louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04979533: Oxygen Insufflation in Microlaryngoscopies
Official title: Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoxia
Keywords: surgery
airway
hypoxia prevention
oxygen insufflation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be a single group of participants in which all receive oxygen insufflation to see if oxygen insufflation is adequate in microlaryngoscopy airway surgery.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \[finger device used in medicine\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.

Detailed description: High flow, low pressure oxygen will be supplied in microlaryngoscopy airway surgery. These procedures are usually performed with jet ventilation (UAB) or intermittent apnea (surgery centers). Jet ventilation provides oxygenation with limited ventilation but come with high risks, such as barotrauma, pneumothorax, mucosa drying, and even death in the most severe cases. Intermittent apnea is a nuisance for the surgeon in that surgical time is often interrupted with having to place the endotracheal tube whenever the patient's oxygen saturation levels fall. The solution is oxygen insufflation, which will give extended oxygenation times for the surgeon to operate without the inherent risks associated with jet ventilation. During the procedure, oxygen tubing will be connected to the surgeon's laryngoscope instead of the jet ventilation tubing. Oxygen flows of 15 L/min will be administered through the laryngoscope to the posterior oropharynx. Endotracheal tube will be placed if oxygenation deemed insufficient due to oxygen saturations of \<90%. Endotracheal tube will be intermittently placed to check and correct carbon dioxide levels.

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria:

* patients who have a tracheostomy

Primary outcomes:
measure: High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures
timeFrame: 30-60 minutes
Secondary outcomes:
measure: Degree of hypercapnia experienced by participants
timeFrame: 30-60 minutes
measure: Participants That Maintain Adequate Oxygenation at 90% or Greater
timeFrame: 30-60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Hollie N Sanders, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06265233: ERP Plus Improv Group Therapy for OCD (IMPROVE Study)
Official title: Pilot Study of Cognitive Behavioral Therapy (CBT) Plus Improv Group Therapy for OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Behavioral Therapy
ExRP (Exposure and Response Prevention)
ERP
Improv comedy
OCD
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 7
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 goal of this study is to pilot test a novel group therapy intervention for adults with OCD.

Detailed description: The intervention will incorporate exposure and response prevention (ERP) with improvisational comedy ("improv") activities. ERP is the gold-standard treatment for OCD. Improv comedy is a type of theater in which actors perform without a script. This study aims to evaluate whether the intervention is helpful for reducing OCD symptoms and intolerance of uncertainty (a mechanism maintaining OCD). It will also explore whether the intervention is feasible and acceptable.

During the group therapy sessions, participants will engage with improv comedy exercises that have been adapted to function as exposures for different types of OCD. Participants will:

* attend an ERP + improv group therapy intervention (90-minute sessions for 12 weeks)
* complete homework in-between sessions
* answer questions
* complete questionnaires.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Ability to speak and understand English
* Clinical diagnosis of obsessive-compulsive disorder (OCD)

Exclusion Criteria:

* Current active suicidality
* Medical or psychiatric illness that could interfere with study participation

Primary outcomes:
measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline and up to 12 weeks
Secondary outcomes:
measure: Change in Intolerance of Uncertainty Score
timeFrame: Baseline and up to 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: 401 Quarry
state: California
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02679833: Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status
Official title: Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cobalamin Deficiency
Keywords: Cobalamin biomarkers
Anemia
Vegan diet
Subclinical
Metabolic functional markers
Holotranscobalamin
Methylmalonic acid
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Institute of Alternative and Sustainable Nutrition (IFANE)
First posted: 2016-02-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.


Eligibility criteria: Inclusion Criteria:

* Adults: men and women
* Stable diet for at least 24 months (omnivorous or a vegan diet).

Exclusion Criteria:

* Pregnancy and lactation
* Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)
* Renal diseases
* Liver diseases
* Patients with cancer (or cancer history)
* Pre-study treatment with vitamin B12 or folate

Primary outcomes:
measure: The change in plasma concentrations of methylmalonic acid
timeFrame: Baseline, 3 months
measure: The change in plasma concentrations of holotranscobalamin
timeFrame: Baseline, 3 months
measure: The change in plasma concentrations of homocysteine
timeFrame: Baseline, 3 months
measure: The change in plasma concentrations of vitamin B12
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of Saarland
state: Saarland
city: Giessen
country: Germany
facility: Institute of Alternative and Sustainable Nutrition
Study officials:
affiliation: Institute of Alternative and Sustainable Nutrition, Giessen, Germany
name: Markus Keller, PhD
role: STUDY_CHAIR
affiliation: Saarland University Hospital
name: Rima Obeid, PhD
role: STUDY_DIRECTOR
References:
citation: Zant A, Awwad HM, Geisel J, Keller M, Obeid R. Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study. Aging Clin Exp Res. 2019 Dec;31(12):1817-1825. doi: 10.1007/s40520-019-01125-6. Epub 2019 Jan 24.
citation: Siebert AK, Obeid R, Weder S, Awwad HM, Sputtek A, Geisel J, Keller M. Vitamin B-12-fortified toothpaste improves vitamin status in vegans: a 12-wk randomized placebo-controlled study. Am J Clin Nutr. 2017 Mar;105(3):618-625. doi: 10.3945/ajcn.116.141978. Epub 2017 Jan 4.
Clinical trial NCT00853333: Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Official title: Sedation and Pain (The Effect of IV Sedation on Pain Perception)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Propofol
Dexmedetomidine
Midazolam
Effects of sedation on pain perception.
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Society of Regional Anesthesia
First posted: 2009-03-02
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).

Detailed description: We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.

Eligibility criteria: Inclusion Criteria:

Healthy subjects

* 19 years or older able to follow study instructions

Exclusion Criteria:

* Age less than 19 or greater than 40
* Pregnant female
* Obesity (BMI \> or =35)
* Non-English speaking/reading participants
* Sleep apnea
* Pulmonary problems such as moderate or severe bronchial asthma
* Cardiovascular problems such as hypertension
* History of claustrophobia
* Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device
* Presence of an unremoved bullet or shrapnel in the body
* Presence of a prosthetic that is not removable
* Presence of a hearing aid needed for hearing
* Head girth exceeding that of the head coil used in the magnet
* Extensive metalwork on or in teeth, or irremovable false teeth or bridgework
* Epilepsy
* Chronic analgesic medication
* Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles)
* History of surgery for which details are unavailable
* Allery due to study drugs
* History of drug abuse

Primary outcomes:
measure: Pain Rating Change
timeFrame: Sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael A Froelich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.
Clinical trial NCT03179033: Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery
Official title: Impact of Fluid and Passive Leg Raising on Cardiac Output in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Heart Device User
Keywords: LVAD
Passive leg raising
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-06-07
Enrollment: 20
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 with heart failure candidate for assist device implantation

Brief summary: Left Ventricular Assist Device (LVAD) implantation is a common surgical procedure in patients with end-stage heart failure. Optimal fluid management is essential for adequate postoperative treatment. It is important to identify which patients will benefit from fluid administration. Passive leg raising (PLR) is a validated dynamic method to predict fluid responsiveness in patients with heart failure by inducing a transient increase in cardiac preload. Objective: To investigate the role of PLR on the management of patients following LVAD implantation in the postoperative period.


Eligibility criteria: Inclusion Criteria:

* Patients after VAD implantation

Exclusion Criteria:

* Age under 18

Primary outcomes:
measure: Responsiveness to passive leg raising in patients early after LVAD implantation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
References:
Clinical trial NCT05530733: Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial
Official title: Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature
Pacifiers
Tube Feeding
Neonatal Nursing
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 90
Sex: ALL
Minimum age (years): 29
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding.


Eligibility criteria: Inclusion Criteria:

* Feeding with the orogastric tube
* Breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula)
* Gestation week between 29+0 weeks and 34+0 weeks
* Weight of 1000 g or more

Exclusion Criteria:

* Receiving mechanical ventilator support
* Development of sepsis
* Presence of neurological disease
* Presence of chromosomal or congenital anomalies
* Presence of intraventricular bleeding
* Unstable physiological parameters
* No breast milk

Primary outcomes:
measure: Heart rate change
timeFrame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
measure: Respiratory rate change
timeFrame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
measure: Saturation level change
timeFrame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
measure: Feeding duration
timeFrame: measured with a stopwatch for 7 months.
measure: Gastric residual volume
timeFrame: Gastric residue will be measured 2 hours after the end of infant feeding.
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Yeliz Taşdelen
state: Kozlu
Study officials:
References:
Clinical trial NCT01421433: A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Official title: Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Clonixin
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Lysine
L-Lysine
Lysine Acetate
Lysine Hydrochloride
Amitriptyline
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
Collaborators: name: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
First posted: 2011-08-22
Enrollment: 160
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: Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.

Detailed description: Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.

Eligibility criteria: Inclusion Criteria:

* Informed of the nature of the study and given written informed consent
* Patients with mild to moderate lumbago
* Aged between 18 and 65 years old

Exclusion Criteria:

* Known allergy or sensitivity to drug components
* Treatment with another anti inflammatory or corticoid
* Treatment with oral anticoagulants
* Treatment with oxidase monoamine 2 weeks before the study
* Treatment with methotrexate
* Stomach or duodenal ulcer and gastritis
* Dehydration
* Acute myocardial infarction or heart failure
* Hyperthyroidism
* Pregnant or lactating patients
* Treatment with lithium
* User of alcohol and barbiturates
* Hepatic or renal failure

Primary outcomes:
measure: Pain average reduction
timeFrame: 7 days
Secondary outcomes:
measure: Identification of possible gastrointestinal effects
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Luiz
Study officials:
affiliation: Hospital São Luiz
name: Rogerio T. Silva, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321333: Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
Official title: A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Thoracic Spinal Cord Injury
Spinal Cord Injury
Spinal Cord Injury Thoracic
Spinal Cord Trauma
Keywords: thoracic spinal cord injury
spinal cord injury thoracic
sub-acute spinal cord injury
human neural stem cells
stem cells
stem cells transplant
stem cells transplant spinal cord injury
Lead sponsor: StemCells, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.

Detailed description: Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

Eligibility criteria: Inclusion Criteria:

* T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI)
* T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT)
* ASIA Impairment Scale (AIS) Grade A, B, or C
* Minimum of six weeks post injury for the initiation of screening
* Must have evidence of preserved conus function
* Must be at stable stage of medical recovery after injury

Exclusion Criteria:

* History of traumatic brain injury without recovery
* Penetrating spinal cord injury
* Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma
* Previous organ, tissue or bone marrow transplantation
* Previous participation in any gene transfer or cell transplant trial
* Current or prior malignancy

Primary outcomes:
measure: Types and frequencies of adverse events and serious adverse events
timeFrame: One year after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Zurich
country: Switzerland
facility: University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
Study officials:
affiliation: StemCells, Inc.
name: Stephen Huhn, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00662987: Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
Official title: Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Keywords: tonsillectomy
antibiotics
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-04-21
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy

Detailed description: STUDY DESIGN : A prospective, randomized, placebo-controlled trial METHODS : All pediatric patients (under the age of 18) scheduled to undergo a tonsillectomy with or without adenoidectomy from an outpatient otolaryngology practice will be recruited for the study. Exclusion criteria include prior use of antibiotics 7 days before surgery, penicillin allergy or medical comorbidity necessitating antibiotic use. Preoperative demographic information will be obtained. Tonsillectomy with or without adenoidectomy will be performed by a single surgeon (JJ) using electrocautery. Patients will be randomized to receive either a 3- or 7-day course of amoxicillin. Parents will be asked to record the following information: analgesic use for the first 7 postoperative days, postoperative days the child initiated her usual diet and level of activity and medical treatment for oral hemorrhage or dehydration. Statistical analysis will be performed to determine a real difference between the two groups with regard to analgesic use, resumption to normal diet and activity, and incidence of oral hemorrhage or dehydration.

Eligibility criteria: Inclusion Criteria:

* tonsillectomy with or without adenoidectomy
* under the age of 18

Exclusion Criteria:

* penicillin allergy
* took antibiotics within 7 days of surgery
* medical comorbidity requiring treatment with antibiotics

Primary outcomes:
measure: analgesic use
timeFrame: 1 week
Secondary outcomes:
measure: time of resumption of normal diet
timeFrame: 1 week
measure: time of resumption of normal activity
timeFrame: 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jacqueline Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson PE, Rickert SM, Jones J. Duration-related efficacy of postoperative antibiotics following pediatric tonsillectomy: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):984-7. doi: 10.1001/archoto.2009.146.