louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00501917: MAGIC Cell-5-Combicytokine Trial
Official title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-07-16
Enrollment: 116
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.


Eligibility criteria: Inclusion Criteria:

* ST elevation acute myocardial infarction
* \< 80years
* successful revascularization of culprit vessel

Exclusion Criteria:

* uncontrolled congestive heart failure
* uncontrolled myocardial ischemia
* uncontrolled ventricular arrhythmia
* malignancy
* serious hematologic disease
* chronic renal failure

Primary outcomes:
measure: change of left ventricular ejection fraction measured by cardiac MRI
timeFrame: 6, 12, and 24month
Secondary outcomes:
measure: wall motion score index exercise capacity BNP
timeFrame: 6,12, 24month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Univesity Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang HJ, Yoon EJ, Lee EJ, Kim MK, Suh JW, Park KW, Lee HY, Park KU, Cho YS, Koo BK, Chae IH, Choi DJ, Han KS, Kim HS, Park YB. Cotreatment with darbepoetin and granulocyte colony-stimulating factor is efficient to recruit proangiogenic cell populations in patients with acute myocardial infarction. Cell Transplant. 2012;21(5):1055-61. doi: 10.3727/096368911X627499. Epub 2012 Mar 22.
citation: Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'. Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.
Clinical trial NCT03741517: Biomarker Study of Pancreatic Neuroendocrine Tumours
Official title: Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neuroendocrine Tumor
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 40
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: Pancreatic Neuroendocrine Tumors

Brief summary: The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, DOTATOC-PET, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 68Ga-DOTATOC and 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in DOTATOC as well as FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Informed consent
* Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.

Exclusion Criteria:

* Patient does not consent
* Pregnancy or no contraceptive in fertile women.

Primary outcomes:
measure: Protocol adherence
timeFrame: Study inclusion
Secondary outcomes:
Other outcomes:
measure: Safety of core needle biopsy: NCI Common Terminology Criteria
timeFrame: At study inclusion and within 48 hours of the procedure
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
Study officials:
References:
Clinical trial NCT01192217: Video-assisted Thoracic Surgery (VATS) Versus Axillary Mini-thoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax
Official title: A Prospective Randomized Study of a Modified Two-port Thoracoscopic Technique Versus Axillary Minithoracotomy for the Treatment of Recurrent Spontaneous Pneumothorax.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Keywords: video-assisted thoracic surgery
axillary mini-thoracotomy
bullectomy
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a prospective randomized study to compare axillary minithoracotomy versus a modified two-port thoracoscopic technique for surgical pleurodesis in patients with recurrent spontaneous pneumothorax operated in a single institution.

The main objective of the study was to investigate possible differences regarding short- and long-term clinical outcome between the two different techniques.


Eligibility criteria: Inclusion Criteria:

* ipsilateral recurrent spontaneous pneumothorax
* first episode of contralateral pneumothorax

Exclusion Criteria:

* None

Primary outcomes:
measure: pneumothorax recurrence rate
measure: Postoperative complication rate
measure: Patient satisfaction with treatment
Secondary outcomes:
measure: Duration of one-lung ventilation
measure: Total operative time
measure: Duration of chest tube drainage
measure: Length of postoperative hospital stay
measure: Incidence of chronic pain
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital Department of Cardiothoracic Surgery
Study officials:
affiliation: AHEPA University Hospital
name: Christos Papakonstantinou, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06266117: Pain, Anxiety, and Comfort Levels in Coronary Angiography
Official title: Investigation of Factors Affecting Pain, Anxiety, and Comfort Levels in Patients Undergoing Coronary Angiography
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain
Anxiety
Nursing Caries
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary angiography in the coronary intensive care unit

Brief summary: The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit.

Detailed description: In the first part, the descriptive information of the patients will be used, and in the second part, "Perianesthesia Comfort Scale", "State/Trait Anxiety Scale" and "General Comfort Scale (GAS)" adapted into Turkish by Üstündağ and Aslan in 2010 will be used. Visual Pain Scale will be used for pain measurement.

It is planned that the data for the Perianesthesia Comfort Scale (PCI) will be collected in the patient's room on the first postoperative day, in approximately 15 minutes, by face-to-face interview method.

Eligibility criteria: Inclusion Criteria:

* over 18 years Conscious patients

Exclusion Criteria:

* Patients undergoing intubation

Primary outcomes:
measure: Pain level
timeFrame: on the 1st postoperative days
measure: Anxiety
timeFrame: on the 1st postoperative days
measure: Comfort
timeFrame: on the 1st postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Faculty of Health Science
state: Merkez
Study officials:
References:
Clinical trial NCT06060717: Evaluation of the F&P Caramel Nasal Mask, US, 2023
Official title: Evaluation of the F&P Caramel Nasal Mask, US, 2023
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.


Eligibility criteria: Inclusion Criteria:

* Persons who are ≥22 years of age
* Persons who weigh ≥66 pounds
* Persons who have been prescribed PAP therapy by a physician
* Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
* Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent

Exclusion Criteria:

* Persons who are intolerant to PAP therapy
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps
* Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
* Persons who have an IPAP pressure of \>30 cmH2O if on BPAP
* Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
* Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: 14±5 days
measure: Epworth Sleepiness Scale
timeFrame: 14±5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01707017: The Effects of Low- and High-intensity Resistance Exercise on Force-velocity Characteristics in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Strength Training in Older Adults
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the impact of high- and low-intensity resistance exercise on force-velocity characteristics, muscle mass and inflammatory processes in older adults. As all training protocols are designed to end with maximal effort, effects are expected to be similar between groups.


Eligibility criteria: Inclusion Criteria:

* age 60 to 80 years

Exclusion Criteria:

* Knee or hip prothesis
* Systematic training
* Cardiovascular disease
* Acute lower back pain
* Dementia

Primary outcomes:
measure: Change in force-velocity characteristics of knee extensors
timeFrame: Baseline, 12weeks, 6 months
Secondary outcomes:
Other outcomes:
measure: Change in muscle volume
timeFrame: Baseline, 12weeks, 6 months
measure: Change in maximal strength (one repetition maximum)
timeFrame: Baseline, 4weeks, 8weeks, 12weeks, 6 months
measure: Change in motivation
timeFrame: Baseline, every week for 12 weeks, 6 months
measure: Change in physical activity
timeFrame: Baseline, 12weeks, 6 months
measure: Change in inflammatory markers in blood
timeFrame: Baseline, 12weeks, 6 months
Locations:
city: Leuven
country: Belgium
facility: Faculty of Kinesiology and Rehabilitation Sciences
Study officials:
References:
citation: Van Roie E, Walker S, Van Driessche S, Baggen R, Coudyzer W, Bautmans I, Delecluse C. Training load does not affect detraining's effect on muscle volume, muscle strength and functional capacity among older adults. Exp Gerontol. 2017 Nov;98:30-37. doi: 10.1016/j.exger.2017.07.017. Epub 2017 Aug 1.
citation: Nuvagah Forti L, Van Roie E, Njemini R, Coudyzer W, Beyer I, Delecluse C, Bautmans I. High Versus Low Load Resistance Training: The Effect of 24 Weeks Detraining on Serum Brain Derived-Neurotrophic Factor (BDNF) in Older Adults. J Frailty Aging. 2017;6(1):53-58. doi: 10.14283/jfa.2017.2.
Clinical trial NCT04130841: Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
Official title: Effects of Internal Limiting Membrane Peeling on Visual Function in Epiretinal Membrane Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease
Epiretinal Membrane
Keywords: Internal limiting membrane peeling
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 135
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The patients who are diagnosed with idiopathic epiretinal membrane and scheduled to undergo epiretinal membrane removal will be treated with conventional vitrectomy and the epiretinal membrane will be removed. After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Age equal to or older than 19 years
* Patients diagnosed with idiopathic epiretinal membrane and scheduled to undergo the epiretinal membrane removal surgery

Exclusion Criteria:

* Accompanied with retinal vascular disease or intraocular inflammation
* Prior treatment with vitrectomy in the study eye
* History of glaucoma

Primary outcomes:
measure: Epiretinal membrane recurrence
timeFrame: 12 months after the surgery
Secondary outcomes:
measure: Best-corrected visual acuity
timeFrame: 12 months after the surgery
measure: M-chart
timeFrame: 12 months after the surgery
measure: Aniseikonia
timeFrame: 12 months after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Associate Professor
name: Un Chul Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647841: Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Pregnancy
Malnutrition
Cachexia
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 218
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+ and HIV- women and their infants attending a semi-rural clinic and/or rural dispensaries for their antenatal and early infancy care in north western Tanzania

Brief summary: The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of northern Tanzania affect fetal growth, pregnancy outcomes and early infant health and development. The study hypothesis is that HIV+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.


Eligibility criteria: Inclusion Criteria:

* Informed consent provided by mothers, and parental consent on behalf of their infants
* Confirmed HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
* Estimated gestational age between 12th and 34th weeks
* Stated intention to remain in the clinic catchment area ≥6 months post-partum
* Singleton birth

Exclusion Criteria:

* None

Primary outcomes:
measure: Maternal cachexia score
timeFrame: Up to 1 month post-partum
Secondary outcomes:
measure: Maternal anthropometric measures
timeFrame: Up to 1 month post-partum
measure: Fetal growth
timeFrame: Up to 1 month post-partum
measure: Pregnancy outcomes
timeFrame: Up to 1 month post-partum
measure: Early infant anthropometrics
timeFrame: Up to 1 month post-partum
Other outcomes:
Locations:
city: Kisesa
country: Tanzania
facility: Kisesa Health Centre
Study officials:
affiliation: Cornell University
name: Joann M. McDermid, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06968741: A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Official title: Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence (SUI)
Keywords: Stress urinary incontinence
Artificial urinary sphincters
Lead sponsor: UroMems SAS
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 140
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, single-arm study


Eligibility criteria: Key Inclusion Criteria:

* Male subjects aged ≥ 22 years old
* Able to read, comprehend and willing to sign an informed consent form
* Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
* Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator

Key Exclusion Criteria:

* Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
* Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
* Currently implanted with an Active Implantable Medical Device (AIMD)
* Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator

Primary outcomes:
measure: Responder rate at 26 weeks post-activation
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
measure: Proportion of subjects reporting change in overall impression of improvement (PGI-I)
timeFrame: 26 weeks
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: UroMems SAS
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT01770041: Paracetamol Metabolism After Liver Surgery
Official title: Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Resection
Paracetamol Administration
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2013-01-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with benign or malignant liver tumours that have been deemed by the hepatobiliary multi-disciplinary team meetiong as requiring surgical intervention.

Brief summary: This observational study will assess the metabolic pathways of paracetamol that are utilised after liver resection.

Detailed description: Paracetamol is normally metabolised by the glucuronidation and sulfation of paracetamol to non toxic end products. If paracetamol is administered in supra-therapeutic doses this pathway becomes saturated and an alternative pathway is utilised. This results in a toxic metabolite called N-acetyl-p-benzoquinone imine (NAPQI). If NAPQI is not metabolised by glutathione to cysteine and mercapturic acid, then NAPQI bind to hepatic cells resulting in necrosis and hepatotoxicity.

Therefore the investigators plan to measure the levels of the paracetamol metabolites in patient undergoing liver resection.

Patients will undergo liver resection according to their onco-surgical requirements. As part of the normal post operative care they will receive 1g paracetamol every six hours unless stated otherwise by the operating surgeon. Urinary samples will be taken for the first 4 post operative days and used for analysis of the urinary paracetamol metabolite levels.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing liver surgery

Exclusion Criteria:

* Contra-indication to paracetamol
* Inability to give written, informed consent.
* Jaundice (Bilirubin \> 100 μmol/L).
* Liver resection combined with secondary surgical procedure.
* Age \< 18 years.
* Pregnant women.

Primary outcomes:
measure: Urinary cysteine
timeFrame: Post operative days 1-4
Secondary outcomes:
measure: mercapturic acid
timeFrame: post operative days 1-4
measure: Glutathione
timeFrame: day of surgery and post operative days 1 and 3
measure: Paracetamol level
timeFrame: day of surgery and post operative days 1 and 3
Other outcomes:
measure: Glucuronamide
timeFrame: Post-operative days 1-4
measure: Sulphate
timeFrame: Post-operative days 1-4
measure: 5-oxoproline
timeFrame: Post-operative days 1-4
measure: Complications
timeFrame: Day of surgery and post-operative days 1-30
measure: Post-operative blood tests (FBC, U&E, LFTs, Coag)
timeFrame: Post-operative dyas 1-7
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
Study officials:
affiliation: University of Edinburgh
name: Michael J Hughes, MBChB
role: PRINCIPAL_INVESTIGATOR
References: