Kornimate/medical-research-clean huggingface dataset:
cd20-cd19 compound car (ccar) t cells for patients with relapsed /refractory b cell malignancies

Conditions: B Cell Lymphoma; B Cell Leukemia

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of cd20-cd19 ccar in patients with relapsed and/or refractory b cell malignancies.

clinical trials with cd19-directed cars have achieved unprecedented remission rates as high as 90%. however, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. cd20-cd19 ccar is a compound chimeric antigen receptor (ccar) immunotherapy with two distinct functional car molecules expressed on a t-cell, directed against the surface proteins cd20 and cd19. cd20-cd19 ccar intends to target the mechanisms of single-car relapse, specifically antigen escape.

Eligibility criteria:
inclusion criteria: 1. diagnosis based on the world health organization (who) 2008 2. histologically demonstrate cd19 or cd20 expressing b cell lymphoma or b all 3. patients have exhausted standard therapeutic options 4. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 5. female must be not pregnant during the study exclusion criteria: 1. patients declining to consent for treatment 2. prior solid organ transplantation 3. potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. prior treatment with cd20xcd3 or cd19x3 bispecific agents

Keywords: cd20 cd19 ccar leukemia lymphoma
immunogenicity of a combined anti-pneumococcal vaccine schedule in patients with anca-associated vasculitis

Conditions: Pneumococcal Infection; ANCA-associated Vasculitis

Summary: exploratory study of anti-pneumococcal immune response in patients with anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis (aav) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -pcv13- followed by a 23-valent non-conjugate pneumococcal vaccine -ppv23- 8 weeks later).

the purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (elisa) and opsonophagocytosis (opa) response rates) in aav-patients receiving immunosuppressive therapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * anca-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to american college of rheumatology criteria * indication for pneumococcal vaccination according to french recommendations (statement of the haut conseil de santé publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, april 25th 2013) exclusion criteria: * history of pneumococcal immunization 36 months to 24hours before vo. * patients with known, or suspected pregnancy * patients planning to get pregnant in the year following inclusion * splenectomy * eosinophilic granulomatosis with polyangiitis (egpa, churg-strauss) flare * infection during the week before inclusion * patient without social security coverage * individuals opposal

Keywords: pneumococcal infection invasive pneumococcal disease (ipd) pneumococcal vaccine vaccinology immunocompromised auto-immune diseases systemic vasculitis anca-associated vasculitis
intervention development and pilot study to prevent untreated native hawaiian and pacific islander opioid use disorder

Conditions: Opioid-use Disorder

Summary: this study will design and pilot/feasibility test a culturally grounded intervention to increase the treatment seeking of pacific islanders with opioid use disorders in formal services.

for the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilot/feasibility test of our conceptual model of culturally grounded intervention components with 20 pacific islander adults with experience with opioid use disorders, then conduct 2 focus groups per site to finalize the components and items for larger r01 pilot and randomized wait-list controlled testing.

Eligibility criteria:
inclusion criteria: * of pacific islander/native hawaiian or part-pacific islander/native hawaiian heritage. * live in utah or hawaii. * for all lay pacific islander adult participants: must be over 18 years of age. * fluent (oral and reading) in english or native hawaiian. for target pacific islander participants with ouds, additional inclusion criteria is: - presence of active oud, as screened via 8-item rapid opioid dependence scale. exclusion criteria: * do not meet inclusion criteria, * are unwilling to participate, * fails to provide or retracts consent, * reside outside the target communities of utah or hawaii
targeted busulfan, fludarabine, etoposide conditioning regimen for hsct in childhood and adolescent all.

Conditions: Acute Lymphoblastic Leukemia

Summary: to evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine, etoposide conditioning regimen in childhood and adolescent all.

busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. high exposure is associated with systemic toxicity such as veno-occlusive disease (vod) and underexposure is associated with graft failure or relapse. in this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Eligibility criteria:
inclusion criteria: 1. patients who are diagnosed as all. 2. patients who need hematopoietic stem cell transplantation 3. age: up to 21 years 4. performance status: ecog 0-2. 5. patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. liver: total bilirubin \ 60 ml/min/1.73m2. 6. patients must lack any active viral infections or active fungal infection. 7. appropriate donor is available: matched in 6/6 of a, b, dr loci. 8. patients (or one of parents if patients age \< 19) should sign informed consent. exclusion criteria: 1. pregnant or nursing women. 2. malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. psychiatric disorder that would preclude compliance.

Keywords: hematopoietic stem cell transplantation
a multicenter, prospective, phase iii randomized controlled clinical study for the treatment of n2-3 nasopharyngeal carcinoma patients

Conditions: Nasopharyngeal Carcinoma; Neoadjuvant Chemotherapy

Summary: at the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. however, distant metastasis is still the main cause of failure in treatment of stage n2-3 nasopharyngeal carcinoma.the severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage n2-3 nasopharyngeal carcinoma. meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. in conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of n2-3 nasopharyngeal carcinoma and improve the survival rate.


Eligibility criteria:
inclusion criteria: 1. non-keratinizing nasopharyngeal carcinoma diagnosed by pathology; 2. according to the uicc/ajcc eighth edition staging criteria, clinical staging was t1-4n2 -3m0 (stage n2-3 nasopharyngeal carcinoma); 3. patients who have not received disease-related anti-tumor system therapy; 4. age 18\~70 years; 5. perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (uln); ast and alt≤2.5 uln; alkaline phosphatase ≤2.5 uln; creatinine clearance rate ≥80 ml/min; 6. complete blood system function: neutrophil count (anc) ≥2×109/l, platelet count ≥100×109/l and hemoglobin ≥9 g/dl; 7. cartesian score ≥70; or ecog ps 0 or 1 8. prior to enrollment, the patients must undergo nasopharynx + neck mri, chest + upper abdomen ct, ect and other examinations of the whole body bone. 9. sign the informed consent. exclusion criteria: 1. patients with distant metastases were identified at the time of diagnosis; 2. patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis; 3. previous cases of other malignancies;complicated with other malignant tumors;except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site; 4. use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment; 5. a woman who is pregnant or lactating; 6. known active hiv or hbv, hcv infection; 7. known to be allergic to drugs that may be used; 8. the researchers did not consider participants to be eligible for this study.

Keywords: nasopharyngeal carcinoma neoadjuvant chemotherapy concurrent chemoradiotherapy
investigation of cogane (pym50028) in early-stage parkinson's disease (confident-pd)

Conditions: Parkinson's Disease

Summary: a study to test the therapeutic benefit of the compound pym50028, versus placebo, in treating early-stage parkinson's disease. therapeutic benefit will be assessed using the unified parkinson's disease rating scale (updrs). it is hypothesised that pym50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of early-stage idiopathic pd within the 2 years prior to screening * subjects who are not currently receiving any pd treatment exclusion criteria: * female of child-bearing potential * history of neurosurgical procedures for pd * history of severe psychiatric illness

Keywords: early-stage
68ga-labeled ny108 pet imaging in patients

Conditions: Prostatic Cancer

Summary: this is a single arm study to evaluate the safety and biodistribution of 68ga-labeled ny108 (68ga-ny108) pet imaging in patients.


Eligibility criteria:
inclusion criteria: 1. patients voluntarily signed informed consent; 2. age 18-75, male; 3. patients diagnosed with prostatic cancer confirmed by histopathology or cytology; 4. at least one measurable solid lesion has been examined according recist1.1 standard; 5. patients with biopsy-proven psma positive; 6. ecog score 0\~3; life expectancy of at least 3 months; exclusion criteria: 1. recovery from major trauma (including surgery) within 4 weeks prior to study treatment; 2. patients with systemic or locally severe infections, or other serious coexisting diseases; 3. patients with allergies or allergies to any component of the imaging agent or antibody; 4. patients who cannot perform pet/ct imaging scan; 5. patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; 6. patients with autoimmune diseases, including rheumatoid arthritis; inadequate control of arrhythmias, including atrial fibrillation; 7. uncontrolled hypertension; 8. syphilis, hbv, hcv, or hiv positive subjects; 9. male subjects of reproductive age cannot take effective contraceptive measures; 10. patients with a history of mental illness or related conditions; 11. other subjects considered unsuitable by researchers.
glucomannan for childhood functional constipation.

Conditions: Functional Constipation

Summary: the purpose of this study is to determine whether administration of glucomannan (dietary fiber) is effective in treating functional constipation in children.

constipation is a common condition in children. in many patients symptoms persist to adulthood and decrease quality of life. the standard treatment, mostly osmotic laxatives such as lactulose or polyethyleneglycols, are often ineffective and may cause adverse events. therefore, alternative treatment measures are being searched for. glucomannan, a water-soluble fiber polysaccharide from the tubers of the japanese konjac plant, has been reported to be effective in constipated children. to date, 2 randomized trials were performed.1,2 one evaluated the effect as glucomannan as an adjunct to standard treatment.1 another was conducted in neurologically impaired children, who constitute a specific population that cannot be compared to patients with functional constipation.2 in both trials, the number of patients was relatively small. well-powered, randomized controlled study is required to evaluate clinical effectiveness of glucomannan as a sole treatment in childhood functional constipation.

Eligibility criteria:
inclusion criteria: * functional constipation diagnosed according to rome criteria iii (duration of symptoms for at least 2 months prior to study inclusion) * age 3 to 16 years * informed consent from parents and/or child exclusion criteria: * organic cause of defecation disorders (hirschsprung's disease, spinal anomalies or anorectal pathology; history of gastro-intestinal surgery) * mental retardation * metabolic disease (e.g. hypothyroidism) * irritable bowel syndrome * intake of medications influencing gastrointestinal motility

Keywords: constipation children
bacteriophage therapy in patients with urinary tract infections

Conditions: Urinary Tract Infection Bacterial

Summary: this is a phase i/ii trial designed to evaluate bacteriophage therapy in patients with urinary tract infections.

this study will evaluate the safety and efficacy of bacteriophage therapy in patients with urinary tract infection (uti). patients to be enrolled will have urinary tract infections due to e. coli and k. pneumoniae. this will include asymptomatic patients with neurogenic bladder and symptomatic patients with complicated urinary tract infections who are at risk of uti recurrence. patients will be followed for bacterial clearance or recurrence of urinary tract infection.

Eligibility criteria:
general inclusion criteria: * males or females ≥18 years of age. * female patients of childbearing potential. * male patients must agree not to donate sperm up for one month. * english-speaking. general exclusion criteria: * stage 4 or greater chronic kidney disease (ckd). * abnormal liver function tests \>3×upper limit of normal (uln). * other conditions which could confound study results. * body mass index of \> 40 or weight less than 50 kg. * known allergy to phage products. * pregnant and/or breastfeeding. * immunocompromised. * need for antiviral medication. * history of severe autonomic dysreflexia.

Keywords: antimicrobial resistance bacteriophage urinary tract infections phage
new prosthesis for comminuted fracture of lateral half of clavicle

Conditions: Bone Fracture; Bone Lesion; Clavicle Fracture

Summary: this study to evaluate the efficacy of new prosthesis in treatment of comminuted fracture of lateral half of the clavicle in adult female.

. lateral clavicle fracture lead to sever pain and affect on shoulder movement . this prosthesis will compensate the lost part of the clavicle due to fracture to return the patient to the daily living activity without pain. this prosthesis will reconstruct the missed part of the clavicle.

Eligibility criteria:
inclusion criteria: * female has right lateral part comminuted fracture clavicle . exclusion criteria: * male patient * cancer bone patient. * pregnant * left lateral part comminuted fracture clavicle

Keywords: comminuted lateral clavicle fracture , new prosthesis,
preliminary clinical study of nmn intervention in mild ulcerative colitis

Conditions: Ulcerative Colitis Chronic Mild

Summary: the goal of this clinical trial is to compare the safety and efficacy of nicotinamide mononucleotide (nmn) and placebo in patients with mild ulcerative colitis (uc). the main question it aims to answer is whether nmn can alleviate the intestinal pathology of uc patients, so as to play a role in uc treatment or adjuvant therapy. participants will be randomized into two groups, an nmn group or a placebo group. patients in the nmn group were treated with nmn intervention for 8 weeks. the placebo group received a placebo intervention for 8 weeks.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, ≤75 years old; 2. clinical diagnosis of mild active uc patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion 2018. 3. agreed to participate in this study, and sign the informed consent. exclusion criteria: 1. patients with alt or ast more than 2 times the upper limit of normal, tbil more than 2 times the upper limit of normal; 2. the creatinine clearance patients less than 60 ml/min. 3. the intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs; 4. crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients; 5. pregnancy and lactation women; 6. people with diabetes or screening period more than 7.0 tendency for fasting glucose/l or glycosylated hemoglobin exceed 6.5%; 7. with serious mental illness, such as drugs and alcohol can't cooperate with the patients; 8. participated in any other clinical investigator within 1 month before the screening period; 9. the researchers determine any other disease or condition is not suitable for patients participate in the study.
optimization of acute treatment in first episode schizophrenia

Conditions: Schizophrenia, First-Episode

Summary: the study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. during a treatment phase of 8 weeks the patients are treated with risperidone or haloperidol. aim of the project is to compare the effects of the atypical neuroleptic risperidone with those of the conventional neuroleptic haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).

considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics, the study aims to reach neuroleptic response under the lowest possible dosage of the study medication (haloperidol or risperidone). therefore the initial dosage of the study medication is 2 mg/d. depending on the patients' symptomatology, the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mg/d. patients with the diagnosis of schizophrenia (f20, according to icd-10-criteria) are consecutively enrolled in the study. the patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks. apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study. major questions of the study are, whether patients, who have been treated with risperidone compared with those, who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects. furthermore it is hypothesised, that the treatment with risperidone has better effects on cognitive disorders/dysfunctions and depressive symptoms and that the patients, who receive risperidone are more compliant and have a higher quality of life.

Eligibility criteria:
inclusion criteria: * icd-10 criteria for first episode schizophrenia * age between 18 and 55 * informed consent exclusion criteria: * legal reasons * insufficient knowledge of the german language * substance abuse or addiction * pregnancy * serious physical illness * organic brain disease * contraindication to neuroleptic treatment

Keywords: first episode, schizophrenia, atypical neuroleptics, negative symptoms
evaluation of sost, tweak, rankl, opg levels in smokers and non-smokers with periodontitis

Conditions: Periodontitis; Smoking

Summary: periodontitis is a chronic inflammatory disease with multifactorial etiology. although periodontal disease is initiated by pathogens within the biofilm layer, disease development and tissue destruction occur as a result of the interaction of periodontal pathogens and the host immune response. it has been determined in the literature that smoking has a significant negative effect on periodontal tissues and increases the risk of periodontitis by 2-5 times. it has been shown that there is a relationship between smoking and the incidence and progression of periodontitis. however, the mechanisms by which this occurs have not been explained. in this study, the effect of smoking on the levels of sclerostin (sost), tumor necrosis factor-like weak inducer of apoptosis (tweak), receptor activator of nuclear factor-kb ligand (rankl), and osteoprotegerin (opg), which are effective in bone metabolism, in gingival crevicular fluid (gcf) and saliva will be evaluated. participants in the study were in accordance with the 2017 world workshop on classification of periodontal and peri-implant diseases and conditions criteria as a result of clinical evaluations systemically healthy, non-smokers diagnosed with stage 2, 3 and/or 4 periodontitis (group 1) (n=26); systemically healthy, diagnosed with stage 2, 3 and/or 4 periodontitis and smokers (group 2) (n=26); systemically and periodontally healthy, non-smokers (group 3-control group) (n=26). clinical periodontal indixes will be obtained from participants meeting the inclusion criteria; gcf and saliva samples will be collected. the samples will be examined by elisa test at gazi university faculty of medicine, department of immunology.


Eligibility criteria:
inclusion criteria: * study participants have no history of periodontal therapy or drug therapy for at least 6 months. exclusion criteria: * pregnancy, lactation, during orthodontic treatment and systemic conditions related to bone metabolism, diabetes were excluded.

Keywords: periodontitis smoking rankl opg tweak sost