louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06187714: Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries
Official title: Effect of Caudal Block Injection Rate on Optic Nerve Sheath Diameter in Pediatric Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Nerve Sheath Diameter
Caudal Block
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients aged 1-7 years for caudal block

Brief summary: Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Optic nerve sheath diameter of the patients will be measured and recorded.

Detailed description: The study will be conducted with patients who will undergo elective surgery and caudal block will be applied between 05.07.2023-05.09.2023 in the Anesthesiology and Reanimation Clinic of Prof. Dr. Cemil Taşçıoğlu City Hospital after Ethics Committee approval and written and verbal consent of the patients. Our prospective observational study will include patients between the ages of 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, whose consent was obtained by their parents for the procedure to be performed. Gender, age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiology) score and medical history of the patients will be recorded. Injection times of pediatric patients who underwent caudal block with 0.125% bupivacaine at a dose of 0.8 ml/kg using a 22 gauge caudal needle will be noted. Optic nerve sheath diameter of the patients will be measured and recorded. Intraoperative hemodynamic parameters, postoperative complications (nausea, vomiting, urinary retention) will also be noted.

Eligibility criteria: Inclusion Criteria:

Patients aged 1-7 years, ASA 1-2, who will undergo elective surgery under general anesthesia, in whom consent has been obtained for the procedure to be performed

Exclusion Criteria:

-

Primary outcomes:
measure: optic nerve sheath diameter measurement
timeFrame: 1st minute after caudal block
Secondary outcomes:
measure: optic nerve sheath diameter measurement
timeFrame: 10th minute after caudal block
Other outcomes:
measure: optic nerve sheath diameter measurement
timeFrame: 20th minute after caudal block
Locations:
city: İstanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
state: Sisli
Study officials:
References:
Clinical trial NCT05591014: The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Official title: The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coagulation Disorder, Blood
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The sensitivity/specificity and diagnostic accuracy of clinicians will be compared before and after the use of novel ROTEM app. The performance of more experienced clinicians will be compared to those with little to no experience in ROTEM. Analysis will be done using a mixed effects model to account for clustering of measurements within clinician groups. Inter-rater reliability analysis will be done to assess the similarity within clinician groups using the ICC.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.


Eligibility criteria: Inclusion Criteria:

* Current residents and attending physicians in the University of Utah Department of Anesthesiology who have a range of experience and exposure to thromboelastography

Exclusion Criteria:

* Refusal to consent or no longer an active member of the University of Utah Department of Anesthesiology

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT06404814: Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis
Official title: Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study focus on the rehabilitation of patients with frozen shoulder through a manual technique called "Spencer MET".The purpose of this approach is to reduce the pain and improve the ROM and quality of life.

Detailed description: By comparing the effectiveness of functional electrical stimulation versus the Spencer technique in patients with adhesive capsuilitis is to determine which treatment approach will yields better outcomes in order to reduce the detrimental effects of disease process.Spencer METs consist of series of seven steps taken in order to decrease pain and stiffness in sholder regiegionn.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetic frozen shoulder
* Patients having frozen shoulder after stroke
* Subjects having stiff shoulder for at least 3 months
* Subjects with bilateral/unilateral frozen shoulder
* Subjects with idiopathic frozen shoulder

Exclusion Criteria:

* Bone fracture within past 12 weeks
* Patients with hyper mobile joints
* Subjects with Rotator cuff pathology
* Dislocated shoulder
* Subjects who had shoulder arthroplasty

Primary outcomes:
measure: Visual Analogue Scale (VAS):
timeFrame: 12 Months
measure: Goniometer
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Johar pain relief center
state: Punjab
Study officials:
References:
Clinical trial NCT01733914: Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Official title: Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shoulder Pain
Keywords: shoulder pain
acupuncture
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: University of Maryland
First posted: 2012-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. We hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Uni-lateral shoulder pain for 6 weeks to 2 years
* VAS score ≤ 50
* 25-65 years of age
* Positive Neer's or Hawkins' signs
* Accept the informed consent

Exclusion Criteria:

* Shoulder pain of neurological origins
* Shoulder pain of neck origins
* Systematic arthritis
* Wrist problems
* Previous shoulder, arm, neck or chest fractures or surgeries
* Mental diseases
* Pregnancy
* Inability to work for more than 3 months before treatment
* Diabetes
* Coagulative dysfunction
* Corticosterone or physicotherapy experience on the affected shoulder in the last 6 months
* Failure to accept the informed consent

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: before and 2, 4, 8 and 16 weeks after treatment start
Secondary outcomes:
measure: The MOS item short from health survey (SF-36)
timeFrame: before and 8 and 16 weeks after treatment start
measure: Constant-Murley score
timeFrame: before and 2, 4, 8 and 16 weeks after treatment start
measure: DASH score
timeFrame: before and 2, 4, 8 and 16 weeks after treatment start
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Province Hospital of Integrative Chinese and Western Medicine, Sichuan
state: Sichuan
Study officials:
affiliation: Peking University
name: Ming Yi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang H, Sun J, Wang C, Yu C, Wang W, Zhang M, Lao L, Yi M, Wan Y. Randomised controlled trial of contralateral manual acupuncture for the relief of chronic shoulder pain. Acupunct Med. 2016 Jun;34(3):164-70. doi: 10.1136/acupmed-2015-010947. Epub 2016 Jan 21.
Clinical trial NCT01960114: Study of Long-Acting Acetaminophen in Postoperative Dental Pain
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Keywords: Acetaminophen
Paracetamol Analgesics
Analgesics
Non-Narcotic Pain
Postoperative Pain
Antipyretics Dental Surgery
Third molar extraction
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 403
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.


Eligibility criteria: Inclusion Criteria:

* Must be at least 17 and less than 46 years of age
* Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
* Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
* Experiencing moderate to severe pain after extraction of third molars.

Exclusion Criteria:

* Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
* Cannot be pregnant (or planning to be pregnant) or nursing a baby
* Unable to swallow whole large tablets or caplets.
* Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Primary outcomes:
measure: Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
timeFrame: 10 Hours
Secondary outcomes:
measure: Time to Confirmed First Perceptible Pain Relief
timeFrame: Within 12 Hours
measure: Time to Meaningful Pain Relief
timeFrame: Within 12 Hours
measure: Duration of Pain Relief
timeFrame: Within 12 Hours
measure: Patient Global Evaluation
timeFrame: 12 Hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: McNeil Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00810914: Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
Official title: Patient Controlled Epidural Infusion Vs. Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Patient controlled epidural anesthesia
Pain control in labor
Lead sponsor: MemorialCare
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.

Detailed description: Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.

Eligibility criteria: Inclusion Criteria:

* Early labor
* Nulliparous

Exclusion Criteria:

* Inductions
* Breech
* Contraindications to regional anesthesia

Primary outcomes:
measure: Total bupivicaine used
timeFrame: End of labor
Secondary outcomes:
measure: maternal satisfaction
timeFrame: End of labor
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
Study officials:
affiliation: Memorial care Health Sytem Physcian
name: Michael Haydon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02868814: The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Official title: The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia


Eligibility criteria: Inclusion Criteria:

* Patients who met the 1990 American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).

Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.

Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.

Primary outcomes:
measure: Change from baseline in mean pain score diary at Endpoint
timeFrame: Baseline and 15 weeks
Secondary outcomes:
measure: Change from baseline in FIQ scores at Weeks 15
timeFrame: Baseline and Weeks 15
measure: Change from baseline in SF-36 scores at Weeks 15
timeFrame: Baseline and Weeks 15
measure: Change from baseline in HADS scores at Weeks 15
timeFrame: Baseline and Weeks 15
measure: Change from baseline in MOS-SS scores at Weeks 15
timeFrame: Baseline and Weeks 15
measure: Quality of Sleep Score from the Daily Sleep Diary
timeFrame: up to 15 weeks
measure: Mean pain score from the subject's daily pain
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiehe Hospital of Beijing
state: Beijing
Study officials:
References:
Clinical trial NCT03691714: Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: An Open-label, Phase II Study of Durvalumab (MEDI4736) in Combination With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Recurrent Head and Neck Cancer
Head and Neck Cancer
Head and Neck Neoplasms
Metastatic Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2018-10-02
Enrollment: 36
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 this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

Detailed description: This research study is designed to see if the study drug, durvalumab, will work better with cetuximab than either medicine alone along with the evaluation of side effects of the drug combination.

Eligibility criteria: Inclusion Criteria:

* Body weight \> 30 kg
* Histologically or cytologically confirmed recurrent or metastatic HNSCC
* Not considered a candidate for other curative therapy (i.e. surgery/RT)
* Documented progression of disease after receiving platinum based regimen
* ECOG performance status 0-2

Exclusion Criteria:

* Nasopharyngeal and salivary gland tumors
* Prior exposure to both immunotherapy drugs and Cetuximab. Single exposure to either immunotherapy or cetuximab is allowed.

Primary outcomes:
measure: Objective response rate
timeFrame: 24 months
Secondary outcomes:
measure: Adverse events
timeFrame: 24 months
measure: Disease control rate
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Shuchi Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04544514: Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
Official title: Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: extreme preterm babies with a gestational age 32 weeks or less were admitted to NICU. Only babies who were treated with CPAP because of clinical signs of respiratory distress were enrolled the study.

Brief summary: Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. They were white lung appearance, lack of preserved areas and loss of pleural integrity. The sensitivity of these findings was found to be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be determined by LUS.

It was observed that lung findings were more severe in LUS performed in the early period because of non-completed fetal lung fluid clearence, but the findings could be improved during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual clinical condition and course of the patient.

This study was planned to find the most reliable and earliest US time. Evaluation with LUS was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be compared with x-ray findings and the correlation of surfactant need with LUS findings would also be investigated.


Eligibility criteria: Inclusion Criteria:

* preterm babies with a gestational age 32 weeks or less
* babies treated with CPAP

Exclusion Criteria:

* If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded.
* congenital heart diseases
* complex congenital malformations
* chromosomal abnormalities.

Primary outcomes:
measure: lung ultrasound at 30 minutes
timeFrame: 30 minutes
measure: lung ultrasound at 1 hour
timeFrame: 1 hour
measure: lung ultrasound at 2 hour
timeFrame: 2 hour
measure: lung ultrasound at 4 hour
timeFrame: 4 hour
measure: lung ultrasound at 6 hour
timeFrame: 6 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kayki G, Yigit S, Tandircioglu UA, Celik HT, Yurdakok M. Lung ultrasound (LUS) and surfactant treatment: looking for the best predictive moment. J Perinatol. 2021 Jul;41(7):1669-1674. doi: 10.1038/s41372-021-01039-0. Epub 2021 Mar 23.
Clinical trial NCT01341314: Finding Early Rheumatoid Arthritis
Official title: Proof of Concept of an Internet-based Series Design Case-finding System for Very Early Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Joint Pain
Stiffness
Keywords: joint pain
stiffness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 200
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: persons with joint pain or swelling for less than 3 months

Brief summary: Research has shown that early aggressive use of medicines may stop rheumatoid arthritis (RA)or slow its damage. The key to this is to find people with early symptoms which could be RA and have them get a diagnosis, treatment and follow-up.

This study will recruit persons who've gone to the internet looking for information about their symptoms. After answering a screening survey, the person with possible symptoms will be linked to the study website for a more detailed symptom questionnaire.

After completing that questionnaire the person will receive information about the second part of the study which includes an examination with a rheumatologist (arthritis doctor)and laboratory tests.

Based on the joint examination and laboratory tests, the rheumatologist will tell the person the likelihood of having RA, and make recommendations and if needed a referral for care and treatment. Treatment is not a part of this study.

This study will also compare the information on the subject's questionnaires to the doctor's joint examination and the laboratory tests with the hope of developing a simple inexpensive case finding questionnaire.


Eligibility criteria: Inclusion Criteria:

* Joint pain or swelling for less than 3 months
* Be able to use the internet

Exclusion Criteria:

* Non English speaking
* Diagnosis of rheumatoid arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: