louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04828980: Utilization of Different Virtual Reality Experiences
Official title: Impact of Different Virtual Reality Experiences on Anxiety and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Pain, Postoperative
Anxiety
Otolaryngological Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

Detailed description: Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.

This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing head and neck surgery
* Are able to provide informed consent

Exclusion Criteria:

* Isolation precautions
* Active eye discharge
* Active nausea or vomiting
* History of seizure, epilepsy, or hypersensitivity to flashing light
* Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset

Primary outcomes:
measure: Change in patient-reported anxiety
timeFrame: baseline, and then 15 minutes later after VR use
measure: Change in patient-reported pain
timeFrame: baseline, and then 15 minutes later after VR use
Secondary outcomes:
measure: Change in blood pressure
timeFrame: baseline, and then 15 minutes later after VR use
measure: Patient experience
timeFrame: 1 minute after use of VR
measure: Change in heart rate
timeFrame: baseline, and then 15 minutes later after VR use
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ryan Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943980: Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery
Official title: Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid
Airway Morbidity
Keywords: Intraoperative nerve monitoring, airway management
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled prospective study of laryngoscopy and evaluation of the Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the C-MAC videolaryngoscope.

Detailed description: Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order to guarantee a sufficient signal quality of the IONM, the electrode must be adequately positioned on the glottis. The present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification 4
* situations where the possibility of accumulated gastric contents
* Participation in another study

Primary outcomes:
measure: Evaluation of the quality of the IONM during thyroid surgery
timeFrame: Quality IONM; intraoperative 1-3 hours
Secondary outcomes:
measure: intubation success
timeFrame: at intubation; < 120 Seconds
measure: Cormack and Lehane Classification
timeFrame: during the laryngoscopy; < 120 Seconds
measure: Percentage of glottic opening
timeFrame: during the laryngoscopy; < 120 Seconds
measure: IDS (intubation difficult score)
timeFrame: < 120 Seconds
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03943680: Plasma Rich in Growth Factors in Post-extraction Sockets
Official title: Clinical Behavior and Molecular Pathways of PRGF in Post-extraction Sockets
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Extraction
Dental Implants
Keywords: Tooth extraction
Socket regeneration
Dental Implants
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: BTI Biotechnology Institute
First posted: 2019-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical success, radiographical volume maintenance and histological bone regeneration after using either a bovine bone xenograft or an autogenous platelet rich plasma enrich in growth factors, known as Endoret®-PRGF®.


Eligibility criteria: Inclusion Criteria:

* Upper or lower premolar or molar tooth in need of extraction and later restoration by dental implant.
* Adjacent and opposing natural teeth present and healthy.
* At least 3 mm from the tip of the dental root to the maxillary sinus or the inferior alveolar canal.

Exclusion Criteria:

* Active local infection.
* Uncontrolled diabetes mellitus.
* Long term (\>10 years) use of oral bisphosphonates.
* Use of intravenous bisphosphonates.
* Recent use (\<3 months) of antibiotics, antiinflammatories or analgesics drugs.
* Pregnancy.
* Smokers of more than 10 cigarettes per day.
* Any oral pathology that needs to be treated before tooth extraction, particularly the presence of more than 25% of sites with bleeding on probing.

Primary outcomes:
measure: Alveolar bone change in Cone Beam Computerized Tomography
timeFrame: Baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Facultad de Odontología
Study officials:
affiliation: Universidad de Granada
name: Pablo Galindo-Moreno, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anitua E, Murias-Freijo A, Alkhraisat MH, Orive G. Clinical, radiographical, and histological outcomes of plasma rich in growth factors in extraction socket: a randomized controlled clinical trial. Clin Oral Investig. 2015 Apr;19(3):589-600. doi: 10.1007/s00784-014-1278-2. Epub 2014 Jul 8.
Clinical trial NCT01650480: HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)
Official title: HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease (COPD) Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
holistic
pilot
intervention
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
First posted: 2012-07-26
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Registered with Lothian General Practice
* Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh

Exclusion Criteria:

* People with lung cancer
* People unable to give informed consent and complete questionnaire booklets in English

Primary outcomes:
measure: FACIT
timeFrame: 3 and 6 months
Secondary outcomes:
measure: The St George Respiratory Questionnaire (SGRQ)
timeFrame: 3 and 6 months
measure: MRC Dyspnoea score
timeFrame: 3 and 6 months
measure: Dyspnoea 12
timeFrame: 3 and 6 months
measure: COPD Assessment Test (CAT)
timeFrame: 3 and 6 months
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 and 6 months
measure: FACIT Spiritual Well-Being sub-scale (FACIT-Sp)
timeFrame: 3 and 6 months
measure: Palliative care Outcome Scale (POS)
timeFrame: 3 and 6 months
measure: EQ-5D
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: City of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: Hilary Pinnock, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kendall M, Buckingham S, Ferguson S, MacNee W, Sheikh A, White P, Worth A, Boyd K, Murray SA, Pinnock H. Exploring the concept of need in people with very severe chronic obstructive pulmonary disease: a qualitative study. BMJ Support Palliat Care. 2018 Dec;8(4):468-474. doi: 10.1136/bmjspcare-2015-000904. Epub 2015 Aug 26.
Clinical trial NCT00463762: Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.
Official title: Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections In Slovakia. An Open, Prospective, Non-Comparative Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Abscess, Intra-Abdominal
Cholecystitis
Wound Infections
Peritonitis
Appendicitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary infections in Slovakia.


Eligibility criteria: Inclusion Criteria:

* Male or female patient of age 18 years or older.
* Patient with intraabdominal/hepatobiliary infection.?

Exclusion Criteria:

* Patients with known hypersensitivity to penicillins, cephalosporins, cefoperazone or to sulbactam.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00493662: Cross-Over Evaluation of Two Lubricating Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2007-06-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the efficacy of two lubricating eye drops for the treatment of dry eye signs and symptoms.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 yrs or older
2. Males or females
3. Any race or ethnic background
4. Patients with present ocular surface discomfort and a SESoD score of at least 2

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia.
4. Current use of Restasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hazleton
country: United States
facility: Hazleton Eye Specialists
state: Pennsylvania
Study officials:
affiliation: Hazleton Eye Specialists
name: Tom Kislan, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05779891: Comparative Effects of Mulligan Straight Leg Raise Technique Versus Slump Stretching on Pain, Disability and Hip Range of Motion in Patients With Chronic Low Back Pain.
Official title: Comparative Effects of Mulligan Straight Leg Raise Technique Versus Slump Stretching on Pain, Disability and Hip Range of Motion in Patients With Chronic Low Back Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effect of mulligan straight leg raise versus slump stretching on pain, disability and hip range of motion in patient with low back pain. . Convenient sampling technique will be used to enroll the patients. Patients will be inquire into basis of pre formulated eligibility criteria. Written Consent will be taken from each patient before starting interventional sessions. Sample size of this study will consist on the participants who will qualify for both inclusion an exclusion criteria. Both groups will receive ultrasonic therapy and hot pack therapy as baseline treatment. Group A will receive mulligan straight leg raise and group B will receive slump stretching. The assessment of patients will be done at baseline, 4th and 8th week. The outcomes from patients will be calculated by using Visual Analogue Scale (VAS), Goniometer and ODI. The comparison between pre-treatment and post-treatment data will be done after 8th week. Data will be analyzed through SPSS 25.


Eligibility criteria: Inclusion Criteria:

* Patients who have active positive knee extension test(APKET).
* Patient having low back pain for more than 3 months.
* Patients who have been sitting for three hours.

Exclusion Criteria:

* Any active infection, tumor, tuberculosis.
* History of trauma.
* Subject with intervertebral disc prolapse.

Primary outcomes:
measure: Low Back Pain
timeFrame: 8 weeks
measure: Range of motion at hip joint
timeFrame: 8 weeks
measure: Disability related to back pain
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: District Headquarters Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00565591: Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
Official title: A Stepwise, Rising Dose Study of Male Subjects With Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI Compared With Placebo Acu-30™ DPI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Asthma
Keywords: asthma
inhaler device
albuterol sulfate
Lead sponsor: Respirics Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.

Detailed description: This is a single blind (investigator unblinded), open label, single exposure, non-randomized, single center, outpatient, stepwise, rising dose study in male subjects with mild intermittent asthma to assess topical safety and tolerability of Albuterol Sulfate Acu-30™ DPI, compared with Placebo Acu-30™ DPI. Increasing doses of each drug will be administered in a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects) with mild intermittent asthma in each step.

Eligibility criteria: Inclusion Criteria

* Mild intermittent asthma (meeting GINA specifications - www.ginasthma.com)
* Medically normal subjects with no significant abnormal findings
* No tobacco (nicotine products) use for at least 2 years before the study starts
* Normal (or abnormal and clinically insignificant) laboratory values at screening (potassium or glucose levels)
* No significant medical or surgical conditions (COPD, cystic fibrosis, severe allergic rhinitis)

Exclusion Criteria:

* Past or present history of experiencing any allergic reaction to the medications/formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
* Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator

Primary outcomes:
measure: To assess the safety and tolerability of Albuterol Sulfate Acu-30™ DPI compared with Placebo Acu-30™ DPI in male volunteers with mild intermittent asthma.
timeFrame: 3 hours
Secondary outcomes:
measure: To perform an exploratory assessment of the pharmacokinetics (PK) of a single dose of Albuterol Sulfate Acu-30™ in a limited population of male volunteers with mild intermittent asthma.
timeFrame: 3 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa Clinical Research Corporation
state: Iowa
Study officials:
affiliation: Private practise
name: Holly Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00314691: Development of New Prenatal Diagnostic Tests From Maternal Blood
Official title: Development of New Prenatal Diagnostic Tests From Maternal Blood
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hereditary Diseases
Keywords: fetal DNA
prenatal diagnosis
maternal plasma
Diagnostic potential of cell-free fetal DNA circulating in maternal blood
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy, B-Thalassaemia...


Eligibility criteria: Inclusion Criteria:

* Mother and father-to-be both older than 18 years old
* Mother and father-to-be affiliated to social security
* Mother and father-to-be have good understanding of the protocol
* Pregnancy of the mother-to-be attested

Exclusion Criteria:

* Mother and father-to-be are younger than 18 years old
* Mother and/or father-to be refusing to participate

Primary outcomes:
measure: Feasibility of fetal gender and genotype determination out of maternal blood
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Sihcus-Cmco
state: Schiltigheim
Study officials:
affiliation: SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE
name: Romain FAVRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00470691: Dorsal Splint or Circular Cast for Colles' Fracture?
Official title: Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles' Fracture
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2007-05-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery.

The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods.


Eligibility criteria: Inclusion Criteria:

* women 50 years and older
* Colles' fracture due to low energy trauma

Exclusion Criteria:

* high energy trauma
* age under 50 years
* dementia

Primary outcomes:
measure: redisplacement
timeFrame: 10 days
Secondary outcomes:
measure: pain
timeFrame: 10 days
measure: number of analgesic tablets
timeFrame: 10 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: Dept of orthopaedic Surgery, St Olavs Hospital
name: Vilh Finsen, MD, PhD
role: STUDY_CHAIR
References:
citation: Wik TS, Aurstad AT, Finsen V. Colles' fracture: dorsal splint or complete cast during the first 10 days? Injury. 2009 Apr;40(4):400-4. doi: 10.1016/j.injury.2008.08.044. Epub 2009 Feb 4.