louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01879735: Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT
Official title: Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholestasis
Primary Sclerosing Cholangitis
Primary Biliary Cirrhosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.

Detailed description: The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.

Eligibility criteria: Inclusion Criteria:

* Patients with cholestatic disorders and healthy subjects

Exclusion Criteria:

* Body weight above 110 kg (catheterization problematic).
* Diabetes
* Pregnant or breast feeding women.

Primary outcomes:
measure: Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar
timeFrame: All measurements are performed in one day.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Nuclear medicine and PET-center
state: Aarhus C
Study officials:
affiliation: Aarhus University Hospital
name: Susanne Keiding, M.D. D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sorensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer 11C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: 10.1016/j.jhep.2017.02.023. Epub 2017 Feb 27.
Clinical trial NCT07013435: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship
Official title: Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphoma
Keywords: quality of life
psychosocial intervention
supportive care
cancer survivorship
resilience
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.

Detailed description: The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.

The main questions it aims to answer are:

* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?
* Will improvements in resiliency lead to improvements in quality of life?

To answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.

Participants will:

* Fill out 4 surveys across 12 months
* Participate in 8 weekly, virtual group sessions
* Submit hair cortisol samples

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking adults (18+ at time of enrollment)
* Within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other)

Exclusion Criteria:

* Active psychiatric or cognitive comorbidity as determined by the site PI or treating clinician

Primary outcomes:
measure: Quality of Life (QoL): Change in PROMIS-29
timeFrame: From enrollment to 6 month follow up
Secondary outcomes:
measure: Resilience: Change in Scores on the Current Experiences Scale (CES)
timeFrame: Enrollment to 3 month follow up
Other outcomes:
measure: Correlation between scores on measures of Resilience (CES) and Quality of Life (PROMIS-29)
timeFrame: 3, 6 and 12 months
Locations:
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03645135: Does Goal Elicitation Improve Patient Perceived Involvement
Official title: Does Goal Elicitation Improve Patient Perceived Involvement?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention.

We will use a random block generator to assign participants to their study arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.

Detailed description: This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.

Eligibility criteria: Inclusion Criteria:

* New patients visiting the orthopaedic service
* English fluency and literacy

Exclusion Criteria:

* Returning patients
* Children
* Non-English speaking patients

Primary outcomes:
measure: Perceived Involvement in Care Scale (PICS)
timeFrame: Immediately after visit
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Robin N Kamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302935: Pain & Expert: Global Pain-assessment: a Prospective Registry
Official title: Pain & Expert: Global Pain-assessment: a Prospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain.

Brief summary: Full assessment of chronic pain patients based on the ICF-model.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic pain for at least 3 months
* Age =\> 18 years
* Patient has been informed of the study procedures and has given written informed consent

Exclusion Criteria:

* Healthy patients or patients with acute pain.
* Addiction to drugs, alcohol (\>5 units per day)
* Evidence of an active disruptive psychiatric disorder that may impact perception of pain, and/or ability to evaluate treatment outcome as determined by investigator
* Pregnancy

Primary outcomes:
measure: Feasibility of a global pain-assessment (i.e. practical use)
timeFrame: at the time of the assessment: one day (cross-sectional)
Secondary outcomes:
measure: norm values for chronic pain patients on all aspects of the global pain-assessment will be reported (i.e. descriptives)
timeFrame: at the time of the assessment: one day (cross-sectional)
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
References:
Clinical trial NCT06416735: Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
Official title: Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension Essential
Salt Excess
Genetic Hypertension
Keywords: Hypertension
Salt
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
Primary purpose: OTHER

Brief summary: The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.

Detailed description: The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration

Eligibility criteria: Inclusion Criteria:

* male patients aged 18-60 years;
* naïve hypertensive patients: newly diagnosed, never previously treated for hypertension;
* BMI\<30 Kg/m2,
* documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg or diastolic BP \>=90 mmHg;
* signature of the informed consent for participation in the study
* patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).

Exclusion Criteria:

known causes of secondary hypertension;

* severe or malignant hypertension; history of renal artery disease;
* significant renal disease (creatinine clearance less than 60 ml/min);
* hyperkalemia (Kpl \> 6mEq/l) at enrollment visit;
* hypercalcaemia (Ca pl \> 2.6 mmol/l) at enrollment visit;
* symptomatic hyperuricemia (\> 7.5 mg/dl);
* liver disease (transaminases greater than 3 times the normal value);
* cardiac pathologies (myocardial infarction, atrial fibrillation, etc.);
* diabetes (fasting blood sugar \>125mg/dl);
* in therapy with statins, NSAIDs, systemic steroids;
* known hypersensitivity to Amiloride or to any of the excipients;
* patients unable to express a valid consent -

Primary outcomes:
measure: Evaluate urinary sodium
timeFrame: 3 hrs and 6 hrs
Secondary outcomes:
measure: Evaluate potassium levels
timeFrame: 3 hrs and 6 hrs
measure: Evaluation of systolic blood pressure
timeFrame: 3 hrs and 6 hrs
measure: Evaluation of diastolic blood pressure
timeFrame: 3 hrs and 6 hrs
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
state: Lombardia
Study officials:
References:
Clinical trial NCT02954835: Negative Pressure Therapy for Groin Wounds
Official title: Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Infection
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

Detailed description: This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing vascular surgery with a groin incision.

Exclusion Criteria:

* Allergy to silver.

Primary outcomes:
measure: Infection rate
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Thomas Bernik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170935: Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
Official title: Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo a primary elective total hip replacement
* Male or female being 18 years or older (women of child bearing potential may not be included)
* Patients weighing at least 40 kg
* Written informed consent for participation

Exclusion Criteria:

* Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke
* Known renal disease
* Known liver disease, alcohol or drug misuse
* Known malignancy
* Treatment with another study drug in the past month

Primary outcomes:
measure: maximum plasma concentration (Cmax)
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: time to maximum plasma concentration (Tmax)
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: total clearance of drug from plasma
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: terminal elimination constant
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: time of last measureable BIBR 953 ZW plasma concentration (Tf)
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: area under the plasma concentration time curve until Tf (AUC0-Tf)
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
measure: area under the plasma concentration time extrapolated to infinity (AUC0-infinity)
timeFrame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: up to 24 hours after drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01531335: Hypocaloric Nutrition in Critically Ill Patients
Official title: Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critically Ill
Keywords: adults
Lead sponsor: Lafrancol S.A.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario San Ignacio
First posted: 2012-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

Detailed description: The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will \>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.

The SOFA score will be assessed every two days until discharge from ICU.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* estimated fasting period of at least 96 hours

Exclusion Criteria:

* parenteral nutrition
* pregnancy
* diabetes
* liver or renal failure
* transplantation
* admitted from another hospital

Primary outcomes:
measure: SOFA (Sequential Organ Failure Assessment) Score
timeFrame: 48 hours since nutritional regime starts
Secondary outcomes:
measure: Insulin Requirements
timeFrame: Daily until day 21 or discharge from ICU
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
state: DC
Study officials:
affiliation: Pontificia Universidad Javeriana
name: Saul Rugeles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05917535: Mentalizing Education in a Psychiatric Out-patient Clinic
Official title: Mentalizing Education in a Psychiatric Out-patient Clinic in North Norway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Education
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Mentalization-based Mental Health Education in a naturalistic patient population from a psychiatric out-patient clinic in North Norway: A randomized controlled study

Detailed description: Half of an unselecected waiting list group of patients (randomized) from a psychiatric out-patient clinic are offered a 6 hour mental health education course abour mentalizing. 1 year follow up period. Primary outcome variable is use of hospital services. Secondary outcome variables are questionnaire scores.

Eligibility criteria: Inclusion Criteria:

* all norwegian speaking patients referred to the outpatient clinic

Exclusion Criteria:

* none

Primary outcomes:
measure: Hospital service us
timeFrame: 1year
Secondary outcomes:
measure: 3 item wellbeing questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
city: Harstad
country: Norway
facility: University Hospital North Norway
Study officials:
affiliation: University Hospital North Norway
name: Poul Lundgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03561935: Beta-blocker vs. Ic Antiarrhythmic Drug for PVC
Official title: Outcome of Medical Treatment for Idiopathic Premature Ventricular Complexes - Beta-blocker vs Ic Antiarrhythmic Agent; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Premature Ventricular Complex
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard medical therapy of idiopathic premature ventricular complex consists of beta blocker and Ic antiarrhythmic agent. However, the difference in the efficacy of two drugs has not been well investigated. This prospective randomized study aimed to compare the efficacy of beta-blocker and Ic antiarrhythmic agent in the treatment of symptomatic patients with idiopathic premature ventricular complex.

Detailed description: A premature ventricular complex is frequently observed in routine clinical practice and patients without structural heart disease occasionally have benign outcomes. The initial therapy of symptomatic premature ventricular complex is medical treatment with beta-blocker, calcium channel blocker or antiarrhythmic agents. However, no large prospective study has been performed to identify the difference in the efficacy between drugs. The current study was designed to compare the efficacy between beta-blocker and class Ic antiarrhythmic agent. Patient with symptomatic PVC more than 6000 episode per 24 hours is included. Exclusion criteria are evidence of structural heart disease, coronary heart disease, significant bradycardia or use of a concomitant antiarrhythmic agent. Patients are randomized into beta-blocker group (propranolol) and Ic antiarrhythmic agent group (propafenone). Response to the drug is evaluated after 2 months from randomization by 24 hours Holter and questionnaire. The primary endpoint is more than 80% PVC reduction or PVC burden less than 300 beats per 24 hours. The secondary endpoint is patient's symptom evaluated by questionnaire and the number of PVCs measured in 24 hours Holter.

Eligibility criteria: Inclusion Criteria:

* over 19 years old \>6000 PVCs/24hrs

Exclusion Criteria:

* Left ventricular ejection fraction \<50% or Significant valvular disease (≥moderate) History of coronary artery disease Use of a concomitant antiarrhythmic agent Significant bradycardia

Primary outcomes:
measure: Reduction in PVC frequency on 24hrs holter
timeFrame: two months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: The Catholic University of Korea
name: Yong-Seog Oh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: