louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02933112: Workflow Validation of an In-home Auto-titrating Mandibular Positioner
Official title: Workflow Validation of an In-home Auto-titrating Mandibular Positioner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Oral appliance therapy
Lead sponsor: Zephyr Sleep Technologies
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Detailed description: One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility criteria: Inclusion Criteria:

1. Minimum 18 years of age
2. Participant has been deemed suitable for oral appliance therapy
3. Prescription for oral appliance
4. Adequate range of motion
5. Adequate dentition
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule

Exclusion Criteria:

1. Loose teeth or advanced periodontal disease
2. Full dentures or dental implants

Primary outcomes:
measure: Integration of the device into the existing workflow of a dental sleep medicine practice
timeFrame: 1 year
measure: Convenience and feasibility of carrying out a multi-night AMP study in the home
timeFrame: 1 year
measure: Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
timeFrame: 1 year
Secondary outcomes:
measure: Time to treatment
timeFrame: 1 year
measure: Number of study visits
timeFrame: 1 year
measure: Length of study visits
timeFrame: 1 year
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Premier Sleep
state: Washington
Study officials:
affiliation: Premier Sleep
name: Stephen Carstensen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06040112: Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Official title: Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Calcific Tendinitis of Shoulder
Atelocollagen
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

Detailed description: Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure.

Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.

Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."

Clinical outcomes will be assessed with functional scores on 6 months after injection.

Eligibility criteria: Inclusion Criteria:

1. Patients in whom calcification of 5mm or more is observed in plain radiographs.
2. In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.
3. Individuals who have agreed to participate in this study and have given written consent themselves.

Exclusion Criteria:

* Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.

  * Patients with hypersensitivity.

    * Patients with a history of anaphylactic reactions.

      * Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.

        * Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.

          ⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.

          ⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.

          ⑨ Patients who are on concomitant medications that include oral steroids.

Primary outcomes:
measure: Constant score (Shoulder function score)
timeFrame: 1, 3, 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT02131012: Intravitreal Celecoxib for Chronic Uveitis
Official title: Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Inflammation
Keywords: Macular edema
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-05-06
Enrollment: 4
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

Detailed description: Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.

After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.

Eligibility criteria: Inclusion Criteria:

* Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects

Exclusion Criteria:

* 15 years or younger Have active ocular infection Pregnancy Phakic subjects

Primary outcomes:
measure: Safety
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05797012: The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
Official title: The Association Among Headache Severity, Head Posture, Cervical Muscle Endurance, and Neck Disorders in Individuals With Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Disorders
Keywords: Headache
Head posture
Neck disorders
Migraine
Cervical endurance
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.

Detailed description: Headache is a general health problem that can be seen in different age groups, is common, depends on many factors, and has a lot of individual and socioeconomic effects. It is stated that the rate of individuals who experience a headache at least once in their lifetime is very high in the general population. Migraine is one of the most common types of primary headache. Neck pain and cervical dysfunctions in individuals with migraine have been the subject of many studies. It is seen that studies examining the relationship between cervical region musculoskeletal system disorders and headache in different types of headaches are increasing day by day. This study aims to determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine. In addition, the relationship between these parameters and quality of life will be examined.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with migraine at any time in his life and complaining of headache,
* Not having any diagnosed chronic disease,
* No past or present mental illness,
* Individuals who can speak, read and write Turkish.

Exclusion Criteria:

* Having any neurological, psychiatric or cognitive disorder,
* Individuals who cannot speak, read or write Turkish.

Primary outcomes:
measure: Headache severity
timeFrame: 1 day
measure: Head posture
timeFrame: 1 day
measure: Cervical muscle endurance
timeFrame: 1 day
measure: Neck disorders
timeFrame: 1 day
measure: General quality of life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Tokat
Study officials:
References:
Clinical trial NCT04967612: Visual Perception After Virtual Implantation
Official title: Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of visual perception through diffractive optical lens designs by virtual implantation.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between and including 18 and 50 years of age;
* Healthy eyes;
* Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;
* Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
* Negative COVID19 screening test prior to every trial visit.

Exclusion Criteria:

* Subjects of less than 18 or more than 50 years of age;
* Monocular CDVA of dominant eye \< 1.0 decimal (\> 0.0 logMAR) without cycloplegia;
* Subject unable to comply with the study protocol or likely to be non-cooperative during the study;
* Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;
* Pseudophakic subjects;
* Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;
* Pathologic miosis;
* Intake of drugs affecting vision;
* Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;
* Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;
* Hyperopes with more than +6 D refraction.

Primary outcomes:
measure: Corrected distance visual acuity
timeFrame: during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: JenVis Research
Study officials:
affiliation: JenVis Research
name: W Sickenberger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05719012: Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19
Official title: Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Long COVID-19
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 0
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: To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19


Eligibility criteria: Inclusion Criteria:

1. The age ranges from 18 to 85 (inclusive), regardless of gender.
2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
3. Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.
4. Be expected to live longer than 1 year.
5. Volunteer to participate in this clinical study and sign the written informed consent.

Exclusion Criteria:

1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
2. T lymphocyte abnormality, HIV positive.
3. Highly allergic or have a history of severe allergy.
4. Pregnant and lactating women.
5. Patients with severe autoimmune disease history;
6. Patients with uncontrolled chronic diseases or serious complications;
7. Patients with malignant tumors;
8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;
9. Patients with severe organ dysfunction
10. Other situations that the researchers think are not suitable for participating in this study

Primary outcomes:
measure: Six min walking distances
timeFrame: Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
measure: Lung function
timeFrame: Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
Secondary outcomes:
measure: Changes of the levels of Inflammatory cytokines
timeFrame: Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
measure: Changes of the scores of Multidimensional Fatigue Inventory
timeFrame: Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hosptial
Study officials:
References:
Clinical trial NCT05550012: A New Deep-learning Based Artificial Intelligence Iterative Reconstruction (AIIR) Algorithm in Low-dose Liver CT
Official title: Evaluation of a New Deep-learning Based Artificial Intelligence Iterative Reconstruction (AIIR) Algorithm in Different Enhancement Phases of Low-dose Liver CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Learning
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: CT-enhanced scans are routine imaging modality for the diagnosis and follow-up of liver disease. However, this means that patients will receive more radiation dose. Therefore, it is necessary to reduce the radiation dose received by patients as much as possible. Deep learning-based reconstruction algorithms have been introduced to improve image quality recently. For many years, researchers attempt to maintain image quality using an advanced method while reducing radiation dose. Recently, a new deep-learning based iterative reconstruction algorithm, namely artificial intelligence iterative reconstruction (AIIR, United Imaging Healthcare, Shanghai, China) has been introduced. In this study, we evaluate the image and diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT.

Detailed description: In our hospital, patients with abdominal pelvic cancer undergo follow-up low-dose CT for the evaluation of treatment plan after clinical treatment or disease progress. The raw-data of low-dose CT were collected retrospectively and reconstructed using KARL and AIIR algorithm. In this study, we evaluate the image and diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT.

Eligibility criteria: Inclusion Criteria:

* those scheduled for contrast-enhanced liver CT

Exclusion Criteria:

* images affected by artifacts (motion or implants)

Primary outcomes:
measure: signal-to-noise ratio (SNR)
timeFrame: 6 months
measure: contrast to noise ratio (CNR)
timeFrame: 6 months
measure: diagnostic confidence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital (The First Affiliated Hospital of Shandong First Medical University)
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Qingshi Zeng
role: STUDY_DIRECTOR
References:
Clinical trial NCT00706212: The Accuracy of CHOLINE PET CT in the Diagnosis of Urological Malignancies
Official title: A Comparative Study to Examine the Accuracy of CHOLINE PET CT in the Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urological Malignancies
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rabin Medical center Urological oncology patients

Brief summary: PET CT is one of the imaging tools that are used for staging of urological malignancies.

C11 Choline is a novel isotope with the advantage of its minimal secretion in the urine. This advantage makes it a potentially better metabolic marker then others such as FDG. Preliminary studies showed \~95% sensitivity in the diagnosis of TCC. Our Goal is to continue the evaluation of this method as a diagnostic and follow up tool in different urological malignancies.


Eligibility criteria: Inclusion Criteria:

* Patients older then 18 years of age
* Full consciousness and awareness
* suspected to suffer from urological malignancy and a candidate for a surgical procedur

Exclusion Criteria:

* known secondary malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson hospital
Study officials:
References:
Clinical trial NCT03089112: Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501
Official title: A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and the Safety Between HGP1607 and HGP1501 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers


Eligibility criteria: Inclusion Criteria:

* 1.age 19\~40 years
* 2.The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
* 3.Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUClast of HGP1607
timeFrame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
measure: Cmax of HGP1607
timeFrame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
measure: baseline corrected AUClast of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
measure: baseline corrected Cmax of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Secondary outcomes:
measure: AUCinf of HGP1607
timeFrame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
measure: Tmax of HGP1607
timeFrame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
measure: T1/2 of HGP1607
timeFrame: 16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h
measure: AUClast of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
measure: Cmax of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
measure: baseline corrected AUCinf of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
measure: baseline corrected Tmax of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
measure: baseline corrected T1/2 of HGP1501
timeFrame: 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Hospital
Study officials:
References: