louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05777850: High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
Official title: High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Typical Atrial Flutter
Catheter Ablation
Keywords: Typical Atrial Flutter Cavotricuspid Isthmus
Cavotricuspid Isthmus
High-Power Short-Duration
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 120
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 aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index \>500 at the anterior half of the CTI and \>400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients with cavotricuspid isthmus dependent flutter referred to ablation
* Patients clinically and hemodynamically stable.
* Patients who give informed consent.

Exclusion Criteria:

* Refusal to participate in the register or inability to understand the informed consent.
* Age under 18.
* Patients who have already undergone previous flutter ablation procedures.

Primary outcomes:
measure: Safety primary outcome: incidence of procedure-related complications.
timeFrame: One year
measure: Efficacy primary outcome: typical atrial flutter recurrence.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Doctor Balmis Alicante
state: A
Study officials:
References:
Clinical trial NCT06739850: Identification of Risk Phenotypes for Sarcopenia Using DXA WBC, Anthropometric and MA Among Young Adults
Official title: Identification of Risk Phenotypes for Sarcopenia Using DXA Whole Body Composition, Anthropometric and Muskuloskeltal Analysis Among Young Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sarcopenia
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 221
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This cross-sectional study aims to identify risk phenotypes for sarcopenia among young adults using Dual-energy X-ray Absorptiometry (DXA) for whole-body composition analysis, along with anthropometric and musculoskeletal assessments.

Brief summary: This cross-sectional study aims to identify risk phenotypes for sarcopenia among young adults using Dual-energy X-ray Absorptiometry (DXA) for whole-body composition analysis, along with anthropometric and musculoskeletal assessments. Sarcopenia, characterized by the loss of muscle mass and strength, is a growing concern, particularly among the aging population.

Detailed description: However, early identification in young adults can allow for preventive strategies to improve long-term health outcomes. This study, involving 221 participants aged 15 to 35, focuses on assessing the correlation between DXA-derived body composition, musculoskeletal fitness, and anthropometric measurements with sarcopenia risk. Primary outcome measures include DXA imaging and dynamometry for body composition and strength evaluation, while secondary outcomes focus on detailed anthropometric and musculoskeletal analyses. By addressing early risk factors in younger populations, this research hopes to enhance understanding of sarcopenia's development and support early intervention strategies. Data collection is conducted at the Center of Nuclear Medicine in Lahore, Pakistan.

Eligibility criteria: Inclusion Criteria:

* Young Adults ( between 15-35) (7)

Exclusion Criteria:

* Elderly Patients
* Children below the age of 18 Years
* Diagnosed Malignancy
* Diagnosed Patients
* Diseased Individuals such as Chronic Illness and Malignancies

Primary outcomes:
measure: DXA
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: CENUM Center Mayo Hospital Rd, Anarkali Bazaar
state: Punjab
Study officials:
References:
Clinical trial NCT01773850: Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
Official title: Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: breast cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-23
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical breast biopsies for lesions detected on mammograms.

Brief summary: The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.


Eligibility criteria: Inclusion Criteria:

* Women at least 18 years old.
* Scheduled for breast biopsy of at least one breast lesion.
* Lesion detected on mammogram.
* Symptomatic by patient self-report, patient self-breast exam or clinical exam.
* Able to provide informed consent.

Exclusion Criteria:

* Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents \<1% of newly diagnosed breast cancer)
* Less than 18 years of age.
* Patient unable to give consent.
* Institutionalized subject (prisoner or nursing home patient).
* Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating

Primary outcomes:
measure: Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
timeFrame: approximately 18 months
Secondary outcomes:
measure: Reader preference - arbitrary units
timeFrame: approximately 18 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yueh Z Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Cherie M Kuzmiak, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qian X, Tucker A, Gidcumb E, Shan J, Yang G, Calderon-Colon X, Sultana S, Lu J, Zhou O, Spronk D, Sprenger F, Zhang Y, Kennedy D, Farbizio T, Jing Z. High resolution stationary digital breast tomosynthesis using distributed carbon nanotube x-ray source array. Med Phys. 2012 Apr;39(4):2090-9. doi: 10.1118/1.3694667.
Clinical trial NCT05797350: Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Official title: Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Al Watany Eye Hospital
Sponsor class: OTHER
Collaborators: name: Moorfields Eye Hospital Centre Abu Dhabi
First posted: 2023-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing the efficacy and safety of Paul glaucoma implant and Ahmed glaucoma valve in refractory childhood glaucoma patients

Detailed description: A prospective randomized controlled trial was conducted at Al Watany Eye Hospital in Egypt. Patients with refractory primary or secondary childhood glaucoma who glaucoma specialist has decided to perform a tube implant to control their intraocular pressure are randomized to receive either Paul or Ahmed glaucoma drainage devices.

Patients will be followed up for at least one year during which the following data are collected.

Age, sex, laterality, preoperative and postoperative intraocular pressure and glaucoma medications at 1,3,6, 9, and 12 months visits. Any intraoperative or postoperative complications will be recorded

Eligibility criteria: Inclusion Criteria:

* Childhood glaucoma patients (whether primary or secondary) including Juvenile open angle glaucoma if the age at the time of surgery was ≤18 years.
* The included patients are those with refractory glaucoma who require a tube to control their intraocular pressure.

Exclusion Criteria:

* Any patient with incomplete data or has a follow-up less than 1 year will be excluded from the study.

Primary outcomes:
measure: IOP Reduction
timeFrame: 1 year
Secondary outcomes:
measure: Glaucoma Medication Alterations
timeFrame: 1 year
measure: Post-operative complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maadi eye subspeciality center
Study officials:
References:
Clinical trial NCT05016050: Digital Therapeutic for Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD)
Official title: A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major Depressive Disorder(MDD)and Generalized Anxiety Disorder(GAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Generalized Anxiety Disorder
Keywords: depression
anxiety
Lead sponsor: Happify Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 367
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.

Detailed description: This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.

Eligibility criteria: Inclusion Criteria:

1. Adults 22 years or older at the time of screening
2. Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder
3. Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
4. Currently residing in the United States

Key Exclusion Criteria:

1. Risk of suicide or has attempted suicide within 24 months of the screening visit
2. Moderate to severe substance use disorder
3. Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder
4. Currently pregnant or planning to become pregnant during the treatment period

Note: Other protocol-defined inclusion/exclusion criteria applied.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline to end of treatment (8-10 weeks)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline to end of treatment (8-10 weeks)
Secondary outcomes:
measure: PHQ-9
timeFrame: Through study completion, average of 14 months
measure: GAD-7
timeFrame: Through study completion, average of 14 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Happify Health (Remote)
state: New York
Study officials:
affiliation: Duke University
name: Roger Vilardaga, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434250: Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy
Official title: Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Ocular Hypertension
Cataract
Keywords: Open angle glaucoma
Ocular hypertension
Cataract
Selective Laser Trabeculoplasty
Eximer Laser Trabeculectomy
Phacoemulsification Cataract Extraction
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 203
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 aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.

Detailed description: This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.

Eligibility criteria: Inclusion Criteria:

* diagnosis of open angle glaucoma or ocular hypertension
* and diagnosis of cataract

Exclusion Criteria:

* diagnosis of angle closure glaucoma
* any optic neuropathy other than glaucoma

Primary outcomes:
measure: Efficacy intraocular pressure
timeFrame: t0 and t=12 month
measure: Efficacy medication
timeFrame: t0 and t=12 month
Secondary outcomes:
measure: Efficacy visual acuity
timeFrame: t0 and t=12 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Ophthalmology
state: ZH
Study officials:
affiliation: UniversityHospital Zurich, Dept. of Ophthalmology
name: Marc Toeteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05627050: AR Training Platform at Home
Official title: Online AR Training Platform for the Elderly and Persons With Chronic Diseases at Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Chronic Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Video Communications, like ZOOM, have been widely used in the time of this epidemic. But how about to design an AR / VR communication system with coaching from clinician to facilitate training at home in this time of epidemic. Vulnerable individuals at home can interact with the training platform and his/her clinician can provide online training progamme with guidance.


Eligibility criteria: Inclusion Criteria:

1. age \>=65 years old or suffering from chronic disease;
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study MoCA\> 21); and
3. Home setting: TV with HDMI input, internet access, and a distance of 1.5m away from TV.

Exclusion Criteria:

1. Any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopaedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker / joint;
2. Severe shoulder or arm contracture/pain;
3. Severe knee or hip contracture/pain;
4. Pregnant women

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 6-month after the first training
Secondary outcomes:
measure: The 12-item Short Form Survey
timeFrame: 6-month after the first training
measure: Barthel Index
timeFrame: 6-month after the first training
measure: Berg Balance Scale
timeFrame: 6-month after the first training
measure: Modified Ashworth Scale
timeFrame: 6-month after the first training
measure: Functional Ambulation Category Test
timeFrame: 6-month after the first training
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, The Chinese University of Hong Kong
name: Raymond Kai-yu Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05083650: Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
Official title: Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Large MHs (diameter \> 550 μm)
Primary purpose: TREATMENT

Brief summary: Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter \> 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.

Detailed description: Interventional study in large macular holes (diameter \> 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.

Eligibility criteria: Inclusion Criteria:

* Not myopic patients (\<6 Dioptre or \<26 mm)
* Large macular hole \>550 μm
* \> 6 months symptoms
* Signing informed consent

Exclusion Criteria:

* Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
* Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
* Patients with ocular surgery

Primary outcomes:
measure: % of macular hole clousure measured with OCT
timeFrame: 6 months
Secondary outcomes:
measure: Best-corrected visual acuity measured with Snellen Chart
timeFrame: 6 months
measure: Superficial and deep retinal capillary plexus density with OCT-A
timeFrame: 6 months
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Instituto de Oftalmologia Conde de Valenciana
Study officials:
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Daniel Rios Esquer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Ishtar A Astorga Carballo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Jose L Rodriguez Loaiza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Zita Chao Loyo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Felipe Esparza Correa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03599050: Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
Official title: Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications.


Eligibility criteria: Inclusion Criteria:

* PCPs and nurses will be enrolled if they fulfill the following criteria:

  1. male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic
  2. age 18 years or older.

No exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.

* Patient eligibility criteria include:

  1. receiving care at the participating clinic
  2. having uncontrolled HTN (BP\>140/90 mmHg) at two visits in the past year
  3. being prescribed at least one antihypertensive medication and are non-adherent
  4. are ≥age 18 years
  5. fluent in English

Exclusion Criteria:

* Unable to give consent
* Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,
* Participating in another HTN-related study.

Primary outcomes:
measure: Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit
timeFrame: 6 Months
measure: Acceptability measured by % of nurses who complete the simulation
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Schoenthaler, MD
role: STUDY_DIRECTOR
References: