louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04061811: Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
Official title: Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
End Stage Renal Disease
Keywords: congestive heart failure (HF)
biomarker
chronic kidney disease (CKD)
hemodialysis (HD)
peritoneal dialysis (PD)
neprilysin (NEP)
growth differentiation factor-15 (GDF15)
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: F-CRIN
First posted: 2019-08-20
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End stage renal disease (ESRD) patients on chronic dialysis.

Brief summary: Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis.

Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts.

Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.


Eligibility criteria: Inclusion Criteria:

* ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months

Exclusion Criteria:

* previous switch of the type of renal replacement therapy from HD to PD or vice versa
* age \<18 years
* pregnancy
* plasma exchange or apheresis in the past 6 months
* unipolar pacemaker
* history of whole extremity amputation

Primary outcomes:
measure: HF diagnosis
timeFrame: Baseline (at study entry (diagnostic biomarker study))
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Inserm Umr S-942
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Michael S Balzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03043911: Improved Patient Safety Through Continuous Bi-channel RR and SpO2 Monitoring With Masimo Patient SafetyNet
Official title: Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Signs and Symptoms, Respiratory
Keywords: early detection
respiratory events
sepsis
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2017-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients to be admitted to the general post surgical floor who meet the inclusion and exclusion criteria will be enrolled after signing the study consent form.

Brief summary: The investigator intend to perform an observational study, by adding Respiratory Rate monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be deactivated. Retrospective analysis of the observational data collected will be utilized to evaluate the potential benefits of additional continuous respiratory rate monitoring.

Detailed description: Addition of acoustic respiratory rate monitoring to an already existing standard of care patient surveillance system that includes oxygen saturation and heart rate monitoring by pulse oximetry will result in earlier and more sensitive detection of respiratory events and possibly early stages of developing sepsis in a post-surgical/orthopedic study population.

An observational study with RRa is an additional blinded parameter to the already existing standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and orthopedic patients), where patients receive opioids for pain management. 300 consecutive patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery, after discharge from the Recovery Room, \& upon admission to the Surgical floor.

Eligibility criteria: Inclusion Criteria:

* • Adult 18yrs of age or older

  * Post-surgical patient receiving opioid pain medication

Exclusion Criteria:

* • Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor placement

  * Finger or skin abnormalities at sensor sites
  * Expected opioid therapy duration less than 24 hours

Primary outcomes:
measure: Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events
timeFrame: with in 24 hours post surgery
Secondary outcomes:
measure: Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis.
timeFrame: with in 24 hours post surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05705011: Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.
Official title: Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CKD Stage 4
CKD Stage 5
Frailty
Cognitive Impairment
Keywords: CKD
FRAILTY
HRQOL
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults are diagnosed with advanced chronic kidney disease, namely, stage 4 and stage 5.

Brief summary: This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease \].

The main question\[s\] it aims to answer are:

* What determines the time to initiate dialysis? Cognitive impairment or frailty?
* What does predict the time to death? Presence of frailty or cognitive impairment?
* What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?


Eligibility criteria: Inclusion Criteria:

* Patients age 65 years or older.
* CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 separated by more than 3 months.

Exclusion Criteria:

* Patients younger than 65 years old.
* Chronic kidney disease stages 1,2, and 3.
* Dialysis dependence
* History of kidney transplantation.
* Initial visit with the health care provider.
* Recent acute kidney injury.
* Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty)
* Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment
* Patients who are blind or with limb amputation.
* Patients who refuse to participate.

Primary outcomes:
measure: Time to death
timeFrame: 36 months
measure: Time to initiate dialysis.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: University of Medicine and Pharmacy "Grigore T. Popa"
Study officials:
affiliation: University of Medicine and Pharmacy "Grigore T. Popa" - Iași
name: Hani Hussien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113111: Effects of Fasting on Self Efficacy
Official title: The Effects of Therapeutic Fasting on Self Efficacy Measures - a Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Fibromyalgia
Rheumatoid Arthritis
Gout
Headache
Arthritis
Gastrointestinal Diseases
Irritable Bowel Syndrome
Inflammatory Bowel Disease
Cardiovascular Diseases
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 120
Sex: ALL
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: Patients being treated in an integrative clinic for internal medicine Patients recommended for fasting therapy during the inpatient treatment

Brief summary: The study aims to investigate

* if a 7 day therapeutic fasting regimen will affect self-efficacy of patients with chronic diseases
* the effects of fasting on physical and mental well-being, quality of life and body awareness/image
* the association between patients characteristics and the perceived health benefit after fasting
* the association between Diagnosis according to traditional Chinese medicine and physical and mental well-being during the course of fasting
* experiences and perceptions of patients during fasting therapy

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* eligible for fasting, i.e. normal weight (no anorexia, no nutritional deficiency, no BMI\<18 or \>35, no eating disorder)

Exclusion Criteria:

* psychiatric disorder
* type 1 diabetes
* hepatitis
* severe somatic disorder (oncological disease, hepatological or nephrological)
* pregnancy

Primary outcomes:
measure: Self efficacy questionnaire
timeFrame: up to 6 months
measure: Bodily self-efficacy
timeFrame: up to 6 months
Secondary outcomes:
measure: Ability and will to change
timeFrame: 2 weeks, 6 months
measure: Easiness of life
timeFrame: 2 weeks, 6 months
measure: Health-related quality of life
timeFrame: 2 weeks, 6 months
measure: Body responsiveness
timeFrame: 2 weeks, 6 months
measure: Body awareness and dissociation
timeFrame: 2 weeks, 6 months
measure: Body Awareness
timeFrame: 2 weeks, 6 months
measure: Symptoms
timeFrame: 2 weeks, 6 months
measure: Depression
timeFrame: 2 weeks, 6 months
measure: Safety
timeFrame: 2 weeks
Other outcomes:
measure: Well-being
timeFrame: 2 weeks
measure: Diagnosis according to traditional Chinese medicine
timeFrame: day 1
measure: Experiences
timeFrame: 2 weeks
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
name: Gustav Dobos, Prof
role: STUDY_DIRECTOR
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
name: Romy Lauche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05790811: Engaging Patients for Physical Exams During Virtual Care Visits
Official title: Validation of Hand & Wrist Physical Exam Video Aid for Improvement of Patient Comprehension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-preformed Hand Examination
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to validate patient-oriented edits to a guided video on self-performed hand examination in participants with no prior hand diagnoses or medical background. The study aims to:

* examine the effect of adding interactive components to an existing orthopedic provider video
* determine if these changes enhance patients' understanding of hand and wrist anatomy as well as carpal tunnel syndrome
* determine if patients are able to use this video to perform an effective physical exam Participants will watch an original physician-oriented training video and a second version (patient-oriented video), which was edited with the input of a patient advisory committee to include interactive elements and a slower speed. The order in which the participants will watch the video will be randomized.

If there is a comparison group: Researchers will compare knowledge scores and general patient preference between the two videos being examined.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* Patients who comprehend and speak English
* Patients with carpal tunnel syndrome confirmed on EMG and/or symptoms consistent with carpal tunnel syndrome, including bilateral hand pain, non-traumatic hand pain, and/or numbness/tingling in hand.

Exclusion Criteria:

* Patients under 18 years of age
* Patients who do not speak or comprehend English
* Patients who have cognitive impairments that would be detrimental to understanding of video
* Patients whose symptoms do not match carpal tunnel syndrome

Primary outcomes:
measure: Knowledge Score immediately following the viewing of a video presenting the knowledge
timeFrame: 10 minutes after viewing the video
Secondary outcomes:
measure: Knowledge Score immediately prior to the viewing of a video presenting the knowledge
timeFrame: 10 minutes before viewing the video
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT04303611: Examining The Role of Family Support in Bariatric Surgery Patients
Official title: To Examine the Role of Family Support for Patients With Obesity Before and After Bariatric Surgery and Whether Family Support Predicts Long-term Weight Loss and Diabetes Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study is Patient Responses to an Obesity Management Questionnaire Administered by SGH Life Centre
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergone bariatric surgery within SGH Life Centre and completed the intake questionnaire

Brief summary: This study aims to examine the role of family support on the adhesion to post-op procedures in patients who have undergone bariatric surgery in Singapore.


Eligibility criteria: Inclusion Criteria:

Undergone bariatric surgery within SGH Life Centre and must have completed the intake questionnaire

Exclusion Criteria:

-

Primary outcomes:
measure: Weight Loss
timeFrame: Immediately post-surgery within first year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT02395211: Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS
Official title: Effects of Proprioceptive Stimulation Under Visual Feedback in Patient With CRPS: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Regional Pain Syndromes
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.

Detailed description: The aim of this study is to evaluate feasibility of a a proprioceptive stimulation under visual feedback treatment protocol (using Gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with Complex regional pain syndrome.

Treatments effect will be evaluated on pain perception, upper extremity functionality and change in pain pressure treshold.

Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years and \< 85 years
* diagnosis of stroke \< 6 months prior to study enrollment
* diagnosis of Complex regional pain syndrome according to Budapest Criteria

Exclusion Criteria:

* neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* pregnancy

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Change measures (weeks: 0,4,16, 28)
Secondary outcomes:
measure: Neuropathic Pain Symptom Inventory
timeFrame: Change measures (weeks: 0,4,16, 28)
measure: McGill Pain Questionnaire
timeFrame: Change measures (weeks: 0,4,16, 28)
measure: Erasmus MC modification to the (revised) Nottingham Sensory Assessment - Italian version
timeFrame: Change measures (weeks: 0,4,16, 28)
measure: Fugl-Meyer Upper Extremity
timeFrame: Change measures (weeks: 0,4,16, 28)
measure: Pressure Pain Threshold
timeFrame: Change measures (weeks: 0,4,16, 28)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02390011: Pilot Study of Coil Arrays in Patients With Advanced Solid Tumor Malignancies
Official title: A Pilot Study of Novel Magnetic Resonance Coil Arrays to Improve the Characterization of Liver Metastases in Patients With Advanced Solid Tumor Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplams
Keywords: Advanced Solid Tumor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Advanced Solid Tumor Malignancies

Brief summary: This is a single center pilot study testing the use of novel coil arrays with MR liver imaging. In part A of the study, up to 30 healthy volunteers will be scanned, with iterative adjustment of coil array geometry and design to optimize imaging characterstics. In Part B of the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring \> 1.5 cm in diameter on standard anatomic scans will undergo MR liver imaging with the newly designed coil array, with the use of gadolinium contrast. Patients with liver tumors will have the option of undergoing a second MR liver scan during the course of subsequent systemic therapy.


Eligibility criteria: Inclusion Criteria (Part B only - Patients with advanced solid tumor):

* Advanced solid tumor malignancy and the presence of at least one liver metastasis measuring \> 1.5 cm in longest diameter in axial dimension on standard anatomic imaging

Exclusion Criteria (Part B only):

* Contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies

Exclusion Criteria (Part A \[Healthy Volunteers\] and Part B):

* Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-Unsafe surgical implants or shrapnel)

Primary outcomes:
measure: Spatial Resolution
timeFrame: Day 1
measure: Scan coverage
timeFrame: Day 1
measure: Mean contrast-to-noise ratio
timeFrame: Day 1
Secondary outcomes:
measure: Minimum size of detectable metastatic lesion
timeFrame: Day 1
measure: Degree signal
timeFrame: Day 1
measure: Time-to-peak signal
timeFrame: Day 1
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rahul Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02474511: the Influence of General Anesthesia on Tumor Metastasis and Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor Recurrence and Metastasis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patient with primary liver cancer.

Brief summary: The purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.


Eligibility criteria: Inclusion Criteria:

* ASA I - III Primary liver cancer tumor is single and diameter is less than 3 centimeter There is no major vascular invasion phenomenon, no lymph nodes or extrahepatic metastases The Child - Pugh belong to type A or type B

Exclusion Criteria:

* Had a history of liver surgery (including radiofrequency ablation) Severe disease of heart, lung, kidney, the immune system INR \> 1.5 or platelet count is less than 45000 cells/mm3 History of opioid addiction Metastatic liver tumors Not sure of primary liver cancer Don't agree to participate in this experiment

Primary outcomes:
measure: Number of participants with tumor recurrence and metastasis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02812511: Pathophysiology Analysis of "Costello Syndrome" on Cellular Models
Official title: Pathophysiology Analysis of "Costello Syndrome" on Cellular Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Costello Syndrome
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 9
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to collect skin biopsies rom patients with Costello syndrome to analyze the molecular mechanisms responsible for this syndrome caused by a mutation in the HRAS gene and the effects of this mutation on energy metabolism and mitochondrial physiology.


Eligibility criteria: Inclusion Criteria:

* Children aged over 2 years and under 18
* Children with a Costello Syndrome or Syndrome Cardio-Facio-Cutaneous

Exclusion Criteria:

* Previous history allergic to anesthetics

Primary outcomes:
measure: Measurement of HRASG12V mutation on mitochondrial energy metabolism
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
state: Aquitaine
Study officials:
References: