louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00819442: Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis
Official title: Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dilated Cardiomyopathy
Keywords: heart failure
desmin
ubiquitin
Lead sponsor: Ministry of Scientific Research and Information Technology, Poland
Sponsor class: OTHER_GOV
Collaborators: name: Polish Academy of Sciences
First posted: 2009-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is evaluation of expression of desmin in cardiomyocytes of patients with idiopathic dilated cardiomyopathy. Analysis of relationship between desmin expression and activities of mitochondrium and expression of ubiquitin.


Eligibility criteria: Inclusion Criteria:

* idiopatic dilated cardiomyopathy, NYHA I, II, III, IV
* dilated left ventricle
* ejection fraction below 45%

Exclusion Criteria:

* diabetes mellitus
* kidney failure (GFR \< 30, creatinine below 2,5 mg/dl

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: qualitative differences in desmin expression in cardiomyocytes of patient with heart failure
timeFrame: one year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Central Hospital of Ministry of Internal Affairs and Administration
Study officials:
References:
Clinical trial NCT00671242: Angiogenesis With Positron Emission Tomography (PET) Tracer Uptake
Official title: Correlation of Angiogenesis With 18F-FMT and 18F-FDG Uptake in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angiogenesis
Non-Small Cell Lung Cancer
Keywords: Fluorine-18-α-methyltyrosine,
Positron emission tomography,
Fluorine-18-fluorodeoxyglucose,
Lung cancer,
Angiogenesis
The median VEGF rate was 45% (range, 10-78%).
High expression was seen in 30 patients (81%, 30/37).
VEGF expression was statistically associated with progressively growing microvessel count.
Lead sponsor: Gunma University
Sponsor class: OTHER
Collaborators: name: J~pharma
First posted: 2008-05-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Purpose: L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT and 18F-FDG uptake in the patients with non-small cell lung cancer (NSCLC).

Method: Thirty-seven NSCLC patients were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. Uptake of PET tracers was evaluated with standardized uptake value. VEGF, CD31, CD34, LAT1 and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical staining, and correlated with the clinicopathologic variables and the uptake of PET tracers.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent a thoracotomy within 4 weeks after 18F-FMT PET and 18F-FDG PET study
* Histology is non-small cell lung cancer

Exclusion Criteria:

* Patient who received neoadjuvant chemotherapy or radiotherapy before surgery
* Patients who have insulin-dependent diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: showa-machi, Maebashi, Gunma
country: Japan
facility: Gunma University Graduate School of Medicine
Study officials:
References:
citation: Kaira K, Oriuchi N, Shimizu K, Ishikita T, Higuchi T, Imai H, Yanagitani N, Sunaga N, Hisada T, Ishizuka T, Kanai Y, Endou H, Nakajima T, Endo K, Mori M. Correlation of angiogenesis with 18F-FMT and 18F-FDG uptake in non-small cell lung cancer. Cancer Sci. 2009 Apr;100(4):753-8. doi: 10.1111/j.1349-7006.2008.01077.x. Epub 2009 Jan 12.
Clinical trial NCT00484042: Activation of Polyamine Catabolism in Patients With Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Polyamines
Keywords: pancreatitis
polyamine
cytokine
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-06-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Background: Polyamines are essential compounds in all mammalian tissues. If tissue spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the other hand, our own data suggests that also in other models of acute experimental pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels. Minor changes were observed also in rats undergoing sham operation only. In addition of pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of the disease, combination of IL-6 and IL-10 at admission can predict organ failure with sensitivity of 95 %, specificity of 88 %.

Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with acute pancreatitis also in the man. These changes are dependent on the severity of pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute pancreatitis compared with other intra-abdominal emergencies. The changes observed return to baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates with IL-6, IL-8, and procalcitonin, and positively with IL-10.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed as acute pancreatitis.
* Patients who are diagnosed as either of gallstone, duodenal ulcer or bleeding, gastric ulcer or bleeding, irritable bowel syndrome, hernia, diverticulitis, retrocecal appendicitis with non-pancreatic acute abdominal pain.

Exclusion Criteria:

* Patients who underwent operation
* Patients who underwent recurrent acute pancreatitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tampere University Hospital
name: Isto H Nordback, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394042: Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint
Official title: Exploratory Evaluation of a Transrectal Scintigraphic Detector (Proxiscan) for Detection of Primary Prostate Cancer Utilizing a Radiotracer Targeting Prostate Specific Membrane Antigen (PMSA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: Biopsy proven primary prostate cancer
Lead sponsor: Radiological Associates of Sacramento Medical Group Inc.
Sponsor class: OTHER
Collaborators: name: Hybridyne Imaging Technologies
First posted: 2011-07-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.


Eligibility criteria: Inclusion Criteria:

* Primary prostate cancer proven by sextant prostate biopsy
* Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
* Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
* In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
* ECOG status of 0 or 1 Pt \> 18 yrs of age

Exclusion Criteria:

* Definitive or concomitant therapeutic intervention within the interval of study intervention
* Prior pelvic therapeutic radiation
* Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
* Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
* Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products

Primary outcomes:
measure: Detection of PSMA antibody (ProstaScint)uptake patterns measured by Proxiscan in comparison with anatomic biopsy reports, conventional SPECT and MRI scans within one month of Proxiscan
timeFrame: Within on month of scan and corresponding MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Roseville PET and Nuclear Imaging Center
state: California
Study officials:
affiliation: Radiological Associates of Sacramento Medical Group Inc.
name: Benjamin Franc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06837870: Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
Official title: A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vascular Closure
Pacemaker Implantation
Leadless Pacemaker
Keywords: perclose
percutaneous closure
leadless pacemaker
venous access
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and older
* Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
* Subjects able to understand and provide written informed consent.

Exclusion Criteria:

* Patients who are pregnant
* Patents who are not able to ambulate prior to the procedure
* Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
* Prisoners or wards of the state.

Primary outcomes:
measure: Time to Hemostasis
timeFrame: During the procedure.
Secondary outcomes:
measure: Time to discharge eligibility
timeFrame: Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.
measure: Major access related complications
timeFrame: 0 and 30 days
measure: Minor access related complications
timeFrame: 0 and 30 days
measure: Patient reported outcomes
timeFrame: 0 and 30 days
measure: Costs
timeFrame: 0 and 30 days
Other outcomes:
measure: Time to Ambulation
timeFrame: Periprocedurally. Periprocedurally, from day 0 up to discharge; typically 0-1 days but up to the time of hospital discharge.
Locations:
Study officials:
References:
Clinical trial NCT03160170: Efficacy of Suction Enabled Retraction Device
Official title: Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Blood Loss
Spinal Surgery
Keywords: open lumbar spine surgery
operative time and efficiency
Suction-Integrated Surgical Tissue Elevator and Retractor
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Ludwig Medical Corporation
First posted: 2017-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue

Elevator \& Retractor \[SISTER\] device to assess:

* Effects on operative time and efficiency of exposure in open lumbar spine cases.
* Effect on total blood loss during the exposure part of the operation.
* Rate of clogging of suction device.

Detailed description: The device, Suction-Integrated Surgical Tissue Elevator \& Retractor \[SISTER\], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Patients undergoing lumbar one to sacral one open instrumentation
* Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine

Exclusion Criteria:

* Less than 22 years old
* Procedure does not involve instrumentation
* Prior lumbar spine surgery involving more than one level
* BMI less than 20 or greater than 35
* Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand)
* Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix)
* Operative cases where a single surgeon performs both sides of exposure
* Pregnant women
* Prisoners
* Adults unable to consent

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: 1.5 hours
Secondary outcomes:
measure: Time of Exposure
timeFrame: 1.5 hours
measure: Rate of Clogging
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Ian Cõté, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01848470: Multiple Ascending Doses Study of CG400549
Official title: Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of Multiple Ascending Doses of CG400549 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.

Detailed description: This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Eligibility criteria: Inclusion Criteria:

* Age:18-55 years, inclusive
* Body Mass Index :19-30 kg/m2, inclusive
* Sex:male
* Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day

Exclusion Criteria:

* Evidence of clinically relevant pathology
* History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
* Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From Time the ICF is signed until Follow up Visit (15 days after study drug administration)
Secondary outcomes:
measure: Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h)
timeFrame: Day1 and Day5
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA International clinical center
Study officials:
affiliation: CrystalGenomics, Inc.
name: Seonggu Ro, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03256370: Association of HMOs and Allergic Manifestations
Official title: The Association Between Human Milk Oligosaccharide and Development of Allergic Manifestations in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Milk Oligosaccharides, Allergic Manifestation
Keywords: Allergic manifestation, Human milk oligosaccharides, Breast Milk
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 150
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal term children (born after 37 weeks gestation) from low risk healthy pregnant women aged 18-40 years divided to 3 groups i. Allergic groups : infants with allergic manifestation ii. High risk control groups : atopic mother with infant no disease iii. Healthy control groups : non- atopic mother with infant no disease

Brief summary: Compare the HMO composition in breast milk of infants with allergic manifestation (atopic dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic mother and healthy infants with non-allergic mother.

Detailed description: * Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project
* After completed informed consent, demographic data was collected and filled in case record form
* Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis

Eligibility criteria: Inclusion Criteria:

1. mothers with breast-fed infant with or without allergic manifestation
2. Intend to participate for follow up and sign consent to participate in the study

Exclusion Criteria:

1. Mothers with any medical illness or high risk infant pregnant
2. Infants with disease which affected allergic disease
3. No inform consent
4. Anything in the opinion of the investigator that would prevent children from completing the study

Primary outcomes:
measure: Atopic dermatitis
timeFrame: first 2 years of life
measure: IgE mediated food allergy
timeFrame: first 2 years of life
measure: Non-IgE mediated food allergy
timeFrame: first 2 years of life
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Chulalongkorn University
state: Bangkok
Study officials:
References:
Clinical trial NCT00661570: Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
Official title: Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Laryngectomy
Keywords: laryngectomy
larynx cancer
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: The Netherlands Cancer Institute
First posted: 2008-04-18
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.


Eligibility criteria: Inclusion Criteria:

* total laryngectomy
* use Provox2 voice prosthesis
* at least two prior prosthesis changes

Exclusion Criteria:

* current puncture problems (f. ex. infection)

Primary outcomes:
measure: Device Life Time
timeFrame: at replacement of voice prosthesis (maximum 1 year)
Secondary outcomes:
measure: Voice Quality
timeFrame: at 3 months or device change (whichever was first)
measure: Ease of Insertion
timeFrame: assessed immediately after insertion procedure
measure: Reason for Replacement
timeFrame: At removal of prosthesis
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: Noord-Holland
Study officials:
affiliation: The Netherlands Cancer Institute
name: Frans JM Hilgers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Cancer Institute
name: Michiel WM van den Brekel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05240170: RIRS for Treatment of Stones in Congenital Anomalous Kidneys
Official title: Retrograde Intrarenal Surgery for Treatment of Stones in Congenital Anomalous Kidneys: Case Matched Comparative Study With Extracorporeal Shockwave Lithotripsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Calculi
Renal Anomaly
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 1st group: RIRS The 2nd group: SWL
Primary purpose: TREATMENT

Brief summary: The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.

Detailed description: In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.

Eligibility criteria: Inclusion Criteria:

* The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.

Exclusion Criteria:

* Pregnant women.
* Uncorrectable coagulation disorders.
* Urinary tract obstruction distal to the stone.
* Active infection.
* Stone in a calyceal diverticulum

Primary outcomes:
measure: Stone-free rate
timeFrame: 3-months after the intervention.
Secondary outcomes:
measure: Complication rate
timeFrame: intraoperative till 3 months postoperative complications
measure: operative time
timeFrame: the procedure time
measure: Re-treatment rate
timeFrame: during the post-operative 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology Department, Al-Azhar University Hospital
Study officials:
affiliation: Al-Azhar University Hospitals, Cairo, Egypt
name: Abul-fotouh Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: