cyrilzakka/clinical-trials huggingface dataset:
Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)

Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax in untreated AL amyloidosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proved treatment-naïve AL amyloidosis
* Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
* dFLC \> 50mg/L

Exclusion Criteria:

* Co-morbidity of uncontrolled infection
* Co-morbidity of other active malignancy
* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
* Seropositive for human immunodeficiency virus
* Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
* Seropositive for hepatitis C (except in the setting of a sustained virologic response)
* Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug
* Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 100×10E9/L.
* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), total bilirubin \> 3 × ULN，eGFR \< 15 mL/min, or receiving renal replacement therapy
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.


Eligibility Criteria:
Inclusion Criteria:

* elective lobectomy
* elective segmentectomy
* 20-90 years
* informed consent given

Exclusion Criteria:

* emergency operations
* pneumonectomy
Effects of Remifentanil on Cardiac Function in Patients With Diastolic Dysfunction

In this study ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction will be recruited to assess the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy.

Our aim in this study is to evaluate the effects of Remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy on ASA 1, 2 individuals with grade 1 or 2 diastolic dysfunction. Methods: 30 ASA 1-2 individuals with grade 1 or 2 diastolic dysfunction whose left ventricular ejection fraction is above 50% will be recruited. The patients will be selected among the ones who planned to undergo elective surgery either under general or regional anesthesia.

Patients with atrial fibrillation, atrioventricular block, severe heart valve disease, tachyarrhythmia-bradyarrhythmia, left ventricular ejection fraction \< 50% and regional contraction anomaly, patients with liver, renal dysfunction, patients with lung disease, acute coronary syndrome, body mass index \>30 kg/m2, no oral intake for solid food more than 8 hours will be excluded from the study.

Baseline echocardiographic examination will be performed in the spontaneously breathing subjects right before the surgical procedure and study drug begins. Then remifentanil infusion will be started at a rate to reach target plasma level of 2 ng/mL. A target Controlled Infusion pump will be used to infuse the study drug. Once the target drug concentration is reached, the final echocardiographic examination will be performed.

After recording the baseline heart rate, respiratory rate, noninvasive blood pressure, pulse oximeter, sedation level, the same parameters will be recorded every 5 minutes during the remifentanil infusion period. Once the final echocardiographic evaluation is performed abovementioned parameters will be recorded for the last time.

Statistical analysis: The sample size calculation is made according to an increase or decrease in E/e' (alpha \<0,05; beta= 0,8).

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older ASA 1, 2 adults with first or second degree diastolic dysfunction.

Exclusion Criteria:

* Atrial fibrillation, Atrioventricular block, tachyarrhythmia, bradyarrhythmia, Left ventricular ejection fraction lower than 50%, body mass index \>30 kg/m2, Liver, kidney and lung disease.
Adherence to Lumefantrine-Artemether

This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.


Eligibility Criteria:
Inclusion criteria:

* age \< 5 years of age.
* axillary temperature \>= 37.5oC
* unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
* parent/guardian's informed consent and willingness to participate in the study

Exclusion criteria:

* any evidence of severe or complicated malaria that would require hospitalization for treatment.
* reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
3. 18 kg/m2 ≤ BMI ≤ 28 kg/m2
4. Conform to the ASA Physical Status Classification
5. Women of childbearing age have a negative pregnancy test and are not nursing

Exclusion Criteria:

1. Subjects with a history of myocardial infarction or unstable angina pectoris
2. Subjects with atrioventricular block or cardiac insufficiency
3. Subjects with a history of ischemic stroke or transient ischemic attack
4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
5. Subjects with concurrent painful physical condition that may affect postoperative pain assessment
6. Subjects with myelopathy or spinal disease
7. Subjects with a history of hemorrhoidectomy
8. Abnormal values in the laboratory
9. Subject with a history of substance abuse and drug abuse
10. Subject with refractory hypertension
11. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
12. History of substance abuse, drug use and/or alcohol abuse
13. HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;
14. Participated in clinical trials of other drugs (received experimental drugs)
15. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series

The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.

To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase.

To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of OCD as defined by DSM-5 \[40\]
* a diagnosis of autism defined by DSM-5
* a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS \[14\]
* age between 12 and 17 years
* ability to read and write Swedish
* access to the internet
* a parent that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* psychosis or bipolar disorder, severe eating disorder
* suicidal ideation
* subject not able to read or understand the basics of the ICBT material
* completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
* ongoing psychological treatment for OCD or another anxiety disorder
Relinking Diagnosed but Untreated HCV Patients Back Into Care.

Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.

Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.


Eligibility Criteria:
Inclusion Criteria:

* Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
* ≥18 years

Exclusion Criteria:

* Positive HCV serology with negative HCV RNA
* Previously eradicated patients in UZ Brussel
Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED

Emergency Department Triage Systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. In this prospective, observational study the performance of the 3-level triage system and the National Early Warning Score (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ED. Observational data for this study is gathered as part of GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).


Eligibility Criteria:
Inclusion Criteria:

* "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse

Exclusion Criteria:

• Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.
PL_GNT01_ISR_Grant 53234273

We carry out a prospective non-interventional, longitudinal, observational multicentre registry designed to improve our understanding of the epidemiology of TTR amyloidosis in our country. The main objective of the proposed study is to determine the occurrence of TTR amyloidosis and describe clinical profile of patients in the population of our country.

Demographic information, TTR genotype, medical history, family history of the disease, and transplant history are assessed at baseline. On return visits, signs and symptoms of the disease are evaluated, general examinations are conducted, and laboratory data, measures of neurologic and cardiovascular function, and quality of life are assessed according to the standard of care for patients.

Specific Aims and Hypotheses

Our working hypotheses are:

1. TTR amyloidosis affects patients in the population of our country;
2. there are specific TTR mutations in the population of our country;
3. there is genotype-phenotype relationship in hereditary TTR amyloidosis;
4. there are risk factors for TTR amyloidosis in the population of our country. These hypotheses will be tested in our specific aims. In aim 1. we will describe the occurrence of TTR amyloidosis in the population of our country, including the hereditary and acquired forms of the disease.

In aim 2. we will determine and characterize high frequency TTR mutations in the population of our country.

In aim 3. we will determine a clinical profile of patients and we will try to enhance understanding of the natural history of TTR amyloidosis, including the variability, progression of the disease, and predisposing factors. We will evaluate patients' quality of life.

In aim 4. we will search for genotype-phenotype relationship in hereditary TTR amyloidosis.

In aim 5. we will evaluate effects of liver transplantation and other treatments on disease progression in our patients. We will advance knowledge of the disease to optimize the assessment, treatment and monitoring of patients.

In aim 6. we will formulate novel hypotheses for further prospective studies. We will form a community of medical experts on amyloidosis (cardiologists, neurologist, internal medicine physicians, as well as other specialists) to create in the future national centre of amyloidosis in our country that would offer the highest standard of care and gather clinical data on this rare disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old with confirmed diagnosis of TTR amyloidosis

Exclusion Criteria:

* Refusal to participate in the study. Light-chain amyloidosis.
Drug Interactions Between Silimarine and Darunavir/Ritonavir

This is a clinical trial to characterize drug interactions between silimarine and the protease inhibitor darunavir/ritonavir.

The silimarine is the main component of milk thistle (Sylibum marianum), a medicinal herb which, due to its attributed hepatoprotective properties, is widely used by HIV infected patients

15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a day during four weeks will be enrolled. After their inclusion in the study, patients will receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks
* HIV viral load in plasma \<50 copies / mL
* Absence of acute infections and / or tumors in the three months prior to inclusion.
* Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.

Exclusion Criteria:

* Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction.
* Active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis).
Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.

To avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis.

In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by MRI.

This study will allow

* to determine whether non-invasive tests effectively measure liver fibrosis
* to compare each non-invase test with results of liver biopsy
* to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* alteration of liver function tests (ALT, AST)
* HCV RNA positive

Exclusion Criteria:

* clotting disorder
* ongoing treatment with anti-coagulant or anti-aggregant
* advanced or decompensated cirrhosis (Child-Pugh class C)
* hepatocellular carcinoma
* other cancer
* history of surgery for brain aneurysm
* pace maker or defibrillator
* ocular metal foreign body
Correlation Between Smartphone Addiction and Back Dysfunction and Core Muscle Morphology and Performance in Asymptomatic Young Adults

The purpose of this study is to investigate the association between smartphone addiction and back pain, function, and lumbar stabilizer cross-sectional area and thickness compared with non-addicted teenagers.

Smartphone prolonged use has been suggested as a risk factor for psychological, visual, and musculoskeletal dysfunctions. The musculoskeletal dysfunction may be related to direct contact use with smartphones as in thumb, elbow, and neck pain. Moreover, indirect long use of smartphones may affect thoracic, lumbar, and lower limbs.

COVID-19 pandemic occurred in a time of outstanding scientific progress and global digitalization. Therefore, smartphone usage became a must for human connection, learning, and entertainment, providing psychological and social support. In the meantime, it was observed a significant increase in overuse and addiction, especially in young and teenage females. The addiction is associated with more musculoskeletal abnormalities when compared to non-addict users. Several studies found an association between smartphone usage and back pain, concomitant with a reduction in thoracic extensors activity. This back pain may affect their quality of life and work-related productivity. However, the relationship between back dysfunction and smartphone addiction is still unclear. A few attempts were done to elucidate this relationship. Yet if proven correct, then preventive measures such as recommendations and precautions regarding smartphone use could be distributed to users by the manufacturers. Furthermore, engineering solutions are needed to optimally design smartphones to alter their weight and sizes to minimize potential adverse effects.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranged from 18 years to 30 years.
2. BMI between 19.0-29.9 kg/m2.

Exclusion Criteria:

1- Previous history of spinal trauma or dysfunction. 2 - Any systemic disease that may affect spine such as ankylosing spondylitis and rheumatoid arthritis.

3 - Cognitive or memory impairment in memory or cognitive function.
Zika Case Definition and Surveillance Study

This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the study cohort.

This prospective, multicenter, cohort study will conduct active and passive surveillance for ZVD and determine its prevalence and seroconversion incidence in areas of Latin America experiencing Zika epidemic activity. A description of the occurrence of dengue virus and chikungunya virus infections in the cohort may also be provided as differential diagnosis of ZVD.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 15 to 40 years on the day of inclusion, currently residing in the site zone, and planning to continue to reside in the site zone for the duration of the study
2. For subjects under the age of majority on the day of inclusion: the assent form has been signed and dated by the subject (if required by local regulations), and the informed consent form has been signed and dated by the parent(s) or legal guardian(s).

For subjects at or over the age of majority on the day of inclusion: the informed consent form has been signed and dated.

3) Subject (and parent/guardian if subject is under the age of majority) able to attend all scheduled visits and to comply with all study procedures 4) In good health, based on medical history and physical examination Exclusion Criteria:

1. Subject is pregnant (as self-reported)
2. Participation in the 4 weeks preceding enrollment, or planned participation during the present study period, in a clinical trial investigating a vaccine, drug, medical device, or a medical procedure
3. Receipt of any dengue or yellow fever vaccine in the 4 weeks preceding the day of enrollment or planned receipt of any dengue or yellow fever vaccine during the study period
4. Receipt of immune globulins, blood or blood-derived products in the past 3 months
5. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
6. History of Zika virus disease, confirmed either clinically, serologically, or virologically
7. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
8. Current alcohol abuse or drug addiction
9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
10. Identified as an investigator or an employee of the investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.