louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02565225: Mobile Medically Supervised Patient Management in Rheumatoid Arthritis
Official title: Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RA patients

Brief summary: The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years, owner of App capable device, RA, informed consent

Exclusion Criteria:

* non German speaking, no App capable device available

Primary outcomes:
measure: Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis.
timeFrame: baseline and change over up to nine months
Secondary outcomes:
measure: Comparison paper-based vs electronic PROM in the App - Differences of the scores
timeFrame: baseline and change after 3 months
measure: Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis.
timeFrame: at 3 months from start and change over 6 more months
measure: Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.
timeFrame: at 3 months from start and change over 6 more months
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Policlinic for Rheumatology & Hiller Research Centre for Rheumatology
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Matthias Schneider, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richter JG, Nannen C, Chehab G, Acar H, Becker A, Willers R, Huscher D, Schneider M. Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. Arthritis Res Ther. 2021 Apr 19;23(1):121. doi: 10.1186/s13075-021-02500-3.
Clinical trial NCT01256125: Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
Official title: Therapeutic Effects of Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allogene MSCs Transplantation
Chronic Liver Diseases Patients
Peripheral Vein
Keywords: allogene MSCs
transplantation
chronic liver diseases
peripheral vein
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease and so on.

Brief summary: Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.


Eligibility criteria: Inclusion Criteria:

1. chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease.
2. age: 15-65 years old.

Exclusion Criteria:

1. pregnant women and women in lactation.
2. other systems and organs disfunction
3. space-occupying lesion were found in liver.
4. concurrent infection with HIV and other immunodeficiency diseases.
5. DIC and active bleeding were confirmed.

Primary outcomes:
measure: Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein.
timeFrame: 1-8 weeks after transplantation
Secondary outcomes:
measure: Long-term follow-up of Allogene MSCs transplantation through peripheral vein.
timeFrame: 3-60 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01198925: Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Official title: Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infectious Disease
Keywords: Infectious disease
piperacillin
continuous infusion
extended infusion
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T \> MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T \> MIC equal to 50% of the dosing interval (50% T \> MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).

A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC


Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years) admitted on the intensive care unit (surgical and medical surgery).
* Starting a treatment with piperacillin/tazobactam
* Signed informed consent
* Hematocrit \>= 21%
* Available arterial line

Exclusion Criteria:

* age \<18 or \>75 years
* patient's weight \<50 or \>100 kg
* renal insufficiency (estimated clearance \< 50 ML /MIN)
* haemodialysis
* WBC \< 1000 103 µl
* estimated survival \<5 days
* meningitis or other proven infections of the CNS
* IgE-mediated allergy to penicillins
* pregnancy
* patients having participated in another study \<30 days before inclusion in the present study
* retrospectively, marked deterioration of the renal function during the study period
* retrospectively, treatment \< 96 h

Primary outcomes:
measure: pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
timeFrame: 6 hours
Secondary outcomes:
measure: 95% probability of target attainment (PTA95) versus MIC of different organisms.
timeFrame: 96 hours
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Johan Decruyenaere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05849025: A Study of Invasive Hemodynamic for MACHD Registry
Official title: Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Congenital Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-08
Enrollment: 50
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: Healthy individuals without cardiac conditions will be recruited from Mayo Clinic in Rochester, MN.

Brief summary: This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.


Eligibility criteria: Inclusion Criteria:

* Capacity to Consent
* BMI \</= 30
* Systolic BP \</= 140mmHg
* Diastolic BP \</= 90
* eGFR \> 30 (within prior 3 months) to confirm kidney function
* Able to undergo an MRI

Exclusion Criteria:

* History of Cardiovascular disease that may affect the results of the testing performed.
* Any Current orthopedic limitations
* Currently taking any cardiac medication
* Pregnancy

Primary outcomes:
measure: Pulmonary vascular reserve
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Egbe, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03219125: Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Official title: Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Bone Marrow Disease
Fat Disorder
Adiposity
Keywords: marrow adipose tissue
bone marrow adiposity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 203
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women

Brief summary: The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.


Eligibility criteria: Inclusion Criteria:

* post-menopausal women : 50-90 years old
* Group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months
* Group 2 (controls) : no history of fragility fracture

Exclusion Criteria:

* Implants that are contraindicated for the magnetic resonance (MR) examination.
* Implants that might create a health risk or other problem during an MR exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant.
* body mass index \[BMI\] \>38 kg/m2, weight \>140 kg
* Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
* Chronic kidney disease with DFG \<30 ml/mn

Primary outcomes:
measure: Bone marrow fat content at lumbar spine
timeFrame: 24 months
Secondary outcomes:
measure: Bone marrow fat content at total hip
timeFrame: 24 months
measure: Bone mineral density at lumbar spine
timeFrame: 24 months
measure: Bone mineral density at total hip
timeFrame: 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Julien Paccou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05277025: Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
Official title: Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Rheumatoid Arthritis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a case-control study of FM, RA and healthy controls (HC) that will be enrolled in a ratio of 1:1:1. Healthy controls will be aged/gender matched to the FM and RA groups.

Brief summary: Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.


Eligibility criteria: Inclusion Criteria:

* Ages 18-70
* Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
* Fulfills the 2010 ACR-EULAR classification criteria for RA
* Healthy volunteers: No significant pain/fatigue/depression/anxiety.

Exclusion Criteria:

* Diabetes
* Cancer
* Advanced liver, kidney or cardiovascular disease
* Neuropathic pain

Primary outcomes:
measure: Pressure Pain Thresholds
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Roland Staud, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06972225: Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.
Official title: Follow-up of MACE in Patients Treated With Drug-eluting Balloons Between 2010 and 2025; a Retrospective Study With Prospective Follow-up From an Institutional Database: EASY-drug-eluting Balloons
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Restenosis, Coronary
Bifurcation Coronary Disease
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients registered in the institutional procedural database who underwent a coronary angioplasty with drug-eluting balloons exclusively between January 2010 and December 2025.

Brief summary: Retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.


Eligibility criteria: Inclusion Criteria:

* Adults (\>=18 years of age)
* Who underwent a coronary angioplasty with drug-eluting balloon between January 2010 and December 2025
* Identified in the institutional procedure database

Exclusion Criteria:

* Incomplete or non-available data on the post-procedural clinical follow-up
* Procedures where other devices were used in combination with drug-eluting balloons.

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: within 10 years of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References:
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
citation: Giacoppo D, Saucedo J, Scheller B. Coronary Drug-Coated Balloons for De Novo and In-Stent Restenosis Indications. J Soc Cardiovasc Angiogr Interv. 2023 Mar 30;2(3):100625. doi: 10.1016/j.jscai.2023.100625. eCollection 2023 May-Jun.
citation: Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
Clinical trial NCT03571425: The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females
Official title: The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals.

Detailed description: Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h) combined with repeated blood and muscle sampling, in order to measure muscle protein synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral protein ingestion (n=10), or enteral protein administration (n=10).

Eligibility criteria: Inclusion Criteria:

* 18-40 years of age
* Body mass index between 18.5 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease
* Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements)
* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism). This excludes oral contraceptives and contraceptive devices.
* A personal or family history of epilepsy, seizures or schizophrenia.
* Presence of an ulcer in the stomach or gut and/or strong history of indigestion
* Known pre-existing liver disease/condition
* Any known disorders in muscle metabolism
* Regular use of nutritional supplements
* Allergy to lidocaine
* Allergy to milk
* Current paracetamol use (i.e. use of paracetamol more than once a week)
* Pregnancy

Primary outcomes:
measure: Postprandial muscle protein synthesis
timeFrame: 5 hours
Secondary outcomes:
measure: Postabsorptive muscle protein synthesis
timeFrame: 2 hours
measure: Whole-body protein synthesis
timeFrame: 7 hours
measure: Whole-body protein breakdown
timeFrame: 7 hours
measure: Whole-body protein oxidation
timeFrame: 7 hours
measure: Whole-body protein net balance
timeFrame: 7 hours
measure: Gastric emptying rate
timeFrame: 5 hours
measure: Blood glucose concentration
timeFrame: 8.5 hours
measure: Serum insulin concentration
timeFrame: 8.5 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Marlou Dirks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06362525: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room
Official title: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Near-Death Experience
Consciousness, Loss of
Quality of Life
Emergencies
Keywords: Dream
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Liege
First posted: 2024-04-12
Enrollment: 100
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: All adult patients admitted in the resuscitation room

Brief summary: This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care.

Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display.

Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.


Eligibility criteria: Inclusion Criteria:

* patients admitted in the resuscitation room of our university hospital
* French speaking

Exclusion Criteria:

* Refusal
* Chronic disorder of consciousness
* Deafness
* Blindness
* Dementia
* Hemineglect
* Aphasia

Primary outcomes:
measure: Detection of potential episodes of disconnected consciousness
timeFrame: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
measure: Detection of potential episodes of connected consciousness
timeFrame: upon awakening/discharge from the resuscitation room (max 21 days after the admission in the room)
Secondary outcomes:
measure: Risk factors
timeFrame: in the resusctiation room admission
measure: Quality of life assessment
timeFrame: at 6-month
measure: Memory content and evolution assessment
timeFrame: at 1-month
measure: Detection of post-traumatic stress disorder (PTSD)
timeFrame: at 6-month
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU of Liège
Study officials:
References: