louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06534671: Diltiazem in Jervell and Lange-Nielsen Syndrome
Official title: Diltiazem in Jervell and Lange-Nielsen Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Jervell and Lange Nielsen Syndrome
Keywords: Long QT syndrome
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 1
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: This study will test the effect of diltiazem, a calcium channel blocking drug, on the QT interval in patients with Jervell and Lange-Nielsen syndrome. This will be a single IV dose and acute effects (within minutes) will be observed.

Detailed description: Subjects will be recruited by study personnel and will be scheduled for a single outpatient visit. If an implanted cardiac device (pacemaker or ICD) is in place, it will be interrogated to ensure no recent rhythm abnormalities. Just prior to administering diltiazem, an ECG and BP will be obtained. If baseline SBP is \< 100 mm Hg or DBP \< 60 mm Hg, the study will be terminated. A single dose of I.V. diltiazem (0.25 mg/kg over 2 minutes) will be administered with 12-lead ECG and BP obtained at 2, 5, 7, 10, 15 and 20 minutes. If at 10 minutes there has been no QT shortening, and the SBP is stable (\<20% drop from baseline and \> 100 mm Hg) a repeat dose (0.35 mg/kg) will be given at 15 minutes, with 12-lead ECG and BP obtained at 17, 20, 22, 25, 30 and 35 minutes. After 20 minutes (single dose) or 35 minutes (2 doses), the test will end and the subject will remain on continuous telemetry for 2 hours. Prior to discharge the IV will be removed. The primary analysis will be a repeated measures (paired) comparison of the QTc at baseline and following diltiazem.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Genetically confirmed diagnosis of Jervell and Lange-Nielsen syndrome
* Able to provide written informed consent

Exclusion Criteria:

* Known hypersensitivity to diltiazem
* Pregnancy
* Congestive heart failure, angina, preexcitation, or chronic obstructive pulmonary disease
* Sick sinus syndrome or atrioventricular block in the absence of a pacemaker/defibrillator
* Any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study in the judgement of the investigator
* Baseline systolic blood pressure less than 100 Hg or diastolic blood pressure less than 60 Hg

Primary outcomes:
measure: QT interval
timeFrame: Baseline
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: Prince J Kannankeril, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00242671: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane
Official title: The Efficacy of Isocapnic Hyperpnoea to Accelerate Recovery After General Anesthesia With Sevoflurane.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: general anesthesia, hyperventilation, carbon dioxide, isocapnic hyperponea
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-10-20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The twilight phase between being asleep and awake during recovery from anesthesia is a precarious time fraught with risks to the post-operative patient. Hyperventilation accelerates the elimination of inhaled anesthetics but reduces their CO2 blood concentrations which delays their resumption of spontaneous breathing. We previously showed that our method of hyperventilation without affecting the CO2 concentration--which we call IH--accelerates the rate of emergence from anesthesia with isoflurane. In this study we will study the effect of IH on the rate of emergence from Sevoflurane anesthesia.


Eligibility criteria: Inclusion criteria:

1. Elective gynecological procedure
2. ASA I-III
3. Age 18-80 years
4. Signed informed consent

Exclusion criteria:

1. ASA IV
2. Patients with contra-indications to Sevoflurane anesthesia or other anesthetics included in the protocol
3. Active smoking, asthma or other history of hyper-reactive airway disease
4. History of chronic obstructive lung disease limiting exercise
5. History of angina, previous myocardial infarction, valvular heart disease, or heart surgery
6. Presence of heart murmurs or neck bruits
7. ECT abnormalities including atrial fibrillation, prolonged P-R interval, prolonged Q-T interval, presence of Q waves in inferior, anterior or lateral leads, criteria for left ventricular hypertrophy, T-wave abnormalities,
8. History of difficult airway access
9. Pulmonary hypertension and/or right ventricle dysfunction
10. History of bulous emphysema, and/or spontaneous pneumothorax
11. History of alcohol or drugs abuse
12. Known history of psychiatric illness and/or medications
13. Patients that required postoperative mechanical ventilation for any reason

Primary outcomes:
measure: Time to recovery from anesthesia as indicated by time to extubation and rate of change of BIS score
Secondary outcomes:
measure: Quality of recovery in the recovery room as indicated by the level of consciousness, incidence of nausea, vomiting, shivering and other phenomena occuring during recovery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04596371: A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy
Official title: A Single-center Prospective Cohort Study for Pure Pulmonary Ground Glass Nodules in Women Preparing for Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pure pulmonary ground glass nodules in women preparing for pregnancy

Brief summary: In this study, about 200 pure GGO in women preparing for pregnancy will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion in women preparing for pregnancy and provide evidence for GGO treatment.


Eligibility criteria: Inclusion Criteria:

- 20-45 years' old found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains Diameter of GGO \> 5mm and \< 3cm

Exclusion Criteria:

- receiving immunosuppressor or steriods receiving chemo- or radio- therapy can not receive regular follow-up

Primary outcomes:
measure: Changes from baseline GGO diameter
timeFrame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
measure: Changes from baseline GGO CT index.
timeFrame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01725971: Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis
Official title: The Use of Forced Oscillation Technique in the Analysis of Respiratory System in Never-smoking Patients With Silicosis:Pathophysiological Study and Evaluation of Diagnostic Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silicosis
Keywords: Silicosis
forced oscillations
respiratory mechanics
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations.

The group with diagnosis of silicosis was established based on a history of substantial exposure to silica dusts and compatible radiological features, together with exclusion of other competing diagnoses.

Brief summary: Silicosis is a chronic and incurable occupational disease that can progress independent of the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may help to improve our understanding of the changes in lung mechanics, as well as in the detection of these changes.

Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory impedance and evaluated the diagnostic use of the FOT in these patients. For this, the investigators used spirometry to classify airway obstruction, which resulted in four categories: control, patients with normal exam, mild obstruction, and moderate-to-severe obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic potential was evaluated by investigating the area under the receiver operating characteristic curve (AUC).


Eligibility criteria: Inclusion Criteria:

* • Volunteers with silicosis for Patients Group;

  * Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

* Smokers

Primary outcomes:
measure: spirometric
timeFrame: 1 day
measure: Forced Oscillation technique
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de janeiro
country: Brazil
facility: Laboratório de Instrumentação Biomédica
Study officials:
References:
citation: Sa PM, Lopes AJ, Jansen JM, Melo PL. Oscillation mechanics of the respiratory system in never-smoking patients with silicosis: pathophysiological study and evaluation of diagnostic accuracy. Clinics (Sao Paulo). 2013 May;68(5):644-51. doi: 10.6061/clinics/2013(05)11.
Clinical trial NCT05495971: Extended Depth of Focus Contact Lenses for Presbyopia
Official title: Extended Depth of Focus Contact Lenses for Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: soft contact lens
Lead sponsor: Visioneering Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will serve as their own control using objective baseline data.
Primary purpose: TREATMENT

Brief summary: VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.

Detailed description: This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.

Eligibility criteria: Inclusion Criteria:

* Suitable and able to wear contact lenses
* Normal best corrected vision (20/25 or better)
* Need reading add +2.00 or stronger

Exclusion Criteria:

* Pre-existing ocular condition that would contraindicating lens wear

Primary outcomes:
measure: LogMAR Visual Acuity
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alpharetta
country: United States
facility: VTI
state: Georgia
Study officials:
affiliation: Visioneering Technologies, Inc
name: Douglas P. Benoit, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06317571: Evaluation of The Effect of Fertility Support Education Given to Infertile Couples
Official title: Evaluation of The Effect of Fertility Support Education Given to Infertile Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: stress
cortisol Level
pregnancy Outcome
infertility
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with intervention group and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment.

Detailed description: Before the treatment, couples were given fertility support training for four weeks. After the treatment was completed, the couples' stress level and quality of life, women's self-efficacy, fertility readiness, cortisol levels and pregnancy outcomes were examined.

Eligibility criteria: Inclusion Criteria:

* diagnosed with primary infertility
* have not received fertility support training before
* can speak Turkish

Exclusion Criteria:

* with psychiatric illness

Primary outcomes:
measure: Infertility Stress Scale
timeFrame: two month
measure: Infertility Self-Efficacy Scale-Short Form
timeFrame: two month
measure: Fertility Readiness Scale
timeFrame: two month
measure: Fertiqol Quality of Life Scale
timeFrame: two month
measure: Blood cortisol level
timeFrame: two month
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi
Study officials:
affiliation: Manisa Celal Bayar University
name: Özge TOPSAKAL, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911571: PRospective Multiple Myeloma Impact Study
Official title: Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: SkylineDx
Sponsor class: INDUSTRY
Collaborators: name: Medex15
First posted: 2016-09-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.

Detailed description: This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.

Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.

A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.

Eligibility criteria: Inclusion Criteria:

* Potentially multiple myeloma according to IMWG criteria
* Candidates for systemic treatment

Exclusion Criteria:

* ECOG Performance Status \> 3
* Tumor sample that fails QA or QC criteria for MMprofiler

Primary outcomes:
measure: Change in treatment intention
timeFrame: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler
Secondary outcomes:
measure: 3 year Progression Free Survival
timeFrame: 3 years after diagnosis
measure: 3 year Overall Survival
timeFrame: 3 years after diagnosis
measure: 5 year Progression Free Survival
timeFrame: 5 years after diagnosis
measure: 5 year Overall Survival
timeFrame: 5 years after diagnosis
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center,
state: North Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
name: Saad Usmani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176171: Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Official title: Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Corneal Cross-Linking
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Negah Eye Center
name: Tehran University of Medical Sciences
First posted: 2022-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) will be divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures will be pre-and postoperative uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry


Eligibility criteria: Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of \>410 µm.

exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Negah Eye Hospital
Study officials:
affiliation: Iran University of Medical Sciences
name: Azad sanginabadi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815771: Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction
Official title: Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction (Randomized Control Pilot Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction.

Detailed description: Arthrocentesis of TMJ then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with Bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of Bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of TMJ internal disc derangement without reduction.

Eligibility criteria: Inclusion Criteria:

* Patients with TMDs not previously surgically treated.
* Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.

Exclusion Criteria:

* Patients refuse to be enrolled in this study.
* Patients with uncontrolled systemic disease.

Primary outcomes:
measure: Mandibular mouth opening
timeFrame: 6 Months
Secondary outcomes:
measure: Post-operative pain
timeFrame: six months follow-up
measure: Joint sound
timeFrame: six months follow-up
measure: Lateral and protrusive movements
timeFrame: six months follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
city: Cairo
country: Egypt
facility: Mohamed Talaat Abbas Hassan
Study officials:
References:
Clinical trial NCT06914271: Effects of Kendall Exercises Versus Kabat Exercises in Patients With Chronic Low Back Pain
Official title: Effects of Kendall Exercises Versus Kabat Exercises in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Low back pain (LBP) is pain, muscle tension, or stiffness under the costal border and above the inferior gluteal folds, with or without leg pain.


Eligibility criteria: Inclusion Criteria:

* Both Genders
* Adults Aged Between 30-65
* Low Back pain should be Persistent for more than 12 weeks
* Visual Analogue scale or VAS of 3 or higher
* Idiopathic pain
* Ability to engage in physical activity and participate in the intervention program
* Willingness and ability to provide informed consent to participate in the study

Exclusion Criteria:

* Low back pain due to other causes

  1. Fibromyalgia
  2. Previous spine surgery
  3. Spondylolisthesis
  4. Spondylolysis
  5. Rheumatoid arthritis or Ankylosing spondylitis
  6. Spinal inflammation or tumor
  7. Spinal or pelvis fracture
  8. Osteoporosis
  9. Respiratory or heart diseases
  10. Stroke
  11. Pregnancy
* Persistent use of pain medication
* Patients who had undergone any other treatments, such as acupuncture or physical therapy, in the last 3 months
* Anticipated inability to comply with study protocols or attend scheduled."

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 Months
measure: Goniometer
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Younas hospital daska
state: Punjab
Study officials:
References: