louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04609748: Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.
Official title: Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Temporomandibular Joint Pain
Keywords: temporomandibular joint
CBD oil
non steroid antyinflammatory drug
nimesulide
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.


Eligibility criteria: Inclusion Criteria:

1. Patients (female and male) aged 18-65 years, able to swallow tablets
2. Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
3. Patients with clinical diagnosis of Temporomandibular Joint Dysfunction

Exclusion Criteria:

1. patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
2. patients allergic to nimesulide or cannabidiol oil
3. patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:

   * gastric or duodenal ulcer disease,
   * severe blood clotting disorders,
   * severe liver dysfunction,
   * severe renal impairment,
   * severe heart failure, pregnancy,
   * breastfeeding,
   * concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)

Primary outcomes:
measure: Pain relief
timeFrame: 15 days
measure: Psychological conditions
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Chair and Depratment of Dental Prosthetics
Study officials:
References:
Clinical trial NCT01168648: Yoga for Stress Management in Health Care Personnel
Official title: Yoga for Stress Management in Health Care Personnel and Its Relation to the Hypothalamus-pituitary-adrenal(HPA)Axis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Stress, Psychological
Stress, Physiological
Keywords: Yoga
Stress
Stress management
Hypothalamus-pituitary-adrenal axis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ekhaga Foundation Stockholm Sweden
name: Region Stockholm
First posted: 2010-07-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel.

Detailed description: Stress, both job related and personal, is an increasing problem in the health care sector. Yoga is said to have a good stress-reducing effect.

The participants will provide blood, urine, and saliva samples. They will take part in two different stress tests. They will also fill in various qualitative questionnaires, including the Swedish questionnaire on health related quality of life (SWEDQUAL), Antonovsky's sense of coherence scale (KASAM), and the Job stress survey (JSS), both before the study starts and after 3 months of participation.

Eligibility criteria: Inclusion Criteria:

* BMI 18-30
* healthy
* work in the health care sector

Exclusion Criteria:

* medication, including contraceptives and all medications or topical skin preparations with cortisone in any form (exception: hormone replacement therapy for hypothyroidism were included if their hormone levels were within the normal range)

Primary outcomes:
measure: Reduced cortisol secretion
timeFrame: Three months
Secondary outcomes:
measure: Reduced stress measured by qualitative questionnaires (SWEQUAL, JSS, KASAM)
timeFrame: Three months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Center for Family and Community Medicine, KI
state: Stockholm
Study officials:
affiliation: KI, Center for Family and Community Medicine
name: Astrid M Grensman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KI, Center for Family and Community Medicine
name: Bikash D Acharya, M sc in Psy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03929848: Cuff Pressure in LMS
Official title: Minimum Cuff Pressure to Prevent Gas Leakage During Mechanical Ventilation in Laryngomicrosurgery - Pilot Study -
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngomicrosurgery
Keywords: cuff pressure, laryngomicrosurgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2019-04-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

Brief summary: The goal of this prospective observational study is to investigate minimum cuff pressure to prevent gas leakage during mechanical ventilation in laryngomicrosurgery.

Detailed description: It has been well known that cuff pressure should be adequately limited to prevent ischemic injury of tracheal mucosa, which is about 20-30 mmHg. However, higher cuff pressure that 20-30 mmHg might be required to prevent gas leakage during general anesthesia for laryngomicrosurgery.

The hypothesis of this study is that the required cuff pressure to prevent gas leakage from mechanical ventilation during general anesthesia for laryngomicrosurgery, and there will be no damage from the required cuff pressure because of short time of surgery.

Eligibility criteria: Inclusion Criteria:

* patients who is scheduled for laryngomicrosurgery due to simple vocal cord cyst or nodule

Exclusion Criteria:

* Who doesn't agree to enroll
* do not use a reinforced tracheal tube of internal diameter of 5.5 mm for male patient
* do not use a reinforced tracheal tube of internal diameter of 5.0 mm for female patient

Primary outcomes:
measure: Cuff pressure
timeFrame: intraoperative
measure: post operative complication
timeFrame: from end of surgery to 1-2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung-Man Lee, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414765: Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
Official title: Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metastatic Renal Cell Carcinoma
Metastatic Melanoma
Keywords: Metastatic Renal Cell Carcinoma
Metastatic Melanoma
Aldesleukin
IL-2
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 26
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: This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.


Eligibility criteria: Inclusion criteria:

* Performance Status Eastern Cooperative Oncology Group: 0 or 1.
* Adequate organ function.

Exclusion criteria:

* Pregnancy or lactation.
* Prior treatment with any form of IL-2.
* Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
timeFrame: From Cycle 1, Day 1 to Cycle 2, Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01626365: Thermosoftening of Double-lumen Tube to Reduce Sore Throat
Official title: The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarseness
Sore Throat
Vocal Cord Injuries
Keywords: double-lumen tube
intubation
thermosoftening
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Preoperative hoarseness or sore throat
* History of upper airway diseases
* Anticipated difficult airway
* Anesthesia time longer than 6 hours

Primary outcomes:
measure: Postoperative hoarseness
timeFrame: up to 3 days after surgery
measure: postoperative sore throat
timeFrame: up to 3 days after surgery
Secondary outcomes:
measure: Vocal cord injuries
timeFrame: up to 1 day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
Clinical trial NCT06483165: F.A.S.T.-BE FAST Stroke Warning Signs Study
Official title: F.A.S.T.-BE FAST Consumer Stroke Warning Signs Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: American Heart Association
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized parallel 2-group design will be used to allow a rigorous assessment of the comparative efficacy of the two acronyms (BE FAST and F.A.S.T.) among English-speaking adults of diverse race and ethnicity.
Primary purpose: OTHER

Brief summary: The goal of this randomized controlled trial is to learn whether the BE FAST (Balance, Eyes, Face, Arm, Speech, and Time) acronym works at least as well or better than the F.A.S.T. (Face drooping, Arm weakness, Speech difficulty, Time to call 911) acronym in helping participants learn and remember the warning signs of a stroke. The main questions it aims to answer are:

* Does the BE FAST acronym increase understanding among participants that calling 911 is the right first step they should take if a stroke is suspected?
* Does the BE FAST acronym perform as well as or better than the F.A.S.T. acronym in helping participants remember stroke warning signs on a letter-aided open-ended basis? Researchers will compare the BE FAST acronym to the F.A.S.T. acronym to see if the BE FAST acronym works at least as well as the F.A.S.T. acronym in teaching participants about the warning signs of a stroke and the importance of calling 911 if they suspect a stroke.

Participants will:

* Take a survey about their knowledge of stroke and its symptoms
* Watch a short video about one of the acronyms and then answer more questions about what they learned
* Take another survey after 30 days about the acronym they learned about


Eligibility criteria: Inclusion Criteria:

* Able and willing to provide written informed consent;
* Have access to a computer, tablet or mobile device with internet services;
* Proficient in reading and writing the English language; and
* Reside outside a medical facility.

Exclusion Criteria:

* Not able to provide written informed consent;
* Do not have access to a computer, tablet or mobile device with internet;
* Not proficient in reading and writing in English language; or
* Reside in a medical facility.

Primary outcomes:
measure: Intent to Call 911 30-Days Post Education
timeFrame: 30 days
Secondary outcomes:
measure: Warning Signs Net Positive Accuracy Score 30-Days Post Education
timeFrame: 30 days
Other outcomes:
measure: Intent to Call 911 Immediately Post-Education
timeFrame: Immediately after intervention
measure: Change in Warning Signs Net Positive Accuracy Score Immediately Post-Education
timeFrame: Immediately after intervention
Locations:
city: Dallas
country: United States
facility: American Heart Association
state: Texas
Study officials:
affiliation: Washington University School of Medicine
name: Opeolu Adeoye, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04552665: Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.
Official title: Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Arrhythmia
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare
First posted: 2020-09-17
Enrollment: 30
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: Patients who undergo a cardiac ablation

Brief summary: The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.


Eligibility criteria: Inclusion Criteria:

* Cardiac Ablation

Exclusion Criteria:

* There is no exclusion criteria

Primary outcomes:
measure: Cardiac Images
timeFrame: Through study completion, an average 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital North Campus
state: New York
Study officials:
affiliation: Staten Island University Hospital North
name: Marcin Kowalski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EPD Solutions, A Philips Compagny
name: Anneleen Viville
role: STUDY_DIRECTOR
References:
Clinical trial NCT01305265: Post-operative Sore Throat as Determined by Endotracheal Tube Inflation Technique
Official title: Post-operative Sore Throat as Determines by Endotracheal Tube Inflation Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Sore Throat
Dysphagia
Hoarseness
Keywords: sore throat
dysphagia
hoarseness
post operative
endotracheal intubation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique.

The investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.


Eligibility criteria: Inclusion Criteria:

* Scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours
* ASA I-3

Exclusion Criteria:

* Planned prolonged intubation
* Planned postoperative ICU admission
* Non English speaking
* Mentally impaired
* Existing tracheal stoma
* Nasogastric tube in place preoperative
* Thyroid / intra-oral surgery
* Previous general anesthesia within the last 2 weeks
* Use of steroids within one week before surgery (IV,inhaled, oral)

Primary outcomes:
measure: Incidence of Tracheopharyngeal Symptoms
timeFrame: within 2 hours after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT00786565: Clinical Evaluation of a New Aspheric Intraocular Lens.
Official title: Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.


Eligibility criteria: Inclusion Criteria:

* Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
* Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion Criteria:

* Patients with corneal damage.
* Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Primary outcomes:
measure: Low Contrast Best Corrected Visual Acuity Following Cataract Surgery
timeFrame: 3 months
measure: Low Contrast Uncorrected Visual Acuity Following Cataract Surgery
timeFrame: 3 months
measure: Photopic Contrast Sensitivity
timeFrame: 3 months
measure: Mesoptic Contrast Sensitivity
timeFrame: 3 Months
measure: Posterior Capsule Opacification Score
timeFrame: 24 months
Secondary outcomes:
measure: High Contrast Visual Acuity
timeFrame: 1 month
measure: High Contrast Visual Acuity Uncorrected
timeFrame: 3 months
measure: High Contrast Visual Acuity Best Corrected
timeFrame: 3 months
measure: High Contrast Visual Acuity
timeFrame: 12 months
measure: High Contrast Visual Acuity Uncorrected
timeFrame: 24 Months
measure: High Contrast Visual Acuity Best Corrected
timeFrame: 24 Months
measure: Low Contrast Visual Acuity
timeFrame: 1 month
measure: Contrast Sensitivity Photopic 1.5cpd
timeFrame: 1 month
measure: Contrast Sensitivity Photopic
timeFrame: 1 month
measure: Contrast Sensitivity Mesoptic 1.5 Cpd
timeFrame: 1 month
measure: Contrast Sensitivity Mesoptic
timeFrame: 1 month
measure: Posterior Capsule Opacification
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05864365: A Biomarker Study of ATH434 in Participants With MSA
Official title: An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy
ATH434
Neurodegenerative disease
Shy-Drager Syndrome
Movement disorders
Autonomic dysfunction
Synucleinopathies
Atypical parkinsonism
Biomarkers
Lead sponsor: Alterity Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy


Eligibility criteria: Inclusion Criteria:

1. Participant has clinical features of parkinsonism.
2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
3. Participant has ataxia and/or pyramidal signs on neurological examination.
4. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

1. Participant is unable to swallow study drug.
2. Participant is unable to attend study visits or complete study procedures.
3. Participant has structural brain abnormality on MRI.
4. Participant has any significant neurological disorder other than MSA.
5. Participant has an unstable medical or psychiatric illness.
6. Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Primary outcomes:
measure: Change in brain volume as measured by MRI
timeFrame: Change from Baseline to Week 52
Secondary outcomes:
measure: Change in iron content in substantia nigra as measured by MRI
timeFrame: Change from Baseline to Week 52
measure: Change in Unified MSA Rating Scale (UMSARS) Score
timeFrame: Change from Baseline to Week 52
measure: Change in Patient Global Impression of Change (PGI-C)
timeFrame: Change from Baseline to Week 52
measure: Change in Clinical Global Impression of Change (CGI-C)
timeFrame: Change from Baseline to Week 52
measure: Change in Neurofilament Light Chain Levels
timeFrame: Change from Baseline to Week 52
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: