louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02999906: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Oral Treprostinil
dual therapy
6 Minute Walk Test
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.


Eligibility criteria: Inclusion Criteria:

1. Between 18 and 79 years of age, inclusive
2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired \> 1 year), or appetite suppressant / toxin use
3. Receiving dual therapy (ambrisentan and tadalafil)
4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

1. Nursing or pregnant
2. PAH due to conditions other than noted in the above inclusion criteria
3. Received PAH-specific drug therapy for \>2 years
4. History of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension
5. Participated in an investigational drug or device study within 90 days prior to signing consent.

Primary outcomes:
measure: Change in 6-Minute Walk Distance (6MWD)
timeFrame: Baseline to Week 28
Secondary outcomes:
measure: Compare the effects of triple therapy versus dual therapy on the time to clinical worsening
timeFrame: Baseline to Week 28
measure: Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations From Baseline to Week 28
timeFrame: Baseline to week 28
measure: Number of Participants with a Change From Baseline World Health Organization (WHO) Functional Classification at Week 28.
timeFrame: Baseline to week 28
measure: Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 28.
timeFrame: Baseline to week 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03623906: Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation
Official title: Comparison of Serrated Polyp Detection Rate Between Carbon Dioxide and Air Insufflation During Colonoscopy: a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Serrated Polyp
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 1280
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. These morphological features may account for their diagnostic difficulty during colonoscopy. Missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. There is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. The investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.


Eligibility criteria: Inclusion Criteria:Patients 45-75-years-old who underwent a colonoscopy -

Exclusion Criteria:polyposis syndrome, Inflammatory bowel disease, previous colorectal operation

-

Primary outcomes:
measure: Serrated polyp detection rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01497106: Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Official title: Effects of Calorie Restriction on Accumulation of Old, Modified Proteins in Abdominally Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin resistance
Abdominal obesity
Calorie restriction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 29
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being done to understand the effects of calorie restriction and weight loss on muscle protein metabolism in adult men and women.


Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI will be between 30 kg/m2 - 38 kg/m2 and waist circumference for women ≥ 88 cm and men ≥ 104 cm
* Age 45 to 65 years.
* Male and Female

Exclusion Criteria:

* Active coronary artery disease
* BMI \< 30 kg/m2 Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Smoking
* Medications known to affect muscle metabolism (beta blockers)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (AST and ALT \> 3 times normal)
* Fasting blood glucose \> 126 mg/dl
* Anti-coagulant therapy (warfarin/heparin)

Primary outcomes:
measure: Change in muscle protein synthesis from baseline to 16 weeks
timeFrame: Measured at week 0 (baseline) and week 16
Secondary outcomes:
measure: Change in insulin sensitivity from 0 (baseline) and 16 weeks
timeFrame: Measured at week 0 (baseline) and week 16
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: K. Sreekumaran Nair, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179606: Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus
Official title: A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Correction of Nasolabial Folds
Lead sponsor: Across Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects no younger than 30 and no more than 75 years of age.
2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.\*)

   \*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.
3. Subjects who have symmetric nasolabial folds.

Exclusion Criteria:

1. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
2. Subjects who have a history of bleeding disorder.
3. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.

Primary outcomes:
measure: Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
timeFrame: baseline, week 12
Secondary outcomes:
measure: Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
timeFrame: baseline, at week 2~24
measure: Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved
timeFrame: at week 2~24
measure: 100 mm visual analogue scale (VAS) scores evaluation
timeFrame: week 0
Other outcomes:
measure: Safty evaluation
timeFrame: for 24weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beom Joon Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Jong Hoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05111106: Symfony Intraocular Lens Retrospective Chart Review
Official title: Experience With Symfony Extended Depth of Focus (EDOF) IOL: A Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Cataract surgery
Glaucoma
Retinopathy
Intraocular Lens
Lead sponsor: Austin Eye
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2021-11-08
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18-90 years old) in need of cataract surgery.

Brief summary: Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL.

Detailed description: This was a retrospective chart review conducted at a single US clinical site. Chart review was conducted by John Odette, MD and research assistants. Eligible charts were identified via a clinic database search of cataract surgeries with IOL implantation of the Symfony IOL during the stated date range. Eligible charts included those of patients 18 to 90 years of age who underwent Femto Laser Assisted Cataract Surgery (FLACS) with implantation of a Symfony IOL. Charts were excluded for lack of postoperative follow-up or if Symfony IOL was not implanted. All qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. Visual acuity was evaluated for patients who underwent cataract surgery with implantation of the Symfony IOL from 09/1/2016 to 05/31/2018. Postoperative evaluations at Month 2 included mean monocular uncorrected visual acuity at near (UNVA) at 40 cm, far distance (UDVA) at 20 ft, and with best correction (CDVA). Outcomes were also compared for toric IOLs versus spherical IOL.

Eligibility criteria: Inclusion Criteria:

* :Phacoemulsification cataract surgery with a Symfony IOL.

Exclusion Criteria:

* : Eyes not implanted with a Symfony IOL or unstable refractive results at final post-operative visit

Primary outcomes:
measure: Monocular uncorrected near visual acuity
timeFrame: 2 months
Secondary outcomes:
measure: Monocular best corrected distance visual acuity
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Austin Eye Center
name: John Odette
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090206: Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Official title: Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Hemophilia B
Vitamin D Deficiency
Keywords: Hemophilia
Vitamin D
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2010-03-19
Enrollment: 20
Sex: MALE
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies will be repeated.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Hemophilia A or B
* ages 2-21 years

Exclusion Criteria:

* therapeutic vitamin D or calcium supplementation within 3 months of study entry

Primary outcomes:
measure: Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity
timeFrame: 1year
Secondary outcomes:
measure: Determine bone mass (density) in hemophilia patients
timeFrame: 1 yr
measure: establish dose and duration of treatment with vitamin D
timeFrame: 1 yr
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Gita V Massey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845806: Neuronal Processing of Diacritics: An fMRI Study
Official title: Neuronal Processing of Diacritics: An fMRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuronal Processing of Diacritics
Keywords: Diacritics
Neuronal Processing
fMRI
Arabic
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be male native arabic speakers that can read and write english. All will be healthy with no history of neurological or psychiatric disorders.

Brief summary: The purpose of this study is to determine brain function in reading arabic diacritics.

Detailed description: fMRI is a well established imaging technique that allows investigators to see regional brain function based off of actions like reading, speaking, playing music, etc. Even the type of language and format of that language can change the area of the brain that is active while performing that action. This study is meant to see the areas of the brain that become active both prior to and during the process of reading diacritic markings in arabic.

Eligibility criteria: Inclusion Criteria

Adult patients may be enrolled in this study if they meet the following inclusion criteria:

* Are male and are 18 years or older, inclusive;
* Consent from the patient
* First language is Arabic
* Must be able to speak and read English
* Right handed
* The subject must pass a dyslexia screen test (Attached to consent form).

Exclusion Criteria

Adult patients will be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions have been met:

* Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
* Are undergoing the MR exam in an emergency situation
* People with psychiatric disorders will be excluded from the study.
* Are claustrophobic and can not tolerate the imaging.
* People with neurological diseases
* Are on any medications for psychiatric, neurological, or chronic pain problems.

Primary outcomes:
measure: Observe regional brain function from reading Arabic diacritics
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Medical School Advanced MRI Center
state: Massachusetts
Study officials:
affiliation: UMASS Medical School
name: Mitchell S Albert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858306: SPHERE Per-AF Post-Approval Study
Official title: SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 200
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: Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.

Brief summary: SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.

Detailed description: The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
3. Patient is ≥ 18 years of age
4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
5. Patient is willing and able to comply with study requirements and give informed consent

Exclusion Criteria:

1. Long-standing persistent AF (continuous AF sustained \>12 months)
2. Prior left atrial catheter or surgical ablation
3. Life expectancy \<36 months
4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
5. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic

Primary outcomes:
measure: Primary Safety Objective
timeFrame: Through 180 days Post-Procedure
measure: Primary Effectiveness Objective
timeFrame: Through 36 months Post-Procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05399706: Sex-specific Differences in AAA Complexity
Official title: Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AAA - Abdominal Aortic Aneurysm
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AAA receiving assessment +/- primary open or endovascular repair.

Brief summary: A retrospective cohort study of computed tomography scans of AAA patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (AAA) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

Detailed description: A retrospective cohort study of computed tomography scans of AAA patients considered for repair.

The study aims to, firstly, identify sex specific differences in abdominal aortic aneurysm (AAA) metrics utilising manual and automated image processing techniques; and secondly, if numbers are sufficient, explore the association between features of AAA complexity and adverse patient outcome.

Eligibility criteria: Inclusion Criteria:

* All adult patients with AAA receiving assessment +/- primary open or endovascular repair at participating centre from 1/1/2010 to 31/12/2020.
* Must have AAA \>= 5cm.
* Must have CT imaging within 1 year of operation or definitive turn down for treatment.

Exclusion Criteria:

* Insufficient CT imaging quality (\>3mm slices) or lack of CT within 1 year of operation.
* Insufficient clinical data to establish risk factors or clinical outcomes.
* Ruptured aneurysm, aorto-iliac occlusive disease, isolated iliac aneurysm, penetrating aortic ulcer, dissection, juxta or supra-renal aneurysm.
* Secondary repair/not primary treatment decision for AAA repair.

Primary outcomes:
measure: Sex-specific differences in thrombus burden
timeFrame: Pre-operative CT
measure: Sex-specific differences in anatomical complexity
timeFrame: Pre-operative CT
Secondary outcomes:
measure: Association between anatomical differences and adverse patient outcome for patients receiving operative repair - need for transfusion, risk of vessel injury, ischaemia (bowel or limb), renal injury and re-intervention/endoleak.
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
References: