cyrilzakka/clinical-trials huggingface dataset:
Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.

Kawasaki disease(KD), the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. Resistance to intravenous immunoglobulin in Kawasaki disease which is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the infusion of intravenous immunoglobulin increases the risk of coronary artery lesions. We will conduct a multicenter, randomized, prospective trial to determine whether the use of infliximab to the children who don't respond to the first dose of IVIG(2g/kg) reduces the risk of coronary artery diseases. The IVIG-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The level of leukocyte (WBC)counts, C-reactive protein, alanine transaminase,interleukin- 1( IL-1), interleukin- 6(IL-6), tumor necrosis factor-a(TNF-a), soluble tumor necrosis factor receptor-1(STNFR-I), soluble tumor necrosis factor receptor-2(STNFR-2), the fever days,and the cost of hospital stay will be analyzed between these two groups.The final outcome is the incidence of coronary artery lesions.

Eligibility Criteria:
Inclusion Criteria:

* (1)Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.(2) Resistance to intravenous immunoglobulin in Kawasaki disease is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the routine primary treatment .(3) the patients aged from 2 months to 12 years old. (4) All included patients required to sign an informed consent form

Exclusion Criteria:

. Exclusion criteria: (1) The patients with severe infections; (2) The patients with a history of tuberculosis or recent close contact with tuberculosis; (3) The patient vaccinated with live vaccine in 6 months; (4)The patients with the application of hormone or other immunosuppressive agents; (5) The patients didn"t want to signed informed consent.
Different Immunosuppressive Treatment in iMN

The primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (iMN)

To date, the first-line immunosuppressive immunosuppressive therapy of iMN includes corticosteroids combined with cyclophosphamide or rituximab (RTX). In recent randomized trials (MENTOR, GEMRITUX), the long-term remission rate of RTX is about 60%, which is similar to the remission rate of cyclophosphamide combined with corticosteroids in early studies. But there is only one published randomized trial (STARMEN) comparing the efficacy of the two protocols head-to-head. In STRAMEN trial, the long-term remission rate of cyclophosphamide+corticosteroids group was 83%, which was significantly higher than the that (58%) of the tacrolimus-RTX group. But in STRAMEN trial, only one single dose of RTX was given which might influence the efficacy of the tacrolimus-RTX arm. Therefore, head-to-head comparison of RTX (more than one dose) and cyclophosphamide+corticosteroid is needed. The optimal dose of RTX in the treatment of iMN is unclear. In MENTOR trial, RTX was given 1g on D1 and D15, and the rate of complete remission at 6 month was 0, so RTX was repeated at 6 month. Based on the experience of our center, most patients need at least one repeated dose of RTX at 6 month.

Based on the previous rationale, the investigators designed this study to compare the efficacy of cyclophosphamide plus corticosteroids with RTX in the treatment of iMN.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic membranous nephropathy
* Female, must be post-menopausal, sterile or have effective contraception
* must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for or RTX\> 6 months
* Angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive therapy or if patients are intolerant to ACEI/ARB.
* proteinuria ≥4g/24h and decreased ≤ 50% from baseline

Exclusion Criteria:

* presence of active infection or a secondary cause of membranous nephropathy
* proteinuria associated with diabetic nephropathy
* pregnancy or breast feeding
* history of resistance to rituximab or alkylating agents or corticosteroid
* Patients who previously achieved remission after treatment of rituximab or alkylating agents but relapsed off rituximab or alkylating agents after 6 months are eligible.
Precoce Medical Care by the Mobil Support for Patients With Glioblastoma

Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life.

This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.

In this context, and despite the lack of impact on overall survival, improving quality of life becomes a priority objective in recent Phase III trials.

The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.

glioblastomas are the most common primary malignant tumours of the central nervous system.They represent about 2000 new cases per year in France.

Despite active treatments including surgery, radiotherapy and chemotherapy, patient survival is limited without possible cure.

Most patients with glioblastoma have impaired cognitive function, autonomy, and quality of life. Exploration of verbal memory in these patients shows that its deterioration is correlated with a more unfavourable prognosis, after adjustment with other usual prognostic factors.

This clinical situation, combined with a limited life expectancy, makes the preservation of quality of life a major objective, in a supportive environment that respects family integration. This is especially true since there is an established relationship between health-related quality of life, as measured by questionnaires.

The feasibility of introducing early accompaniment in GBM should be assessed in the diagnostic and therapeutic announcement environment. In order to measure the expected impact as favorable in the patient and his family, a broad survey of the classic domains of quality of life and more specifically dedicated to neurological symptomatology.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient ( ≥ 18 years),
* Histological diagnosis of Glioblastoma
* Oncology caret at ICM (regardless of treatment: Stupp protocol, chemotherapy alone, targeted therapy, etc.);
* Patient consent signed after informed information.

Exclusion Criteria:

* Patient unable to consent to the study
* Major impairment of the general health : performance status OMS =4;
* Patient not affiliated with a French social security
Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis

Pain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (CP).In pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. In CP, pain occurs in 80-90% of patients and strongly affects quality of life. For both conditions, the majority of pain is addressed using the WHO analgesic ladder. However, more invasive pain therapies are often necessary.

Currently, in several centers in the Netherlands, treatment with IV lidocaine is already used in clinical practice in patients with pancreatic cancer and CP. Based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. Therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and CP.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* NRS score ≥4 despite previous pain treatment with non-opioid analgesics, opioids or TCAs. Or pain treatment with non-opioid analgesics, opioids or TCAs with adequate effect on pain, but unable to reduce the opioids;
* For CP:

  * Diagnosis of CP based on the M-ANNHEIM diagnostic criteria;17
* For pancreatic cancer:

  * Diagnosis of pancreatic cancer (all stages)
  * Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  * Life expectancy ≥ 3 months;
* Consensus of surgeon/gastroenterologist and anesthesiologist for suitability for treatment

Exclusion Criteria:

* Patients with contra-indications for intravenous lidocaine i.e. medical history of non-adequate liver function, hypersensitivity to local anesthetics, New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months, shock, and conduction abnormalities (defined as second and third degree atrioventricular (AV) blocks, or atrial fibrillation);
* Patients who underwent invasive pain therapies: such as endoscopic treatment or surgery for chronic pancreatitis, and splanchnic nerves or coeliac plexus blocks, neurolysis, or PRF for pancreatic cancer.
A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations

To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.

The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.

Eligibility Criteria:
patients receiving tacrolimus for the treatment of lupus nephritis
Assessing Arrhythmias After Ablation Using Implantable Recorders

The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years
* Undergoing ablation for atrial fibrillation at the University of Pennsylvania

Exclusion Criteria:

* Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 18 years to less than 55 years
* Body weight 50kg or greater
* Body mass index (BMI) between 18 and 42.0 kg/m2

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Evidence or history of alcohol or substance abuse
Fluid Biopsy for the Diagnosis of Lung Cancer

This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.

PRIMARY OBJECTIVE:

I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.

SECONDARY OBJECTIVES:

I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.

II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.

OUTLINE:

Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.

After completion of study, patients are followed for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a diagnostic biopsy for possible lung cancer or
* Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
* Planning or completed in the last 2 weeks a CT lung cancer screen
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
A Study of the Effectiveness of Moderna COVID-19 Vaccine

This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC).

The primary objective of this study is to evaluate the vaccine effectiveness (VE) of receipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severe COVID-19 disease.

SARS-CoV-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a COVID-19 diagnosis code. Severe COVID-19 disease will be defined as COVID-19 hospitalization or mortality.

This study utilized electronic healthcare data collected within the Kaiser Permanente Southern California (KPSC) integrated healthcare system which provides care to over 4.6 million individuals. Participants in this study received vaccination and were assessed for study outcomes as part of routine care. Vaccination information and study outcome status was assessed using procedure, diagnostic, and laboratory code information. Medical chart review was conducted to assess the association of severe outcomes (hospitalization and death) with COVID-19 illness.

Analyses assessing absolute vaccine effectiveness will identify participants who receive Moderna COVID vaccine from the KPSC electronic healthcare database and match them to unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination (index date). Vaccinated and unvaccinated participants will then be followed-up in the database for the occurrence of study outcomes. Cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.

Analyses of relative vaccine effectiveness will identify participants who receive specific dose number and formulation of Moderna COVID vaccine (Group N) from the KPSC electronic healthcare database and match them to a group of vaccinated participants with a different dose/formulation type (i.e. Group n-1). Similar matching criteria will be applied. Both groups will be followed for study outcomes and cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after Food and Drug Administration \[FDA\] authorization to vaccinate younger age groups)
* KPSC member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap)

Exclusion Criteria:

* Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the index date
* Receipt of 2 doses of Moderna COVID-19 vaccine \<24 days apart for 2-dose exposed cohort
* Receipt of any COVID-19 vaccine \<14 days after the index date
* No health care utilization and no vaccination from the 2 years prior to the index date through the index date
* Occurrence of a COVID-19 outcome \<14 days after the index date
Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis Pigmentosa

OBJECTIVES:

I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to normalize the level of DHA in red blood cells, and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa.

PROTOCOL OUTLINE: This is a randomized, parallel, double blind study. Patients receive 2 gel capsules per day of either docosahexaenoic acid (DHA) enriched oil or a placebo oil. Oral DHA supplementation continues daily for 3 years.

All patients are followed every 6 months for the 3 year duration of the study.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of X-linked retinitis pigmentosa

Early stage disease Sufficient cone function determined by recordable ERG (30 Hz amplitude; greater than 0.32 microvolts) Visual fields greater than 20 degrees Sufficient rod function (greater than 3.0 microvolts amplitude)

Media clarity sufficient for fundus photography

--Prior/Concurrent Therapy--

No concurrent use of anticoagulant medication

--Patient Characteristics--

* No chronic metabolic disease that may interfere with fatty acid metabolism
* No bleeding of clinical significance
Cell Marker Predictors in Barrett's Esophagus

The purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus.

Patients with a history of Barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* History of Barrett's esophagus; scheduled for routine upper endoscopy

Exclusion Criteria:

* Under 18 years of age
* Unable to consent on own behalf
Permian Health Women's Lung Health Study

The goal of this cross-sectional observational study is to estimate the prevalence of lung function impairment as measured by spirometry in a population of Gambian women aged 15 and older. The main question\[s\] it aims to answer are:

* What is the prevalence of lung function impairment in Gambian women
* What is the prevalence of eosinophilic inflammation in Gambian women

Consenting participants will undergo

* Spirometry
* Fractional exhaled nitric oxide (FENO) testing
* α1-antitrypsin testing in patients with lung function impairment as assessed by spirometry


Eligibility Criteria:
Inclusion criteria:

* Self-identified female sex
* Age \> 15 years: This age cutoff was chosen (as opposed to 18) because of the unique cultural norms and practices in the country where experiences and exposures occur at an earlier age than women in Western countries.

Exclusion criteria:

* Age \< 15 years
* Non-resident household member
* Any acutely unwell individual
* Pregnancy
* Any known history of active pulmonary disease (including TB) on treatment.
* Individuals unable or unwilling to give consent.
Corticosteroid Rhythms in Hypoparathyroid Patients

The investigators hypothesise that parathyroid hormon (PTH) depletion interferes with normal activity of the hypothalamus-pituitary-adrenal (HPA)-axis and the renin-angiotensin-aldosterone-system (RAAS), which in turn may impact morbidity and quality of life. The main objective of the current study is to test if PTH deficiency influences the secretion of corticosteroids and whether any abnormalities in the HPA-axis and the RAAS-system can be reversed by PTH infusion.

Visit 1: Optimizing conventional treatment regarding s-magnesium, s-calcium, s-phosphorous and 25-hydroxyvitamin D (25(OH)D)-levels.

Visit 2 (In-hospital 4-7 days): Day one: 24h microdialysis sampling, venous blood sampling and 24h urine will be collected. Day 2: Start of PTH pump-treatment. Day 3-x: dose adjustment of PTH pump therapy according to Calcium Levels, the first two days after started PTH six daily venous blood-samplings will be performed. Day x: 24h microdialysis sampling and 24h urine-sampling and a venous blood sampling. Restart of conventional treatment.

The Control patients (healthy volunteers and patients with hyperparathyroidism) will perform 24h microdialysis-sampling only.

Eligibility Criteria:
Inclusion Criteria:

* Postsurgical hypoparathyroidism of at least one year duration. Undetectable PTH values (\< 0.3 pmol/l) or less than 1.3 pmol/l despite hypocalcaemia (Reference range PTH: 1.3-6.8 pmol/L) must be documented before inclusion. 25-hydroxyvitamin D (25(OH)D) should be \> 50 nmol/l prior to baseline.
* Healthy male and female volunteers, aged 18-60 years
* Patients with primary hyperparathyroidism, defined as simultaneous increased PTH and serum calcium levels, normal or increased urine calcium to exclude hypocalciuric hypercalcemia, normal kidney function (estimated glomerular filtration rate (eGFR) above 60), aged 18-60 years

Exclusion Criteria:

* Patients with diabetes mellitus, Addison's disease and patients on steroid medication will not be included in this study.
* Other exclusion criteria are unstable cardiovascular disease, active malignant disease, epilepsy, pregnancy or lactation, significant hepatic or kidney disease (alanine aminotransferase (ALAT) and or aspartate aminotransferase (ASAT) \> 2 times upper limit of normal, eGFR \< 30 ml/min), pharmacological treatment with PTH the last 3 months, treatment with other drugs that could interfere with interpretation of the results. Allergy to metacresol, lidocaine or multiple allergies.
The Double Burden of Malnutrition Among Adolescents in Low-income and Middle-income Countries

Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.

We used the most recent Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight. The GSHS is a World Health Organisation (WHO) initiative, designed to assess health behaviours of adolescents through cross-sectional school-based surveys, across several countries using similar standardised procedures. The HSBC study are WHO sponsored cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to examine the physical and mental health of adolescents in the WHO European Region and North America.

Eligibility Criteria:
Inclusion Criteria:

* Low-income or middle-income countries with completed Global School-Based Student Health Survey or Health Behaviour in School-Aged Children surveys.
* Adolescents aged 12-15 years
* Recorded sex, height and weight

Exclusion Criteria:

- High-income countries