cyrilzakka/clinical-trials huggingface dataset:
Contrast RISK (Reducing Injury Sustained by Kidneys)

Diagnostic and therapeutic cardiac catheterization procedures are important interventions to reduce the risk of death, avoid future cardiovascular events, and improve quality of life of people with heart disease. However, exposure to the radiocontrast dyes required for these procedures can lead to contrast-induced acute kidney injury (CI-AKI); a common and costly complication. There are accurate ways to identify patients at increased risk of this complication and strategies to prevent CI-AKI. This involves ensuring that patients who are at risk have procedures done with the minimum amount of X-ray contrast dye required, and that they receive optimal intravenous fluids at the time of the procedure.

This study will evaluate the implementation of a strategy where computerized decision support tools are used to help doctors identify patients at risk of CI-AKI, as well as make decisions about how much contrast dye to use and how much intravenous fluid to provide to patients who are identified at risk of CI-AKI in cardiac catheterization.

Overview: Randomized stepped-wedge trial to evaluate the impact of implementing a computerized decision support strategy that incorporates CI-AKI risk prediction and calculation of safe contrast dye limits and intravenous fluid recommendations.

Study Population: Adult patients undergoing diagnostic or interventional coronary angiography procedures will be eligible if not already receiving dialysis. Patients receiving emergency primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction will be excluded.

Intervention: Multivariable clinical risk prediction model to estimate risk of CI-AKI and safe contrast limits for patients above the median (\>5%) predicted risk of CI-AKI. Intravenous fluids recommendations based on weight and left-ventricular end-diastolic pressure will also be provided for patients identified above the median risk of CI-AKI.

The National Cardiovascular Data Registry (NCDR) Cath-PCI Registry AKI risk model will be used to estimated the predicted risk of CI-AKI, and safe contrast limits will be estimated using the ePRISM, Acute Kidney Injury Model with Contrast Sensitivities and Dialysis Risk (Health Outcomes Sciences) software, incorporated within the Alberta Provincial Project for Outcomes Assessment in Coronary Heart Disease (APPROACH) Cardiac Catheterization software.

Study Design: Using a stepped-wedge design, clusters of cardiologists who perform diagnostic or therapeutic cardiac catheterization in each centre will be randomized to be introduced to the intervention at sequential time points spaced over 20 months. At each step, cardiologists who have not yet been randomized will serve as controls.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing diagnostic coronary angiography or coronary intervention in Alberta

Exclusion Criteria:

* Emergency primary percutaneous coronary intervention for ST-elevation myocardial infarction
* Receiving dialysis at time of cardiac catheterization procedure
* Non-Alberta resident
Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.

This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.

Eligibility Criteria:
Inclusion Criteria:

1. At \<16 weeks of gestation, normal NT scan
2. At least 1 high risk factor or at least 2 moderate risk factors
3. Intend to receive prenatal examination and deliver in this institution
4. Signed a written informed consent for participation in the study

Exclusion Criteria:

1. Aspirin initiated after 16 week
2. Intolerant or allergic to aspirin
3. Aspirin adherence was \<80%
4. Miscarriage or termination of pregnancy before randomization
5. drop out (do not return to the hospital for delivery).
6. Lost to follow-up
MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery
* Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery.
* Case meets the International Consensus Meeting criteria for infection
* Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable

Exclusion Criteria:

* Unable or unwilling to undergo either treatment
* Lacking capacity to consent to research
* Refusal to consent to study for any reason
* Re-revision of prosthetic knee infection if first revision was for infection
* Presence of tuberculosis infection
Immune Resistance Interrogation Study

This is a prospective research study which will include patients who have progressed on immunotherapy as their most recent line of therapy. This study aims to characterize whether patients who fail to respond to immunotherapy versus patients who respond initially but after a period of time progress demonstrate different genomic, transcriptomic, epigenetic, immunophenotyping profiles. Patients will have a one-time fresh tumor biopsy. Serial blood samples (total amount of blood drawn may not exceed the lesser of 50 mL or 3 mL/kg in an 8 week period), archival tissue (if available) and one stool sample will be collected.

Although there has been some success with the use of immunotherapy treatments specifically antibodies that block the programmed death 1 receptor (PD1/L1), the majority of cancer patients either fail to respond (primary resistance) or respond initially but progress after a period of time (acquired resistance) when treated with immunotherapy agents. The hypothesis being tested is whether patients who have primary versus acquired resistance to immunotherapy demonstrate different genomic, transcriptomic, immunophenotypic and/or epigenetic profiles.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histological or cytological diagnosis of solid malignancies, with at least one tumor lesion amenable to core needle biopsy and consent to such a procedure.
* Patients must have progressed on immunotherapy (defined as anti-PD1/PD-L1 antibodies given as monotherapy or as part of a combination therapy) as their most recent line of therapy. Patients will be classified into two groups: 1) those who benefitted from immunotherapy with either complete response (CR), partial response (PR) or prolonged stable disease (SD) lasting at least 6 months with subsequent progression or who had disease progression after at least 12 weeks from the last dose of immunotherapy in the adjuvant setting (i.e. acquired resistance), 2) those whose disease is primary refractory to immunotherapy with disease progression at their first on-treatment imaging, those who benefitted from immunotherapy with stable disease (SD) but progressed in \<6 months or those that had progressive disease earlier than 12 weeks from the last dose of immunotherapy in the adjuvant setting.
* Patients must be of good performance status, ECOG 0-1, for subsequent anticancer therapy, with either standard treatment or within the context of a clinical trial.
* Patients must be ≥ 18 years old.
* Patients must have provided voluntary written informed consent.

Exclusion Criteria:

* Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
* Any contraindication to undergoing venipuncture.
* Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimens and interpretation of study results.
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students

This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.

Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.

Eligibility Criteria:
Inclusion Criteria:

* (1) is a registered student at a participating school, (2) self-reports body image concerns

Exclusion Criteria:

* meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
Human Internal BIOASTER's Samples Collection

BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics.

Hibiscus is a non-interventional, monocentric study aimed at building up a a collection of biological samples (stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair) collected from BIOASTER employees. These samples to be used for scientific purposes including the technological development of Bioaster s collaborative and in-house research projects.


Eligibility Criteria:
Inclusion Criteria:

Some inclusion criteria can be defined according to the needs of the scientific objective. For example, it is up to volunteers to decide whether or not to participate if they meet the following criteria:

* Age criteria (e.g.: specific, non-identifying range sought: 30-40 years)
* BMI criteria (for example: BMI between 18.5 and 29 kg/m2)
* Gender criteria (e.g.: women only)

Exclusion Criteria:

Some of the following non-inclusion criteria may be defined according to the needs of the project:

* Minor subject
* Health criteria (e.g. presence or absence illness/infection/vaccination/allergy/anti-infective treatment in the last 3 months prior to the date of sampling)
* Smoker status
* Severe chronic illness (active cancer, HIV, severe renal failure, ongoing severe heart, liver or biliary disorders, arthritis)
* Diagnosed acute or chronic gastrointestinal disease or complication (e.g. celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn\&#39;s disease, hemorrhoids, irritable bowel syndrome),

In all cases, it will be requested that volunteers with the following criteria do not participate in the study:

* Pregnant or breast-feeding women
* Subjects under curatorship or guardianship
* Subjects under legal protection.
EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US.

Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are \>22; inclusive of males and females.
2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
3. Imaging suggestive of greater than or equal to 30% necrotic material
4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm
5. Subject can tolerate repeated endoscopic procedures
6. Subject capable of giving informed consent.
7. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.

Exclusion Criteria:

1. Subject unable to give informed consent.
2. Subject is unwilling to return for repeated endoscopies.
3. Documented Pseudoaneurysm \> 1cm within the WOPN
4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
6. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
7. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
8. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
ROM Outcomes in Patients Undergoing a Primary TKA

The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary TKA after photographing final knee range of motion immediately post-operatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph.

The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary total knee arthroplasty (TKA) after photographing final knee range of motion immediately postoperatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph. The knee will be photographed in maximum flexion and extension. The primary objectives will be to compare the range of motion of the operative knee at 2 weeks and 6 weeks postoperatively. In the investigator's institution, patients who have failed to achieve 90 degrees of flexion at a postoperative period of 6 weeks undergo manipulation of the knee under anesthesia (MUA). The investigators will also measure how many patients require MUA in the photograph group and non-photograph group. MUA will be performed if patients fail to achieve 90 degrees of flexion at 6 weeks post-op.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is between the age of 22-89
2. Patient is scheduled to undergo a unilateral, cementless primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 22 or over the age of 89
2. Patient has preoperative stiffness/contracture of the knee secondary to post-traumatic arthritis
3. Patient is scheduled to undergo a bilateral TKA surgery
4. Patient is unable to read and speak English
A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia

The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).

Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.
A Study Into the Future Cardiovascular Disease (CVD) Risk of Phenylketonuria (PKU) Patients on a Low Phenylalanine Treatment Diet (LPD).

This study will assess the cardiovascular disease (CVD) risk in Phenylketonuria (PKU) patients on a low-phenylalanine diet (LPD).

Ultrasound tests, diet information and routine blood samples will be collected once per patient at their next outpatient appointment.

32 adults with PKU will be studied and compared to reference data for healthy people. The results will show if the PKU CVD risk differs from healthy people, and if CVD risk varies within people with PKU.

Cardiovascular disease (CVD) is the largest cause of deaths worldwide each year. Many factors affect CVD including diet, genetics, exercise and smoking. It is unclear if Phenylketonuria (PKU) and the low-phenylalanine diet (LPD) affect CVD risk.

CVD risk can be predicted by measuring the thickness of the artery wall in the neck which supplies blood to the head. Thickness is measured using a non-invasive, safe ultrasound test (similar to pregnancy jelly scans). A wall thicker than normal indicates an increased CVD risk. A wall thinner than normal indicates a lower CVD risk.

Eligibility Criteria:
Inclusion Criteria:

* Phenylketonuria patients at Guys and St Thomas' Centre for Inherited Metabolic Diseases, who have a diagnosis of Phenylketonuria at birth (following the introduction of the newborn screening programme), and who are over the age of 18 will be invited to take part in the study.
* The study will only include patients diagnosed at birth, which will allow a better assessment of the effects of the diet, which are not influenced by a late diagnosis and a prior diet which is not low-Phenylalanine.

Exclusion Criteria:

* Phenylketonuria patients at Guys and St Thomas' Centre for Inherited Metabolic Diseases, who have a diagnosis of Phenylketonuria after birth (not diagnosed during newborn screening), will be excluded from taking part in the study.
* If patients are pregnant, or plan to be pregnant during the study they will also be excluded.
* Patients with a previous history of cardiovascular disease, and/or a history of cardiovascular disease in their immediate family will also be excluded.
* Patients that are unable to understand and consent to the study (i.e. due to language issues or lacking capacity) will also be excluded.