Kornimate/medical-research-clean huggingface dataset:
drug-drug interaction study assessing effect of itraconazole on pf-07321332/ritonavir in healthy participants

Conditions: Healthy Participant

Summary: the purpose of this study is to estimate the effect of a strong inhibitor of cyp3a4 (itraconazole) on the pharmacokinetics (pk) of pf-07321332/ritonavir in healthy participants.


Eligibility criteria:
inclusion criteria: 1. male and female participants who are overtly healthy as determined by medical evaluation including medical history, pe, laboratory tests, vital signs and standard 12 lead ecgs. 2. participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. female participants must have a negative pregnancy test. 4. bmi of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). - exclusion criteria: 1. positive test result for sars-cov-2 infection at the time of screening or day -1. 2. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 3. clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged pr interval, cardiomyopathy, heart failure greater than nyha 1, underlying structural heart disease, wolff parkinson-white syndrome). 4. any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). 5. history of hiv infection, hepatitis b, or hepatitis c; positive testing for hiv, hbsag, or hcvab. hepatitis b vaccination is allowed. 6. other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to covid-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Keywords: drug-drug interaction itraconazole cyp3a4 inhibitor
assess the non-inferiority of gsk biologicals' mencevax™ acwy (manufactured by a new process) vs mencevax™ acwy (the already existing vaccine in the market) when given as a single dose to subjects aged 2-30 yrs

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing mencevax™ acwy vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

"randomized study with four groups to receive one of the following vaccination regimens: - one of the 3 lots of gsk biologicals' mencevax™ acwy vaccine manufactured by the new process (3 different groups) - gsk biologicals' already existing mencevax™ acwy

Eligibility criteria:
inclusion criteria: * healthy male or female between 2 and 30 years of age at the time of vaccination. * if the subject is female, she must be of non-childbearing potential. if a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * vaccination with a meningococcal vaccine within the last five years. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after. * history of or known exposure to meningococcal serogroup a, c, w135 or y disease or contacts with subjects who had meningococcal disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Keywords: neisseria meningitidis serogroups a & c diseases hib diseases
assessment of the effect of adalimumab on response to influenza virus and pneumococcal vaccines in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the immunogeneicity of the influenza virus and standard 23-valent pneumococcal virus in subject with ra receiving adalimumab or placebo


Eligibility criteria:
inclusion criteria: * male/females at least 20 years of age. * females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control. * females have a negative pregnancy test at screening. * diagnosis of ra and met acr criteria. * must discontinue any tnf at least 2 months prior to baseline. * in condition of general good health. exclusion criteria: * history of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with listeria or tb; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix. * history of current acute inflammatory joint disease. * use of tamiflu or symmetrel within 3 months of study drug administration. * recent (3 month) history of influenza or pneumococcal bacterial infection. * known positive human immunodeficiency virus (hiv) status. * positive hepatitis b or hepatitis c virus. * positive ppd \>5 mm. * chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.

Keywords: vaccines with adalimumab dosing
study of icotinib hydrochloride cream in patients with mild to moderate psoriasis

Conditions: Mild to Moderate Psoriasis

Summary: this is a phase ii study to evaluate the efficacy and safety of icotinib hydrochloride cream in patients with mild to moderate psoriasis.

icotinib hydrochloride is an oral, small-molecule epidermal growth factor receptor (egfr) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (nsclc) in china. over-expressions of egfr and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and tkis have been considered as potential antipsoriatic agents. icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. this is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase ii study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. approximately 260 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: * clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total body surface area (bsa), and affected area on the limb and/or trunk ≥ 1% bsa. the long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively. * in good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs. * men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study. * have signed a written informed consent before entering the study. exclusion criteria: * psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis. * evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * drug-induced psoriasis. * present with or had historical interstitial lung disease. * in the opinion of the investigator, the subjects were not considered appropriate candidates.

Keywords: egfr inhibitor, topical agent, psoriasis, phase 2
comparison of two pulmonary vein ablation techniques for persistent af

Conditions: Chronic Atrial Fibrillation; Persistent Atrial Fibrillation

Summary: investigator initiated, randomized controlled trial of two radiofrequency (rf)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (af). two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation

atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects approximately 2.7 million u.s. adults. percutaneous catheter ablation is an effective treatment option for individuals with persistent af. pulmonary vein isolation (pvi) has emerged as the gold standard for paroxysmal af with excellent success rates, however, individuals with persistent af procedural efficacy from pulmonary vein isolation is not optimal. therefore, improved ablation strategies for these individuals are needed. this randomized controlled trial will compare two radiofrequency ablation strategies, pvi alone and pulmonary vein isolation plus left posterior atrial wall (lpaw) isolation in individuals with persistent af. both strategies are currently used to treat persistent af, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious. two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for af. for group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. for group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall. all subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. if indicated, antiarrhythmic drugs will be discontinued. for the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for af, and then two-week ambulatory monitors at 3 months and one year post ablation.

Eligibility criteria:
inclusion criteria: 1. have symptomatic persistent af (i.e., a sustained episode lasting more than 7 days). 2. refractory to at least one antiarrhythmic agent. 3. undergoing ablation for the first time. exclusion criteria: 1. paroxysmal af 2. sustained atrial fibrillation lasting more than 3 years 3. left atrial diameter of 60 mm or greater

Keywords: persistent atrial fibrillation radiofrequency ablation catheter ablation
a study demonstrating the effect of latanoprost in combination with timolol, latanoprost alone and timolol alone on eye pressure in open angle glaucoma or ocular hypertension in patients

Conditions: Ocular Hypertension; Glaucoma; Open-angle Glaucoma

Summary: the purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (phxa41) has better iop lowering effect than the individual monotherapies.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * patients currently on iop reducing therapy: iop greater than or equal to 25mmhg (two iop determinations at pre-study separated by at least one hour) or patients without iop reducing therapy: iop greater than or equal to 30mmhg (two iop determinations at pre-study separated by at least one hour). exclusion criteria: * history of acute angle closure or closed/barely open anterior chamber angle. * current use of contact lenses. * ocular surgery or argon laser trabeculoplasty (alt) within three months prior to pre-study visit. * ocular inflammation/infection occurring within three months prior to pre-study visit. * hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions. * other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement. * cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (the routines for prescribing topical b-blocking agents will be followed. * bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (the routines for prescribing topical b-blocking agents will be followed). * pregnancy * women of childbearing potential who has not used adequate contraceptive methods during the last three months. * inability to adhere to treatment/visit plan. * have participated in any other clinical study within one month prior to pre-study visit.

Keywords: open-angle glaucoma ocular hypertension glaucoma
safety and antiviral study of ach-126, 443 (beta-l-fd4c) in the treatment of adults with chronic hepatitis b infection.

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine the safety and antiviral hbv activity of ach-126,443 (beta-l-fd4c) in the treatment of subjects of previous achillion-sponsored phase 1 and 2 studies in chronic hepatitis b infection.

evaluation of safety and antiviral activity of the 5mg dose of ach-126,443 for up to three months of treatment in the population described.

Eligibility criteria:
inclusion criteria: * participants in previous phase 1 or 2 trials of ach-126,443 who met entry criteria for previous studies. * adults ? 18 years of age * chronic hbv infection, known to be hbsag positive ? 6 months * plasma hbv dna level ? 100,000 copies/ml prior to initiation of ach-126,443 in an earlier study * plasma hbv dna level that in the medical judgment of the investigator, warrant's antiviral treatment * hiv negative * basic hematologic and chemistry parameters within acceptable limits (defined in protocol) * no need for excluded medications * subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal) exclusion criteria * hiv infection * active hepatitis c co-infection * concurrent systemic antiviral treatment * treatment for hbv infection with lamivudine (3tc) for longer than three (3) months since participation in previous trial of ach-126,443 * previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start * alcohol abuse * pregnancy or breast-feeding * inability to tolerate oral medication * ast\>10.0 times the upper limit of normal * alt\>10.0 times the upper limit of normal * any clinical condition or prior therapy that, in the investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements * use of investigational drug not approved by medical monitor

Keywords: e-antigen positive, treatment naïve chronic hbv infected, lamivudine resistant chronic hepatitis b, achillion
cytokine assay in tears of healthy children and with vernal keratoconjunctivitis: case control study and monitoring of cases at 6 months

Conditions: Vernal Keratoconjunctivitis; Healthy Children

Summary: the ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. it has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. the main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

the ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. it has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. the main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

Eligibility criteria:
inclusion criteria: * childrens between 3 and 18 years * affiliated at system of french social security * signed by the holders of parental authority of the sheet and written consent to participate in this study * first consultation at clermont-ferrand hospital for vernal keratocunjunctivitis exclusion criteria: * subject suffering from acute or chronic eye disease in which the physician investigator resound with the results: uveitis, glaucoma, retinopathy * subject who had undergone eye surgery * subject having an infection the day of collection: ent, digestive, urinary * subject with cancer, mental illness or any other condition in which the physician investigator sound informed consent and / or the results * pregnant subject * subject with contact lenses * subject who judged by the investigating physician not enough cooperating to allow a safe collection

Keywords: vernal keratoconjunctivitis cytokines mediators tears
enhancing inhibition with tdcs in low back pain

Conditions: Low Back Pain

Summary: this cross-over study intends to use consecutive days of active versus sham transcranial direct current stimulation (tdcs) to enhance descending inhibition and look at resulting clinical effects in people with low back pain.


Eligibility criteria:
inclusion criteria: * otherwise healthy men and women * aged 18-60 years * continuous pain (\>3days pain/week) episode lasting at least 3 months, sufficient to limit daily activities * pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at the time of recruitment * able to speak, read and understand english exclusion criteria: * pregnancy * low back pain associated with menstruation * currently seeking active treatment for low back pain * red flags symptoms (i.e. fever, malaise, progressive neurologic deficit, significant trauma, prolonged corticosteroid use or osteoporosis, pain worst at night, urinary or faecal incontinence, or unintended weight loss) * drug addiction defined as the use of cannabis, opioids or other drugs * current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial * current or previous chronic or recurrent pain condition other than low back pain * current regular use of analgesic medication or other medication which may affect the trial * lack of ability to cooperate
pharmacokinetic study of epzicom tablet

Conditions: HIV Infection

Summary: this study was designed to explore the drug levels in the blood in japanese hiv-infected patients taking epzicom tablet at least for 2 weeks prior to administration of the study drug. pharmacokinetics after administration of epzicom tablet will be investigated in a total of 8 subjects.


Eligibility criteria:
inclusion criteria: * a japanese hiv-infected patient who continues to use one epzicom tablet in the morning (00:00 to 12:00) at least for 2 weeks prior to administration of the study drug. * a patient who agrees to abstain from alcohol from 48 hours prior to administration of the study drug until completion of blood sampling for pharmacokinetic analysis. exclusion criteria: * a patient developing aids (patients who developed aids in the past but have no symptoms or findings that may serve as indicators at screening may be eligible for the study.) * a patient with a history of hypersensitivity to the study drug and the ingredients (lamivudine, abacavir sulfate) of the study drug

Keywords: epzicom lamivudine abacavir pharmacokinetics japanese
strength training exercises to minimise late effects of childhood leukaemia or lymphoma among adolescents

Conditions: Cancer

Summary: we aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. based on randomization, they will either 1) commence 16 weeks of training with steel or 2) commence 16 weeks of circuit training. steel training involves exercises for major muscle groups using free weights, body weight, or tailored machines. circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. the training takes place in local centers either with friends or with other participants in the project. before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. the effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (bmi, waist circumference, blood pressure, and blood analysis).

the trial is designed as a national randomised clinical trial. participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either steel or the circuit training programme. a researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. the study will be conducted at aalborg university hospital, rigshospitalet, odense university hospital, and aarhus university hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.

Eligibility criteria:
inclusion criteria: * ten to 19 years of age at the point of inclusion * a minimum of 12 months since the last chemotherapy with no upper limit * ability to understand the physical intervention and general participant advice exclusion criteria: * participation in another research study that includes similar treatment * pregnancy * cardiac arrhythmia during exercise * psychological disorders interfering with treatment * presence of a clinical condition that needs immediate treatment * planned surgeries within the subsequent 12 months that may interfere with performing exercises * any contraindications to performing physical exercise as evaluated by the recruiting medical doctor