louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02573272: Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Official title: Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with focal epilepsy on stable treatment for the last two years

Brief summary: Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests.
* patients with stable and identifiable antiepileptic treatment during the last two years.
* patients according to the investigator are able to provide clinical data necessary for the development of the study
* Patients who signed informed consent

Exclusion Criteria:

* Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.

Primary outcomes:
measure: Carotid IMT millimeters
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital Torrecardenas
state: Almeria
Study officials:
References:
Clinical trial NCT06760572: Airway Data Collection With the Entarik Feeding Tube System
Official title: Airway Data Collection With the Entarik Feeding Tube System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Feeding Tube
feeding tube placement safety
feeding tube placement
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.

Detailed description: The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years old.
2. Able to provide informed consent.
3. Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.

Exclusion Criteria:

1. Known major upper airway malformation.
2. Presence of clinically significant respiratory infection.
3. Known bleeding disorder.
4. Currently pregnant.
5. Current basilar skull fracture.
6. Known sensitivities or allergies to the feeding tube components.
7. Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.

Primary outcomes:
measure: Percentage of accurate airway verifications by the Entarik feeding tube system
timeFrame: During the airway placement procedure
measure: Incidence of Adverse Events
timeFrame: During the airway placement procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Theranova, LLC
name: Daniel Burnett, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01529372: REnAL denervatIon by ultraSound Transcatheter Emission
Official title: REnAL denervatIon by ultraSound Transcatheter Emission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Hypertension
Keywords: Hypertension
Blood pressure
Renal denervation
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 20
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: The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.


Eligibility criteria: Inclusion Criteria:

* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
* 18 years of age or older
* Negative pregnancy test for female patients of childbearing potential
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary hypertension
* Main renal arteries length \< 20 mm
* Main renal arteries diameter \< 4 mm
* Renal artery stenosis
* Iliac/femoral artery stenosis precluding insertion of the catheter
* Allergy to contrast media
* Currently participating in the study of an investigational drug or device
* Hemodynamics abnormality
* Moderate to severe renal insufficiency

Primary outcomes:
measure: Percentage of successful interventions
timeFrame: Up to 24 hours
measure: Percentage of patients with device- or procedure-related adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in ambulatory blood pressure
timeFrame: 12 months
measure: Change from baseline in anti-hypertensive medication intake
timeFrame: 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Université de Toulouse et CHU
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
state: Île-de-France
Study officials:
affiliation: Hôpital Pitié-Salpêtrière
name: Gilles Montalescot, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01035372: Pilot Study on the Tolerability of Dietary Dried Plum
Official title: Pilot Study on the Tolerability of Dietary Dried Plum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Elderly
Keywords: healthy older people
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Dried plums (Prunus domestica L.) have traditionally been recognized for their health benefits related to conditions such as constipation, irregular menstrual cycles and mouth sores. This dried fruit provides high levels of fiber, vitamins and minerals. Dried plum has also been shown in animal studies to have beneficial effects on bone and can prevent the loss of bone caused by low hormone levels such as occurs after surgical removal of the ovaries. We also have shown that dried plum can prevent the loss of bone associated with aging in mice. Very few therapies for osteoporosis actually reverse bone loss and improve bone strength. The potential therapeutic value of dried plum in men and women with hormone deficiency or age-related osteoporosis is clear.


Eligibility criteria: Inclusion Criteria:

* Age between 50 yrs and 75 yrs
* Nonsmokers
* Normal renal and hepatic function

Exclusion Criteria:

* Subjects who must follow a specific diet
* Subjects on any daily medications that affect bone health
* Subjects too heavy for the DEXA machine (weight limit 300 lbs)
* Subjects whose BMD by DEXA indicates osteoporosis
* Subjects unwilling to follow the diet specified
* Pregnant women
* Subjects who are unable to understand the consent form.

Primary outcomes:
measure: urinary calcium excretion
timeFrame: one month
Secondary outcomes:
measure: ability to tolerate the diet
timeFrame: one month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: SFVAMC
name: Bernard Halloran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deyhim F, Stoecker BJ, Brusewitz GH, Devareddy L, Arjmandi BH. Dried plum reverses bone loss in an osteopenic rat model of osteoporosis. Menopause. 2005 Nov-Dec;12(6):755-62. doi: 10.1097/01.gme.0000185486.55758.5b. Epub 2005 Nov 8.
Clinical trial NCT00384072: Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Official title: A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopause
Osteoporosis
Keywords: postmenopausal
women
SERM
osteoporosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-04
Enrollment: 500
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.


Eligibility criteria: Inclusion Criteria:

1. Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
2. Subjects must qualify for one of the following categories (a or b):

   1. Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
   2. Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor

Exclusion Criteria:

1. One (1) or more osteoporotic vertebral fractures (T4 - L4)
2. BMD T-score at the lumbar spine or femoral neck less than -2.5
3. Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis

Primary outcomes:
measure: The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary outcomes:
measure: Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
measure: Serum bone markers at 3 and 6 months
measure: Lipid profile at 3 and 6 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Tianjin
country: China
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Kaohsuing
country: Taiwan
city: Kaoshsuing
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Tapei
country: Taiwan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06453668: A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Official title: A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: ALS
Keywords: Amyotrophic Lateral Sclerosis
Neuroinflammatory
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 48
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.


Eligibility criteria: Key Inclusion Criteria:

* Male or female patients ≥ 18 to 80 years of age.
* Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.
* Patients on existing ALS treatment must have been on a stable dose for 28 days.

Key Exclusion Criteria:

* Patient with severe systemic infections, current or within the two weeks prior to randomization.
* Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
* Use of other investigational products or treatment in another investigational drug study within 30 days of screening
* Pregnant or nursing (lactating) women.

Primary outcomes:
measure: Evaluation of the safety of TCD601 in adult patients with ALS
timeFrame: 12 Months
Secondary outcomes:
measure: Evaluation of the pharmacokinetics (PK)
timeFrame: 12 Months
measure: Correlation of ALS disease status with leucocyte phenotypic profiles
timeFrame: 12 Months
measure: Evaluation of levels of biomarkers
timeFrame: 12 Months
measure: Length of time from trial entry to tracheostomy / death
timeFrame: 12 Months
measure: Assessment of clinically relevant changes in laboratory measurements
timeFrame: 12 Months
measure: Evaluation of pharmacodynamics (PD) of TCD601
timeFrame: 12 Months
measure: Assessment of clinically relevant changes in vital signs
timeFrame: 12 Months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: ITB-Med LLC
name: Fredrik Julin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03691168: Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
Official title: Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inherited Retinal Dystrophies
Keywords: Inherited retinal dystrophies, Gene screen
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inherited retinal dystrophies

Brief summary: Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients with IRDs whose mutations have been identified
2. 4\~70 years old
3. Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG

Exclusion Criteria:

1. Has participated in other interventional treatment studies;
2. Patients with severe systemic diseases, mental dysplasia, mental illness;
3. Unable to accept eye examination patients;
4. Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis
5. At the initial visit, the patient's binocular vision is displayed as no light.
6. Both eyes have a history of internal eye surgery

Primary outcomes:
measure: Visual acuity
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: XiaoDong Sun, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056168: Validation of a Dermatology-Specific Treatment Satisfaction Instrument
Official title: Validation of a Dermatology-Specific Treatment Satisfaction Instrument
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriasis
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Brigham and Women's Hospital
First posted: 2021-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (≥ 18 years) dermatology patients with psoriasis from LAC+USC and Keck Medical Centers, the Brigham and Women's Hospital, and the Mount Sinai Hospital.

Brief summary: The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years)
* Psoriasis patients undergoing some form of treatment

Primary outcomes:
measure: Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: April Armstrong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771368: Reduction of Bacteria in MRSA Positive Ulcers
Official title: A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Leg Ulcer
Pressure Ulcer
Lead sponsor: Nitric BioTherapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: 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 determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers


Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent
* Must be 19 years of age or over
* Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
* Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover

Exclusion Criteria:

* Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Is \< 19 years of age
* Has a clinically infected ulcer
* Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
* Has been using systemic antibiotics during 7 days prior to enrolment into this study.
* Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
* Has an Ulcer / Lesion size beyond the inner borders of the wound cover
* Is septic or has other signs of an invasive infection
* Has used any other investigational product within 30 days preceding study participation.
* Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety.
* Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.
* Has a known allergy to any of the products that are part of this protocol
* Suffers from a condition which, in the opinion of the Investigator, would seriously interfere negatively with the normal parameters of immune response to an infection.
* Is using any of the prohibited concomitant medications or treatments

Primary outcomes:
measure: Reduction in bacteria
timeFrame: Post Treatment Day 3
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 3 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT00006068: Does Islet Transplantation Eliminate Hypoglycemia?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-07-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.


Eligibility criteria: Inclusion Criteria:

* Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: