cyrilzakka/clinical-trials huggingface dataset:
Spartan FRX Project Reproducibility Study

The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 \*2, \*3 and \*17 genotypes from genomic DNA obtained from buccal swab samples. The objective of the study is to evaluate the performance of the FRX System under multivariate conditions including different days, sites, operators and systems.

The FRX system is comprised of hardware and consumable components. The hardware components of the system include an Analyzer (thermal cycler with fluorescence detection capability), a notebook computer and a printer. The consumable component of the FRX system is a sample collection kit. Each kit contains a buccal swab (used to collect the patient sample) and a tube containing the reagents required for genomic DNA extraction and PCR (polymerase chain reaction) amplification stages of the test.

The Spartan FRX System is capable of detecting three CYP2C19 SNPs(single nucleotide polymorphism) (\*2, \*3, \*17) in each test performed. An individual sample collection kit is required for each SNP tested; therefore three sample collection kits are required for each test performed on the system.

To perform a test, the user collects three buccal samples from the patient and then inserts a sample into each of the three reagent tubes (one for each of the CYP2C19 loci \*2, \*3 and \*17). The reagent tubes are placed into the Analyzer and the FRX system automates the processes of DNA extraction, PCR amplification, fluorescent signal detection and data analysis. The system provides the user with a printed result listing the patient genotypes at the \*2, \*3 and \*17 loci.

The objective of the study is to evaluate the performance of the FRX System under multivariate conditions. Specifically, the following variables will be included in the study:

* Test site - x3
* Operator - x6 (2 per site)
* Day - x15 (5 non-consecutive days per site)
* FRX System - x16

Test performance is defined as the number of correct genotype calls, expressed as a percentage of the total number of tests performed on the system.

For both the first-pass and second-pass results, 1-sided 95% confidence lower limits will be calculated using the score method for the % correct calls (i.e. % agreement).

Genotype results from the FRX system will be compared with results of DNA sequencing. The result of the FRX System test will be determined to be correct if the genotype calls for all three SNPs are identical to the genotypes determined by DNA sequencing for that sample/individual.

Results of the Reproducibility Study will be acceptable if the lower bound of a 1-sided 95% confidence limit of the total correct call rate per genotype is greater than or equal to 95%, based on second-pass results.

Eligibility Criteria:
Inclusion Criteria:

* Above 16 years of age
* Must have required genotype

Exclusion Criteria:

* None
IMAGE-Endocarditis: Resonance Magnetic Imaging at the Acute Phase of Endocarditis

Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

Patients with definite or possible infective endocarditis are included in this protocol, at the acute phase of the disease.

Resonance magnetic imaging (head and abdomen) will be performed systematically before Day 7.

The impact on the diagnosis and therapeutic options will be assessed, as compared to pre resonance magnetic nuclear (RMN) imaging declaration.

Eligibility Criteria:
Inclusion Criteria:

* Acute phase of infective endocarditis

Exclusion Criteria:

* Contra indication to RMN
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
* Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
* Stable asthma

Exclusion Criteria:

* Asthma exacerbation during screening
* Known malignancy
* Known immunodeficiency
* Pre-existing lung disease other than asthma
* Uncontrolled clinically significant medical disease
* Current smoker
* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
* Prior allergic reaction to a monoclonal antibody
* Patients (men and women) of reproductive potential who are not willing to use contraception
* Pregnancy
Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation

By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Liver Transplantation
* 18 years old or older

Exclusion Criteria:

* None
Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine

This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects

It is a non-randomized, open label study to evaluate a licensed OrniFlu® inactivated vaccine (produced by Microgen Russia) which will be given to healthy adult volunteers who participated in a double blind placebo-controlled study Protocol No.: GPO AVIAN FLU Vaccine-V02-2 at Vaccine Trial Centre and Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University in February to May 2013.

A total of 60 subjects, of whom 40 received two doses of LAIV H5N2 (prime-boost group), and 20 received placebo (control group) in the previous study will be asked to return to the clinic to receive a single dose of an inactivated H5 influenza vaccine.

Total foloww up is 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the Phase II study Protocol No.: GPO AVIAN FLU Vaccine-V02-2
* Healthy
* Age 18-49 years old
* Having Thai ID card or equivalent
* Anti HIV - Negative
* All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
* Able to read and write and sign written informed consent.

Exclusion Criteria:

* Known history of egg allergy
* Having had recently influenza infection confirmed as H5
* Receiving other vaccination against H5N1
* History of bronchial asthma
* History of chronic lung diseases
* History of chronic rhinitis
* History of immunodeficiency state
* History of immunosuppression\< 6 months prior to immunization
* History of heavy smoking (more than 5 packs per day)
* History of alcoholic (pure drink 200 ml per day)
* Acute infectious and noninfectious diseases (within 2 weeks)
* HIV positives
* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
* Participation in other research study or stop participant less than 1 month
* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
* Poultry workers
Efficacy of a Spirulina Supplement for Amelioration of Benign ThYroid Nodules

Clinical trial with a double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo. Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient. It is expected that a decrease in the thyroid nodules occurs with the supplement administration. Compared with placebo there will be a decrease of at least 20% in the volume or the largest diameter of the nodules during the 6-week administration of the supplement.

Clinical trial with double-blind, placebo-controlled, crossover design; enrolls approximately 30 euthyroid patients with benign thyroid nodules, who will receive for 6 weeks a spirulina-based supplement, and for another 6 weeks placebo.

* The sequence of administration supplement - placebo is unknown to the doctor or the patients
* The supplement and placebo are placed in identical capsules and vials by DVR Pharm
* The respective capsules are administered twice a day Thyroid ecography will be performed three times for each patient, and blood tests including TSH, free T4, free T3 and ceruloplasmin/Copper will also be performed 3 times for each patient.
* Echography and blood tests will be performed for each patient initially, after 6 weeks, and after 12 weeks It is expected that a decrease in the thyroid nodules occurs with the supplement administration.
* there will be a direct comparison of the nodules dimensions on the ecographic examinations, in millimeters, and of the blood levels of the molecules which reflect thyroid function

Eligibility Criteria:
Inclusion Criteria:

* euthyroid adults (normal TSH)
* no criteria for malignancy is present (size, fine needle aspiration, lymph nodules)
* no other medication/supplement administered for thyroid, no steroids, beta-blocker

Exclusion Criteria:

* suspicion of malignancy / shown
* autoimmune disease
* abnormal thyroid function
* Wilson disease
* contraception with intrauterine device
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents

Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.

The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.

As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis for rare epilepsy (based on ORPHA codes)
* holders of parental authority not opposed
* Be followed in one of the declared centers of the study

Exclusion Criteria:

* opposition from the holders of parental authority or the patient
INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.

Prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (MDI) and HbA1c\> 7%. Patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI), treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R), quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.


Eligibility Criteria:
Inclusion Criteria:

* Patients with DM1 plus 1 year of evolution.
* Age ≥18 and \<65 years.
* HbA1c prior to study inclusion\> 7%.
* MDI intensive insulin therapy in basal-bolus regimen.
* Patients candidates for telemonitoring. Approximately 50% of the patients should work with phone or tablet with Android operating system with active data rate to use wireless solution (bluetooth) OnLine MenaDiab® telemedicine. The remaining patients will work with the USB cable solution telemedicine MenaDiab® OnLine.
* Patients who have given written informed consent.

Exclusion Criteria:

* Treatment with ISCI.
* Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled).
* Pregnant or planning pregnancy.
* Diabetes mellitus type 2.
* Severe psychological disorders.
* Lack of cooperation (informed consent).
* Patients who are participating in other clinical studies.
Growth Mindset Intervention for Older Adults With Chronic Disease

This study was conducted to develop and investigate the effectiveness of a growth mindset intervention based on growth mindset theory.

The study employed a quasi-randomized controlled trial design conducted over 12 weeks. Before conducting the study, the researchers numbered the wards of internal medicine departments (excluding intensive care units) according to the order of bed number. The wards were then randomly divided into intervention wards and control wards using a random number generator. Patients were recruited to the control group (e-health only) in the control ward and the intervention group (growth mindset intervention+ e-health) in the intervention unit. Participants in the control group could undergo the training after the study concluded.

Eligibility Criteria:
Inclusion Criteria:

* aged≥60 years
* diagnosed≥1 chronic disease
* owned at least one smartphone
* could communicate clearly in writing or orally
* were willing to participate in this study

Exclusion Criteria:

* could not use WeChat or phone to communicate
* diagnosed as mental illness or cognitive impairment
* suffered from acute severe disease or lost self-care ability
* undergoing other similar training
An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma

This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age at diagnosis
* Histologically confirmed new diagnosis of unresectable or metastatic melanoma
* Patients with tumor samples available for assessment of BRAF V600 mutation

Exclusion Criteria:

* Prior systemic therapy for metastatic disease
* Participation in interventional clinical trials
Effects of Modafinil, Caffeine and Methylphenidate in Healthy Volunteers

In this study the investigators compare three stimulants to each other. The effects of these agents on cognitive performance (eg, attention and memory) and on the brain are being measured. The hypothesis is that stimulants will have a positive effect on cognitive performance.

Each study participant will receive once a placebo and once methylphenidate or modafinil or caffeine. Methylphenidate (also known as Ritalin ®) is a drug that is used in the treatment of attention deficit / hyperactivity disorder (ADHD) in children, adolescents and adults. Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness). In the study. These substances are given in the study only once and in the dosages in which is also used for the treatment of the above diseases. In the case of caffeine , the dosage corresponds to two cups of coffee.


Eligibility Criteria:
Inclusion Criteria:

* Men
* 18 - 35 years
* Written consent (according to Arzneimittelgesetz (AMG) § 40 (1) 3b)
* Good knowledge of German
* Right-handedness

Exclusion Criteria:

* Known hypersensitivity to the study medication
* All contraindications to the study medication: arrhythmia, hyperthyroidism , glaucoma , pheochromocytoma , congestive heart failure , diabetes mellitus, known liver and kidney dysfunction, vascular disease , angina, haemodynamically significant congenital heart disease , cardiomyopathy , myocardial infarction, channelopathies, arterial hypertension , cerebrovascular diseases , such as cerebral aneurysm , vascular abnormalities , including vasculitis and stroke.
* Participation in other clinical trials during or within one month prior to this clinical trial
* Medical or psychological circumstances that may endanger the proper conduct of the trial
* Existing serious somatic diseases, even if they are not covered by the contraindications according to product information
* Existing psychiatric disorders and psychiatric disorders in prehistory
* Smoker or ex-smoker for less than 5 years
* Regular caffeine consumption \> 4 cups per day
* Subjects with irregular day -night rhythm (eg shift workers )
* Unwillingness to the storage and disclosure of pseudonymous data as part of the clinical trial
* Accommodation in an institution by court or administrative order (according to AMG § 40 (1) 4 )
* MRI contraindications ( eg pacemakers , metallic or electronic implants , metallic splinters , tinnitus, surgical clips )
Rate of Infection After Using Antibiotic Loaded Cement and Regular Cement in Total Knee Arthroplasty

Our study will be a prospective study To compare between the rate of infection after using antibiotic loaded cement and regular cement after total knee arthroplasty in primary knee osteoarthritis.this will be at assiut university trauma hospital .There are 2 groups ,first group is patients will be treated with regular bone cement ,the second one is patient will be treated with antibiotic loaded bone cement, commonly used antibiotics includeGentamycin powder.

Total Joint arthroplasty (TJA) is among the major and most successful orthopedic surgeries . It is indicated when there is impaired joint function that requires prosthesis replacement .Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are the most replaced joints . TKA is becoming more common over the world, with 5 million degenerative knee joint replacement procedures projected by 2030 .

Although perioperative antimicrobial procedures have improved significantly, periprosthetic joint infection (PJI) following TKA remains a serious complication for patients and a significant burden on the healthcare system . PJI is a leading cause of TKA revision surgery, accounting for more than 15% of all revisions.that can cause a long hospital stay, increase the risk of readmission, and lead to poor patient outcomes, such as decreased function and a lower quality of life. In the worst case, PJI can lead to amputation or even death .

Antibiotic-loaded bone cement (ALBC) has been recommended to reduce the risk of PJI. The aim of such a strategy is to promptly release antibiotics at the action site with very little systemic exposure, which may not be achieved by systemic antibiotics due to insufficient blood supply (1) but in the literature, it is uncertain whether ALBC or plain bone cement (PBC) should be used in PTKA. ALBC has been shown to decrease significant complications, although it has the disadvantage of diminishing cement strength. A meta-analysis published in 2015 discovered no statistically significant difference in the incidence of PJI in patients receiving two cement materials during PTKA , another meta-analysis was done in 2022 demonstrated that the preventive application of ALBC during PTKA could reduce the rates of deep PJI, However, the existing related articles are mostly single-center and retrospective studies, and further high-quality ones are needed for confirmation ,so we will conduct our study to compare between ALBC and PBC in TKA infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient with primary knee osteoarthritis.
* Patient underwent total knee arthroplasty.

Exclusion Criteria:

* Patient with rheumatoid knee osteoarthritis.
* Patient with post-traumatic knee osteoarthritis.
* Patient with knee tumor.
* Patient has allergy to antibiotics used in the study.
* Patient with any operative procedure in the knee.
Suicidal Behavior in Patients Diagnosed with Bipolar Disorder

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.

The purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients with Bipolar Disorder. Additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program. Groups will include topics such as interpersonal/social rhythm and mindfulness interventions, as well as interventions focused on understanding and changing thoughts to better cope with Bipolar Depression.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Diagnosis of Bipolar Disorder (BD)
* Able to provide written informed consent

Exclusion Criteria:

* Cognitive impairments
* Acutely psychotic
* Medically unstable
* History of schizophrenia spectrum disorder
* History of mood incongruent psychotic symptoms
* History of primary substance disorder
* History of primary organic disease and/or dementia