louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03149055: Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Official title: A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Malignancy
Myeloproliferative Disorder
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2017-05-11
Enrollment: 99
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 purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).


Eligibility criteria: Inclusion Criteria:

* Subjects of greater than or equal to 18 years of age of either sex and of any race.
* Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder.

Exclusion Criteria:

* Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA.
* History of allergy or intolerance to ISA.
* Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal.
* Familial short QT syndrome.

Primary outcomes:
measure: Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)
timeFrame: 14 weeks post HCT
measure: Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)
timeFrame: 26 weeks post HCT
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT05615155: Efficacy of C-PRF vs i-PRF in Thin Gingival Biotype Subjects
Official title: Efficacy of C-PRF Versus i-PRF on Gingival Thickness & Keratinized Tissue Width in Subjects With Thin Gingival Biotype: ( Split Mouth Controlled Clinical Trials)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thin Gingival Biotype
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.

Detailed description: Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.

Gingival biotype is an important clinical parameter that plays an important role in determining the gingival health in the future and the possibility of developing gingival recession or other gingival unhealthy condition that is related to thin gingival biotype.

Gingival biotype is consist of gingival thickness and keratinized tissue width, and its either thin or thick, and the later is more favourable to withstand the developing of gingival diseases and unhealthy condition, with this study we compare the effect of i-PRF injection which is approved in many previous clinical trials that it affects the gingival biotype and increases gingival thickness and the keratinized tissue width, and compare it to newly developed PRF generation (C-PRF) which is Concentrated Platelet Rich Fibrin.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and no systemic disease or pregnancy.
2. Non-smoker.
3. Subjects with clinically healthy intact periodontium; bleeding on probing (BOP)\<10%, probing pocket depth (PPD)≤3mm, intact periodontium (no probing attachment loss). (Chapple et al., 2018).
4. Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018).
5. No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth.
6. No blood-borne conditions.
7. Any symptoms of recent acute illness e.g., COVID-19.

Exclusion Criteria

1. Active orthodontic treatment.
2. Previous periodontal surgery.
3. Use of blood thinners.
4. Use of any drugs that might lead to gingival enlargement.
5. Attrition.
6. Gingival Recession.
7. Thick gingival biotype.

Primary outcomes:
measure: measure the mean differences gain of GT&KTW
timeFrame: baseline and 3 months
Secondary outcomes:
measure: measure the mean difference gain of GT&KTW
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
state: Alresafa
Study officials:
affiliation: University of Baghdad
name: Sajjad ah Shakir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076255: Head and Neck Maskless Immobilization Device in Immobilizing Patients With Head and Neck Cancer or Intracranial Tumors Undergoing Radiation Therapy
Official title: A Single Institution Pilot Study Using a Head and Neck Maskless Immobilization Device (MID) for Patients With Head and Neck Cancer or Intracranial Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain and Nervous System
Intracranial Neoplasm
Head and Neck Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. Maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy

SECONDARY OBJECTIVES:

I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.

Eligibility criteria: Inclusion Criteria:

* Patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time
* Age ≥ 18 years old
* Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf
* Provide signed and dated informed consent form

Exclusion Criteria

* History of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the RT planning process
* Patient requires a neck brace for medical reasons
* Skull or bony defect in the area contacting the immobilization straps
* RT delivered by clinical setup only (no CT simulation)

Primary outcomes:
measure: Accuracy measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Voichita Bar Ad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02617355: Interference Between Surgical Magnetic Drapes and Pacemakers
Official title: Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromagnetic Interference
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.

Detailed description: Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.

This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.

Eligibility criteria: Inclusion Criteria:

* Patients with a pacemaker
* 18 years or older

Exclusion Criteria:

* Patients with implantable cardioverter-defibrillator (ICD)
* Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
* Refusal/Inability to consent
* Language other than French or English

Primary outcomes:
measure: Percentage of magnetic interference
timeFrame: Within 2 minutes after placement of surgical magnetic drape to the patient's chest
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Valerie Zaphiratos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05850455: Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Official title: A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.

Detailed description: Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs

Eligibility criteria: Inclusion Criteria:

1. Patients American Society of anesthesiologists' physical status (ASA) I to II.
2. Aged 18 to 50 years.
3. Both sexes.

Exclusion Criteria:

* Spinal malformation
* Recurrent LDH
* Multi segment LDH
* Patients younger than 18 years or older than 50 years
* Patients with hypersensitivity to one of the used drugs

Primary outcomes:
measure: Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
timeFrame: 4 hours
measure: Heart rate
timeFrame: 9 hours
measure: Postoperative anesthetic complications
timeFrame: 2 days
measure: Satisfaction rate of anesthesia
timeFrame: 1 hour
measure: Systolic and Diastolic Blood pressure
timeFrame: 9 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain shams University
Study officials:
References:
Clinical trial NCT00856414: Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Aging
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)


Eligibility criteria: Inclusion Criteria:

* Female subjects of any race, 35-55 years of age
* Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion Criteria:

* Previous botulinum toxin therapy
* Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face
* Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
* History of facial nerve palsy
* Allergy or sensitivity to any component of the study medication

Primary outcomes:
measure: The First Visit Onset of Efficacy as Measured by Physician Assessment
timeFrame: 14 Days
measure: The First Visit Onset of Efficacy as Measured by Subject Assessment
timeFrame: 14 Days
Secondary outcomes:
measure: Average Subject Assessment Score in Improvement of Appearance of Frown Lines
timeFrame: 14 Days
measure: Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score
timeFrame: Baseline, Day 14
measure: Percentage of Patients Reporting Self-Perception of Age (SPA)
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: West Palm Beach
country: United States
state: Florida
city: Livonia
country: United States
state: Michigan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Beer KR, Boyd C, Patel RK, Bowen B, James SP, Brin MF. Rapid onset of response and patient-reported outcomes after onabotulinumtoxinA treatment of moderate-to-severe glabellar lines. J Drugs Dermatol. 2011 Jan;10(1):39-44.
Clinical trial NCT00556114: A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging
Official title: A Pilot Study of Functional Optical Coherence Tomography for Ocular Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Diabetic Retinopathy
Age-Related Macular Degeneration
Central Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Keywords: eye exam
Retina
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-11-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and community sample.

Brief summary: Growing evidence shows that altered blood flow plays a major role in many vision-threatening diseases including glaucoma, diabetic retinopathy, age-related macular degeneration, Central Retinal Vein Occlusion, and Branch Retinal Vein Occlusion. Optical coherence tomography, an established imaging technique use for eye exam in clinical ophthalmology, provides high-resolution cross sectional images of the retina and has increased our ability to understand many eye diseases.

Detailed description: Optical Coherence Tomography is a non-invasive technique use a broadband light source to illuminate the area of study with light in the near infrared spectrum, then obtains static images of tissue structure from interference signals of the back-reflected light.

Optical Coherence Tomography a non-contact, non-invasive means of documenting both tissue structure and blood flow changes in ocular disease and can provide high resolution cross-sectional images of tissue structure, direct visualization of blood flow in blood vessels of the eye.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older with normal eye, or has been diagnosed with eye disease.

Exclusion Criteria:

* Less than 18 years of age.

Primary outcomes:
measure: Medical exam tool
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute, University of California,Irvine
state: California
Study officials:
affiliation: Ophthamology, University of California,Irvine
name: Baruch D Kuppermann,, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute University of California Irvine
name: Zhongping Chen, Ph,D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204514: The Effects of Surgery for Painful External Snapping Hip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Pain
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery for painful external snapping hip in The North Denmark Region between 2008-2013 with at least 1 year follow-up time.

Brief summary: The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for painful external snapping hip
* 18 years or older

Exclusion Criteria:

* Inability to comply with the protocol (e.g. due to dementia)

Primary outcomes:
measure: Self-reported pain
timeFrame: 1-6 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Orthopedic Surgery
Study officials:
affiliation: Orthopedic Surgery Research Unit + Department of Health Science and Technology, Aalborg University
name: Søren T Skou, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedic Surgery
name: Stine Jorstad, BSc
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery
name: Ole Simonsen, MD, DMSc
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery
name: Anders C Laursen, MD
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery
name: Michael Ulrich, MD, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440214: Targeting Emotion Dysregulation to Reduce Suicide in People with Psychosis
Official title: Targeting Emotion Dysregulation to Reduce Suicide in People with Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Suicide
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 68
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: People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Psychosis spectrum disorder as assessed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorder Studies
* Heightened suicide risk as determined by a score of 8+ on the Suicide Behaviors Questionnaire-Revised (SBQ-R). This cutoff may be revised downwards (toward lower suicide risk) if recruitment appears difficult, but will not be revised upwards.
* Enrollment and engagement in outpatient mental health services with at least one mental health service in the previous month
* 6+ grade equivalent reading level as assessed by the Wide Range Achievement Test 4 (WRAT-4)

Exclusion Criteria:

* Chart diagnosis of intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.

Primary outcomes:
measure: Suicidal Ideation
timeFrame: Four months
measure: Emotion Dysregulation
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
References: