Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of double staining with brilliant blue g for macular surgery

Conditions: Macular Hole; Epiretinal Membrane

Summary: study designed to evaluate the safety and efficacy of double staining with brilliant blue g 0.025% as an adjuvant to macular surgery. patients undergoing surgery for macular hole or epiretinal membrane will be included. safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.


Eligibility criteria:
inclusion criteria: * patient age 18 years of older * signing of informed consent * macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome) exclusion criteria: * diagnosis of glaucoma * known allergy to brilliant blue g
stem cells for treating critical ischemia

Conditions: Critical Limb Ischemia; Ischemic Ulcers

Summary: collection of bone marrow blood selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

about 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.in the cell therapy lab this blood is harvested and mononuclear cells are separated.this procedure takes roughly 4 hours.after dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.this procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

Eligibility criteria:
inclusion criteria: * fontaine's classification grade 3 and 4 patients exclusion criteria: * record of cancer in the last 5 years * over 80 years * diabetic retinopathy

Keywords: rest pain ischemic ulcers
efficacy of the extract of carica papaya as an inhibitor of streptococcus mutans

Conditions: Streptococcus, Other Specified Group; Dental Plaque

Summary: papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on streptococcus mutans, this can be exploited in the dental area. the objective of the study was to determine the efficacy of carica papaya peel extract (suckling) as an inhibitor of streptococcus mutans in students of the dental faculty of the national university of caaguazú in 2018.

specific objectives * to determine the inhibition of the extract of the peel of carica papaya (baby) at 3% on streptococcus mutans by age and sex grouping. * to quantify the inhibition of the extract of the peel of carica papaya (baby) at 3% on the growth of streptococcus mutans before, at 10 minutes and 8 days of use in the experimental group. * quantify the inhibition of 0.12% chlorhexidine gluconate on the growth of streptococcus mutans before, after 10 minutes and 8 days of use in the control group. * compare the count of colony forming units (cfu) between both groups.

Eligibility criteria:
inclusion criteria: * participants that signed the informed consent exclusion criteria: * allergic to carica papaya * ongoing medical or dental treatment that could interfere with the results.

Keywords: saliva dental plaque streptococcus mutans
oral multiple-dose study in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: a study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of fk949e (extended-release formulation of quetiapine) in patients with major depressive disorder (mdd).

the objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of fk949e (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (mdd).

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder by the m.i.n.i. according to the dsm-iv-tr * female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study. * patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator. exclusion criteria: * a current or past history of a dsm-iv-tr axis i disorder other than major depressive disorder within 6 months prior to provision of written informed consent. * diagnosis of a dsm-iv-tr axis ii disorder that was considered to have a major impact on the patient's current psychiatric status. * a history of substance or alcohol abuse or dependence excluding caffeine and nicotine. * patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme cyp3a4 from 14 days prior to screening assessment and throughout the study period. * patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis b or c, or acquired immunodeficiency syndrome (aids) (carrier). * patients being treated for hypertension or patients with clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina). * patients with concomitant hypotension or orthostatic hypotension (hypotension is defined as systolic blood pressure of less than 100 mmhg) * conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease) * a current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma). * a history of transient ischemic attack (tia). * a history of seizure disorder, except for febrile convulsions * application of electroconvulsive therapy within 90 days prior to the start of study drug administration * use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to screening assessment and throughout the study period * a score of ≥ 3 on the ham-d17 item (suicide) or a suicide attempt within the past 6 months. patients judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator.

Keywords: antipsychotic fk949e quetiapine
the comparison of ebus-tbna, tbmc via a tunnel, and tbfb via a tunnel in diagnosing mediastinal lymphadenopathy.

Conditions: Lymphadenopathy Hilar; Lymphadenopathy Mediastinal

Summary: the goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (ebus-tbna, ebus-tbmc via a tunnel, and ebus-tbfb via a tunnel) in mediastinal/hilar lymph node biopsies. participants will divided into ebus-tbna group, ebus-tbmc via a tunnel group, and ebus-tbfb via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake ebus-tbna, ebus-tbmc via a tunnel, or ebus-tbfb according to the group. researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * at least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure; * patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form. exclusion criteria: * the lesion is a mediastinal cyst or abscess; * combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; * ebus assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. consider biopsy to be high risk and inappropriate for continuation of biopsy; * ebus did not detect lesions in the hilum and/or mediastinum; * those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
a phase iii, multicentre, double-blind, placebo-controlled withdrawal study in patients with hyperphosphatemia

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Summary: this is a phase iii multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing mci-196 with placebo for 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or over * clinically stable haemodialysis or peritoneal dialysis * stable phosphate control * on a stabilised phosphorus diet * female and of child-bearing potential have a negative serum pregnancy test. * male subjects must agree to use appropriate contraception. exclusion criteria: * current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. * body mass index (bmi) \ =40.0 kg/m2 * a current or history of significant gastrointestinal motility problems * a positive test for hiv 1 and 2 antibodies * a history of substance or alcohol abuse within the last year. * seizure disorders * a history of drug or other allergy * a temporary catheter as a vascular access * participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Keywords: chronic kidney disease dialysis hyperphosphatemia phosphate binder
a study to investigate the safety and efficacy of elsubrutinib and upadacitinib given alone or in combination in participants with moderately to severely active systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: the main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (upa), and abbv-599 (elsubrutinib/upadacitinib) high dose and low dose combinations vs placebo for the treatment of signs and symptoms of systemic lupus erythematosus (sle) in participants with moderately to severely active sle and to define doses for further development.


Eligibility criteria:
inclusion criteria: * participant has clinical diagnosis of systemic lupus erythematosus (sle) at least 24 weeks prior to screening, meeting at least 4 of the 11 revised criteria for classification of sle according to the 1997 update of the 1982 american college of rheumatology (acr) or meeting at least 4 of the 2012 slicc classification criteria, including at least 1 clinical criterion and 1 immunologic criterion. * at screening, must have at least one of the following: * antinuclear antibody (ana)+ (titer ≥ 1:80) * anti-dsdna+ * anti-smith+ * sledai-2k (sle disease activity index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at screening: * if 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints. * if participant has rash and principal investigator (pi) considers it to be attributable to sle, participant must consent to skin photograph collection for adjudication. * score must be re-confirmed at the baseline visit. * physician's global assessment (phga) ≥ 1 during screening period. * must be on background treatment, stable for 30 days prior to baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (\<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (mtx) (≤ 20 mg). * no combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials. exclusion criteria: - participant using intravenous (iv) or intramuscular (im) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

Keywords: systemic lupus erythematosus (sle) abbv-105 upadacitinib abbv-599 elsubrutinib
repetitive transcranial magnetic stimulation (rtms) for the treatment of negative symptoms in schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is a major psychotic disorder that presents an enormous burden to the patients and their relatives. despite treatment with second generation antipsychotics, negative symptoms and cognitive impairment often persist and determine an unfavourable course including reduction in life quality. prefrontal repetitive transcranial magnetic stimulation (rtms), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic treatment was demonstrated to be safe and was associated with improvement in negative symptoms in the majority of the small placebo-controlled trials. the primary objective of the trial is to investigate the efficacy of high-frequency rtms (add-on to antipsychotic therapy) in the treatment of negative symptoms in schizophrenia compared to sham stimulation (placebo).


Eligibility criteria:
inclusion criteria: * male or female in-patients and out-patients, 18 - 60 years of age * diagnostic criteria for schizophrenia according to icd-10/dsm iv * panss negative sum score \> 20 points, 1 of items n1 - n7 (range 1 to 7) ≥ 4 (at least moderate) * improvement in panss negative sum score less than 10 % in the last 2 weeks prior to study entry, stable antipsychotic medication * informed consent exclusion criteria: * clinically relevant psychiatric comorbidity, verbal iq \< 85 * history of epileptic seizures, organic brain disease * instable medical comorbidity or condition * previous treatment by rtms * factors not compatible with the use of tms, e.g. cardiac pace makers or other metallic implants, pregnancy

Keywords: schizophrenia, negative symptoms, tms, magnetic stimulation
ketamine and scopolamine infusions for treatment-resistant major depressive disorder

Conditions: Major Depressive Disorder

Summary: ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. scopolamine infusions produced also a significant improvement in depression that was sustained over time. we therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. the results from this study could lead to the development of new strategies for the treatment of patients with trd.

patients will undergo two weeks of prospective observation, they will then receive iv infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. the schedule of administration will be twice a week of three weeks. after this phase the subject will be followed with assessments every two weeks for three months.

Eligibility criteria:
inclusion criteria: * outpatients with sever treatment-resistant depression * currently depressed * currently under regular psychiatric care * on an aggressive antidepressant regimen, stable for 4 weeks exclusion criteria: * no history of other major psychiatric illnesses, including bipolar disorder * no history of psychosis * no history of drug abuse * no major medical illness or unstable medical condition.
study of the efficacy and safety of longidaze® for the treatment of patients with external genital endometriosis

Conditions: External Genital Endometriosis

Summary: a study is being conducted to evaluate the efficacy and safety of longidaze for the prevention and treatment of external genital endometriosis .

the aim of the study is to compare the outcomes of complex therapy in patients with external genital endometriosis who, in addition to hormonal therapy, were prescribed longidaze®, vaginal and rectal suppositories, 3000 iu, with the outcomes of therapy in patients who received only hormonal therapy.

Eligibility criteria:
inclusion criteria: 1. documented informed consent; 2. patients over 18 years of age with active menstrual function; 3. women with external genital endometriosis, confirmed morphologically and visually during laparoscopic or laparotomy surgery performed 10 years to 2 weeks prior to day 0; 4. patients in the framework of routine clinical practice in accordance with the instructions for use, prior to inclusion in the study, are assigned one of the following therapy regimens: * monotherapy with dienogest 2 mg daily for at least 6 months per os * complex treatment with dienogest 2 mg daily for at least 6 months per os in combination with vaginal and rectal suppositories longidaze® 1 suppository 1 time every 2 days 10 suppositories, and then 1 suppository 1 time in 7 days 17 suppositories for another 120 days; 5. willingness to use barrier methods of contraception. exclusion criteria: 1. women before menarche or after menopause 2. adenomyosis; 3. amenorrhea (more than 3 months in a row within 6 months before screening); 4. patients who are scheduled to undergo surgery for endometriosis during the study; 5. hormone therapy for endometriosis or the use of aromatase inhibitors within 16 weeks prior to day 0; 6. daily use of pain relievers for 7 consecutive days or more due to any other reason other than endometriosis; 6. participation in clinical trials less than 30 days before the screening visit and / or 5 drug half-lives, whichever is longer.

Keywords: longidaze external genital endometriosis bovhyaluronidase azoximer
moxifloxacin in adjuvant treatment of patients with operable breast cancer

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare disease-free survival (dfs) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.

this is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. the main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. this study is designed to recruit up to 520 subjects.

Eligibility criteria:
inclusion criteria: 1. have provided written and signed informed consent; 2. histologically confirmed invasive ductal carcinoma; 3. planned to received (neo)/adjuvant chemotherapy; 4. eastern cooperative oncology group (ecog) score of 0 to 1; 5. normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 6. women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; pre-menopause women are contracepted with medically acceptable methods during the study period. 7. compliance with the study protocol. exclusion criteria: 1. pregnant or breast feeding; 2. eastern cooperative oncology group (ecog) score ≥ 2; 3. hypersensitivity to moxifloxacin or quinolones compounds; 4. concomitant with other antitumor therapies or participating in other clinical trials; 5. have a history of heart disease, such as arrhythmia, conduction block, s-t segment elevation, ischemic heart disease, or congenital heart disease; 6. severe uncontrolled co-infection, or severe metabolic disorders; 7. a clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 8. poor compliance, unwillingness or inability to follow protocol to continue the study; 9. any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Keywords: moxifloxacin operable breast cancer adjuvant treatment disease-free survival safety
the treatment of 2 chinese medicines in clozapine-induced hypersalivation in schizophrenia

Conditions: Schizophrenia; Clozapine; Hypersalivation; Traditional Chinese Medicine

Summary: the goal of this research is hoping to combine traditional chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

clozapine, an antipsychotic drug, is an important clinical medicine which is used for schizophrenia and preventing for its relapse; clozapine is better than some other atypical antipsychotics. however, in clinical uses, clozapine often could induce hypersalivation, it is not only influencing patient's appearance, also deteriorating sleeping quality which could deter patient discontinuing to take medicine. in previous researches, suo quan wan and wu lin san had been proven effective for hypersalivation and no significant side-effects, nevertheless, it still lack of systematical scientific trial reports. the ingredients of suo quan wan are wu yao, san yao and yi zhi ren; the ingredients of wu lin san are gui zhi, fu ling, zhu ling, ze xie and bai ju, both have bi-directional regulatory functions for body fluid and saliva. the goal of this research is hoping to combine traditional chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

Eligibility criteria:
inclusion criteria: 1.20 year and older. all genders. 2.psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study. 3.using clozapine as an antipsychotic drug and has a side-effect of hypersalivation. 4.testee agree and sign informed consent forms to do this experiment. exclusion criteria: 1. use clozapine as an antipsychotic drug not over 8 weeks. 2. testee have other diseases could influence saliva secretion, such as parkinson's disease. 3. pregnant, prepare to pregnant within half a year or in the lactation period. 4. add or alter following medicines within 2 weeks: 4.1 central acting 2-adrenergic receptor agonist 4.2 anticholinergic/antimuscarinic drugs 4.3 b-adrenoreceptor blockers, diphenhydramine, botulinum toxin injection 5. testee's lever function test (ast/alt) is higher than 3 (4 weeks medication). 6. testee's kidney function test (cr) is higher than 2.5mg/dl (4 weeks medication). 7. testee have participate other medicine trial within one month.

Keywords: schizophrenia clozapine hypersalivation suo quan wan wu lin san
the effect of the art-based mandala intervention on the quality of life of cancer patients receiving chemotherapy

Conditions: Cancer; Chemotherapy Effect; Fatigue; Quality of Life; Rumination; Alexithymia

Summary: the aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

a randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature. the aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Eligibility criteria:
inclusion criteria: * 18 years or older * conscious and no communication problems * being literate * having a cancer diagnosis * receiving chemotherapy treatment (planned to continue treatment for 8 more weeks) * willing to participate in our study voluntarily exclusion criteria: * not being willing to participate in the research * desire to leave the study at any time * deterioration of compliance with the working criteria during the time of the study, * those who do not participate in up to four mandala applications during the study period * those who cannot use a pen * those with a diagnosis of psychiatric and neurological disease * patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks

Keywords: cancer chemotherapy effect fatigue quality of life rumination alexithymia