Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety study of a booster dose (5th) of diphteria-tetanus-pertussis-polio vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Polio

Summary: an open clinical trial to study the immune response and safety after giving a booster dose (5th dose) of a combination vaccine against diphteria-tetanus-pertussis-polio to healthy adolescents 15-16 years of age. the first three doses were given during the first year of life, according to the norwegian child immunization program. the fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old. in 2006 there was a change in the child immunization program in norway: a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio is given to children 6-7 years old. this study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.


Eligibility criteria:
inclusion criteria: * healthy adolescents who have previously received a dose of a vaccine against diphteria, tetanus, pertussis and polio in a clinical trial in 1998 * written informed consent from the adolescent and one of his/her parents * the family must understand norwegian exclusion criteria: * serious chronic diseases * vaccination against tetanus last 12 months * immunization with a diphteria vaccine component after the study in 1998 * suspected or confirmed immune deficiency * immunological/immunosuppressive treatment * pregnancy * serious reactions to previous immunization with any of the vaccine components * acute fever (axillary temperature ≥ 38°c) at the the of vaccination. (postpone vaccination)

Keywords: diphteria-tetanus-pertussis-polio vaccine booster immunization vaccine effect (diphtheria-tetanus-acellular pertussis-polio) immunity safety
study of ataluren (ptc124) in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmcf) who completed participation in the double-blind study ptc124-gd-009-cf (nct00803205), as assessed by adverse events and laboratory abnormalities. the secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (fev1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram \[ecg\] measurements, vital signs).


Eligibility criteria:
key inclusion criteria: * ability to provide written informed consent (parental/guardian consent and participant assent if less than \[\<\] 18 years of age). * evidence of completed participation in the double-blind study, ptc124-gd-009-cf (study 009). * body weight greater than or equal to (≥) 16 kilograms (kg). * performance of a valid, reproducible spirometry test using the study-specific spirometer during the screening period. * confirmed laboratory values within the central laboratory ranges at screening. * in male and female participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 60-day follow-up period. * willingness and ability to comply with all study procedures and assessments, including scheduled visits, drug administration plan, laboratory tests, and study restrictions. key exclusion criteria: * chronic use of systemic tobramycin within 4 weeks prior to screening. * evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to screening or between screening and randomization. * any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for cf or for cf-related conditions within 4 weeks prior to screening and randomization. * known hypersensitivity to any of the ingredients or excipients of the study drug. * exposure to another investigational drug within 4 weeks prior to screening. * treatment with intravenous antibiotics within 3 weeks prior to screening. * history of solid organ or hematological transplantation. * ongoing immunosuppressive therapy (other than corticosteroids). * positive hepatitis b surface antigen, hepatitis c antibody test or human immunodeficiency virus (hiv) test. * known portal hypertension. * pregnancy or breast-feeding.

Keywords: cystic fibrosis nonsense mutation premature stop codon ptc124 ataluren
ventriculo-arterial coupling in cirrhotics

Conditions: Cirrhosis

Summary: cirrhotic in intensive care unit have a very specific haemodynamic status. cardiovascular abnormalities in advanced liver cirrhosis are characterized by a hyperdynamic circulation featuring increased heart rate and high cardiac output, concomitant with decreased systemic vascular resistance. as liver cirrhosis progresses, cardiac dysfunction, known as cirrhotic cardiomyopathy, is associated with prognosis of these patients. specifically, diastolic dysfunction has been more emphasized for estimating clinical outcome in cirrhotic patients, whereas systolic dysfunction has limited prognostic implications in hepatorenal syndrome patients. however, in most cirrhotic patients, cardiac dysfunction is latent and only manifests under stressful conditions because reduced ventricular contractility in these patients is masked by pronounced arterial vasodilation and increased arterial compliance. therefore, a load-dependent index such as left ventricular ejection fraction is insensitive to detect systolic cardiac impairment in the resting state in cirrhotic patients. hence, a more appropriate index is required to evaluate the integration of the ventricular and arterial systems in cirrhotic cardiovascular disorders. interaction between the left ventricle and the arterial system has been explained on the basis of end-systolic pressure-volume relation. left ventricular end-systolic elastance (ees), as quantified by the ratio of end-systolic pressure to end-systolic volume, is an index of the load-independent ventricular contractile state. given this pressure-volume relationship, effective arterial elastance (ea) can be calculated by the ratio of end-systolic pressure to stroke volume, indicating a net measure of arterial load. the ratio of these values (ea/ees), designated ventriculo-arterial coupling (vac), represents the integrated interaction of the ventricular and arterial systems. we can evaluate it with non-invasive echocardiographic method. we analyse vac among cirrhotic patients admitted in intensive care unit, with non-invasive echographic method thanks to records made from august 2018 to april 2019. hypothesis: vac decrease from the baseline value when mean arterial pressure is improved.


Eligibility criteria:
inclusion criteria: * liver cirrhotic patients (any cause, any level) * with acute decompensation * admitted in intensive care unit in croix rousse hospital, lyon, france * who receive norepinephrine as hemodynamic therapy * blood pressure monitoring thanks to an arterial line (radial, humeral or femoral) * urinary catheter, suprapubic catheter or any comparable device to monitor urine output. * the patient did not object to take part of the study. exclusion criteria: * acute hemorrhage (clinical definition or hemoglobin lower than 70g/l at admission) * patient requiring kidney replacement therapy * patient requiring invasive mechanical ventilation * any pathology that makes non-invasive ventriculo arterial coupling assessment impossible (non-sinus rhythm, severe valvular disease) * patient who objects to take part of the study
xenogenic keratoplasty from porcine cornea

Conditions: Porcine Corneal Xenograph

Summary: acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.

acellular porcine cornea eligibility criteria: 1. fresh porcine cornea, 2. porcine cornea keeping transparent without scar, neovascularization or corneal ulcer, 3. porcine cornea keeping integrative corneal epithelium and endothelium, 4. acellular porcine cornea keeping transparent.

Eligibility criteria:
inclusion criteria: * patients with severe infectious corneal ulcer * the ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment * the infected corneas have risks of penetrating * the depth of ulcers are less than 400um * the bridge of the ulcers is away from corneal limbal more than 1mm * patients aged 18 or older * patients able and willing to sign the informed consent form exclusion criteria: * patients with severe infectious corneal ulcer in stable stage * patients with corneal ulcers after viruses infection, such as herpes simplex virus * patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation * the ulcers are not cover pupil zone and will not result in visional defect in future * the depth of ulcer is less than 50um * patients has history of keratoplasty surgery

Keywords: xenogenic
vagus nerve stimulation in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to examine the short-term effects of vagus nerve stimulation (vns) by auricular stimulation (stimulation of the auricular branch of the vagus nerve which innervates the ear) in rheumatoid arthritis (ra). ra is characterized by a chronic systemic inflammation affecting the joints but also carries an increased risk for extra-articular manifestations as well as other organ manifestations such as cardiovascular disease (cvd), which significantly contributes to morbidity and mortality in this disorder.


Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of ra based on the acr guidelines. disease activity measured as activity score (das-28 crp) will be used 2. none of the exclusion criteria (see below). exclusion criteria: 1. minors (\<18 years of age) and mentally incompetent individuals 2. one or more of the following conditions: immunosuppressive condition (which includes malignancy, chronic alcoholism, diabetes), severe chronic dementia, psychiatric illness with active psychosis, current intravenous or other serious illicit drug use 3. pregnancy 4. terminal status referred for palliative care only 5. homeless status 6. iddm and niddm patients will not be enrolled in this study 7. previous history of ischemic cardiovascular disease including myocardial infarction, unstable angina, and bradytachyarrythmias 8. moderate or severe anemia. hemoglobin levels will be determined at screening. a cut-off level of \< 10 mg/dl in women and \< 11 mg/dl in men is selected. 9. smoking 10. subjects taking concomitant medications potentially affecting autonomic function such as anti-cholinergic medications and beta-blockers.
evaluation of the effectiveness and safety of remote electrocardiographic monitoring in patients with atrial fibrillation following ablation therapy

Conditions: Atrial Fibrillation (AF)

Summary: background: atrial fibrillation (af) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. conventional intermittent ecg monitoring lacks sufficient sensitivity to detect asymptomatic af recurrence effectively. objective: to compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using memo patch 2 after catheter ablation in af patients. the study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring. study population: patients diagnosed with af and treated with catheter ablation. intervention: participants will undergo three sessions of remote ecg monitoring using memo patch 2 and memo link (first session only), spanning approximately one year after catheter ablation. hypothesis: long-term monitoring with memo patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including af, atrial flutter, and atrial tachycardia) following catheter ablation.


Eligibility criteria:
inclusion criteria: * 1. adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial. 2. individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition. 3. individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition. exclusion criteria: * 1. individuals with a history of catheter ablation prior to obtaining informed consent. 2. individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders. 3. individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices. 4. individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial. 5. individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision. 6. pregnant or breastfeeding women.

Keywords: atrial fibrillation circulatory system ekg remote monitoring gateway memo-patch
metabolic responses after 12-week hypocaloric diet supplemented with a cereal-based plant protein biscuit

Conditions: Appetite

Summary: biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. in the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack. at the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Eligibility criteria:
inclusion criteria: * non-diabetic women with overweight/obesity * constant body weight for the last three months before enrollment * standard dietary and physical activity habits exclusion criteria: * pregnancy * lactation * chronic medical illness * use of nutritional supplements * alcohol consumption \>2 drinks per day

Keywords: cereal-based biscuit enriched with plant proteins appetite regulation glycemic control hormone responses
troxacitabine in treating patients with chronic myelogenous leukemia

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.

objectives: i. determine the response rate, in terms of achieving complete hematologic remission, partial hematologic remission, hematologic improvement, partial response, or back to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated with troxacitabine. ii. determine the proportion of patients whose disease returns to chronic phase and remains at that level for at least 3 months when treated with this drug. iii. determine the toxicity profile of this drug in these patients. iv. determine the duration of survival of patients treated with this drug. outline: this is a multicenter study. patients receive troxacitabine iv over 30 minutes on days 1-5. treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 4 weeks until relapse. projected accrual: a maximum of 50 patients will be accrued for this study within 14 months.

Eligibility criteria:
disease characteristics: diagnosis of philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (cml) with blasts of non-lymphoid origin blastic phase defined as: at least 30% blasts in the blood or bone marrow or presence of extramedullary infiltration outside the liver or spleen no leukemic cns involvement patient characteristics: age: 16 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: bilirubin no greater than 2.0 mg/dl ast or alt less than 3 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl or creatinine less than 1.8 mg/dl if creatinine clearance at least 45 ml/min other: no known hypersensitivity to troxacitabine or its analogues no active uncontrolled serious infection no other severe medical condition that would preclude study no neurologic or psychiatric disorders that would preclude informed consent no uncontrolled underlying medical condition or underlying condition that could be aggrevated by treatment not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 24 hours since prior hydroxyurea prior sti571 for blastic phase chronic myelogenous leukemia allowed no other prior chemotherapy for blastic phase disease endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: at least 14 days since prior investigational agents and recovered no other concurrent investigational agents

Keywords: relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic myelogenous leukemia, bcr-abl1 positive
triptolide-containing formulation as treatment for autosomal dominant polycystic kidney disease (adpkd)

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: triptolide was shown in experimental studies to inhibit the cyst formation and growth in adpkd models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric adpkd patients in our clinical practice. it remains to be shown the effect of triptolide-containing formulation on total kidney volume (tkv) enlargement and renal function protection in adpkd patients.

randomized controlled trial

Eligibility criteria:
inclusion criteria: * adpkd patient older then 40 years of age without gender limitation * estimated glomerular filtration rate (egfr) higher than 60 ml/min 1.73m2 * documented kidney volume progression with yearly increasing rate more than 6% * informed consent exclusion criteria: * female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception * impaired liver function as increased liver enzymes (2-fold above normal values) * uncontrolled hypercholesterolemia (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) under lipid lowering therapy * granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3) * hepatitis b or c, hiv infection * malignancy * mental illness that interfere with the patient ability to comply with the protocol * drug or alcohol abuse * known hypersensitivity to similar drugs as triptolide-containing formulation

Keywords: adpkd triptolide
trial assessing efficacy, safety and tolerability of proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibition in paediatric subjects with genetic low-density lipoprotein (ldl) disorders

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: a study to assess safety and efficacy of evolocumab (amg-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

a study to evaluate the effect of 24 weeks of subcutaneous (sc) evolocumab compared with placebo, when added to standard of care, on percent change from baseline in low-density lipoprotein cholesterol (ldl-c) in pediatric subjects 10 to 17 years of age with heterozygous familial hypercholesterolemia (hefh).

Eligibility criteria:
inclusion criteria: * male or female ≥ 10 to ≤ 17 years of age (before 18th birthday) * diagnosis of heterozygous familial hypercholesterolemia * on an approved statin with stable optimized dose for ≥ 4 weeks * other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6 weeks) * fasting ldl-c ≥ 130 mg/dl (3.4 mmol/l) * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: * type 1 diabetes, or type 2 diabetes that is or poorly controlled * uncontrolled hyperthyroidism or hypothyroidism * cholesterylester transfer protein (cetp) inhibitor in the last 12 months, or mipomersen or lomitapide in the last 5 months * previously received evolocumab or any other investigational therapy to inhibit proprotein convertase subtilisin/kexin type 9 (pcsk9). * lipid apheresis within the last 12 weeks prior to screening. * homozygous familial hypercholesterolemia

Keywords: hypercholesterolemia elevated cholesterol high cholesterol heterozygous familial hypercholesterolemia pcsk9 mutations paediatric pediatric childhood familial hypercholesterolemia
ipg replacement study (preference-h)

Conditions: Parkinson Disease

Summary: this post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a medtronic® constant voltage or constant current device to a st jude medical infinity™ or st jude medical brio™ constant current system. as electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.


Eligibility criteria:
inclusion criteria: * subject (and caregiver, if applicable) signed the approved informed consent; * subject is ≥ 18 and ≤ 74 years of age; * subject is bilaterally treated with deep brain stimulation (dbs) in the subthalamic nucleus (stn) using a constant voltage device (i.e. soletra™, itrel™, kinetra™, activapc™ or activarc™ ipg) and is responding satisfactory to cv stimulation in the investigator's opinion; * in the physician's opinion, the subject is a suitable candidate for an ipg replacement with different stimulation paradigm; * subject needs and/or requests an ipg replacement within 12 months after consent and the current ipg has at least 2.6 v output left (i.e. approx. 30% of full battery capacity) at the time of subject enrollment; * pd symptom onset is no longer than 20 years; * subject has a hoehn \& yahr score \<iv (on stim); * subject with a normal cognitive function (mmse ≥25); * subject is fluent speaker (as judged by the investigator) of the language spoken in the country where the investigational site is located. exclusion criteria: * ipg battery has less than 30% battery life at the time of consent; * need to replace or reposition the leads or extensions during the ipg replacement procedure; * subject had \>10 recurrent falls experienced in the 3 months prior to consent; * subject is unwilling to change to either a st jude medical infinity™ or brio™ dbs system for the ipg replacement; * subject is unable to attend the study visits.

Keywords: sjm infinity™ sjm brio™ implantable pulse generator (ipg) replacement sjm-cip-10135 deep brain stimulation (dbs)