louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03284411: Spinal Cord Stimulation (SCS) Dosing Study
Official title: Spinal Cord Stimulation (SCS) Dosing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Back Pain
Leg Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 30
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: This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

Detailed description: This feasibility study assessed the following outcomes:

* Patient satisfaction
* VAS pain scores

Eligibility criteria: Inclusion Criteria:

1. 22 years of age or older
2. Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
3. Has approproate SCS settings
4. Willing and able to provide signed and dated informed consent
5. Capable of comprehending and consenting in English
6. Capable of getting into the supine and sitting positions
7. Willing and able to comply with all study procedures and visits
8. On stable (no change in dose, route, or frequency) prescribed pain medications

Exclusion Criteria:

1. Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
2. Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
3. Implanted with quadripolar lead
4. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
5. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
6. Has untreated major psychiatric comorbidity
7. Has serious drug-related behavioral issues
8. Has unresolved major issues of secondary gain

Primary outcomes:
measure: SCS Therapy Satisfaction
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Pain Doctors
state: Arizona
city: Lawrenceville
country: United States
facility: Georgia Pain and Wellness Center
state: Georgia
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana Pain Specialists
state: Kentucky
city: Somerset
country: United States
facility: Drez One, LLC
state: Kentucky
city: Cape Girardeau
country: United States
facility: Regional Brain & Spine
state: Missouri
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Spokane
country: United States
facility: Northwest Pain Care, Inc.
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02078011: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound
Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Fibroadenoma
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Theraclion SAS, Paris, France
First posted: 2014-03-04
Enrollment: 20
Sex: FEMALE
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 purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).

This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
* Fibroadenoma is palpable
* Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
* Fibroadenoma volume is between 2 cc and 10 cc
* Patient must give written informed consent (personally signed and dated) before completing any study-related procedure

Exclusion Criteria:

* Patient is pregnant or nursing
* Patient with breast implants in the target breast
* Patient with a breast cyst within the fibroadenoma to be treated
* Patient participating in another clinical trial involving an investigational drug, device or biologic

Primary outcomes:
measure: Change in volume of fibroadenoma
timeFrame: baseline, 3, 6, and 12 months
measure: Size of fibroadenoma
timeFrame: baseline, 3, 6, and 12 months
measure: Patient reported outcomes
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: David Brenin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03595111: Myocardial Biopsy in Congenital Cardiac Surgery
Official title: Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Protection
Keywords: Cardiac Protection
Pediatric
Myocardial biopsy
Cardiopulmonary Bypass
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
Primary purpose: SCREENING

Brief summary: Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Detailed description: Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

Eligibility criteria: Inclusion Criteria:

Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes.

Hemodynamic stability.

Exclusion Criteria:

Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

Primary outcomes:
measure: Myocardial biopsy
timeFrame: within 24 hours
Secondary outcomes:
measure: The inotropic score
timeFrame: within one month
measure: Serum cardiac troponin level
timeFrame: first 24 hours
measure: 30-day mortality
timeFrame: 30 days
measure: Type of cardiac rhythm on return
timeFrame: within 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06249711: Ultrasonic Treatment of Food Addiction
Official title: Noninvasive Targeted Neuromodulation for Treatment of Food Addiction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Overweight
Obesity
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.


Eligibility criteria: Inclusion Criteria:

* History of at least one self-reported unsuccessful dietary effort to lose body weight
* Body mass index more than or equal to 30 kg/m\^2 or more than or equal to 25 kg/m\^2 with the presence of at least one of the following weight-related comorbidities: hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.

Exclusion Criteria:

* Lifetime history of a serious suicide attempt
* MRI intolerance or contraindication
* Pregnant or breast feeding
* Diabetic (HbA1c more than 48 mmol/mol or 6.5%)
* A self-reported change in body weight more than 10 lbs within 60 days before screening
* Clinically inappropriate for participation in the study as determined by the study team

Primary outcomes:
measure: Change in body weight (%) from baseline week 0 to week 16
timeFrame: The body weight will be taken prior to each intervention (once per week)
measure: Number of participants who achieved body weight reduction >= 5%
timeFrame: Assessment at week 16
measure: Food Cravings Questionnaire-State
timeFrame: During and immediately after each weekly intervention
measure: Hamilton Depression Rating Scale, 17 item
timeFrame: For up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jan Kubanek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06561711: Optimization of Minocycline for Helicobacter Pylori Rescue Treatment
Official title: Optimization of Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Multicentre, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
rescue therapy
minocycline
tetracycline
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 476
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: The efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* Previous history of tuberculosis
* Allergy to any of the study drugs
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University school of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05712811: Comparison of Cryotherapy and Peeling Agent in the Treatment of Common Warts
Official title: Cryotherapy Versus Topical Tricholoacetic Acid 90% in Treatment of Common Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To compare the efficacy of cryotherapy using liquid nitrogen (cryoget method) versus trichloroacetic acid 90% (applicator method) in treatment of common warts.

Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from Jun 2022 to Nov, 2022.

Detailed description: A total of 60 patients were enrolled in this investigation by non-probability consecutive sampling technique. Sample size was calculated using WHO sample size calculator and patients were randomized into two equal groups, A and B, each comprising of 30 patients through lottery method. Patients with common warts such as hard lesions, raised lumps with rough surfaces at the back of their fingers, around nails and palm of their hands between the ages of 18 and 60 were included, whereas those with genital warts, cardiac, hepatic, renal, or hypercholesterolemia were excluded.

Eligibility criteria: Inclusion Criteria:

* Patient presented with common warts in dermatology opd

Exclusion Criteria:

* • Patients with warts on toes and tip of fingers

  * genital warts
  * cardiac, hepatic and renal disease
  * hypercholesterolemia
  * hypersensitivity reactions

Primary outcomes:
measure: Comparison of cryotherapy and Tricholoracetic acid 90% in treatment of common warts
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Cmh abbottabad
state: Kpk
Study officials:
References:
Clinical trial NCT00754611: The Evolution and Management of Migraine Recurrence Beyond 24 Hours
Official title: The Evolution and Management of Migraine Recurrence Beyond 24 Hours: A Prospective Study of Tertiary Care Center Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Rowan University
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2008-09-18
Enrollment: 100
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: Patients at the University Headache Center, aged 18 or older, with a diagnosis of migraine with and/or without aura as defined by ICHD-II criteria

Brief summary: What is the course of migraine headache recurrence, how is it managed, what characteristics are associated with it, and how does it influence patient satisfaction with treatment?


Eligibility criteria: Inclusion Criteria:

* Female and male patients at University Headache Center with \> 6 month diagnosis of migraine with and/or without aura (ICHD-II)
* Greater than or equal to 18 years old

Exclusion Criteria:

* Greater than 15 days/month total headache days
* Analgesic use greater than 15 days/month (other than aspirin less than or equal to 325mg/d)

Primary outcomes:
measure: Primary efficacy outcomes will be sustained pain free response between 4 and 72 hours after initial abortive medication dosing (lack of recurrence over 72 hours)
timeFrame: 4 to 72 hours
Secondary outcomes:
measure: Pain response and pain free data
timeFrame: 30 minutes, 1,2,4,24,48,and 72 hours
measure: Rate of recurrence, time of recurrence, time to re-dosing
timeFrame: 72 hours
measure: Rate of recurrence among multiple attacks per subject
timeFrame: 72 hours
Other outcomes:
Locations:
city: Stratford
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Loretta Mueller, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856811: Condylar Position Changes in Anterior Disc Displacement with Reduction
Official title: Condylar Position Changes in Anterior Disc Displacement with Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disorder
Lead sponsor: Sana'a University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: the goal of this clinical trial is to know if TMJ lavage does change the condyle position in patients diagnosed with unilateral anterior disc displacement with reduction. The main questions it aims to answer are:

* Is the condyle position in anterior disc displacement with reduction joints are the same in normal joints?
* Does TMJ lavage will affect the condyle position, or affects the contralateral condyle position? Researchers will compare condyle position in unilateral anterior disc displacement with reduction to the normal joint using CBCT before and after lavage to see if any changes in position will occur in even side.

Participants will:

Make CBCT for both condyles before lavage and after three months post lavage. Visit clinic after two weeks, one month, and three months to evaluate the clinical data.


Eligibility criteria: Inclusion Criteria:

* • Unilateral anterior disc displacement with reduction according to Helkimo's clinical dysfunction index including (Covert et al., 2021a).:

  1. Impaired range of movement.
  2. Impaired TMJ dysfunction.
  3. Muscles pain.
  4. TMJ pain.

Exclusion Criteria:

* • Bilateral anterior disc displacement with reduction.

  * Previous fracture in TMJ.
  * Any pathological lesion in TMJ.
  * Congenital craniofacial anomalies.
  * Any previous surgical procedure in TMJ.
  * Any medically compromised patient (mental deficiency, osteoporosis...)
  * Previous arthrocentesis in TMJ.
  * Partial or complete edentulous patients.
  * Any psychological patient.

Primary outcomes:
measure: measuring joint spaces in coronal, sagittal and axial views in mm as follows: sagittal view: measuring superior, posterior and anterior space, coronal measuring medial and lateral joint spaces, axial measuring the intercondylar distance and angle
timeFrame: three months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Sana'a
country: Yemen
facility: Sana'a University
Study officials:
References:
Clinical trial NCT05846711: The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.
Official title: The Accuracy of Manual BPPV Diagnostics: A Randomized Crossover Study With Comparison of Manual Diagnostic and Diagnostic in TRV Chair, When Using VNG Goggles in Both Scenarios.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
BPPV
Vertigo
Vestibular Disorder
Vestibular Diseases
Labyrinth Diseases
Inner Ear Disease
Keywords: TRV reposition chair
Dix-Hallpike maneuver
Supine Roll Test
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim is to investigate the accuracy of manual diagnostics of benign paroxysmal positional vertigo (BPPV) by comparing it to BPPV diagnostics in mechanical rotational chair (TRV chair). VNG (videonystagmography) goggles will be used in both scenarios.

Furthermore, the investigators will examine the importance of angulation and velocity in relation to the diagnostic outcome.

Detailed description: Open-label, randomized controlled trial with cross over comparing manual bedside BPPV diagnostics with diagnostics in a mechanical rotational chair (TRV chair) when using VNG goggles in both scenarios.

Patients with a history of positional vertigo will be considered for enrollment and randomized to which diagnostic modality they begin with. Each subject will wait for minimum 30 minutes between the two diagnostics.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Classic BPPV-patient history (short lasting (\<1 minute) positional rotatory vertigo, no accompanying tinnitus or hearing loss, and no focal neurological findings.
* Understand written and spoken Danish

Exclusion Criteria:

* Pregnancy
* Weight ≥ 150 kg and or Height ≥ 2m
* Neck and spine immobility to a degree where MD on examination bed is impossible
* Insufficient cooperation during diagnostic testing
* Sedative antihistamines taken within the past seven days
* Comorbidities: Heart failure (EF \< 40), known cerebral aneurysm, cerebrovascular events (\<3 months) or dissection disease
* Spontaneous or gaze evoked nystagmus

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 2 year
Secondary outcomes:
measure: Head angulation during diagnostic bedside examination.
timeFrame: 2 year
measure: Angular velocity during diagnostic bedside examination
timeFrame: 2 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
state: North Denmark Region
Study officials:
affiliation: Department of Otolaryngology, Head & Neck Surgery and Audiology
name: Malene Hentze Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: