louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06129799: Exercise CMR in (p)LF-LG AS
Official title: Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis, Severe
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients prior to TAVR

Brief summary: Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.


Eligibility criteria: Inclusion Criteria:

* paradoxical or conventional severe low-flow low-gradient aortic stenosis

Exclusion Criteria:

* CMR incapable device
* unable to undergo 40 min scan (can not lie flat, claustrophobia)
* renal insufficiency (eGFR \<30 ml/min/1.73m²)
* allergy against contrast agent
* unable to exercise in supine position

Primary outcomes:
measure: Composite of events: number of participants with cardiovascular death or heart failure hospitalisation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Hospital Goettingen
Study officials:
References:
Clinical trial NCT01284699: Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Official title: Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
With Inclusion Criteria for STN Deep Brain Stimulation
Presenting a Contraindication to Intracerebral Electrode Implantati
Keywords: Parkinson
contraindication to Intracerebral electrode implantation
Gamma Knife radiosurgery
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.

Detailed description: Subthalamic nucleus (SNT) deep brain stimulation (DBS) is the reference treatment for severe drug resistant Parkinson's disease, responsible to dopaminergic therapy, to the state of complication. The efficacy of this therapeutic approach has transformed the functional prognosis of these patients. Unfortunately, those of the patients presenting with contraindications for anaesthesia or electrode implantation are excluded of these therapeutic hope.

Gamma Knife radiosurgery is a neurosurgical procedure going to operate in the brain of the patients without opening the skull without infection or bleeding risk.

Gamma Knife radiosurgical treatment will be done in two separate times (GK1 and GK2). Treatment of the second side (GK2) will be done at least 12 months after the treatment of the first side (GK1), in the same methodology as the first treatment. The major risk of onset of acute ballism although low is planned to be managed by the standard protocol by the recruiting team involved in the trial.

Eligibility criteria: Inclusion Criteria:

* patients presenting with contraindications for anaesthesia or electrode implantation

Exclusion Criteria:

* contraindications for a surgical treatment
* Pregnant or breast-feeding women

Primary outcomes:
measure: Evaluation of the safety and efficacy
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
affiliation: APHM
name: Jean -Marie REGIS, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00698399: Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients
Official title: Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients, Phase II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Keywords: liver
transplant
TMAO
NGAL
cystatin-C
Ischemia Reperfusion Injury
Liver Transplant
LTx
allantion
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2008-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from those on the list awaiting liver transplantation at Vanderbilt University Medical Center (VUMC). They will be recruited by the investigators prior to the time of their transplantation surgery

Brief summary: This is an observational study examining serum markers in patients who are undergoing either a cadaveric liver transplant or a living related liver transplant.

Detailed description: The Departments of Anesthesiology are conducting an observational trial of markers in the serum of patients who are undergoing liver transplantation surgery. This study will utilize the biological markers, trimethylamine-N-oxide (TMAO), NGAL, and cystatin-C, sensitive markers of renal medullary injury in the blood and allantoin, a marker of oxidative stress as indicators of renal injury in a kidney during liver transplants. It is hypothesized that: (1) these markers are less pronounced in living donor liver transplant recipient patients than in cadaveric liver transplant recipients, and (2) these markers are less pronounced in cadaveric liver transplant recipients in which a "piggy-back" technique was used versus recipients in which a total venous occlusion technique was used. This study will be done in a multi-center format, along with researchers at UCSF

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class I-V.
* Patient is undergoing elective Liver Transplant Surgery.
* Patient is an adult, 18 years old or older.

Exclusion Criteria:

* Patients \< 18 Years of Age
* Patients who are pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jeffrey M Waldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01518699: Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Effect of Ha44 Gel on the ECG in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediculosis
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.

Detailed description: This study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult subjects (total of 57 subjects).

Eligibility criteria: Inclusion Criteria:

* healthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (BMI) of 18 to 33 kg/m2,
* Female subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods
* The subject has normal 12-lead ECG results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator).

Exclusion Criteria:

* has evidence of cardiac conduction abnormalities
* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age
* potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
* laboratory test results at Screening are \>2 x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), \>1.5 x ULN for bilirubin, or \>1.5 x ULN for creatinine
* history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
* febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week before clinic admission
* supine mean systolic blood pressure \<90 or \>140 mmHg and a mean diastolic blood pressure \<50 or \>90 mmHg
* positive for HIV or hepatitis C antibody or hepatitis B antigen (HBsAg)

Primary outcomes:
measure: Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical
state: Wisconsin
Study officials:
affiliation: Spaulding Clinical
name: Albert Dietz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05938699: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution
Official title: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution - A Double-Masked, Placebo-Controlled, Phase 3b Clinical Trial (Whistler)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Open Angle Glaucoma
Keywords: glaucoma
NCX 470
nitric oxide
prostaglandin analogue
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
2. Either gender
3. Subjects without glaucoma
4. Qualifying IOP at Screening Visit

Exclusion Criteria:

1. Narrow anterior chamber angles or disqualifying central corneal thickness in either eye
2. Clinically significant ocular disease in either eye
3. Uncontrolled systemic disease
4. Serious hypersensitivity to topical anesthetic eye drops
5. Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications

Primary outcomes:
measure: Change in AHD
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT00223899: A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Official title: A Phase 1, Multi-Center, Open-Label, Dose-Escalation Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Melanoma
Keywords: Melanoma
Electroporation
IL-2
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followed by electroporation.

Detailed description: Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s).

Subjects will be enrolled to receive one course of treatment. A course of treatment is two cycles, each cycle consisting of four weekly injection/electroporation administrations followed by an observation period of two weeks.

Subjects' tumors will be evaluated at Screening, at the end of Cycle 2, and at six months (Week 26) from the initial drug administration.

Eligibility criteria: Inclusion Criteria - Key criteria include:

* Confirmed recurrent metastatic melanoma
* Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
* Able to carry out normal daily activities and light work without assistance
* Not currently receiving chemotherapy or immunotherapy
* Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
* Able and willing to give informed consent.

Exclusion Criteria - Key criteria include:

* History of brain tumors (resected or stereotactically treated is allowed)
* History of liver tumors
* Subjects whose melanoma can be cured by surgery
* Pregnant
* Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.

Primary outcomes:
measure: Safety of intratumorally injected VCL-IM01 followed by electroporation in subjects with recurrent metastatic melanoma
timeFrame: After all subjects have been enrolled
Secondary outcomes:
measure: Overall response rate, duration of response, treated tumor response rate, assessment of injected tumor(s) for induration, inflammation, and erythema, and serum levels of IL-2.
timeFrame: After all subjects have been enrolled
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Location #2
state: Alabama
city: Denver
country: United States
facility: Location #3
state: Colorado
city: Chicago
country: United States
facility: Location #1
state: Illinois
city: Montclair
country: United States
facility: Location #4
state: New Jersey
Study officials:
affiliation: Vical
name: Dmitri D. Kharkevitch, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05275699: Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Official title: Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Keloid
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.

Detailed description: Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. The progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation.

Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment, and follow-up of keloid.

This study aims to explore whether FAP plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: FAPI expression and SUV
timeFrame: through study completion, an average of 1 year
measure: therapy response
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00153699: Relationship Between Topiramate Use and Ocular Angle Status
Official title: Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma, Angle-Closure
Keywords: Side effects
Topiramate
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Eye Hospital
First posted: 2005-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.

Detailed description: Topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. There were case reports of acute angle closure glaucoma (AACG) associated with its use. AACG is particularly common in Asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from AACG.

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-75 with an indication for starting topiramate.

Exclusion Criteria:

* Patients with known allergy or intolerance to topiramate.
* Recent exposure to topiramate (\<3 months).
* Moderate to severe renal failure.
* Known history of renal calculi or hepatic failure
* Inability to give informed consent.
* Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception.
* Patients known to have angle-closure glaucoma.

Primary outcomes:
measure: Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
timeFrame: 4 weeks
measure: best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
timeFrame: 4 weeks
measure: and ultrasound biomicroscopy of angle and anterior segment.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Eye Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Hong Kong Eye Hospital
name: Dexter YL Leung, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Howan Leung, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01752699: Methadone in Post-Herpetic Neuralgia Pain
Official title: Methadone in Post-Herpetic Neuralgia Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-herpetic Neuralgia
Keywords: neuropathic pain,
post-herpetic neuralgia,
methadone,
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 10
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: Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic (\>6 months) symptomatic PHN
* with visual analogical scale \>40/100mm
* use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)

Exclusion Criteria:

* Don't full the criteria above

Primary outcomes:
measure: Change in baseline Pain
timeFrame: baseline (visit inclusion) and three moths latter
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.