louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06111742: Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety
Official title: Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 178
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.


Eligibility criteria: Inclusion Criteria:

* 4 to 14 years of age;
* Undergoing non-emergent surgery at Yale New Haven Children's Hospital requiring general anesthesia;
* Chooses inhalational induction as induction method;
* Surgery qualified under one or more of the following fields: otolaryngology, ophthalmology, orthopedics, dentistry, gastrointestinal, general surgery

Exclusion Criteria:

* Altered mental status;
* Significant audiovisual deficits (per parent report and at discretion of study team);
* Received pharmacologic premedication

Primary outcomes:
measure: Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
timeFrame: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),
Secondary outcomes:
measure: Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score
timeFrame: Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)
measure: Healthcare Professional Opinions on BERT Assessed With Health Professional Survey
timeFrame: During first 10 study days
measure: Patient Induction Compliance Assessed by Induction Compliance Checklist
timeFrame: At Induction of Anesthesia
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Department of Anesthesiology
name: Anthony Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01550042: Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
Official title: Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 4
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: Patients admitted with a ischemic stroke of undetermined etiology

Brief summary: Recent studies demonstrated that prolonged rhythm observation increases the detection of atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial fibrillation in these patients has important therapeutic implications for the anticoagulation regimen. However, data on optimal monitoring duration and method of AF detection are limited.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age Recent episode (≤60 days) of cryptogenic ischemic stroke
* Undetermined etiology with negative evaluation (including cardioembolism work- up) according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST)
* Implantation of an implantable loop recorder within two months after index event
* Able of providing informed consent

Exclusion Criteria:

* Pre-existing indication for vitamin K antagonist
* Untreated hyperthyroidism
* Indication for pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT)
* Severe co-morbidity not likely to complete follow-up for one year

Primary outcomes:
measure: Documented Atrial Fibrillation (AF)
timeFrame: One year
Secondary outcomes:
measure: Time to documented AF
timeFrame: One year
measure: Recurrent stroke
timeFrame: One year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente / Thoraxcenter
state: OV
Study officials:
affiliation: Medisch Spectrum Twente
name: Marcoen Scholten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991042: Study of Cytokines Serum Levels in Chronic Low Back Pain
Official title: Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interleukines
Keywords: Cytokines
Low back pain
Intervertebral disk displacement
Interleukins
Tumor necrosis factor-alpha
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of Bahia
First posted: 2009-10-07
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to:

* evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease
* measured cytokines levels in chronic low back pain and in healthy subjects.

Detailed description: 23 patients with at least three months of back pain due to herniated disk disease were selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³ 5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst imaginable pain).

The exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

Eligibility criteria: Inclusion Criteria:

* 23 patients

  * least three months of back pain due to herniated disk disease
  * pain severity had to be 5 points on the Numerical Rating Scale (NRS)
* 10 healthy volunteers:

  * without previous history of back pain

Exclusion Criteria:

* One or more of the following:

  * psychiatric disorders
  * systemic or inflammatory disease
  * history of allergy
  * presence of motor deficits
  * history of blood dyscrasia
  * pregnancy
  * active infection, tumor
  * use of analgesic drugs in the week before
  * inability to come to the hospital for evaluation.

Primary outcomes:
measure: cytokines levels in patients with chronic low back pain and in healthy subjects
timeFrame: 30 days after collect
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Durval C Kraychet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320042: 1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
Official title: 1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Ultra for Astigmatism Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Baseline Visit at which informed consent will be obtained and eligibility will be assessed.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Visual Acuity
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch site 1
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06067542: Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction
Official title: Evaluation of the Clinical and Microbiological Effects of Chlorhexidine Toothpaste on Wound Healing Following Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Impaction
Tooth Diseases
Keywords: chlorhexidine, wisdom teeth, dental surgery
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the postoperative clinical and microbiologic effects of chlorhexidine toothpaste and chlorhexidine-free toothpaste with the same content were compared after bilateral mandibular impacted third molar surgery. Similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste with the same content but without chlorhexidine. Teeth were extracted by the same dentist at 14-day intervals. For microbiological analysis, saliva samples were taken before the first tooth extraction, before the second tooth extraction 14 days later and on the 28th day and sent to the microbiology laboratory. Wound healing, edema and trismus in both extractions were evaluated 1 week after tooth extraction. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment and recorded 14 days after tooth extraction.


Eligibility criteria: Inclusion Criteria:

* Volunteers with bilateral fully impacted mandibular wisdom teeth

Exclusion Criteria:

* Patients were excluded from the study if they did not understand the clinical procedures of the study,
* Had allergies or intolerance to any of the substances used in the study,
* Patients on anticoagulant or psychiatric treatment,
* Pregnant or breastfeeding,
* Patients using oral contraceptiveswere,
* Diabetic,
* Patients with periodontal disease or active infection
* Smokers of more than 10 cigarettes per day,
* Poor oral hygiene

Primary outcomes:
measure: Mouth opening measurements
timeFrame: 0-28 days
measure: Facial edema
timeFrame: 0-28 days
measure: Wound healing
timeFrame: 0-28 days
measure: Visual Analog Scale
timeFrame: 0-28 days
measure: Microbiological analysis
timeFrame: 0-28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University
Study officials:
References:
Clinical trial NCT05261542: Intraoperative Flow Cytometry In Colorectal Cancer
Official title: Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 106
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed with colorectal cancer and being treated by standard colectomy or/and neoadjuvant theraphy according to current guidelines.

Brief summary: This study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.

Detailed description: Tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.

Eligibility criteria: Inclusion Criteria:

biopsy proven colorectal cancer signed informed consent for participation

Exclusion Criteria:

Primary outcomes:
measure: Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.
timeFrame: 2017-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
state: Epirus
Study officials:
References:
Clinical trial NCT02812342: Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Official title: Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Keywords: Alopecia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.

Detailed description: This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU
* Stable hair loss present for 6 months or longer
* No treatment for alopecia areata in the past 1 month
* No evidence of spontaneous hair regrowth

Exclusion Criteria:

* Patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study
* Patients whose current episode of AT or AU is more than 5 years
* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
* Patients known to be HIV or hepatitis B or C positive
* Patients with positive tuberculin skin test or positive QuantiFERON® TB test
* Patients with leukopenia or anemia
* Patients with renal or hepatic impairment
* Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors
* Women who are pregnant or nursing

Primary outcomes:
measure: Percent Change in Severity of Alopecia Tool (SALT) Score
timeFrame: 6 Months
Secondary outcomes:
measure: Treatment Response Assessed as the Number of Participants With Hair Regrowth
timeFrame: 6 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Brett King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayart CB, DeNiro KL, Brichta L, Craiglow BG, Sidbury R. Topical Janus kinase inhibitors for the treatment of pediatric alopecia areata. J Am Acad Dermatol. 2017 Jul;77(1):167-170. doi: 10.1016/j.jaad.2017.03.024. No abstract available.
Clinical trial NCT04798742: Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength
Official title: Gluteus Maximus Transfer Following THA Does Not Improve Abductor Strength - a Case-control Gait Analysis Study of 15 Patients With Gluteus Medius Disruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gluteus maximus transfer following THA does not improve abductor strength - a case-control gait analysis study of 15 patients with gluteus medius disruption

The investigators have compared 15 gluteus maximus transferred patients with the use of a gait analysis system based on reflective markers and force plates to objectively evaluate the gait performance pre- and postoperatively.

Detailed description: The gluteus maximus flap transfer (GMT) is a surgical technique to improve gait kinematics and kinetics as well as reduce pain and ameliorate functional outcome in patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA). The investigators used a gait analysis system based on reflective markers and force plates to objectively evaluate gait performance pre- and postoperatively.

Methods Gait analysis was performed in 15 patients who underwent GMT and were examined with an optical tracking system before and at a minimum of 13 months after the operation. Mean age was 69 years (SD=11), all were females. Median follow-up time was 24 (13-60) months. The primary outcome was hip abduction moment (Nm/kg) during gait. The control group consisted of 66 subjects without any gait pathology.

Eligibility criteria: Inclusion Criteria:

* Patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (THA)

Exclusion Criteria:

* THA prior to the muscle transfer

Primary outcomes:
measure: Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer - a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption
timeFrame: Preop
measure: Abductor strength measurement with use of an optical tracking system after Gluteus maximus transfer- a case-control gait analysis study of 15 patients pre- and postoperative with gluteus medius disruption
timeFrame: Postop 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Roland Zügner
Study officials:
affiliation: Göteborg University
name: Roland Zügner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whiteside LA. Surgical technique: Transfer of the anterior portion of the gluteus maximus muscle for abductor deficiency of the hip. Clin Orthop Relat Res. 2012 Feb;470(2):503-10. doi: 10.1007/s11999-011-1975-y.
Clinical trial NCT01754142: Korean Post-marketing Surveillance for Kombiglyze XR®
Official title: Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 755
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 with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled

Brief summary: The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* ≥ 18 years of age
* Have diagnosed Type 2 diabetes mellitus (T2DM)
* Are initiating Kombiglyze XR treatment within the approved Korean indications

Exclusion Criteria:

* Being treated for an indication not approved for the use of Kombiglyze XR in Korea
* Is contraindicated for the use of Kombiglyze XR as described in the Korean label

Primary outcomes:
measure: Occurrence of known and unexpected adverse events, especially serious adverse events
timeFrame: 30 days after last dose of study drug (Approximately up to 4.5 years)
measure: Incidence of adverse events under the routine drug use
timeFrame: 30 days after last dose of study drug (Approximately up to 4.5 years)
measure: Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)
timeFrame: Baseline and Week 12
measure: Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)
timeFrame: Baseline and Week 24 (for patients that have a post Week 12 follow-up visit)
Secondary outcomes:
measure: Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs
timeFrame: Approximately up to 4.5 years
measure: Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs
timeFrame: Approximately up to 4.5 years
measure: Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs
timeFrame: Approximately up to 4.5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: