louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00565630: Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops
Official title: Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Lead sponsor: Advanced Ophthalmic Pharma
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Detailed description: Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle.

Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective cataract surgery

Exclusion Criteria:

* Known allergy to quinolone compounds

Primary outcomes:
measure: Aqeous concentration of Vigamox
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Ophthalmology, TAMC, Tel Aviv, Israel
name: Adi Michaeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695430: Brief Cognitive Behavioral Therapy for People with Physical Disabilities
Official title: Telehealth-delivered Brief Cognitive Behavioral Therapy to Prevent Suicides in People with Physical Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Disability Physical
Disability Hearing
Disability, Vision
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2023-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of a psychotherapy (non-medication) treatment, Brief Cognitive Behavioral Therapy for Suicide Prevention, in reducing suicide ideation and attempts for people with physical disabilities.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Disability impacting vision, hearing, or mobility
* Past-week suicidal ideation or past-month suicide attempt

Exclusion Criteria:

* Inability to provide informed consent
* Lack of internet connection and web camera

Primary outcomes:
measure: Scaler for Suicide Ideation
timeFrame: Weekly change through treatment completion, an average of 3 months
Secondary outcomes:
measure: Self-Injurious Thoughts and Behaviors Interview-Revised
timeFrame: Through treatment completion, an average of 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Universitty Wexner Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01608230: Human Tumor Sequencing Project
Official title: Human Tumor Sequencing Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer

Brief summary: This study is being done to learn more about genetic mutations in cancer cells and to find out how the development of new technologies can increase knowledge of these mutations and possibly predict an individual's response to certain treatments.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a solid tumor or blood borne cancer
* 18 years or older
* Eligible to have blood drawn

Primary outcomes:
measure: Determine biomarkers of clinical utility and copy number variants through genetic analysis.
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
References:
Clinical trial NCT00833430: Avascular Necrosis (AVN) Long-Term Follow-up
Official title: Hedrocel Avascular Necrosis (AVN) Intervention Implant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Avascular Necrosis
Femoral Head Collapse
Keywords: AVN
Femoral Head Collapse
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled at investigational sites who had Stage I or Stage II Osteonecrosis of the femoral head and who would qualify for core decompression based upon physical and radiographic exam and medical history.

Brief summary: Long-term follow-up of IDE patients for publication

Detailed description: This device (Hedrocel AVN Intervention Implant) was approved via 510(k) on April 15, 2005. One site was left open to follow patients to 5 year follow-up for publication of device survivorship.

Eligibility criteria: Inclusion Criteria:

* Patient qualifies for core decompression based on physical exam
* No history of core decompression
* Patient is willing and able to provide written informed consent

Exclusion Criteria:

* Patient has been diagnosed as Stage 0, III, IV, V or VI using the Steinberg/UPenn staging system.
* Patient's BMI is \>40
* Patient is mentally compromised
* Patient has neurological condition in ipsilateral or contralateral limb, which affect lower limb function
* The patient has had a proximal femoral osteotomy or internal fixation in the affected hip.
* The patient has undergone previous treatment for AVN
* Previous hip conditions
* Patient's bone stock is insufficient
* Patient has diagnosed systemic disease
* Patient is a pregnant female
* Patient is unable or unwilling to attend postop follow-up visits
* Patient has received investigational drug within the previous 6 months or an investigational device within the last 12 months
* Patient has an active or latent infection
* Patient has metal sensitivity
* Patient is a prisoner

Primary outcomes:
measure: Safety, Efficacy and longevity of device with patient as opposed to conventional total hip replacement
timeFrame: 5 Year Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopedic Clinic
state: Georgia
Study officials:
References:
Clinical trial NCT05963230: ScanNav Anatomy PNB FDA Data Collection Plan
Official title: ScanNav Anatomy PNB FDA Data Collection Plan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Recordings
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers from the San Diego, California, USA region.

Brief summary: To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories:

* Femoral Nerve (Femoral)
* Interpectoral (PECS I) and pectoserratus (PECS II)
* Transversus abdominis plane (TAP)
* Serratus Plane (SP)
* Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age;
* Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

* Aged \<18 years of age;
* Unwilling or unable to provide informed consent.
* Previous history of medical interventions that may affect the anatomy of the chosen scan areas, e.g. hip replacements.

Primary outcomes:
measure: Ultrasound scan recordings
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Taylor Research
state: California
Study officials:
affiliation: Intelligent Ultrasound
name: James Bowness, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148430: A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
Official title: A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Specific Chimeric Antigen Receptor (CAR) T Cells
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: B Cell ALL
B-Cell Lymphoma
B-cell Non Hodgkin Lymphoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.


Eligibility criteria: Inclusion Criteria:

* Patients (age \>/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study

Exclusion Criteria:

* Patients with uncontrolled systemic fungal and bacterial infections
* Patients with known hypersensitivity to E. coli-derived proteins
* Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities
timeFrame: 4 weeks
measure: Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation
timeFrame: 28 days from the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Meridian Health (Data collection only)
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jae Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danish H, Santomasso BD. Neurotoxicity Biology and Management. Cancer J. 2021 Mar-Apr 01;27(2):126-133. doi: 10.1097/PPO.0000000000000507.
Clinical trial NCT06792630: A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients
Official title: A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Hematopoietic Stem Cell Transplant
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 98
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 主要研究目的：

1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的：

1. 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平；
2. 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。

Detailed description: 本研究将采用单中心、前瞻性的平行随机对照试验对2024年12月1日至2025年12月1日期间首次接受造血干细胞移植的患者进行招募。对照组实施常规护理措施和出院的常规延续护理措施，干预组从移植+1天开始进行笑治疗，住院期间为移植后+1天至出仓，按照笑的口令"hihihi（拼音拼读），哈哈哈，茄子茄子茄子，七喜七喜七喜，哈哈哈哈哈哈"，30遍口令为1次训练，1天进行1次。出仓及出院后，干预组患者集中线上笑疗法干预，1次/周，重复30遍口令，至移植后1年。分别于移植后3个月、6个月、1年对两组患者在预后、疲劳、焦虑及抑郁、幸福感以及创伤后成长、生存质量及结局指标上进行组间比较，明确笑疗法在造血干细胞移植患者心理健康及生存质量中的效果。

Eligibility criteria: Inclusion Criteria:

Patients with a pathologically confirmed diagnosis of hematologic malignancy; Patients undergoing their first hematopoietic stem cell transplant; Age ≥ 16 years; Those who have some reading and writing ability; Those who can cooperate in completing the questionnaires and assessments; Informed consent and voluntary participation in the study.

Exclusion Criteria:

Those with severe mental illness or personality disorders; Those who cannot operate a smartphone independently; Those with severe visual and hearing impairments; Those who are critically ill and cannot receive the intervention.

Primary outcomes:
measure: Overall survival
timeFrame: 3 months, 6 months, and 1 year
measure: Progression-free survival
timeFrame: 3 months, 6 months, and 1 year
measure: Time to treatment failure
timeFrame: 3 months, 6 months, and 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00388830: Emergency Ultrasound of the Gallbladder
Official title: "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Keywords: Gallbladder
Ultrasound
Emergency Medicine
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2006-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.

Detailed description: Ultrasonography of the gallbladder is currently the diagnostic modality of choice in determining cholelithiasis and cholecystitis. Historically this test has been performed in the Radiology suites where the patient was expected to fast for times of six to ten hours. Patients presenting to emergency departments (ED) have also been required to wait to have their study performed in order to have better visualization of the gallbladder. However, few studies have examined whether a fasting time matters in determining gallbladder pathology. Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding their patients in the ED to wait for a test. Finally, with the advent of emergency bedside ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing gallbladder pathology, it is possible to now determine an answer within minutes. We will test to see if EPs trained in the use of emergency bedside ultrasound can effectively and efficiently determine gallbladder pathology and if fasting has an impact on their ability to perform a quality ultrasound.

Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 18 and 75
* Ability to consent for study

Exclusion Criteria:

* Inability to give informed consent
* Known pregnancy
* Prior cholecystectomy
* Inability to consume a fast food breakfast
* Known history of cholelithiasis

Primary outcomes:
measure: time to perform scan
measure: diagnosis of pathology
measure: performance of adequate measurement
measure: overall adequacy of the scan
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Robert O'Connor, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01366430: Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Official title: Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: BPPV(benign paroxysmal positional vertigo)
HC-BPPV(BPPV involving the horizontal semicircular canal)
Nystagmus
Treatment outcome
Horizontal Canal Benign Paroxysmal Positional Vertigo
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2011-06-06
Enrollment: 170
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).

Detailed description: A randomized prospective study of patients with HC-BPPV. Patients with geotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the barbecue maneuver, Gufoni's maneuver, and sham group in geotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

Eligibility criteria: Inclusion Criteria:

* a history of brief episodes of positional vertigo, direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) ear in both the lateral head turning positions,
* no spontaneous nystagmus during upright sitting position
* absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus

Exclusion Criteria:

* central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus

Primary outcomes:
measure: Immediate therapeutic effects for the treatment of geotropic HC-BPPV
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Cholabuk-do
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Cholanam-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyungki-do
Study officials:
References:
Clinical trial NCT02444130: Presbyopia Compensation: Looking for Electrophysiological Predictors
Official title: Presbyopia Compensation: Looking for Electrophysiological Predictors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Keywords: multifocality
monovision
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with presbyopia

Brief summary: The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.

Detailed description: For each participant, presbyopia was compensated with contact lenses by monovision during three weeks and multifocality (three weeks again). A break of two weeks without any presbyopia compensation came in between the two phases of the test that were randomized.

All subjects were tested three times: before any compensation, after three weeks with monovsion and after three weeks with multifocality.

Each testing session was strictly the same including visual examinations and VEPs (visual evoked potentials).

Eligibility criteria: Inclusion Criteria:

* normal acuity

Exclusion Criteria:

* stereoacuity disorder
* neurological disorders

Primary outcomes:
measure: Visual acuity at baseline
timeFrame: baseline
Secondary outcomes:
measure: electrophysiological recordings at baseline
timeFrame: baseline
measure: electrophysiological recordings change with monovision
timeFrame: after 3 weeks with monovision contact lenses
measure: electrophysiological recordings with multifocality
timeFrame: after 3 weeks with multifocality contact lenses
measure: quantitative measurement of stereopsis at baseline
timeFrame: baseline
measure: quantitative measurement of stereopsis with monovision
timeFrame: after 3 weeks with monovision contact lenses
measure: quantitative measurement of stereopsis with multifocality
timeFrame: after 3 weeks with multifocality contact lenses
measure: Visual acuity change with monovision
timeFrame: after 3 weeks with monovision contact lenses
measure: Visual acuity change with multifocality
timeFrame: after 3 weeks with multifocality contact lenses
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital Tours
Study officials:
affiliation: University Hospital, Tours
name: Pierre-Jean Pisella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.
Clinical trial NCT04817930: Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
Official title: Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Microgenia
Keywords: Chin microgenia
Orthognathic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year


Eligibility criteria: Inclusion Criteria:

* Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
* No prior surgery involving the chin

Exclusion Criteria:

* Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.
* Patients with systemic diseases that carried high risk for general anesthesia.

Primary outcomes:
measure: soft tissue effect
timeFrame: after one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Assistant lecturer. OMFS. Cairo University
name: Mohamed Shawky
role: PRINCIPAL_INVESTIGATOR
References: