Kornimate/medical-research-clean huggingface dataset:
nsaid treatment in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: central mechanisms may play a role in pain perception during osteoarthritis (oa).local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (il) 4 tnf-alpha, il-6 and il-8) is considered to be a major source of pain. certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. nsaids have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. indeed, the osteoarthritis research society international (oarsi) recently recommended the use of nsaids for management of knee and hip oa in symptomatic patients. these drugs have been shown to influence cytokine metabolism in the synovial fluid of oa patients with satisfactory relief of painful osteoarthritic joints. the aim of the current study was to explore whether nsaid treatment inhibits tnf-alpha, il-6, il-8, and vegf secretion in the synovial fluid of osteoarthritic joints. in particular, diclofenac, ibuprofen and celecoxib were studied. under the hypothesis that relationships between proinflammatory cytokines and the clinical status of oa patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with oa. the effects of nsaids on signal transduction pathways in the synovial membrane were also investigated.

not desired

Eligibility criteria:
inclusion criteria: patients eligible for the study were: * older than 50 years and * had primary knee oa diagnosed according to the clinical and radiological criteria of the american rheumatism association. further inclusion criteria were: * clinical signs of joint inflammation (warmth, swelling or effusion) and * a disease severity grade 2 or 3 according to the kellgren-lawrence classification exclusion criteria: * allergy to nsaids, * progressive serious medical conditions (such as cancer, aids or end-stage renal disease), * history of gastrointestinal ulcer or bleeding, * a hemoglobin concentration lower than 11.5 g/dl, * renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or * liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).

Keywords: knee osteoarthritis
action-effect anticipation in patients with parkinson's disease : a study of the sensory attenuation marker.

Conditions: Parkinson Disease

Summary: the ideomotor theory of action control is considered to be central to the understanding of human voluntary action. according to the ideomotor theory, an action is represented in terms of its desired sensory effects and actions are selected by internally activating these effect representations. recent imagery and behavioral studies showed that this anticipated representation of action-effects triggered a "sensory attenuation", meaning a decrease of perceptive performances or a decrease of sensory event-related potentials (erp) for an expected event. thus, the sensory attenuation constitutes a relevant behavioral tool to investigate sensory anticipation impairment in patients with parkinson's disease. in a behavioral paradigm, patients and matched control participants have to perform a perceptive task on predicted visual action-effects mixed with mispredicted visual action effects. performances should be better in mispredicted visual action effects for control participants only.


Eligibility criteria:
inclusion criteria: * parkinson's disease * normal or corrected vision exclusion criteria: * other pathology or neurological or psychiatric history * known pregnancy or breastfeeding * absence of affiliation to the french social security * person under legal protection * patient's opposition to participate

Keywords: parkinson's disease action-effect prediction sensory attenuation voluntary action
a comparative study of hall technique, modified hall technique and conventional stainless-steel crown restorations in the treatment of primary molars with proximal caries lesions.

Conditions: Dental Caries

Summary: the purpose of this study is to compare the effectiveness of the hall technique and modified hall technique to the conventional stainless-steel crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.


Eligibility criteria:
inclusion criteria: * medically fit children * children who exhibit cooperative behavior at initial bitewing radiograph procedure * children with symptom-free or reversible pulpitis restorable first and second primary molars in both arches * teeth with d1 lesions will be included * no periapical or furcation pathologies on bite wing radiographs exclusion criteria: * medically compromised children * children with uncooperative behavior during bitewing radiograph process * primary molars with irreversible pulpitis * teeth with furcation or peri radicular pathologies

Keywords: molars
study of biomarkers of the response to biotine

Conditions: Multiple Sclerosis; Biotine

Summary: biotine is proposed by neurologists to patients with a progressive form of multiple sclerosis (ms) in the context of a nominative temporary authorization for use (tau) as a disease-modifying treatment for their ms. a recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo. the objective of this study is to identify blood biomarkers to determine good responders as early as possible. in addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis. the management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * inactive progressive form of ms according to the lublin classification and recorded in the burgundy edmus database * patients with health insurance cover * patients who have provided written informed consent (ofsep) exclusion criteria: * patients unable to understand the information sheet * patients with remittent or active progressive ms * patients with a change in the disease-modifying treatment within the previous 3 months * patients treated with corticosteroids in the month before inclusion * impossibility to provide patients with the necessary information * patients in custody * patients under guardianship
safety, tolerability and pharmacokinetics of sar113945 following intra-articular administration in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: primary objective: * assess the safety and tolerability of single intra-articular doses of sar113945 in patients with knee osteoarthritis. secondary objective: * assess systemic exposure of sar113945 following intra-articular delivery.

the total study duration per subject ranges from 4 to 20 weeks broken down as follows: * screening within 4 weeks before dosing, * follow-up of 4 weeks (28 days) after the single dose of study medication, * prolonged by a maximum of 12 weeks if plasma pk level \> limit of quantification (loq) at day 28.

Eligibility criteria:
inclusion criteria: * male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having: * x-ray or magnetic resonance imaging (mri) evidence for kellgren lawrence grades ii./iii joint space narrowing and osteophyte formation, * western ontario macmaster (womac) score ≦ 72, * american college of rheumatology (acr) clinical and radiographic criteria for osteoarthritis. exclusion criteria: * any uncontrolled, chronic condition or laboratory finding which, in the opinion of the principal investigator, could potentially put the patient at increased risk. * secondary osteoarthritis. * moderate/severe renal impairment. * underlying hepatobiliary disease and/or elevated alanine aminotransferase (alt) \> 3 upper limit of normal range. * intra-articular injection within 3 months. * presence of local skin abnormality at the affected knee joint. * unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic. * any investigational product within 3 months. * any patient unlikely to comply with the requirements of the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study to reduce duration of antibiotic therapy in haematological patients with fever and neutropenia

Conditions: Febrile Neutropenia

Summary: clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

the optimal duration of the empirical antimicrobial therapy (at) in hematological patients with febrile neutropenia (fn) is unknown. the infectious diseases society of america (idsa) recommends maintaining at at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". this recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by idsa. the main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical at in hematological patients with fn).

Eligibility criteria:
inclusion criteria: * adult patients (equal or older than 18 years) of both sexes admitted in the department of clinical hematology who develop a febrile neutropenia. including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation. * informed consent signed. exclusion criteria: * fever with etiologic diagnosis. * patients with epilepsy. * pregnant or lactating women. * patients with hiv infection. * patients with severe renal failure.

Keywords: febrile neutropenia antimicrobial treatment procalcitonin
a phase iii study of entecavir vs lamivudine in adults with chronic hepatitis b infection and positive for hepatitis b e antigen

Conditions: Chronic Hepatitis B

Summary: the purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis b infection who are hepatitis b e antigen positive.


Eligibility criteria:
* male and female subjects =/\> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis b infection; * documentation of positive hepatitis b e antigen (hbeag) status.; * the absence of coinfection with immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis d virus (hdv); * the absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease; * less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis b (e.g., adefovir, famciclovir and lamivudine)
memory preservation of prophylactic cranial irradiation with hippocampal avoidance (premer-trial)

Conditions: Small Cell Lung Carcinoma

Summary: the main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (pci) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients. in addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.

prophylactic cranial irradiation (pci) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (sclc) who have shown benefit after chemotherapy with or without thoracic radiotherapy. because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of pci should result in lower rates of memory loss. previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (imrt) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives. the main objective of this trial is compare neurocognitive functioning following hippocampal avoidance pci to standard pci treatment measured by free and cued selective reminding test (fcsrt). the fcsrt measures verbal learning and memory. the fcsrt emphasizes encoding specificity during learning and recall. one of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (mri). others objectives are to evaluate quality of life (qol) and the rate of metastases in the hippocampus.

Eligibility criteria:
inclusion criteria: * new diagnosed cytological or histologically confirmed small cell lung carcinoma (stage i-iv) candidate for pci, for example, without progressive disease after chemo-radiotherapy in stage i-iii or after response after chemotherapy in stage iv * performance status ≤ 1 * negative mri of the brain within one month before protocol entry * patient must give written informed consent before registration exclusion criteria: * prior radiotherapy to the brain * history of brain metastases * pregnancy or lactation
ctbs on first-episode drug naive patients with schizophrenia

Conditions: Schizophrenia

Summary: ctbs is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of ctbs on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

ctbs is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of ctbs on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia in accordance with dsm-5 * the course of the disease less then 2 years * accepting antipsychotics treatment for less then 2 months exclusion criteria: * diagnosed with other mental disease in accordance with dsm-5 * comorbid with other severe physiological disease * used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before * drug or alcohol abuse * pregnant or lactating contraindication to rtms
cardiac safety study of brentuximab vedotin (sgn-35)

Conditions: Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to evaluate cardiac safety of brentuximab vedotin (sgn-35) in patients with cd30-positive cancers. the study will assess electrical activity of the heart before and after brentuximab vedotin administration. patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.


Eligibility criteria:
inclusion criteria: * relapsed or refractory cd30-positive malignancy * adequate organ function * ecog performance status \<2 exclusion criteria: * cardiac abnormalities (abnormal rhythm, history of significant cardiac event) * current diagnosis of primary cutaneous alcl * acute or chronic graft-versus-host disease * prior hematopoietic stem cell transplant within specified timeframe

Keywords: antibodies, monoclonal antibody-drug conjugate antigens, cd30 disease, hodgkin drug therapy hematologic diseases immunotherapy lymphoma monomethylauristatin e lymphoma, large-cell, anaplastic
real-world evaluation screening study and registry of dyskinesia in patients taking antipsychotic agents

Conditions: Tardive Dyskinesia

Summary: prospective study to quantify the prevalence of possible tardive dyskinesia (td) in outpatient psychiatry practices in the united states (us), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.


Eligibility criteria:
inclusion criteria: * patient has a cumulative lifetime exposure to antipsychotic medication of three months or more * patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the dsm-5 * patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period) * patient is able to read and understand english * patient is willing and able to comply with the study requirements exclusion criteria: * patient is unable to provide informed consent.
pharmacokinetics of biphasic insulin aspart 50 and 70 in japanese healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in japan. the aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (nn-x14mix50) and biphasic insulin aspart 70 (nn-x14mix70) in japanese healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy * japanese * body mass index (bmi) of 19-27 kg/m\^2 (both inclusive) * fasting blood glucose between 3.8-6 mmol/l (68.4-108.0 mg/dl) (both inclusive * considered generally healthy upon completion of medical history and physical examination, as judged by the investigator or sub-investigator exclusion criteria: * clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator or sub-investigator(s) * any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the investigator or sub-investigator * any inter-current illness that may affect blood glucose, as judged by the investigator or sub-investigator * hepatitis b or c, or hiv (human immunodeficiency virus) * use of prescription drugs within 2 weeks preceding the screening * use of non-prescription drugs, except routine vitamins or drugs that may not * blood donation of more than 1150 ml within the last 12 months * subjects with a first degree relative with diabetes mellitus * history of or presence of diabetes * history of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder * previous history of serious allergy or anaphylactic reaction * subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse * subjects who smoke more than 5 cigarettes per day
study evaluating 2 dosing regimens of tru-015 in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this study will evaluate the efficacy and safety of two dosing regimens of a compound known as tru-015 in combination with methotrexate (mtx) in patients with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-tnf use. exclusion criteria: * any prior use of rituximab or other b cell depleting agents. * any significant health problem other than rheumatoid arthritis * clinically significant laboratory abnormalities

Keywords: active rheumatoid arthritis anti cd20
efficacy and safety of longan extract spray (p80 spray) in volunteers with coronavirus disease 2019 (covid-19)

Conditions: Infection Viral

Summary: the objectives of this study are to evaluate efficacy and safety of longan extract spray (p80 spray) in volunteers with coronavirus disease 2019 (covid19).patients who infected covid 19 (positive covid 19 rt-pcr from nasal swab) are enrolled in the study. they will be treated with standard treatment of covid 19. in addition, the patients will received longan extract nasal spray (p80 spray) or placebo nasal spray for 3 days (6 times). after that, they will be nasal swabbed for detecting covid 19 infection. adverse event will also be evaluated by physician or nurse.

patients who infected covid 19 (positive covid 19 rt-pcr from nasal swab) and pass inclusion criteria are enrolled in the study. the patients will be checked the clinical symptoms and chest x-ray by physician. they will be treated with standard treatment of covid 19. in addition, the patients will received longan extract nasal spray (p80 spray) or placebo nasal spray for 3 days (6 times). physician or nurse will ask for adverse events every day. after 3 days, the patients will be nasal swabbed for detecting covid 19 infection.

Eligibility criteria:
inclusion criteria: * age 18-60 years * positive nasal swab test of coronavirus disease 2019 (covid-19) (reverse transcriptase-polymerase chain reaction (rt-pcr) เป็นบวก (cycle threshold \<40)) * mild symptom with normal chest radiograph * no history of chronic obstructive pulmonary disease (copd) and other chronic lung diseases, chronic kidney disease (ckd), cardiovascular diseases and congenital heart diseases, cerebrovascular diseases, poorly controlled diabetes,bmi \> 35 kg/m2, cirrhosis, immunocompromised condition * can read and write * vulnerable to participate exclusion criteria: * allergic history to longan * uncontrollable disease status * pregnancy or lactation * participated in other studies

Keywords: longan nasal spray covid 19 efficacy safety