louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01509495: Impedance Measurements in Heart Failure Patients
Official title: Impedance Measurements in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Heart Failure
Keywords: Heart Failure
HF
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2012-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure impedance during inpatient treatment.


Eligibility criteria: Inclusion Criteria:

* patients admitted to hospital for symptoms of congestive heart failure
* patients older than 18 years
* patients willing and able to give informed consent

Exclusion Criteria:

* patients who will require adrenergic or positive inotropic medications
* patients enrolled in a concurrent study that may confound the results of this study
* patients unable or unwilling to participate in study procedures
* patients who are pregnant
* patients who are mentally handicapped or legal incompetent
* patients who are dependent on investigator or sponsor

Primary outcomes:
measure: Impedance Measurement of Patients in Heart Failure, impedance change first to last measurement
timeFrame: every 4 hours up to 48 hours
Secondary outcomes:
measure: Accuracy of Respiratory rate determined by impedance measurements
timeFrame: every 4 hours up to 48 hours
measure: Correlation between hemodynamic (central venous or arterial pressure) and impedance measurements (optional)
timeFrame: every 4 hours up to 48 hours
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Nemocnice Na Homolce
city: Würzburg
country: Germany
facility: Universitätsklinik Würzburg, Medizinische Klinik und Poliklinik I
state: Franken
city: Bratislava
country: Slovakia
facility: NUSCH
Study officials:
affiliation: Klinikum St. Elisabeth Straubing, Med. Klinik II, St.-Elisabeth-Str. 23, 94315 Straubing, Germany
name: Sebastian KG Maier, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: NUSCH, Cardiac Surgery, Pod Krasnou horkou 1, 83348 Bratislava, Slovakia
name: Eva Goncalvesova, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemocnice Na Homolce, Cardiology, Roentgenova 2/37, 150 30 Praha 5, Czechia
name: Petr Neuzil, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05838495: Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
Official title: A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm, non-randomized, open-label, observational study
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.

Detailed description: The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.

Eligibility criteria: Inclusion Criteria:

* Medically stable, enterally tube-fed children
* Aged 1 to 13 years (inclusive) at the time of screening.
* Currently tolerating enteral feeding and should be appropriate for study formula
* Requires enteral tube feeding to provide 90% or more of their nutritional needs
* signed informed consent

Exclusion Criteria:

* Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
* Currently using or has previously used the study product
* Any medical condition or contraindicated medications that would contraindicate use of the study product
* Any illness within \~5-7 days of screening and/or baseline lasting \>48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
* Participation in another interventional clinical study
* Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.

Primary outcomes:
measure: Nutritional efficacy - energy
timeFrame: 14 days
Secondary outcomes:
measure: Nutritional efficacy - protein
timeFrame: 14 days
measure: Frequency of nausea
timeFrame: 14 days
measure: Frequency of vomiting
timeFrame: 14 days
measure: Bristol Stool Chart
timeFrame: 14 days
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jessie Hulst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nestle Health Science Canada
name: Cindy Steel, MSc
role: STUDY_CHAIR
affiliation: Nestle Health Science USA
name: Krys Araujo Torres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02654795: Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke
Official title: AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.


Eligibility criteria: Inclusion Criteria:

* history of ischemic stroke or transient ischemic attack
* history of AF/AL
* known status of anticoagulation at the time of stroke (treatment dose, INR level)

Exclusion Criteria:

* hemorrhagic stroke
* serious renal impairment with GFR \<30 ml/min
* hyperthyroidism
* allergy to the contrast agent
* mental inability to sign the informed consent
* receptive aphasia

Primary outcomes:
measure: The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59
Study officials:
References:
Clinical trial NCT03677895: What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Official title: What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Impingement Syndrome
Keywords: rotator cuff disorder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients with rotator cuff disorders receving subacromial hyaluronic acid injection
Primary purpose: TREATMENT

Brief summary: To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients

Detailed description: Objective: To evaluate the correlations between structure of supraspinatus tendon (impingement, tendinopathy or partial tear, as well as full thickness tear) on ultrasonography and its response to subacromial hyaluronic acid injection in rotator cuff disease patients and also investigate the factors associated with clinically important improvement after subdeltoid hyaluronic acid for rotator cuff disorder.

Design: Prospective, longitudinal comparison study.

Participants: Patients with rotator cuff disease

Intervention: Three subacromial injection with hyaluronic acid with 2 week-interval.

Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 4 and post-treatment at week 12.

Eligibility criteria: Inclusion criteria were patients

1. with clinically and ultrasonographically diagnosed rotator cuff disease of the shoulder-impingement, tendinosis and tear;
2. who reported shoulder pain more than 3 months;

Exclusion Criteria:

1. presence of another medical or psychological condition, including cancer, rheumatoid arthritis, endocrine disease (i.e., diabetes), major depression, or schizophrenia;
2. previous major trauma history at currently affected shoulder; 3 primary osteoarthritis of the glenohumeral joint in a simple radiograph; 4previous injection history at the affected shoulder within 3 months

Primary outcomes:
measure: constant shoulder score
timeFrame: 12 weeks
Secondary outcomes:
measure: pain intensity measured by visual analog scale
timeFrame: 0, 6, 12 weeks
measure: Shoulder Pain And disability index
timeFrame: 0, 6, 12 weeks
measure: glenohumeral joint range of motion
timeFrame: 0, 6, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Jia Chi Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01439295: Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Official title: Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Keywords: Ascorbyl peroxide
Bronchopulmonary dysplasia
Redox status
Necrotising entercolitis
Retinopathy of prematurity
Patent ductus arteriosus
Intraventricular hemorrhage
Periventricular leucomalacia
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-09-23
Enrollment: 51
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants less than 33 weeks of getation

Brief summary: Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.

Detailed description: This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia).

Eligibility criteria: Inclusion Criteria:

* Preterm infants less than 33 weeks of gestation\<
* Admission to CHU Sainte-JUstien neonatal intensive care unit
* Receiving Parenteral nutrition during the first week of life
* Parental consent

Exclusion Criteria:

* Major congenital anomalies
* Sever perinatal asphyxia

Primary outcomes:
measure: Bronchopulmonary Dysplasia
timeFrame: 4 Months
Secondary outcomes:
measure: The redox status (in blood)
timeFrame: First week of life (week 1) and 36 semaines CA
measure: Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)
timeFrame: 4 Months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: University of Montreal, Sainte-Justine Hospital
state: Quebec
Study officials:
affiliation: University of Montreal, Sainte Justine Hospital
name: Ibrahim Mohamed, Mb CHB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Montreal, Sainte-Justine hospital research center
name: Jean-claude Lavoie, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01879995: Phenylketonuria and Hyperphenylalaninemia Nutrition Study
Official title: Nutrition Status of Adult and Adolescent Patients With Classical Phenylketonuria (PKU) and Hyperphenylalaninemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonuria (PKU) and Hyperphenylalaninemia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with phenylketonuria or hyperphenylalaninemia, in treatment at the participating centres

Brief summary: The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural protein), and supplementation with a protein substitute (a mixture of amino acids free from phenylalanine, also containing micronutrients and vitamins) and special low-protein foods, to meet the patient's energy requirements. When diet and treatment is relaxed after childhood, adult and adolescent patients with phenylketonuria are at risk for malnutrition, depending on the compliance with treatment and the intake of amino acid supplements.

In this study, nutrition status of patients with PKU and hyperphenylalaninemia is systematically assessed under ongoing current treatment, in relation to Phe-tolerance, compliance with treatment, and psychosocial issues.

Study participants do not undergo any specific therapeutic or diagnostic intervention.


Eligibility criteria: Inclusion criteria:

* PKU (Phenylketonuria) or hyperphenylalaninemia
* male or female, minimum age 16y
* signed informed consent

Exclusion criteria:

- patient who can not comply with the study protocol (e.g. unable to fill in questionnaires by themselves or a representative)

Primary outcomes:
measure: Macronutrient and micronutrient intake, calculated from a nutrition protocol (four consecutive days)
timeFrame: assessed during 4 consecutive days max. within 1 month after a regular consultation in the outpatient clinic
Secondary outcomes:
measure: Phenylalanine level (umol/l)
timeFrame: assessed at the end of the four-day nutrition protocol (see primary outcome)
measure: Plasma amino acid profile
timeFrame: determined at a routine visit at the outpatient clinic, on average 1x per year
measure: Concentrations of micronutrients, minerals and vitamins
timeFrame: determined at a routine visit at the outpatient clinic, on average 1x per year
measure: body weight (kg)
timeFrame: determined at a routine visit at the outpatient clinic, on average once every 6 - 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
state: ZH
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition
name: Michel Hochuli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067295: Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
Official title: Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-10-04
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men diagnosed with advanced (metastatic) prostate cancer at Norris Comprehensive Cancer Center and Los Angeles County hospital.

Brief summary: This study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.

Detailed description: PRIMARY OBJECTIVE:

I. To create an annotated biorepository with prospectively collected blood and urine samples from men with advanced prostate cancer.

OUTLINE: This is an observational study.

Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* \* Men of all racial and ethnic groups 18 years of age or older

  * Men with a diagnosis of advanced (metastatic) prostate cancer who are scheduled to begin a new systemic treatment (including first or subsequent lines of therapy)
  * Prior participation on clinical trials is allowed

Exclusion Criteria:

* \* Inability to give informed consent

Primary outcomes:
measure: Collection of biological specimens and clinical data for future research related to prostate cancer.
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Amir Goldkorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03203395: Screening for Depression and Anxiety in Patients With Heart Disease
Official title: Screening for Depression and Anxiety in Patients With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Symptoms
Depressive Disorder
Anxiety
Anxiety Disorders
Panic Attacks
Heart Diseases
Collaboration
Keywords: Depression
Anxiety
Panic Attacks
Collaborative Care
Heart disease and depression
Heart disease and anxiety
Heart disease and panic attacks
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Extrastiftelsen
name: LHL - The Norwegian Heart and Lung Patient Organization
First posted: 2017-06-29
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear of physical activity and excessive worry. Patients currently receiving treatment for heart disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If such symptoms are detected, patients will be offered a counselling session with a clinical psychologist. Further, routines for collaborative communication between clinical psychologist, cardiologist and the patient's general physician will be emphasized.


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years under treatment for myocardial infarction, heart failure, tachyarrhythmia and/or valvular heart disease at the Department of Internal Medicine, Diakonhjemmet Hospital.

Exclusion Criteria:

* Unable to provide informed consent.
* Unable to read and/or understand Norwegian.
* Unable to complete a survey.

Primary outcomes:
measure: Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.
timeFrame: 15 minutes
measure: Detection of patients with or at risk for depression and/or anxiety disorders.
timeFrame: 1 hour
measure: Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
name: Torkil Berge, Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06095895: Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
Official title: Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pharmacokinetics
Area Under Curve
Tacrolimus
Immunosuppressive Agents
Mycophenolic Acid
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric kidney transplant patients from Radboudumc using tacrolimus and/or mycophenolic acid.

We will collect data for one year, in this period we expect to include 30 patients.

Brief summary: This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant patients using tacrolimus and/or mycophenolic acid
* Age between 0 and 18 years
* Indication for an AUC measurement - judgement of clinician

Exclusion Criteria:

* Incapacitated patients
* No informed consent
* Not proficient in the Dutch language

Primary outcomes:
measure: Bias
timeFrame: 1 year
measure: Precision
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Nynke Jager, Dr
role: PRINCIPAL_INVESTIGATOR
References: