Kornimate/medical-research-clean huggingface dataset:
a phase ⅲ clinical study of combined cisplatin versus placebo combined with intracavitary cisplatin injection in the treatment of malignant pleural effusions

Conditions: Malignant Pleural Effusion

Summary: malignant pleural effusion or ascites is a common complication of malignant tumor, the objective of this study is to compare the efficacy of endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed cancer of any primary tumor type, patients with malignant pleural effusion or ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.) 2. at least a medium amount of malignant pleural effusion or ascites conformed by confirmed by b ultrasound, clinical judgment requires local therapy. 3. karnofsky performance status ≥60 4. life expectancy of at least 3 months 5. adequate hematologic, cardiac, renal, and hepatic function 6. the serum pregnancy test of female subjects of childbearing age during the screening period was negative; with a fertile female/male subjects must be willing to throughout the study period (i.e., for the first time since the drug delivery to the end of the study drug dosing after 90 days) to take reliable contraceptive methods, including but not limited to: abstinence, male partners have accepted vasectomy, female sterilization, intrauterine device effectively and effective birth control pills. exclusion criteria: 1. participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks evidence of bleeding diathesis, serious infection 2. received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration; 3. endostatin, bevacizumab, ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy 4. has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment) 5. had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period 6. bilateral pleural effusion or enveloped pleural effusion or ascite 7. with severe copd or a history of intestinal adhesions 8. uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms 9. active infections that require systemic treatment 10. pregnant or lactating women 11. history of illness, treatment, or laboratory abnormality that may interfere with the outcome of the study and prevent subjects from participating fully in the study, or participation is not considered by the investigator to be in the subjects' best interest.
impacts of a continuing education activity targeted at copd case managers

Conditions: Lung Diseases, Obstructive

Summary: this study aims to compare the impacts of two versions of a continuing education activity targeted at copd case managers on educational outcomes: 1) participation; 2) satisfaction; 3) learning; 4) competence; 5) performance; 6) patient health outcomes.

this study has a quasi-experimental design. the study is based on the expanded outcomes framework for planning and assessing continung medical education by moore (2009). one groupe of participants will attend the former version of the continuing education activity, and the other group will attend its new version. data will be collected at t0 (before the activity, which will be held at t1); at t2 (immediately after the activity); at t3 (1-month post-activity); at t4 (2-month post-activity); at t5 (4-month post-activity); at t6 (10-month post-activity). participation will be assessed at t0. satisfaction will be assessed at t2. learning will be assessed at t0 and t3. competence will be assessed at t2. performance will be assessed at t4. patient health outcomes will be assessed at t5 and t6.

Eligibility criteria:
inclusion criteria for attendees: * attending the continuing education activity * providing patient education to individuals with copd in professional setting. exclusion criteria for attendees: * none inclusion criteria for copd patients: * doctor-diagnosed copd. exclusion criteria for attendees: * none
prevention for the restenosis of intracranial artery stent implantation treated with herbal medicine c117

Conditions: Occlusion and Stenosis of Unspecified Cerebral Artery

Summary: prevention for the restenosis of intracranial artery stent implantation treated with herbal medicine c117--prisit trial

intracranial artery stenosis (icas) is a common cause of ischemic stroke worldwide. at present, percutaneous transluminal angioplasty and stenting serve as a possible treatment option for icas patients, however, intracranial in-stent restenosis(isr) limited its use in clinical practice, which led to recurrent stroke even death, meanwhile, from the point of chinese medicine, in-stent restenosis(isr) regard as the unhealthy environmental influences with shapes, therefore, we have design two control group on the basis of conventional secondary prevention, one use herbal medicine for blood-acting and stasis-dissolving, and another use the similar looking placebos, after 12 months of treatment, we will evaluate the rate of all-cause stroke and all-cause mortality, moreover, we also record the vascular restenosis rate which may cause recurrent ischemic stroke, the aim of this study was to evaluate the safety and efficacy of herbal medicine c-117.

Eligibility criteria:
inclusion criteria: 1. older than 18 years of age 2. 70-90% stenosis of intracranial responsible angiopathic area under the dsa angiography (as judged through the wasid method);after operation vascular stenosis less than 50%. 3. the score of mrs≤3 4. to rule out intracranial hemorrhage by ct ormri 5. adhere to the medication exclusion criteria： 1. together with intracranial tumors or avm 2. the lesion area where implant stent previons 3. fetch intracranial artery thrombus by emergency surgical operation 4. vascular serious circuity 5. myocardial infarction need to antithrombotic 6. moyamoya disease or cerebral vasculitis

Keywords: intracranial artery in-stent restenosis herbal medicine
femoral nerve block compared to exparel in total knee replacement

Conditions: Osteoarthritis; Pain

Summary: the main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (exparel) provides better postoperative pain relief and functional outcome following total knee replacement (tkr) than the current standard new england baptist hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.

a prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (exparel) alone.

Eligibility criteria:
inclusion criteria: • patients between the ages of 18 - 73 who are undergoing primary, unilateral, total knee replacement at the new england baptist hospital in boston, massachusetts are eligible to participate. exclusion criteria: * patients with revision or complex total knee replacements and are under the age of 18, or over the age of 73 will be excluded. * patients with an asa 4 level will be excluded. * patients with a body mass index of less than 20, and over 40, will be excluded. * patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.

Keywords: total knee arthroplasty amide local anesthetic
the serotonergic transmitter system in dementia and affective disorders

Conditions: Mood Disorders; Alzheimer Disease

Summary: the aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography \[pet\]) to gain knowledge about early pathophysiological changes in alzheimer's dementia and mood disorders.


Eligibility criteria:
inclusion criteria: * moderate to severe alzheimer's disease * individuals genetically predisposed to affective disorder * healthy gender and age matched controls exclusion criteria: * contraindications to magnetic resonance imaging (mri) * use of psychoactive drugs * past or present affective disorder * other systemic diseases that may affect brain function

Keywords: affective disorder alzheimer dementia healthy controls
the effect nature sounds and music on hemodialysis patients

Conditions: Hemodialysis Complication; Anxiety

Summary: the study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients. the study was conducted between september 6, 2019 and march 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in antalya province, met the inclusion criteria and consented to participate in the study. patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. the data were collected by face-to-face interview technique using the "descriptive characteristics form", "vital signs monitoring form", "state anxiety inventory" and "trait anxiety inventory". ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. number, percentage, mean, standard deviation, minimum and maximum, the the shapiro wilk normality test, one-way analysis of variance, chi-square tests, the kruskal wallis test, dunn-bonferroni test, tukey hsd, three-way analysis of variance and bonferroni corrected two ratio z test were employed in the evaluation of the data.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * age range between 18 and 79, * receiving hd treatment for at least six months, * receiving three sessions of hd treatment per week on a regular outpatient basis at the same institution. exclusion criteria: * any problem that prevents cognitive, affective and verbal communication, * having any psychiatric condition, * use of anxiolytic medication, * out of the criteria for inclusion in the study,
safety and efficacy study of oms721 in patients with thrombotic microangiopathies

Conditions: Thrombotic Microangiopathies

Summary: the purpose of this study is to assess the safety, efficacy, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of oms721 in patients with thrombotic microangiopathies (tma).

this is a phase 2, uncontrolled, 3-stage, ascending-dose-escalation study in patients with 1 of 3 forms of tma: atypical hemolytic uremic syndrome (ahus), thrombotic thrombocytopenia (ttp), and hematopoietic stem cell transplant - associated tma (hsct-associated tma). in stage 1 of the study, oms721 was administered to 3 cohorts, with dose escalation by cohort to identify the optimal dosing regimen. in stage 2, the dose selected in the first stage was administered to expanded cohorts of patients with distinct etiologies (ahus alone in 1 cohort and ttp or hsct-tma in the other cohort). patients completing stage 2 were eligible for continued treatment in stage 3 if they tolerated oms721 treatment and derived clinical benefit. enrollment in the study has been completed.

Eligibility criteria:
inclusion criteria: 1. are at least age 18 at screening (visit 1) 2. have a diagnosis of primary ahus, persistent hsct-associated tma or ttp 3. no clinically apparent alternative explanation for thrombocytopenia and anemia exclusion criteria: 1. had eculizumab therapy within three months prior to screening 2. have stec-hus 3. have a positive direct coombs test 4. have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)

Keywords: tma, ahus, hsct-associated tma, ttp
combination of duloxetine and pregabalin to improve postoperative pain

Conditions: Postoperative Pain

Summary: postoperative pain is mediated by different mechanisms at multiple neural sites. thus, multimodal analgesics can reduce the postoperative pain. although opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia. therefore,lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds. recently, antidepressants such as duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (ssnri), have accomplished pain relief in persistent and chronic pain as in fibromyalgia, postherpetic neuralgia, diabetic neuropathy, osteoarthritis and musculoskeletal pain. the analgesic effect of duloxetine is attributed to its ability to enhance both serotonin and norepinephrine neurotransmission in descending inhibitory pain pathways. moreover, some studies have promoted its use to improve the quality of recovery after surgery and reduce the acute postoperative pain after knee replacement surgery , mastectomy , hysterectomy , and after spine surgery. in addition it can improve postoperative quality of recovery through mood improvement that can be helpful in the postoperative period. the main objective of the present study was to examine perioperativelythe analgesic efficacy with the combination of duloxetine and prgabalinon postoperative pain when given as part of a multimodal pain strategy in patients undergoing surgery on liosuction. in addition to evaluating the patient's satisfaction and the adverse effects related to the combination of both medications.


Eligibility criteria:
inclusion criteria: * patients aged from 18 to40 years. * asa i-ii. * undergoing elective mega -liposuction surgery * bmi from 18 to 50 kg/m2 2. exclusion criteria: * patient refusal * contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs asa iii-iv. * patients aged less than 18 or more than 40. * body mass index \>50. * suffered from severe psychiatric disease or drug addiction; * chronic opioid consumption, * a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction * inability to use a pca device * history of parenteral or oral analgesic intake within the last 48hours.
study using cabenuva™ for the treatment of human immunodeficiency virus (hiv)-1, administered in infusion centers (ic) or alternate sites of administration (asa) in the united states (u.s.)

Conditions: HIV Infections

Summary: glacier (giving long acting cabenuva in an infusion center/asa) is an interventional study examining the administration of cabenuva (cabotegravir long acting \[la\] plus rilpivirine la) intramuscular (im) in infusion centers/asas in united states. in this study, the intervention is the process of using an infusion center/asa as the location to receive the cabenuva im injections. the acceptability and feasibility of the ic/asa to deliver cabenuva im injections will be assessed from the perspectives of the participants, hiv care providers and ic/asa staff. in this study, month 1 is the baseline visit. cabenuva is a registered trademark of viiv healthcare.


Eligibility criteria:
inclusion criteria * adults (greater than or equal to \[\>=\]18 years old) at the time of signing the informed consent. * hiv-1 infected and have been prescribed cabneuva per the united states prescribing information (uspi). * participants can be enrolled * if they have been taking oral vocabria + edurant or other art for approximately 1 month (at least 28 days) prior to baseline/month 1, or * already taking cabenuva prior to baseline/month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the uspi, or * prescribed direct to inject and receive their 1st injection without an oral lead in at the infusion center/asa on the last day of any other antiretroviral therapy * agreement to receive cabenuva im injections at participating infusion center/asa. exclusion criteria * participants are excluded from the study as dictated in the prescribing information (cabenuva \[uspi\]) in consultation with the hiv care provider. * contraindications, as per the current prescribing information \[cabenuva uspi\] * new health condition / prohibited medication reported - other reason at the discretion of the hiv care provider or ic/ asa staff

Keywords: hiv cabenuva intramuscular cabotegravir rilpivirine
vasculopathic injury and plasma as endothelial rescue in septic shock (shock) trial

Conditions: Septic Shock

Summary: efficacy and safety of octaplaslg® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial

this is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase iia trial in patients with septic shock investigating the efficacy and safety of administrating octaplaslg® as compared to crystalloids, such as ringer-acetate (standard of care) in a total of 40 patients. 40 patients will be enrolled: * patients in the active treatment group (n = 20 patients) will receive octaplaslg® as volume support according to trial algorithm. * patients in the standard of care group (n = 20 patients) will receive crystalloids, such as ringer-acetate, as volume support according to trial algorithm. all patients will be treated according to the standard icu care.

Eligibility criteria:
inclusion criteria: 1. adult intensive care patients (age ≥ 18 years) and 2. sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection and 3. quick sofa (qsofa) with two or more of 1. respiratory rate ≥ 22/min 2. altered mentation (glasgow coma scale score \< 15) 3. systolic blood pressure ≤ 100mmhg and 4. septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain map ≥65 mm hg and having a serum lactate level \>2 mmol/l despite adequate volume resuscitation and 5. requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure and 6. respiratory failure requiring intubation and mechanical ventilation exclusion criteria: 1. documented refusal of blood transfusion or 2. treatment with gpiib/iiia inhibitors \< 24h from screening or 3. withdrawal from active therapy or 4. previously within 30 days included in an interventional trial or 5. known iga deficiency with documented antibodies against iga or 6. known hypersensitivity to octaplaslg®: the active substance, any of the excipients (sodium citrate dihydrate, sodium dihydrogenphosphate dihydrate or glycine) or residues from the manufacturing process (tri (n-butyl) phosphate (tnbp) and octoxynol (triton x-100)) or 7. known severe deficiencies of protein s or 8. pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hcg) or 9. severe cirrhotic hepatic failure with expected need for treatment with terlipressin
safety and efficacy of intra-articular ozone injections for knee osteoarthritis

Conditions: Osteoarthritis Knee

Summary: prospective, interventional, non-randomized, open label, single group assignment, single center.


Eligibility criteria:
inclusion criteria: * 55 to 79 years of age * symptomatic knee osteoarthritis * vas pain intensity is at least 40 mm on a 100 mm scale * must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits. exclusion criteria: * any known tumor of the ipsilateral knee. * any known infection of the treated knee. * osteoarthritis of the operated knee kelgren lawrence \< grade 2. * chemotherapy treatment in the past 12 months. * patients who are sensitive to ozone. * pregnant women, or breastfeeding women. * evidence of any significant systemic disease (such as but not limited to hiv infection, hepatitis infection or htlv infection), known coagulopathies, that might compromise the subject's welfare. * substance abuse or alcohol abuse. * participation in other clinical trials in parallel to this study.
acetylic salicylic acid for the treatment of chronic obstructive pulmonary disease

Conditions: COPD

Summary: the pathomechanisms of copd are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. available therapy is in most cases symptomatic. experimental and clinical observations suggest that treatment with asa might be beneficial in the treatment of copd in terms of respiratory and lung-functional improvement. to evaluate the efficacy of asa as add-on therapy in copd in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. adult male and female patients (n=74) with proven copd gold grade ii-iii will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). they will receive either 500 mg asa per day or matching placebo over 12 weeks. primary efficacy endpoints are changes in the lung-functional parameter fev1 (forced expiratory 1-second volume) after 12 weeks of treatment. secondary endpoints are the health score of the st. georges respiratory questionnaire (sgrq) and peak-flow (pef).


Eligibility criteria:
inclusion criteria: * copd gold ii or iii exclusion criteria: * long term nsaids, pregnancy et al.