Kornimate/medical-research-clean huggingface dataset:
phase i/ii study of the tolerance and efficacy of combined use of didanosine (2',3'-dideoxyinosine; ddi) and lentinan in hiv-positive patients

Conditions: HIV Infections

Summary: to determine the tolerance and side effects of a combination of lentinan and didanosine (ddi) compared with ddi alone. to determine whether the combination of lentinan and ddi produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, t-cell subsets, and a decrease in p24 antigen.

patients are randomized to receive either lentinan (40 patients) or placebo (10 patients) in combination with ddi for at least 26 weeks; those tolerating their dose may be offered continuation of therapy for an additional 26 weeks.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * absolute cd4 count of 200 - 500 cells/mm3. * no active opportunistic infection or kaposi's sarcoma. prior medication: allowed: * prior ddi for no longer than 3 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * lymphoid malignancy. * pancreatitis. * peripheral neuropathy. * critical illness. concurrent medication: excluded: * antiretroviral agents other than ddi. * steroids. * cytotoxic agents. * immunosuppressive agents. * immunomodulators. * 1-thyroxine. concurrent treatment: excluded: * radiotherapy. prior medication: excluded within 1 month prior to study entry: * antiretroviral agents other than ddi (patients may have received prior ddi for no longer than 3 months total). * steroids. * cytotoxic agents. * immunosuppressive agents. * immunomodulators. prior treatment: excluded: * radiotherapy within 1 month prior to study entry. active drug abuse.

Keywords: didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex lentinan
safety/efficacy study of rexin-g to treat pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the goal of the adaptive trial design is to determine the over-all safety of escalating doses of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii registration protocol.

the clinical trial is a safety and efficacy study using escalating doses of rexin-g that incorporates a phase ii component that will evaluate the efficacy of rexin-g using an adaptive trial design. each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. unlike a standard phase i protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. continued rexin-g treatment will enable the targeted genetic medicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. the treatment strategy is to achieve tumor control as quickly as safely possible. the goal of the adaptive trial design is to confirm the over-all safety of rexin-g and to determine the optimal dosing regimen for rexin-g that would document the significant clinical benefits required to support a phase ii/iii pivotal trial.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed recurrent or metastatic pancreatic cancer that has failed gemcitabine and that is measurable. 2. adequate hepatic function: total bilirubin \ 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits. 3. performance status must be \< 1 (ecog 0-1) with a life expectancy of at least 3 months. 4. hemoglobin \> 9 gms% 5. absolute granulocyte count \> 1000/ul, and platelet count \> 100,000/ul. 6. serum creatinine of less than 1.5 mg%. 7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit. 8. accessibility of peripheral or central iv line 9. age \> 10 years 10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity. 11. the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years. 2. woman who are pregnant or nursing 3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception. 4. patients who are transfusion dependent (more than one transfusion per month) 5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol. 6. patient who do not meet the inclusion criteria.

Keywords: pancreatic cancer rexin-g treatment
quality of life and health economic measurements in allergic patients treated with immunotherapy

Conditions: Hypersensitivity; Asthma; Rhino-Conjunctivitis; Quality of Life; Effects of Immunotherapy

Summary: grass pollen and house dust mites (hdm) are the most common allergens causing allergic rhino-conjunctivitis (rc) and/or asthma (a). subcutaneous allergen specific immunotherapy (scit) reduces symptoms and use of medication. the purpose of sabal is to assess the effect of scit on disease severity classifications in terms of number of days affected- and sick days on patients with grass pollen and/or hdm induced disease. these outcome measures will be gathered in one single measure: quality adjusted life years (qaly)


Eligibility criteria:
inclusion criteria: * adults (\> 16 years) and allergic to grass pollen and/or house dust mites. exclusion criteria: * allergic patients who had been immunotherapy treated before.
dexmedetomidine versus gabapentin premedication on the emergence agitation after rhinoplasty

Conditions: Anesthesia

Summary: to compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

emergence agitation (ea) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). this may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. premedication with dexmedetomidine and gabapentin are promising options for ea.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists grade i or ii. * sex: both sexes. * age between 18 and 40 years. * patients scheduled for rhinoplasty under general anesthesia exclusion criteria: * declining to give written informed consent. * history of allergy to the medications used in the study. * history of cardiovascular diseases including bradycardia, heart block, and hypertension. * history of chest problems including bronchial asthma. * had a history of drug or alcohol abuse. * taking opioids or sedative medications. * inability to communicate with patients to evaluate postoperative pain. * hepatic or renal failure. * psychiatric disorders with antipsychotics or antidepressants. * bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
study to assess the efficacy, safety and tolerability of mt- 8554 in subjects with painful diabetic peripheral neuropathy

Conditions: Painful Diabetic Peripheral Neuropathy

Summary: a study to investigate the safety, tolerability and efficacy of multiple doses of mt-8554 in subjects with painful diabetic peripheral neuropathy


Eligibility criteria:
inclusion criteria: * male subjects and female subjects aged ≥18 years * subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy * a body mass index ranging from 18 to 45 kg/m2 exclusion criteria: * subjects who have participated in a clinical study of any imp (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study * unstable or uncontrolled diabetes * clinically significant 12-lead ecg abnormalities
prevention of pocket hematoma after implantation cardiovascular implanted electronic devices

Conditions: Hematoma Postoperative; Cardiac Resynchronization Therapy Devices; Compression Bandages

Summary: as the number of implanted cardiovascular implanted electronic devices (cieds) increases, the incidence of their complications also grows. pocket hematoma is an important complication of cied implantation, which has been reported in 2.9-9.5% of cieds patients. pocket hematoma can cause significant pain and interfere with proper wound healing, and it also increased the risk of infection and may prolong length of stay. pocket compression is usually applied to compress bleeding vessels and reduce bleeding after implantation. a conventional compression method is to place a sandbag over the pocket, and then using adhesive tape to fix the sandbag. due to adhesive tape is elastic and the tape may be pulled by patients' activity, sandbag easily migrated from the site. therefore, nurse must readjust the position of sandbag, or even remove the adhesive tape and perform re-compress. furthermore, adhesive tape can cause skin erosion. all of which not only result in patients' discomfort and dissatisfaction, but also increase the burden on nurses and wastes resources. we designed a pocket compression fixation belt. we assumed that using this fixation belt can ensure the compression effect while avoiding sand bag displacement, reducing skin erosion and decrease the workload of care.


Eligibility criteria:
inclusion criteria: * registry of patients undergoing pm, icd, and crt-p or crt-d device implantation in the first affiliated hospital of xi'an jiaotong university. exclusion criteria: * (1) age\ 80 years, (2) a history of any psychiatric illness, (3) a history of open wounds in the infraclavicular region, (4) coagulation disorder or bleeding diathesis, (5) anticoagulation or antithrombotic treatments could not be interrupted, (6) refusing to participate. this study was approved by the ethics committee of the first affiliated hospital of xi'an jiaotong university (approval number xjtu1af2020lsk-040).
mace and first operating room systolic blood pressure in patients undergoing non-cardiac surgery implications for the hypertension threshold

Conditions: Major Adverse Cardiac-cerebral-kidney Event

Summary: to find the threshold of first operating room sbp above which mace risk increases.

to find the threshold of first operating room sbp above which mace risk increases. by reviewing data from 2012-2017 in pku first hospital.

Eligibility criteria:
inclusion criteria: * 18-100yr non-cardiac surgery exclusion criteria: * missing data file
effect of an artificial pancreas in patients undergoing hepatic resection

Conditions: Liver Diseases

Summary: this study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

this study recruited 70 patients undergoing elective hepatic resection for liver diseases. perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. we prospectively divided patients into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusions of insulin determined by the control algorithm of the artificial pancreas.

Eligibility criteria:
inclusion criteria: * this study recruited 70 patients undergoing elective hepatic resection for liver diseases. perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. exclusion criteria: * weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease

Keywords: surgical site infection
dexmedetomidine hydrochloride in the prevention of organ failure following severe acute pancreatitis

Conditions: Pancreatitis, Acute Necrotizing

Summary: cytokines such as such as tnf-a, il-1, il-6 correlate with the severity of pancreatitis.neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. the investigators aim to use dexmedetomidine hydrochloride to decrease the activity of sympathetic nervous system, thus relieve inflammation response.

infected pancreatic necrosis (ipn) and multiple organ dysfunction syndrome (mods) are major complications of acute pancreatitis which determine disease severity and outcome.it is concluded that systemic inflammation in sap characterized by the endocrine release of different cytokines, such as tnf-a, il-1, il-6 and many others. these cytokines correlate with the severity of pancreatitis. neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. dexmedetomidine hydrochloride is a high selected a-2 adrenoreceptor agonists.some studies have shown that dexmedetomidine hydrochloride could improve the outcome of sepsis patients and decrease the development of organ failure. the investigators aim to use dexmedetomidine hydrochloride to decrease the activity of sympathetic nervous system,thus relieve inflammation response.

Eligibility criteria:
inclusion criteria: * patients diagnosed with severe acute pancreatitis within 48h * apache ii≥8 * patients or the family agreed to receive the treatment, and signed the informed consents exclusion criteria: * patients were allergy to the drug * patients were diagnosed with arrhythmia * patients with artificial permanent pacemaker implantation
the spleen in sickle cell anemia and sickle cell thalassemia

Conditions: Sickle Cell Anemia; Thalassemia

Summary: the spleen in sickle cell anemia and sickle cell thalassemia is usually enlarged in the first years of life but the immune protection provided is considered insufficient. in homozygous sickle cell patients the spleen usually developed recurrent infarcts and after the first decade of age become fibrotic. acute splenic sequestration is also frequent in those patients and this is considered as an indication for splenectomy. in comparison in sickle cell thalassemia patients, hypersplenism is more frequent. the purpose of this study is to compare the clinical and laboratory issues related to the spleen in two groups of sickle cell patients.

clinical and laboratory characteristics related to the spleen in sca patients will be studied. two groups of patient will be compared, a group of sickle cell patients (homozygous) and a second group of patients with sickle cell beta thalassemia. in those patients that splenectomy was performed the incidence of infections will be recorded besides the indications for splenectomy and the incidence of thrombotic events or thrombocytosis.

Eligibility criteria:
inclusion criteria: * all the patients followed up at the pediatric hematology unit exclusion criteria: * patients lost from follow up of with insufficient data

Keywords: splenectomy thrombocytosis infections spleen sickle cell thalassemia
a phase 2 in adult subjects with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: a phase 2 in adult subjects with hereditary angioedema

a phase 2, open-label, multicenter study to assess the efficacy and safety of bw-20805 in adult subjects with hereditary angioedema

Eligibility criteria:
inclusion criteria: * must have given written informed consent and be able to comply with all study requirements. * males or females 18 to 70 years of age at the time of informed consent. * documented diagnosis of hae-1/hae-2. * at least 2 hae attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition * access to and ability to use ≥ 1 acute medication(s) * female subjects must be non-pregnant;non-lactating, and either surgically sterile * male subjects with wocbp partners, dual contraception is required if no surgically sterile exclusion criteria: * any clinically significant medical or psychiatric condition or medical history that, in the opinion of the investigator, makes the subject unsuitable for participation in the study * any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, hae with normal c1-inh, idiopathic angioedema, or recurrent angioedema associated with urticaria * history or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. * have undergone major surgery within 3 months prior to screening. * history of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk * history of allergic reaction to an oligonucleotide or n-acetylgalactosamine * prior treatment with any oligonucleotides within 6 months if single dose or 12 months if multiple doses prior to screening. * exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening. * with any of the abnormalities in clinical laboratory tests at screening and run-in period * clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening. * positive for human immunodeficiency virus (hiv), hbsag, hepatitis c or syphilis infection * active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
mitochondrial function in circulating cells and muscle tissue

Conditions: Healthy; Obesity; Insulin Sensitivity; Women

Summary: the main goal of this project is to determine whether mitochondrial function in circulating cells is related to that measured in the muscle fibers of the same subjects.

data from human and animal models strongly suggests that reduced tissue mitochondrial function can be an early marker for detection of dysfunctional metabolism. it is unclear if tissue mitochondrial dysfunction can be detected using less invasive methodology. in this project, the investigators plan to study mitochondrial bioenergetics in circulating cells and paired muscle biopsies in two metabolic disparate groups of women; healthy lean vs. overweight/obese with/without insulin resistant women of similar age. women of similar age that are either healthy lean or overweight/obese with/without insulin resistance will be recruited to participate in one study that includes a blood draw and a muscle biopsy. mitochondrial function in circulating blood cells and muscle tissue will be determined. the association between circulating blood cells and muscle tissue mitochondria respiration will be determined for the two groups combined, and differences between groups will also be investigated.

Eligibility criteria:
inclusion criteria: * women * 25-35 years of age * either healthy lean (bmi\ 30) exclusion criteria: * medication that can affect study outcomes, as determined by the principal investigator, including anti-diabetic medication * chronic diseases, acute inflammation, chronic renal failure (glomerular filtration rate \<45), or heart problems

Keywords: mitochondria women muscle pbmc
physiotherapy efficiency on child asthma

Conditions: Child; Asthma Crisis

Summary: the study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.


Eligibility criteria:
inclusion criteria: * child (6 to 17 years old) * hospitalized in pediatric unit for asthma crisis exclusion criteria: * patient who can't participate because of his healthcare (resuscitation...) * impossibility to measure peak expiratory flow (pef)
a phase 2, multicenter, open-label study to assess the immunogenicity of an investigational hib vaccine (nu300)in toddlers

Conditions: Infectious Disease

Summary: evaluate the safety and tolerability of a single booster dose of nu300, co-administered with prevnar 13® over a 28 day period following the injection compared to a single booster of acthib co-administered with prevnar 13® over a 28 day period following the injection. evaluate the immunogenicity, as determined by anti-prp polysaccharide response, of a single booster dose of nu300 co-administered with prevnar 13® compared to a single booster dose of acthib® co-administered with prevnar 13®. evaluate the individual igg antibody quantitative response to the 13 antigens in prevnar 13® following nu300 co-administration with prevnar 13® compared to the igg antibody response to the pneumococcal polysaccharides following acthib® co-administration with prevnar 13® 28 days following injection.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from the parent or guardian of the subject 2. male or female subjects 12-15 months of age at the time of booster vaccination, who had previously received complete primary vaccination series with a licensed hib product and prevnar 13® in accordance with the fda approved labels. 3. subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol 4. subjects free of obvious health problems as established by medical history and clinical examination before entering the study exclusion criteria: 1. previous booster vaccination against hib and/or prevnar 13® 2. any confirmed or suspected haemophilus influenzae or pneumococcal illness. 3. administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 28 days after administration of study vaccines (before the blood draw at visit 2). 4. chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study. 5. any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination. 6. early pre-term birth (delivery before 32 weeks). 7. major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc. 8. concurrent participation in another clinical study at any time during the study period or within the previous 6 months in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product, formula, or device) 9. presence of a moderate or severe illness with or without fever at the time of vaccination (fever is defined as a temperature of ≥ 38.0c \[100.4f\]). 10. known history of thrombocytopenia or any coagulation disorder. 11. known hypersensitivity to any of the components of the vaccines. 12. known hypersensitivity to latex. 13. the subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at visit 1