louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01505335: The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)
Official title: The Use of Novel us Device (Jetguide) to Measure the Distance to the Roof of the IAC (Inferior Alveolar Canal)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Comparison Between Ultrasound and Clinical Measurements
Keywords: alveolar nerve, inferior
ultrasound
digital radiography, dental
nerve injury
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects attentding the clinic, requiring dental implant therapy in the posterior part of the lower jaw.

Brief summary: The purpose of this human clinical trial is to validate the accuracy of Jetguide® US device in detecting the inferior alveolar canal (IAC) and to compare it to measurements performed on computerized tomography images.

Detailed description: To date, the most accurate method to assess the distance from the alveolar crest to the IAC is cone beam computerized tomography (CBCT). This technique carries with it some potential concerns, including measurements errors, inability to perform intra-operative radiographs substantial financial and radiation costs.

In the present study patients will have a CBCT of the mandible taken. Sites where implants will be inserted will be marked on the CBCT, measurements of the distance from bone crest to the roof of the inferior alveolar canal (BC-IAC) will be performed.

During implant surgery the depth of the osteotomy (OD) will be measured using a periodontal probe; OD and the distance from the bottom of the osteotomy to the roof of the IAC (residual distance - RD) will be measured using a standard JetGuide® device. In addition, standard panoramic radiographs will be taken with a surgical gauge in the osteotomy which will enable us to measure the RD radiographically.

The correlation between the radiographic and clinical BC-IAC distance will be the primary outcome variable. The same correlation for the RD between the Jetguide readings and the linear measurements on the panoramic radiographs will serve as the secondary outcome variable.

Eligibility criteria: Inclusion Criteria:

* missing teeth in the premolar and molar areas of the lower jaw

Exclusion Criteria:

* pregnancy
* pacemakers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Dept. of Periodontology
Study officials:
affiliation: Rambam Health Care Campus, Haifa, Israel
name: Prof. Eli Machtei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05309135: A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction
Official title: A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Edema
Lead sponsor: Aurion Biotech
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 22
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 purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.


Eligibility criteria: Key Inclusion Criteria:

1. Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements
2. Clinical diagnosis of corneal edema secondary to endothelial dysfunction
3. Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye

Key Exclusion Criteria:

1. Keratoconus or other conditions of corneal thinning/ectasia
2. Progressive stromal or anterior corneal dystrophies
3. Pre-operative corneal epithelial, sub-epithelial or stromal staining, scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment with HCEC-1
4. Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.
5. Relative Afferent Pupillary Defect (RAPD) in the study eye
6. Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.

Primary outcomes:
measure: Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)
timeFrame: 12 months
measure: Incidence and severity of non-ocular TEAEs
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry
timeFrame: 12 months
measure: Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score
timeFrame: 12 months
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Site
Study officials:
References:
Clinical trial NCT04401735: Effects and Safety of Epidural PDRN vs. Placebo
Official title: Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Stenosis Lumbar
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.

Detailed description: Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.

Eligibility criteria: Inclusion Criteria:

* 1. Adults aged between 19-80 years old
* 2. Radiological confirmation of spinal stenosis on MRI
* 3. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
* 4. Follow-up possible during 3 months the clinical trial

Exclusion Criteria:

* Not able to comply fully with the protocol, including treatment, follow-up or study procedures
* pregnant or feeding women
* Alcohol/drug abuse
* Anticoagulant medication

Primary outcomes:
measure: visual analogue scale(VAS)
timeFrame: 12 weeks post - injection
Secondary outcomes:
measure: visual analogue scale(VAS)
timeFrame: 4, 8 weeks post - injection
measure: CGI(Clinicians Global Impression)
timeFrame: 4, 8 weeks post - injection
measure: treadmill test
timeFrame: 8 weeks post - injection
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university Bundang hospital
state: Kyoung-ki-do
Study officials:
References:
Clinical trial NCT02265835: Anastomotic Airway Complications After Lung Transplantation
Official title: Anastomotic Airway Complications After Lung Transplantation : Risk Factors, Treatment Modalities and Outcome : a Single Center Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Bronchoscopy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 432
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung transplant recipients between 1/2005 en 12/2012

Brief summary: Retrospective analysis of data concerning anastomotic airway complications after lung transplantation.


Eligibility criteria: Inclusion Criteria:

* Lung transplantation

Exclusion Criteria:

* heart and lung transplantation

Primary outcomes:
measure: presence of anastomotic airway complication
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01826435: Improving Medication Adherence in Hypertensive Patients
Official title: Improving Medication Adherence in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study team is proposing a single arm intervention to test the effect of an electronic intervention on medication use among individuals with a prescription for hypertension/high blood pressure. The investigator proposes that technology like text messaging, email, web applications and mobile apps with proven, nurse intervention scripts, will lead to significant, cost-effective improvements in hypertension medication use.

Detailed description: The intervention will incorporate a scalable electronic intervention using Email/Web Apps and Short Message Service (SMS)/Mobile Web Apps. The study team will examine the participants' responses to the electronic encounters in the technology-only intervention throughout the 3-month study timeframe.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the primary care clinic for the past 6 months
* New or existing prescription for hypertension
* Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (\>140/90 Hg)

Exclusion Criteria:

* Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
* Diagnosis of metastatic cancer;
* Active diagnosis of psychosis or dementia documented in medical record;
* Does not have access to the appropriate technology required
* Is not willing to use said device to receive notifications for the study;
* Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
* Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
* Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
* Unable to read and understand spoken English
* Participation in another cardiovascular disease (CVD) study
* Another household member enrolled in study;
* Arm size \> 50cm

Primary outcomes:
measure: Proportion of Days Covered (PDC)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System Clinic
state: North Carolina
Study officials:
References:
Clinical trial NCT04981925: Predictors of Pain Relief From Mindfulness-based Stress Reduction (MBSR) in Multiple Forms of Chronic Pain Patients
Official title: Predictors of Pain Relief From Mindfulness-based Stress Reduction in Multiple Forms of Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain Syndrome
Keywords: chronic pain
rheumatoid arthritis
fibromyalgia
neuropathy
neuralgia
pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall objective of this study is to better understand how Mindfulness-based Stress Reduction (MBSR) is the most helpful in terms of management of chronic pain symptoms.

The studies hypothesis is that an Interventional Response Phenotyping study (light phenotyping) can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic pain disorders.

Detailed description: Participants enrolled in this study will receive 8 weeks of MBSR therapy and complete surveys at various time points pre-treatment - post treatment.

Eligibility criteria: Inclusion criteria for MBSR Study

* Ages 18+
* Any form of self-reported chronic pain (except cancer related pain)

Exclusion criteria for MBSR study

* Unable to speak and write English
* Visual or hearing difficulties that would preclude participation
* Chronic pain from cancer.

Primary outcomes:
measure: PROMIS physical function 6b
timeFrame: 8 weeks (after MSBR)
Secondary outcomes:
measure: Change in PROMIS pain intensity, anxiety, pain interference
timeFrame: Baseline (pre-treatment), 8 weeks
measure: Change in PROMIS pain intensity, anxiety, pain interference
timeFrame: Baseline (pre-treatment), 8 and 12 weeks
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (pre-treatment), 8 and 12 weeks
measure: Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
timeFrame: 8 weeks (after MSBR)
measure: Change in Chronic Pain Acceptance Questionnaire (CPAQ)-8
timeFrame: Baseline, 8 weeks (after MSBR)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd Favorite, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02898025: Low Level Laser Therapy and Interferential Current in Osteoarthritis
Official title: Low Level Laser Therapy and Interferential Current in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 168
Sex: ALL
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: This study aims to evaluate the effectiveness of the low level laser therapy and interferential current in 168 patients with knee osteoarthritis

Detailed description: Interventional

Eligibility criteria: Inclusion Criteria:

* History of osteoarthritis of the knee characterized by pain of mild or moderate intensity
* Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria
* Patients with knee osteoarthritis (s) according to the ACR criteria
* VAS 3 to 8
* 5 to 12 Lequesne
* No complaint of pain in other joints of the lower limbs
* Without neurological and cognitive disorders
* No loss of sensation in the lower limbs
* No surgery on the knee (s) in the last 6 months
* Pain symptoms for at least 6 months
* No infiltrations (s) knee (s) in the last 4 weeks
* No use of analgesics 4 hours before treatment

Exclusion Criteria:

* Individuals younger than 18 and older than 80 years
* Complaints from other diseases of the lower limbs, knee prosthesis and / or hip joint instabilities and / or surgery in lower limbs, heart disease, uncontrolled hypertension and diabetes, coagulation disorders in anticoagulant therapy, pregnant women, fibromyalgia and individuals who can not perform isokinetic test who have difficulty performing the TUG, and those that are experiencing abnormal sensitivity to algometry

Primary outcomes:
measure: Pain intensity measured by a numeric pain scale ranging from 0 to 10.
timeFrame: 4 weeks
measure: Pressure Pain Threshold measured by a pressure algometer. Pressure will be recorded in kPa.
timeFrame: 4 weeks
Secondary outcomes:
measure: TUG (Timed Up & Go Test)
timeFrame: Measure at baseline, 4 weeks, 3 months, 6 months
measure: Isokinetic Muscle Assessment
timeFrame: Measure at baseline, 4 weeks, 3 months, 6 months
measure: LeQuesne Questionnaire
timeFrame: Measure at baseline, 4 weeks, 3 months, 6 months
measure: WOMAC (Western Ontario and McMaster Universities Arthritis Index)
timeFrame: Measure at baseline, 4 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNICID
state: SP
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Richard E Liebano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.
Clinical trial NCT02540525: Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence
Official title: Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Due to Sling-shot
Keywords: stress incontinence
transobturator sling
single-incision mini-sling
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. OBJECTIVE:

   To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
2. METHODS:

This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value \>.05 rejects the noninferiority hypothesis of the mini-sling.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Clinical and urodynamic diagnosis of stress urinary incontinence
* Absence of associated neurological diseases
* No clinically significant detrusor instability (ie, to determine which symptoms are proportionally more significant for patient incontinence efforts)

Exclusion Criteria:

* urodynamic changes suggesting a reduction in bladder capacity, bladder compliance or suggestive of bladder outlet obstruction
* Coagulopathies
* Pregnancy
* History of sensitivity to foreign body
* Acute Urinary Tract Infection
* Sequelae of high exposure to ionizing radiation
* Use of drugs that can result in high and / or risk of significant postoperative complications surgical risk, including any drug that interferes with blood clotting
* anesthetic contraindication to the procedure
* Vulvovaginitis: presence of vaginal discharge with laboratory proven infection

Primary outcomes:
measure: Comparison of the cure rates between the mini sling and classical transobturator tapes
timeFrame: Up to one year
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 0, 1, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculty of Medicine of ABC
state: São Paulo
Study officials:
affiliation: FACULTY OF MEDICINE OF ABC
name: EMERSON OLIVEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092625: Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Disease
Keywords: Elevated Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 442
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 purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed description: The duration of treatment is 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who have cholesterol levels within normal ranges as identified by the study

Primary outcomes:
measure: Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Secondary outcomes:
measure: Safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cruz-Fernandez JM, Bedarida GV, Adgey J, Allen C, Johnson-Levonas AO, Massaad R. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. Int J Clin Pract. 2005 Jun;59(6):619-27. doi: 10.1111/j.1368-5031.2005.00565.x.