Kornimate/medical-research-clean huggingface dataset:
safety and preliminary efficacy of mor103 in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: gm-csf is considered to have a key role in the initiation and progression of arthritic inflammation. the purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of mor103, a human antibody to gm-csf, in patients with active rheumatoid arthritis.

rheumatoid arthritis (ra) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. ra primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity. pro-inflammatory cytokines, such as tumor necrosis factor-alpha (tnfα), interleukin (il)-1, il-6 and granulocyte macrophage colony stimulating factor (gm-csf), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. several preclinical findings support an anti-gm-csf therapy for ra.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis (ra) per revised 1987 acr criteria * active ra: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the pip joint * crp \> 5.0 mg/l (rf and anti-ccp seronegative); crp \>2 mg/l (rf and/or anti-ccp seropositive) * das28 ≤ 5.1 * stable regimen of concomitant ra therapy (nsaids, steroids, non- biological dmards). * negative ppd tuberculin skin test exclusion criteria: * previous therapy with b or t cell depleting agents other than rituximab (e.g. campath). prior treatment with rituximab, tnf-inhibitors, other biologics (e.g. anti-il-1 therapy) and systemic immunosuppressive agents is allowed with a washout period. * any history of ongoing, significant or recurring infections * any active inflammatory diseases other than ra * treatment with a systemic investigational drug within 6 months prior to screening * women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide * significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity) * hepatic or renal insufficiency

Keywords: rheumatoid arthritis gm-csf mor103
topical application of curcumin orabase in oral submucous fibrosis (osmf)

Conditions: Oral Submucous Fibrosis

Summary: curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the east indian plant curcuma longa. curcuma longais a member of the zingiberacae (ginger) family of botanicals and is a perennial plant that is native to southeast asia. turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.

anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of nf-κb and cox-2 (increased levels of cox-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines il-1b, il-6, and tnf-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase c, that mediate inflammation and tumor-cell proliferation. curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. antioxidants are implicated in the pathogenesis of osmf and hence this preparation may be helpful in resolution of this lesion.

Eligibility criteria:
inclusion criteria: * subjects showing classic clinical signs of osmf and not under any intervention for the same will be included. exclusion criteria: * subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.

Keywords: oral submucous fibrosis curcumin
effect of physical therapy exercise program and low-level laser therapy on the treatment of cervicogenic somatosensory tinnitus

Conditions: Tinnitus, Subjective

Summary: to determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment


Eligibility criteria:
inclusion criteria: * age ranged from 45 to 55 years old both sex * unilateral tinnitus * stable tinnitus for at least 3 months * suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (cst) exclusion criteria: * tinnitus with clear ontological etiologies as perforation of the tympanic membrane * external otitis media * conductive hearing loss * patients with a traumatic cervical spine injury, tumors * any history of exposure to ototoxic drugs/substances * psychotic disorders with auditory hallucination
clinical study of ebv-tcr-t cells for ebv infection after allogenic hsct

Conditions: EBV Infection After Allogenic HSCT

Summary: this is a multi-center, single arm, open-label, phase i study to determine the safety and effectiveness of ebv-tcr-t cell immunotherapy in treating ebv virus infection after allogenic hsct.

eb virus (ebv) infection after allogeneic hematopoietic stem cell transplantation (hsct) is common and can be lethal without prompt treatment. in this prospective study, hla-a\*02:01/11:01/24:02-restricted ebv-specific t cell receptor (tcr) will be introduced into the t cells of hsct donors by ex vivo lentiviral transduction to generate ebv-tcr-t cells. an escalated dose ranging from 3×10\^5/kg to 1×10\^6/kg of ebv-tcr-t cells will be infused into patients with ebv infection. the safety, efficacy, pharmacokinetics and cytokine levels of allogenic ebv-tcr-t cell therapy will be evaluated.

Eligibility criteria:
inclusion criteria: * age 14-75 years, gender unlimited. * diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-hsct), with ebv infection after allo-hsct. * karnofsky score ≥ 70(age ≥16y) or lansky score ≥ 50(age\<16y). * tcr-t cell donor inclusion criteria: 1) age 8-70 years; 2) understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 hla match with tcr-t cell recipients enrolled; 4) lymphocyte count = (0.8\~4) × 10\^9/l; 5) have sufficient venous circulation, without any symptoms that do not allow blood cell isolation. exclusion criteria: * patients with uncontrolled active agvhd one day before tcr-t cell infusion. * patients with severe kidney disease (cr \> 3×normal value), liver damage (tbil \>2.5×upper limit of normal value, alt and ast \> 3×upper limit of normal value) or heart failure (nyha heart function grade iv) one week before tcr-t cell infusion. * anticipated to take immunosuppressive hormones on the day of tcr-t cell infusion. * have other malignancies. * have relapsed and uncontrolled hematologic malignancies. * serologically positive for hiv-ab or tap-ab. * pregnant or lactating women. * anticipated to have other cell therapies in 4 week post tcr-t cell infusion. * participated in any other clinical study of drugs and medical devices before 30 days of enrollment.

Keywords: ebv infection allogenic hsct
overcoming barriers to hiv/aids care and art initiation

Conditions: Engagement in HIV Care

Summary: the study will evaluate interventions to improve engagement in hiv care following hiv diagnosis through a voluntary counseling and testing program. the specific aims are to (1) determine if a vct-based intervention of cd4 count testing, alone or in combination with peer counseling, improves linkage to hiv/aids care; (2) assess the impact of the intervention on art initiation. the study will recruit 450 hiv-positive individuals from vcts and randomize a third to standard counseling and referral, a third to receive cd4 testing at the vct with results return by phone after 1 weeks, and a third to receive the same cd4 testing combined with peer counseling. these combined investigations will create a comprehensive understanding of obstacles to appropriate hiv/aids care and result in new interventions to achieve measurable outcomes in applied settings.


Eligibility criteria:
inclusion criteria: * at least 18 years or older and * testing hiv-positive for the first time at a voluntary counseling and testing (vct) center. * willing to receive counseling to encourage linkage to care at a comprehensive care center (ccc). * willing to have a cd4 count test conducted at the enrollment visit. * willing to have a telephone follow-up where they may receive additional counseling and/or have their cd4 count results returned to them. * willing to be contacted over 1 year to determine if they linked to care. exclusion criteria: * previous positive hiv test. * currently taking antiretroviral medications. * currently pregnant (females only). * currently participating in another research study or trial. * not planning to remain in nairobi for the next 12 months (not including short trips out of nairobi).
revefenacin peak inspiratory flow rate (pifr) study in copd

Conditions: Chronic Obstructive Pulmonary Disease, COPD; Low Peak Inspiratory Flow Rate (PIFR)

Summary: this study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized revefenacin with spiriva once daily delivered via the handihaler® on lung function in subjects with copd and a low peak inspiratory flow rate.


Eligibility criteria:
inclusion criteria: * subject is a male or female subject 40 years of age or older with a diagnosis of copd. * subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. * subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures. exclusion criteria: * subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug. * subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. * subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.

Keywords: chronic obstructive pulmonary disease, copd low peak inspiratory flow rate (pifr)
trial of erlotinib in patients with jak-2 v617f positive polycythemia vera

Conditions: Polycythemia Vera

Summary: the primary objective of this study is to determine the overall response rate to erlotinib in patients with polycythemia vera (pv). response rate will be assessed by improvement in the complete blood count, ultrasound of the spleen, and jak2 molecular status. it is purposed in this study to explore a possible molecular targeting of the driving mechanism of pv.

this is a phase ii open-label study. patients will be screened for mpn diagnoses and patients with polycythemia vera proven to have jak2v617f mutation will be given the option to enroll. consenting patients will take erlotinib daily for 16 weeks. blood work and pharmacokinetics will be drawn for serum level monitoring. doses will be administered according to side effects or held. first assessment will be at day 15 wth subsequent assessments at 28 day intervals. non-responders will be taken off the study and managed according to standard of care. patients who do respond will continue taking the therapy for a total of 12 months. observation will be for a total of 12 months after finishing treatment. in addition to the clinical aspect of this study, there will be correlative studies where molecular response will be checked and its correlation with clinical response.

Eligibility criteria:
inclusion criteria: * who 2008 diagnosis of polycythemia vera hemoglobin \> 18.5 g/dl for men (16.5 g/dl for women) and presence of jak2v617f mutation and either bone marrow trilineage myeloproliferation or subnormal serum erythropoietin level patients may be on active treatment (phlebotomy, aspirin) ecog performance status 0,1,2,or 3 adequate hepatic function, adequate renal function exclusion criteria: * patient with active malignancy patients with clinically significant cardiac disease within 1 year opthalmologic or gastrointestinal abnormalities concurrent cytoreductive therapy is not allowed
a 52-weeks observational study to evaluate the safety of brolucizumab in patients with namd

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with beovu kit for intravitreal injection in namd patients.

the observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye. however, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. this was set in order to collect data as much as possible based on the clinical effect of the drug. if 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.

Eligibility criteria:
inclusion criteria: 1. patients must provide written consent to cooperate in this study before treatment with beovu kit for intravitreal injection 2. patients using beovu kit for intravitreal injection for the first time for the following indication: * indication: age-related macular degeneration with subfoveal choroidal neovascularization exclusion criteria: 1. patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as beovu kit for intravitreal injection

Keywords: japan brolucizumab neovascular age-related macular degeneration (namd) non-interventional study post-marketing surveillance
evaluation of the uses of a digital-assisted self-rehabilitation device (tele-park)

Conditions: Parkinson Disease; Parkinson's Syndrome

Summary: evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).


Eligibility criteria:
inclusion criteria: patients: * men and women over the age of 18 * with parkinson's syndrome due to idiopathic parkinson's disease or related syndromes * presenting a complaint about balance and/or walking * with possible walking over a perimeter of at least 100 meters with or without technical aid * hoehn and yahr scale \< or = to 4 * formulating their free and informed consent in writing. health professionals: - physiotherapists and physiatrists hospital or voluntary volunteers practicing in the territory of health 5 in brittany agreeing to participate in the study exclusion criteria: * orthopedic and rheumatologic pathologies that may prevent the achievement of measures * comprehension disorders preventing the implementation of the protocol

Keywords: parkinson serious game self management rehabilitation telemedicine
intravascular identification and drug-eluting balloon treatment of vulnerable lipid-rich plaques

Conditions: Coronary Artery Disease

Summary: rationale: two-thirds of intracoronary thrombi causing acute coronary syndrome (acs) result from rupture of lipid-rich plaques (lrp). after treatment of the culprit lesion in acs patients, additional lrps are found in approximately 50% of patients. near infrared spectroscopy (nirs) combined with intracoronary ultrasound (ivus) can identify these vulnerable plaques during coronary angiography (cag) and is able to assess plaque characteristics and the lipid-core burden index in a 4mm segment (lcbimm4). it is currently unknown whether treatment of lrps leads to plaque stabilization, potentially reducing the number of subsequent acs. we hypothesize that lrps can be treated with balloons coated with an antiproliferative drug (i.e. drug-eluting balloons; deb) to deliver selective pharmacotherapeutic treatment to halt the local atherosclerotic process and subsequently reduce the risk for atherosclerotic events. objectives: to determine the change in plaque characteristics of non-culprit lrps, as measured with ivus/nirs, after treatment with deb in patients with acs. study design: prospective single-arm clinical trial study population: patients with non-st-elevation acute coronary syndromes intervention: if a lrp is detected with ivus/nirs, it will be treated with deb. in case multiple lrps are detected, only one will be treated. main study endpoints: the difference in lcbimm4 between baseline and 9 months of plaques treated with deb.


Eligibility criteria:
inclusion criteria: * patient has an acute coronary syndrome without st-segment elevation on the ecg (nste-acs), including non-st-elevation myocardial infarction and unstable angina pectoris, defined according to the fourth universal definition of myocardial infarction. * an invasive revascularization strategy for nste-acs with pci is chosen. exclusion criteria: - angiographic exclusion criteria: 1. previous coronary artery bypass-grafting; 2. presence of a chronic total occlusion; 3. too many (complex) coronary lesions requiring staged pci procedure(s); 4. procedural complication of the index pci; - clinical exclusion criteria: 5. unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes); 6. patients with st-segment elevations on the ecg requiring immediate primary pci; 7. body weight \> 250 kg; 8. known renal insufficiency (estimated glomerular filtration rate \[egfr\] \<30 ml/min/1.73m2 or subject on dialysis); 9. hypersensitivity or allergy to contrast with inability to properly pre-hydrate; 10. presence of a comorbid condition with a life expectancy of less than one year; 11. participation in another trial; 12. subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.

Keywords: lipid-rich plaque non-st-elevation myocardial infarction near-infrared spectroscopy drug-eluting balloon
study with dendritic cell immunotherapy in resected hepatic metastasis of colorectal carcinoma

Conditions: Colorectal Carcinoma; Hepatic Metastasis

Summary: in this randomized multicentric phase ii study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.


Eligibility criteria:
inclusion criteria: 1. age over 18 years. 2. confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment. 3. capacity of understanding and signing the informed consent and to undergo the study procedures 4. availability of tumor tissue, for maturing dendritic cells 5. adequate renal, hepatic and bone marrow function exclusion criteria: 1. clinically relevant diseases or infections. 2. concurrent participation in other clinical trial or administration or other antitumoral treatment 3. concurrent cancer, with the exceptions allowed by the principal investigator (pi). 4. pregnant or breast feeding women 5. immunosuppressant treatment

Keywords: colorectal carcinoma resectable hepatic metastasis adjuvant treatment dendritic cells
bacteriophage therapy for morganella morganii prosthetic joint infection

Conditions: Prosthetic Joint Infections of Hip

Summary: this is a single-patient, phase i/ii clinical trial that aims to evaluate the potential of a bacteriophage drug product to treat and prevent the recurrence of a morganella morganii prosthetic joint infection of the hip. the patient has exhausted all conventional therapies, both surgical and medical, at considerable detriment to their quality of life. the treatment involves 2 intra-articular injections of bacteriophages into the joint and surrounding area and 14 days of intravenous phage therapy. the goal is to eliminate the infection and prevent further complications, providing a potential new treatment avenue for patients with difficult-to-treat infections.


Eligibility criteria:
inclusion criteria: * diagnosis of active chronic prosthetic joint infection * causative bacteria is susceptible to bacteriophage therapy in vitro * history of multiple failed antibiotic and surgical interventions exclusion criteria: * stage 5 chronic kidney disease * cirrhosis * a known allergy to phage products * fever * involvement in another clinical trial * pregnancy

Keywords: bacteriophage periprosthetic joint infection phage therapy
mechanisms responsible for cardiac and skeletal muscle energetic impairment in diabetes

Conditions: Diabetic Cardiomyopathy

Summary: diabetes increases the risk of heart failure. this is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. we plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.


Eligibility criteria:
inclusion criteria: * diabetes mellitus(who definition) * hba1c \<9 * no history of chest pain * no evidence of coronary artery disease or peripheral vascular disease * left ventricular ejection fraction over 50% * no evidence of respiratory disease exclusion criteria: * patients \< 16years or who cannot provide informed consent * evidence of significant epicardial coronary artery disease * evidence of peripheral vascular disease * abnormal liver function tests * clinically apparent peripheral neuropathy * severe chronic renal failure (creatinine \>250) or diabetic nephropathy * concomitant use of amiodarone, quinidine, haloperidol or selective serotonin (5ht) uptake inhibitors such as fluoxetine and paroxetine which may inhibit the cyp2d6 enzyme * patients on statin therapy for primary dyslipidemia. * patients with recurrent hypoglycaemia * women of child bearing age who are not using effective contraception (or if pregnancy test positive)

Keywords: perhexiline diabetes diabetic cardiomyopathy high energy phosphate kinetics magnetic resonance spectroscopy