion and exclusion criteria apply as per biogen idec protocol

Keywords: multiple sclerosis avonex interferon beta-1a patients at high risk to develop multiple sclerosis
preoxygenation using niv in hypoxemic patients

Conditions: Critical Illness; Hypoxemia

Summary: critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. for the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (niv) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method. objectives: to find out whether niv, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.

during the inclusion period (at least 10 min and maximum 30 min), the patients ware a high fio2 mask, driven by 10-15l/min oxygen and are randomly assigned to control or niv group. preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. for the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15l/min oxygen. patients allow to breath spontaneously with occasional assists (usual preoxygenation method). for the niv group, pressure support mode is delivered by an icu ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 ml/kg. the fraction of inspired oxygen (fio2) was 100% and we used a peep level of 5 cmh2o.

Eligibility criteria:
inclusion criteria: * adults patients with acute respiratory failure requiring intubation exclusion criteria: * encephalopathy or coma, cardiac resuscitation

Keywords: preoxygenation non invasive ventilation continuous positive airway pressure, intubation, organ failure
biologic national registry

Conditions: Arthritis, Rheumatoid; Spondylitis

Summary: binar is an open and multicentric tunisian national registry performed by nearly 100 rheumatologists

binar is a tunisian, descriptive, non-interventional, multicenter and prospective clinical study performed in rheumatology consultations, of both public and liberal sectors. eligible patients are recruited by successive inclusions until the end of the recruitment period, set at one year. a scientific committee validates the scientific writing, a steering committee supervises the clinical operations of the project and a data review committee supervises the management of the data and carries out all the missions of audit and control of validity of the collected data, as well as the planning of statistical analysis. collected data are managed by the dacima clinical suite®, the electronic data capture platform which complies with the fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient followed for rheumatoid arthritis according to acr eular criteria or spondylitis including all disorders (axial, peripheral, enthesitis). * patient on biological treatment at the time of inclusion * first biological treatment initiated ≤ 2 years * informed consent, read and signed exclusion criteria: * evolutionary neoplasia at the time of inclusion * other associated systemic diseases, except sjögren's syndrome * consent not obtained * pregnant or lactating woman

Keywords: biologic safety litar dacima tunisia
severity of bleeding as a predictor of quality of life (qol) in women with heavy menstrual bleeding (hmb) under dydrogesterone treatment

Conditions: Menorrhagia; Metrorrhagia

Summary: dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. as a c-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. dydrogesterone (duphaston©) is indicated for dysfunctional bleeding. in this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on qol with the reduction in severity of bleeding.


Eligibility criteria:
inclusion criteria * females aged 18 to 45 years * subjects presenting with heavy menstrual bleeding (hmb) * subjects with pictorial blood assessment chart (pbac) score of 100 or more * subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial exclusion criteria * subjects with structural or organic pathology as an underlying cause of hmb. * subjects with hypersensitivity to dydrogesterone * known or suspected progestogen dependent neoplasms * subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause * subjects with acute or chronic liver disease * patients with depressive illness * subjects who are known to have rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * nursing mothers * use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc) * use of non-steroidal anti inflammatory drugs (nsaids)

Keywords: metrorrhagia menorrhagia
healthy normal single ascending dose and crohn's patient multiple ascending dose

Conditions: Inflammatory Bowel Disease

Summary: healthy normal single ascending dose and crohn's patient multiple ascending dose

a phase i, double blind, placebo-controlled, safety and tolerability study of zp1848 administered as ascending single dose, subcutaneous bolus injections in healthy subjects followed by a multiple dose cohort of patients with stable crohn's disease in remission

Eligibility criteria:
inclusion criteria: * healthy adult male and/or females, 18 to 50 years of age * body mass index (bmi)18-30. chrons inclusion * adult male and/or females, 18 to 60 years of age (inclusive). * body mass index (bmi) ≥ 18 and ≤ 30 (kg/m2). * crohn's disease activity index (cdai) score \< 150. * in a stable state of crohn's disease as per the investigator's opinion. * free of steroid treatment (therapy targeted for the gi tract only) within the 3 months prior to day 1. exclusion criteria: * history or presence of dysplasia, cancer, chronic hepatitis, hiv, tuberculosis (tb), or histoplasmosis. * fistula within the 3 months prior to dosing. 3. ostomy (having ostomy now or at any time in the past). 4. any surgery for the treatment of inflammatory bowel disease (ibd) within the 3 months prior to day 1. 5. short bowel syndrome (sbs). 6. any other condition, chronic disease, or prior therapy, which in the opinion of the investigator/investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
volanesorsen early access program for patients with familial chylomicronemia syndrome (fcs)

Conditions: Familial Chylomicronemia

Summary: the purpose of this program is to provide expanded access to volanesorsen for up to 100 patients with familial chylomicronemia syndrome (fcs).

the program is intended to provide expanded access to volanesorsen for eligible patients with fcs who have limited or no available treatment options.

Eligibility criteria:
inclusion criteria: * patients who participated in the approach open label trial, must have completed the open label extension trial for volanesorsen for a length of time consistent with the study protocol (≥ 1 year). patients in the approach open label trial for less than a year require approval from akcea to participate in the eap. patients who did not participate in the approach open label trial require approval from akcea for entry into eap. * patients not participating in the approach open label trial must have a diagnosis of fcs as determined by the participating physician, as outlined in the volanesorsen eap protocol. akcea will review each application to determine eligibility. * male patients and female patients of childbearing potential must continue to use appropriate contraception with their partners, or refrain from sexual activity exclusion criteria: * patients who have any new conditions or worsening of existing conditions which in the opinion of the physician would make the patient unsuitable for treatment with volanesorsen. * volanesorsen naïve patients with baseline platelet values ≤ 140,000/mm3 * patients not willing to adhere to mandatory blood draws for platelet monitoring * patients who in the opinion of akcea's medical team, are not eligible candidates for volanesorsen therapy. * any patient who plans to or becomes pregnant. * any patient who was withdrawn from the approach open label study due to a serious adverse event related to volanesorsen therapy.

Keywords: familial chylomicronemia familial lipoprotein lipase deficiency hyperlipoproteinemias familial hyperlipoproteinemia type 1 hyperlipoproteinemia type 1 hyperchylomicronemia, familial lipoprotein lipase deficiency, familial hyperlipidemias dyslipidemias lipid metabolism disorders lipid metabolism, inborn errors metabolic diseases metabolism, inborn errors genetic diseases, inborn
the treatment of moderate to severe allergic rhinitis with electroacupuncture combined with microneedle knife

Conditions: Allergic Rhinitis (Disorder); Electroacupuncture; Microneedle Knife

Summary: based on the inclusion and exclusion criteria, patients with allergic rhinitis who meet the requirements are selected as trial subjects, and the efficacy is clarified in a randomized controlled design trial. we will use the total nasal symptom score as the primary outcome index, serum chemokine, intercellular adhesion molecule-1, eosinophil cationic protein, total non-nasal symptom score, and rhinitis-related quality of life scale as secondary outcome indexes, and oral cetirizine hydrochloride tablets and nasal budesonide spray as the control group, the efficacy of the subjects in the electroacupuncture combined with microneedle knife group and the drug group will be observed respectively before treatment, after 2 weeks of treatment, after 4 weeks, 1 month follow-up after the end of treatment, and 3 months follow-up after the end of treatment. 4 weeks later, 1 month follow-up after the end of treatment and 3 months follow-up after the end of treatment.


Eligibility criteria:
inclusion criteria: 1. those with clinical and laboratory diagnosis of moderate to severe allergic rhinitis; 2. aged ≥18 years and ≤75 years, with no restriction on gender or ethnicity; 3. not taking drugs such as antihistamines or nasal steroids within 1 month before enrollment; 4. those who voluntarily participated in this study and signed an informed consent form, and who were able to adhere to outpatient treatment for 4 weeks. exclusion criteria: 1. atrophic rhinitis, hypertrophic rhinitis, vasomotor rhinitis, acute and chronic sinusitis, nasal polyps, severe septal deviation, eosinophilia non-allergic rhinitis; 2. those with other allergic diseases such as asthma, urticaria, and colds that cause nasal congestion, runny nose, and sneezing; 3. those who have serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems in combination; 4. pregnant or lactating women, psychiatric patients, patients with malignant tumors.