Kornimate/medical-research-clean huggingface dataset:
factors on therapeutic drug monitoring and safety of voriconazole in critically ill elderly patients

Conditions: Invasive Fungal Infection

Summary: this was a prospective clinical study that all voriconazole-treated adult chinese patients with invasive pulmonary infection admitted to zhengzhou central hospital affiliated to zhengzhou university from july 2018 to june 2023. the initial voriconazole serum trough concentration, correlation of various factors, and risk prediction factors for voriconazole serum trough concentration and hepatotoxicity were compared between elderly and non-elderly patients.

a prospective observational study was conducted from july 2018 to june 2023 in zhengzhou central hospital affiliated to zhengzhou university. this study was carried out in accordance with the following criteria: (1) patients who met the criteria for diagnosis of ifi, (2) age ≥ 18 years, (3) the duration of vcz treatment course ≥ 7 days. patients were excluded who fulfilled any of the following criteria: (1) patients who allergic to vcz, (2) use other anti-fungal drugs during the use of vcz, (3) do not qualify for blood sampling monitored by blood concentration, (4) pregnant or lactating women, (5) patients who haven't completely and accurately efficacy and safety data, (6) patients who are treated with a combination of liver enzyme inducers and inhibitors (carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on),(7) patients who are treated with a combination of paxlovid or azvudine. grouping: patients were divided into the elderly group (group a, ≥ 60 years) and the non-elderly group (group b, \< 60 years) according to ages. all the recruited patients were treated with voriconazole. voriconazole was intravenously administered 2 times at the loading dose of 6 mg/kg or orally administered 2 times at the loading dose of 400mg at 12h intervals, followed by a maintenance dose of 4 mg/kg or 200 mg at 12 h intervals.

Eligibility criteria:
inclusion criteria: * patients who met the criteria for diagnosis of ifi * age ≥ 18 years * the duration of vcz treatment course ≥ 7 days. exclusion criteria: * patients who allergic to vcz * use other anti-fungal drugs during the use of vcz * do not qualify for blood sampling monitored by blood concentration * pregnant or lactating women * patients who haven't completely and accurately efficacy and safety data * patients who are treated with a combination of liver enzyme inducers and inhibitors(carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on) * patients who are treated with a combination of paxlovid or azvudine.
prospective epidemiological study of the prevalence of hla-b*5701 in hiv-1 infected patients

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection; HIV-1 Infection

Summary: this study is a cross-sectional observational study to evaluate the prevalence of hla-b\*5701 in the european area and in major european ethnotypes. any hiv-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for hla-b\*5701. patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. they will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess hla-b\*5701 status by local and central laboratories. in selected sites patients may be asked to provide an additional blood sample. this sample will be used to develop and validate different methodologies for assessing hla-b\*5701 status.


Eligibility criteria:
inclusion criteria: * hiv-1 infected patients over the age of 18 years * patient is willing and able to understand and provide written informed consent exclusion criteria: * none

Keywords: hiv hla-b*5701 prevalence treatment experienced treatment naive
effects of somnage® in the management on sleep and mood in cancer patients

Conditions: Breast Cancer; Lung Cancer; Colon Cancer

Summary: the aim of this placebo-controlled randomized study is to evaluate the effects of melatonin 1mg/zn 30% vnr/mg 100% vnr (food supplement) in the management on sleep quality and mood alteration in cancer patients

the main objective of this study is to evaluate the activity of a food supplement, made of melatonin, zinc and magnesium on sleep quality in cancer patients, compared to placebo. secondary objectives are to evaluate the activity of melatonin, zinc and magnesium on the quality of life, on the fatigue and on the mood alteration in cancer patients. the study will also assess the safety of the food supplement under investigation. in two small subgroups, on voluntary basis, some additional assessments will be done (arm band, nutritional change diary, dxa in one group and activity tracker in another group)

Eligibility criteria:
inclusion criteria: 1. male and females aged between 18 and 75 years (included) 2. pittsburgh sleep quality index (psqi) score ≥ 5 3. diagnosed for breast, lung or colon-rectal cancer 4. metastatic first chemotherapy line 5. planned duration of chemotherapy treatment at least 63 days 6. negative to pregnancy test 7. patients able to swallow exclusion criteria: 1. known hypersensitivity reaction to melatonin, zinc or magnesium or any components of the product 2. known current drug or alcohol abuse. 3. use of other investigational drug(s) within 30 days before study entry or during the study 4. clinically significant findings on physical examination or presence of known clinically significant disease that would interfere with study evaluation 5. patients treated with benzodiazepines, hypnotic, anticonvulsant, antipsychotic or antidepressant drugs in the two months before screening visit 6. patients receiving or planned to receive warfarin 7. chronic treatment with steroids with daily dose over 10 mg prednisone or equivalent product 8. brain metastases
effectiveness of a electroencephalogram (eeg) biofeedback for the treatment of adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aim of this study is to investigate if electroencephalogram (eeg) biofeedback incorporating the use of video games is effective in improving inattentive symptoms in children with adhd.

this study will enroll 20 outpatient subjects aged 7 to 12 newly diagnosed with adhd who have never received treatment with medication. these children should have inattentive symptoms, i.e. diagnosed with combined or inattentive subtype of adhd, and should not have any of the exclusion criteria. based on the gender ratios from other studies, we will enroll 8 boys and 2 girls into the intervention group, giving a male:female ratio of 4:1. 10 will be in the 'intervention' group and 10 in the 'control' group. informed consent will be obtained from the parents, and assent from the subjects, prior to any form of assessment or intervention as part of the study. intervention the 10 subjects in the intervention group will take part in a total of 20 sessions spread over a 10-week period. each subject will first need to master a simple concentration task involving a fishing game. after this, the child will go on to play a second soccer game. each game employs the bci system, and is controlled by the child's concentration, which is fed to the computer via the eeg leads. the child watches the game on a computer screen. each session may take approximately thirty minutes. the other 10 children in the comparison group will act as controls. at the clinic visit at baseline assessment, they will play the fishing game. there will be no further intervention subsequently. assessment the following questionnaires will be administered to all subjects in both study groups at week 5, week 10, and at 3 months post-intervention (week 22): 1. adhd rating scale: parents and teachers 2. child behaviour checklist (cbcl): parents 3. teacher's report form (trf): teachers in addition, for those subjects in the intervention group, they will be given 2 worksheets (1 maths and 1 short comprehension exercise) at the end of the intervention during visits 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 over the 10-week period. their eeg activity will be recorded during the completion of these worksheets.

Eligibility criteria:
inclusion criteria: * satisfy dsm-iv-tr criteria for adhd (combined or inattentive subtype) exclusion criteria: * present or history of medical treatment with stimulant medication and/or atomoxetine * co-morbid severe psychiatric condition or known sensori-neural deficit, e.g. complete blindness or deafness * history of epileptic seizures * known mental retardation (i.e. iq 70 and below) * predominantly hyperactive/impulsive subtype of adhd

Keywords: attention deficit hyperactivity disorder electroencephalogram biofeedback inattention brain-computer interface system
clinical study of umbilical cord blood mononuclear cells (ucb-mncs) in the treatment of traumatic fracture healing

Conditions: Bone Nonunion

Summary: the aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.

umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.in this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.

Eligibility criteria:
inclusion criteria: * traumatic long bone fracture. * noninfectious bone nonunion, delayed bone union. * 3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space \< 5mm. * no shortening, angulation and displacement. * there was no obvious callus growth 8 months after local bone grafting. exclusion criteria: * there are infection foci at and near the fracture end after fracture. * 3 months after the fracture, tests showed partial callus growth. * combining shortening, angulation and displacement phenomena. * partial callus grew 8 months after local bone grafting.

Keywords: umbilical cord blood mononuclear cells traumatic fracture healing bone nonunion
ruxolitinib as a salvage therapy for hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(hlh).


Eligibility criteria:
inclusion criteria: 1. meet hemophagocytic lymphohistiocytosis (hlh)-04 diagnostic criteria; 2. treated with hlh-94 no less than 2 weeks before enrollment and did not achieve at least pr; or relapsed patients after remission； 3. life expectancy exceeds 1 month; 4. age≥1 year old and ≤75 years old, gender is not limited； 5. before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal； 6. serum human immunodeficiency virus(hiv) antigen or antibody negative； 7. hepatitis c virus (hcv) antibody is negative, or hcv antibody is positive, but hcv rna is negative； 8. both hepatitis b virus (hbv) surface antigen and hbv core antibody were negative. if any of the above is positive, peripheral blood hepatitis b virus dna titer should be detected, and less than 1×103 copies/ml can enter the group； 9. informed consent. exclusion criteria: 1. pregnancy or lactating women； 2. allergic to ruxolitinib； 3. active bleeding of the internal organs； 4. uncontrollable infection； 5. serious mental illness; 6. non-melanoma skin cancer history; 7. patients unable to comply during the trial and/or follow-up phase; 8. participate in other clinical research at the same time.
the efficacy and safety of tbcb vs tbfb in diagnosis of ggo

Conditions: Lung Ground-Glass Opacity

Summary: the aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (tbcb) and transbronchial forceps biopsy (tbfb) in the diagnosis of lung ground-glass opacity.

the conventional biopsy method for lung ground-glass opacity (ggo) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. the investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in ggo diagnosis. the study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive ebus examination before biopsy to check whether the ggo lesions exist or not. this is a parallel-control study that patients with ggo lesions will be randomized to either tbcb group or tbfb group for biopsy. the primary aim is to compare the diagnostic yields of the two biopsy techniques. the secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.

Eligibility criteria:
inclusion criteria: 1. male or female aged between 18 and 80. 2. ct or other imaging examination suggest a tendency towards malignant ggo (size ≥ 8 mm). the ground glass composition is more than 50%. 3. thin-slice ct scan with bronchial access or adjacent lesions. 4. multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of ggo. 5. it is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy. 6. ability to read, understand and sign icf. exclusion criteria: 1. disseminated ggo, suspected of benign or infectious lesions. 2. preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels. 3. there are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency. 4. intolerance or difficulty in cooperating with bronchoscopy, etc. 5. routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc. 6. vulnerable groups, such as pregnant women, etc. 7. some other special situations investigator consider subjects are not suitable to participant in this study.

Keywords: lung ground-glass opacity transbronchial cryobiopsy forceps biopsy diagnosis
impact of regional anesthesia on chronic post-operative pain

Conditions: Breast Cancer

Summary: approximately 55,000 cases of breast cancer are diagnosed in italy every year and the first-line therapy for carcinoma in situ, stage i, ii and iiia is surgical removal of the tumour. the incidence of chronic pain after breast cancer surgery is confirmed around 30%. this study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery

approximately 55,000 cases of breast cancer are diagnosed in italy every year and the first-line therapy for carcinoma in situ, stage i, ii and iiia is surgical removal of the tumour. the incidence of chronic pain after breast cancer surgery is confirmed around 30%.persistent postsurgical pain, defined in the icd-11 as pain that develops or increases in intensity after a surgical procedure or tissue damage and persists beyond the healing process for at least 3 months after the initial event and is considered a complication of surgery. several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions, including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia. the purpose of this multicenter prospective observational study is to evaluate, through the propensity score methodology, how much the use of loco-regional anesthesia techniques can improve the outcome, in terms of the development of chronic post-surgical pain, of patients undergoing to oncological breast surgery

Eligibility criteria:
inclusion criteria * age \> 18 * oncological breast surgery: * simple mastectomy, * mastectomy + sentinel lymph node biopsy, * mastectomy + axillary hollowing, * mastectomy + reconstruction, * simple quadrantectomy, * quadrantectomy + sentinel lymph node biopsy, * quadrantectomy + axillary hollowing, * bilateral interventions will also be considered) exclusion * age \< 18

Keywords: breast cancer breast surgery oncological breast surgery multimodal analgesia chronic postoperative pain
tension-free vaginal tape (tvt) versus bulking agent for the treatment of post vulvectomy urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: the surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. this surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. the radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. as consequence women treated for vulvar cancer may develop urinary incontinence. the incidence of this complication has been differently reported, but seems to reach the 100%. poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards. based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.

women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). patients of group 1 will be treated with the tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection. all eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic evaluations. during the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient. data will be analyzed using the intention-to-treat principle and a p value of 0.05 or less will be considered significant.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence by self report, examination and test * history of radical vulvectomy exclusion criteria: * systemic disease and/or drugs known to affect bladder function * current chemotherapy or radiation therapy * detrusor instability

Keywords: bulking agent emivulvectomy radical vulvectomy tvt urinary incontinence vulvar cancer
comparative bioavailability of betamethasone oral solution metered spray (gtx-102) in healthy subjects

Conditions: Ataxia Telangiectasia

Summary: a randomized, open-label, crossover study to evaluate the comparative bioavailability, pharmacokinetics, and safety of gtx-102 administered as an oral spray compared to intramuscular injection - betamethasone and an oral solution of betamethasone in healthy subjects. four groups of subjects will receive 2 treatments each and randomized in 2-way crossover.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects between the ages of 18 and 55 years, inclusive. 2. willing and able to provide written informed consent prior to participating in the study. 3. able to communicate clearly with the investigator and staff; able to read, complete questionnaires, and understand study procedures. 4. able to complete all screening period evaluations, and stay in the clinic testing facility for up to 2 consecutive days on 2 separate occasions. 5. body mass index (bmi) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive. exclusion criteria: 1. has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine (stable thyroid hormone replacement therapy is not excluded), neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the investigator considers should exclude the participant, or that could interfere with the interpretation of the study results. 2. has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug. 3. has any clinically significant medical condition, physical examination finding, vital signs, ecg abnormality (at screening), or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at screening or at admission to the study center, as deemed appropriate by the investigator
safety and clinical activity of qel-001 in a2-mismatch liver transplant patients

Conditions: Rejection; Transplant, Liver; Liver Failure; Liver Diseases

Summary: the purpose of this study is to evaluate the safety and tolerability of qel-001 in the prevention of liver transplant rejection following immunosuppression withdrawal. qel-001 is a product made from a patients own cells, which are genetically modified and designed to help the transplant recipient's body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

this study is a multicenter, first-in-human, open-label, single-arm study of an autologous car t regulatory (car-treg) in hla-a2 mismatched liver transplant recipients. the aim is for the car-tregs to be activated on recognition of hla-a2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ.

Eligibility criteria:
inclusion criteria: * written informed consent. * subject who are hla a2/a28 negative who have received hla a2-mismatch liver transplant 12 months to 5 years prior to study entry. * able and willing to use contraception. * be on stable maintenance of immunosuppression for at least 12 weeks prior to study entry. exclusion criteria: * severe cardiac, respiratory disease or any other major organ dysfunction. * subjects with prior non-liver solid organ or hematopoietic stem cell transplant. * known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug. * positive serology for human immunodeficiency virus (hiv), active or latent tuberculosis (tb) or other clinically active local or systemic infection. * use of investigational agents within 3 months of screening. * subjects with history of autoimmune disease requiring use of immunosuppression or biologics within 24 months prior to study entry. * subject with history of malignancy in the past 5 years. * medical or social condition that is not compatible with adequate study follow-up and any other reason that, in the opinion of the site investigator or medical monitor, would render the subject unsuitable for participation in the study. * protocol defined laboratory value for the following parameters: * alanine aminotransferase (alt) and either alkaline phosphatase (alp) or gamma-glutamyl transferase (ggt), * kidney function e.g. egfr, * white blood cells, * hemoglobin, * platelets.

Keywords: regulatory t cells chimeric antigen receptor autologous genetically modified cells