cyrilzakka/clinical-trials huggingface dataset:
Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection.

Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.

Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose.

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg).

Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
* Patients with clinical suspicion of disease of PE
* Referral to CTPA diagnosis, treatment planning or follow-up.
* Peripheral venous catheter (PVC) =/\< 18 G

Exclusion Criteria:

* Contraindication to iodinated contrast medium
* Age \< 18 years
* Lack of informed consent
* Pregnancy
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients

This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
* Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
* Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints and hsCRP \>10mg/L

Exclusion Criteria:

* Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
* Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
* Use of high potency opioid analgesics
* Pregnant or nursing (lactating) women
* Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.

Other protocol-defined inclusion/exclusion criteria may apply
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility Criteria:
Inclusion Criteria:

* Obese but otherwise healthy females
* Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
* BMI ≥ 30 and ≤ 45 kg/m2
* Stable body weight during the past 2 months

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of type 1 or type 2 diabetes mellitus
* Current smokers
Conduction System Pacing vs Biventricular Pacing in Systolic Dysfunction and Wide QRS: Mortality, Heart Failure Hospitalization or Cardiac Transplant

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS: mortality, heart failure hospitalization or cardiac transplant (CONSYST-CRT II trial).

Superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.

To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy.

This study will randomize 320 patients to a strategy of biventricular pacing versus conduction system pacing.

CONSYST-CRT II study will analyze a clinical endpoint as primary endpoint and the following parameters in both groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic dyssynchrony (atrioventricular, interventricular, intraventricular) and global longitudinal strain.

As a secondary endpoint, baseline predictors of response to conduction system pacing and biventricular pacing according to cardiac magnetic ressonance and electrocardiographic imaging will be studied.

Clinical, electrocardiographic, echocardiographic follow-up will be performed during 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient must indicate acceptance to participate in the study by signing an informed consent document.
* Patient must be ≥ 18 years of age.
* Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
* Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
* Resynchronization therapy indication for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
* LVEF \<=35% in NYHA class III or IV, atrial fibrillation and intrinsic QRS \>=130 ms, provided a strategy to ensure biventricular capture is in place.

Exclusion Criteria:

* Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
* Pregnancy.
* Participating currently in a clinical investigation that includes an active treatment.
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis

The purpose of this study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and activity of RO7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range of \>= 25 and \<=45 kilograms per square meter (kg/m\^2)
* MASH with fibrosis score of F3 or F4 confirmed by transient elastography measurement \>=12.0 kPa and \<=25.0 kPa
* Agreement to adhere to the contraception requirements

Exclusion Criteria:

* Weight gain or loss \>5% in the 3 months prior to baseline or \>10% in the 6 months prior to baseline
* Bariatric surgery within 1 year prior to baseline
* Current signs or prior history of decompensated liver disease
* Complications or clinical evidence of portal hypertension
* Lack of peripheral venous access
* Other causes of liver disease based on medical history and/or centralized review of liver histology
* History of liver transplantation
* Current or prior history of hepatocellular carcinoma (HCC)
* Uncontrolled hypertension
* Concomitant Type 1 diabetes, or Type 2 diabetes with HbA1c \>10%
* History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening
* Initiation of a medication of an antidiabetic, weight loss, lipid-modifying or anti-depressant drug class
* Active tuberculosis requiring treatment within the 12 months prior to baseline
* History of organ transplant
CRF2 Agonist for the Treatment of Worsening Heart Failure

This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)

This is a phase 2b, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (CRF2) peptide agonist, COR-1167, in subjects with WHF, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (HF) associated with volume overload

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Heart failure hospitalization (HFH) during previous 12 months
* Prescribed an oral loop diuretic for at least 1 month preceding the index event
* NT-proBNP ≥1,000 pg/mL or BNP ≥250 pg/mL
* Requires treatment with i.v. diuretics for volume overload
* At least 1 risk factor for diuretic resistance
* Admitted to the hospital not more than 48 hours prior to randomization

Exclusion Criteria:

* Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia)
* Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV
* Requirement for, or planned use of LVADs, IABP, or any type of MCS
* History of solid organ transplant or active on a transplant list
* SBP \<100 mmHg
* eGFR \< 20 mL/min/1.73 m2
* CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study
* Severe stenotic cardiac valvular disease
* Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (\> 2 L/min)
* Uncorrected severe hyperthyroidism or hypothyroidism
* Severe restrictive, obstructive, or infiltrative cardiomyopathy
* Body weight \< 70 kg
* Use of any investigational drug(s) within 5 half-lives of screening
* At high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the Investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult
* Presence of any other conditions (e.g. geographic, social) actual or anticipated, that the Investigator feels would restrict or limit the subject's participation or compliance with all study procedures Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
Calcium and Lipid Metabolism

We hope to determine if supplementing the diet of women who habitually consume low levels of calcium, with 1500 mg of calcium a day for three months will increase fat oxidation and decrease fat storage. We will also measure concentrations of lipids, glucose, hormones and enzymes associated with fat and carbohydrate metabolism to determine alterations and mechanism of the metabolic changes.

The incidence of obesity has rapidly increased in recent years and reached epidemic proportions in the United States. Recent epidemiological data has shown an inverse relationship between calcium intake and body fat and emerging research suggests that inadequate dietary calcium consumption may increase obesity. Studies in mice have shown that an increase in dietary calcium consumption creates a shift in the utilization of energy stores from carbohydrates to fat and a shift in the partitioning of energy from storage (as fat) to expenditure (as heat).

We will give 1500 mg of calcium a day for three months to women who habitually consume low levels of dietary calcium. The following measurements will be made before and after calcium supplementation: body fat by DEXA, lipolysis by infusion of stable isotopes of 1,1,2,3,3-\[2H5\] glycerol , hepatic glucose production by infusion of stable isotopes of 6,6-\[2H2\] glucose, lipogenesis by measurement of fatty acid synthase activity (14C radiochemical assay) , mRNA expression ( Real Time Polymerase Chain Reaction) and protein content (ELISA), indirect calorimetry measurement of non-protein respiratory quotient (NPRQ), energy expenditure, fat and carbohydrate oxidation. Serum calcium, glucose, cholesterol, triglycerides, LDL, HDL, parathyroid hormone, leptin, free fatty acids, adiponectin, 1,25(OH)2D, 25(OH)D and urinary calcium excretion will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 30 kg/m2
* Taking oral contraceptives
* Having regular menses

Exclusion Criteria:

* Pregnant
* History of metabolic bone, renal or thyroid disease,
* History of diabetes mellitus, or gestational diabetes mellitus
* Cigarette smoking
* Self-administration of calcium supplements
* Regular aerobic activity, i.e. jogging \> 1 mile/day
B-vitamins Treatment for Improvement of Cognitive Function

Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.

We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.

Eligibility Criteria:
Inclusion Criteria:

* age \> 65 years and glomerular filtration rate (GFR) \> 35 ml/min

Exclusion Criteria:

* acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
* furthermore, people who had dementia (mini-mental state-examination scores MMSE \< 15)
* those treated with B-vitamins
* those with renal insufficiency
* those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate
Chronic Sucrose Intake, Markers of Health and Biomarker Identification

With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome.

Excessive free sugar intake is of concern within the general public, as intakes have been associated with weight gain and cardiovascular disease. Average intakes are over double that of the 5% of total energy intake that is recommended by the Science Advisory Committee on Nutrition, but intakes are calculated from observational measures that lack sensitivity and discovery and validation of a new biomarker from biological fluids may allow for more specific measurement and a better understanding of intake:disease relationships. Furthermore, understanding the biochemistry of sucrose intake will allow the identification of damage occurrence and alternative metabolic pathways, as well as novel protein damage that occur with chronic sucrose exposure.

This study aims to identify a biomarker of chronic sucrose consumption using metabolite profiling technology. The study will be composed of a randomised controlled intervention trial, in which participants will be required to consume an amount of sucrose (0-120g/d) every day for 7 days and provide biofluid samples (urine and blood) before the initiation, during and following the intervention; that will undergo metabolic analysis. Furthermore, participants will have their anthropometrics and dietary intake monitored throughout the study. The biomarker will also be validated against the dietary information and correlated with indices of health and sucrose-induced damage. The investigators will also monitor the feasibility and acceptability of chronic sucrose intake during the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-64, healthy diagnosis

Exclusion Criteria:

* gastrointestinal issues, doesn't consume sugar
Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)

The aim of this study is to confirm or rule out the residual presence and viability of SARS- CoV-2 in the respiratory tract and lung parenchyma of patients previously infected with SARS-CoV-2.

Presence and viability of SARS-CoV-2 in lung tissue will be assessed with reverse transcriptase-polymerase chain reaction (PCR) and viral culture. The histological location of residual SARS-CoV-2 will be determined with fluorescence immunohistochemistry and single molecule fluorescence in situ hybridization, targeting viral proteins and RNA respectively.

The investigators will collect residuary lung tissue after medically indicated pulmonary resections at the Thoracic Surgery Department of University Hospitals Leuven. More specifically the investigators will collect lung tissue from patients that had earlier PCR proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies.

Furthermore, for negative control of the methodology the investigators will also collect lung tissue from patients that have no signs for earlier SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires medically indicated pulmonary resection
* Informed consent

Exclusion Criteria:

* Active SARS-CoV-2 infection/COVID-19
* No informed consent
Hair Regrowth After Bicoronal Incision

Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. However, many factors may be confounders such as wound tension and cauterizing the incision. This study will investigate the effect a bevelled incision has on hair growth preservation compared to a standard incision that incises the skin perpendicular to its surface irrespective of hair follicle angles. Following informed voluntary consent, subjects who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right side of this bilateral incision will be randomized to receive either a bevelled or a standard incision and the left side will receive the opposite type. During routine surgical follow-up the hair growth within the scar of the two sides will be recorded for comparison and it is our hypothesis that the side with the bevelled incision will have more hair within the scar.


Eligibility Criteria:
Inclusion Criteria:

* Bicoronal Incision required as part of surgical plan
* Incision within hair-bearing scalp

Exclusion Criteria:

* Previous Bicoronal Incision
* Unfit for Surgery
* Unable to provide informed consent
* Unable to comply with followup
* Preexisting alopecia of scalp
* Cutaneous malignancy of scalp
Train-of-four Monitoring Using the Tetragraph

This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients requiring anesthetic care and use of neuromuscular blockade
* Weight range of 20 - 60 kg

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for TOF monitoring
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients
Prevention of Insomnia Using a Stepped Care Model in Adults

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population.

Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.

This interventional study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial. A total of 18 districts will be included in the study and the randomization will be carried out based on the districts. The stepped-care CBT-I intervention will be sequentially rolled out to the 4-6 districts per step according to a computer-generated random number while the remaining clusters will continue to stay unexposed to the CBT-I intervention over the control period. Therefore after 4-step exposure, all clusters will receive the stepped-care CBT-I intervention. A total of 3 follow-up assessments (post intervention, 3-month and 12-month follow up) will be conducted to assess the effectiveness and long-term effects of the stepped care model.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese adults aged 18-70 years old,
2. The score of Insomnia Severity Index \< 10.

Exclusion Criteria:

1. present with psychotic disorders such as bipolar disorder and schizophrenia,
2. present with severe depression or suicidal ideation,
3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
4. unable to provide consent
Optimization of a Tool for Predicting Postoperative Clinical Evolution After Lumbar Surgery

The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Eligible for lumbar decompression surgery, instrumented or not
* Social insured
* Having given consent
* Eligible for the acts described in Protocole

Exclusion Criteria:

* Minor
* Pregnant or breastfeeding woman
* Safeguard measure or guardianship
* Arthrodesis on more than 2 levels
* Interventions linked to a traumatic or infectious context are excluded