louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03751579: Indirect Measurement of Respiratory Quotient in Coelioscopic Surgery
Official title: Validation of the Respiratory Quotient Measurement Measured Indirectly in Coelioscopic Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Quotient Measurement
Keywords: coelioscopic
surgery complications
respiratory quotient
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for coelioscopic surgery

Exclusion Criteria:

* Cardiac and thoracic surgery
* Preoperative oxygen therapy

Brief summary: The measurement of VO2 and VCO2 makes it possible to calculate the respiratory quotient (RQ) (VCO2 / VO2) which is a reflection of human energy metabolism and therefore of anaerobiosis. A study has been conducted in our department to demonstrate the ability of the indirectly measured RQ from the inspired and exhaled breath analysis of the anesthetic respirator to predict the onset of anaerobic metabolism and postoperative complications in the operating room.

But, because of artificially increase of carbon dioxide due to insufflation, coelioscopic surgery was an exclusion criteria of our pilot study.

However, no study has examined the impact of coelioscopy on the indirect measurement of RQ


Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* Adults admitted to the operating room for coelioscopic surgery

Exclusion Criteria:

* Cardiac and thoracic surgery
* Preoperative oxygen therapy

Primary outcomes:
measure: Indirect respiratory quotient by measurement of VO2 and VCO2
timeFrame: during coelioscopic surgery
Secondary outcomes:
measure: occurence of at least one post-operative complication
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Bar S, Santarelli D, de Broca B, Abou Arab O, Leviel F, Miclo M, Dupont H, Guinot PG, Lorne E. Predictive value of the respiratory exchange ratio for the occurrence of postoperative complications in laparoscopic surgery: a prospective and observational study. J Clin Monit Comput. 2021 Aug;35(4):849-858. doi: 10.1007/s10877-020-00544-5. Epub 2020 Jun 12.
Clinical trial NCT00586079: Deep Brain Stimulation in Patients With Parkinson's Disease
Official title: The Effect of Deep Brain Stimulation on Movement-Related Cortical Potentials in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of deep brain stimulation surgery on movement-related cortical potentials in patients with Parkinson's disease.

Detailed description: Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona will have electroencephalographic (EEG) measurements with the stimulator on followed by EEG measurements with the stimulator off. Patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease will have EEG measurements before and after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona, or who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.

Exclusion Criteria:

* Patients unable to do repetitive dorsiflexion of the wrist due to orthopedic problems.
* Pregnant women.
* Prisoners or institutionalized individuals.

Primary outcomes:
measure: The primary measures are six EEG bereitschaftspotential areas and amplitudes.
timeFrame: 12 months
Secondary outcomes:
measure: Unified Parkinson's disease rating scale score.
timeFrame: At time of EEG measurement.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Virgilio Evidente, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03859479: Cold Snare Polypectomy of Non-pedunculated Colorectal Adenomas
Official title: A Prospective Randomized Controlled Trial of Cold Snare Polypectomy vs. Conventional Polypectomy for Non-pedunculated Colorectal Adenomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Polyp
Keywords: Cold snare polypectomy
Hot snare polypectomy
Сolorectal polyps
Endoscopic treatment
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2019-03-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomised controlled trial of cold vs hot snare polypectomy of non-pedunculated colorectal adenomas.

Detailed description: Diagnostic colonoscopy will be performed in all patients. If a polyp, appropriate for inclusion criteria, is identified, an endoscopic polypectomy will be assigned. All eligible polyps will be randomly assigned (1:1) to endoscopic polypectomy with either the cold snare resection or hot snare resection (control group). Randomization will be stratified using random numbers. After resection, the marginal mucosa will be carefully observed with used of magnification and image enhancement (near focus imaging or narrow band imaging) for determine residual tissue. The time period when the snare will be entered in the bowel lumen and until a polyp will be retrieved will be recorded by a stopwatch.

All polyps will be retrieved for morphological examination to estimate R0/R1resetion. After polypectomy all patients will be observed for 3-4 days in-hospital to diagnose and eliminate complications (delayed bleeding and perforations). All patients will have a control colonoscopy 6 months after polypectomy to investigate long-term results.

Eligibility criteria: Inclusion Criteria:

* Patients with non-pedunculated colorectal adenomas who had provided written informed consent

Exclusion Criteria:

* known coagulopathy.
* polyposis of the alimentary tract.
* inflammatory bowel disease.
* malignant polyps.
* associated diseases in the stage of decompensation

Primary outcomes:
measure: R0 resection rate
timeFrame: 14 days
measure: Complete resection rate
timeFrame: 1 day
Secondary outcomes:
measure: Incidence of local recurrence
timeFrame: 6 months
measure: The immediate bleeding or immediate perforation rate after polypectomy
timeFrame: 1 day
measure: Complication rate
timeFrame: 14 days
measure: Use of submucosal injection
timeFrame: 1 day
measure: Polyp retrieval rate
timeFrame: 1 day
measure: The procedure time
timeFrame: 1 day
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT05775679: Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
Official title: Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cleft Lip and Palate
Keywords: CLEFT-Q
Psychometrics
Test-retest reliability
Interpretability
Responsiveness
Lead sponsor: Department of Plastic and Reconstructive Surgery
Sponsor class: NETWORK
Collaborators: name: Karolinska University Hospital
name: Linköping Univeristy Hospital
name: Umeå University Hospital
name: Uppsala University Hospital
First posted: 2023-03-20
Enrollment: 260
Sex: ALL
Minimum age (years): 8
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients with cleft lip and/or palate who have been operated as infants and opt for secondary surgery to improve appearance, occlusion or speech.

Brief summary: The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are:

1. Are CLEFT-Q scores reliable over time?
2. Can CLEFT-Q detect change following surgical treatment intervention?
3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
6. What are the main expectations that patients express before a surgical intervention?
7. How do patients perceive that the results after surgical interventions meet their expectations?
8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?

Participants will

1. Fill out the questionnaire CLEFT-Q twice with a two-week space.
2. Before and 1 year after an operation.
3. Be interviewed about their experiences related to an operation or using CLEFT-Q.

Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.


Eligibility criteria: Inclusion Criteria:

* Cleft lip and/or palate
* Planned secondary surgery of the nose, lips, jaw or to improve speech
* Can speak and read Swedish

Exclusion Criteria:

* Multiple surgeries at once

Primary outcomes:
measure: CLEFT-Q change scores
timeFrame: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.
Secondary outcomes:
measure: Photograph
timeFrame: Before surgery and after 6 months or 1 year.
measure: Speech
timeFrame: Before surgery and after 1 year.
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skania University Hospital
state: Skania
Study officials:
affiliation: Mia Stiernman
name: Mia Stiernman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06833879: Activity Tracking Study in Healthy Volunteers (MK-0000-419)
Official title: A Pilot Study to Evaluate the Use of a Wrist-worn Accelerometer Device for Physical Activity Monitoring in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, researchers want to learn if a watch can be used to track physical activity in healthy people. The watch will collect the data and send it to a database using a data storage device.

The goal of this study is to measure:

* The number of people who wear the watch as instructed
* The number of working watches and data storage devices returned at the end of the study
* The number of watches that successfully sent data back to a database
* The overall daily activity for people including the number of daily steps taken and how much time is spent doing non-exercise activity and mild to intense exercise.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to:

* Is in good health
* Is willing to comply with study restrictions

Exclusion Criteria:

The key exclusion criteria include but are not limited to:

* History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* History of cancer

Primary outcomes:
measure: Number of Participants that Wear Watch as Instructed
timeFrame: Up to approximately 2 weeks
measure: Number of Provisioned Watches and Data Storage Devices That Were Returned
timeFrame: Up to approximately 2 weeks
measure: Number of Watches and Data Storage Devices that Successfully Transmit Data
timeFrame: Up to approximately 2 weeks
measure: Average Daily Overall Activity Count
timeFrame: Up to approximately 2 weeks
measure: Average Daily Total Step Count
timeFrame: Up to approximately 2 weeks
measure: Average Daily Time (minutes) in Nonsedentary Activity
timeFrame: Up to approximately 2 weeks
measure: Average Daily Time (minutes) in Moderate-to-Vigorous Physical Activity
timeFrame: Up to approximately 2 weeks
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 weeks
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 2 weeks
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC (Site 0001)
state: Florida
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc. (Site 0002)
state: Kansas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03657979: TAP-Block in Abdominal Aortic Surgery
Official title: Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Aneurysm, Abdominal
Keywords: analgesia
TAP-block
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.


Eligibility criteria: Inclusion Criteria:

* Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
* Person who has given his written consent

Exclusion Criteria:

* Emergency surgery
* Patient with infection
* Use of opioids in the long term
* History of chronic pain
* Higher functions incompatible with the functioning of the PCA
* Patients under guardianship

Primary outcomes:
measure: Evaluation of morphine consumption at 24 postoperative hours
timeFrame: 24 hours
Secondary outcomes:
measure: Evaluation of Visual Analogue Scale scores at 24 postoperative hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dijon Cedex
country: France
facility: Cardiovascular and thoracic surgery unit, CHU Dijon
Study officials:
affiliation: Anesthesia unit
name: Claude GIRARD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular and thoracic surgery unit
name: Eric STEINMETZ, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02367079: Diathermy Compared With Sham Diathermy in Doms Management
Official title: Diathermy Compared With Sham Diathermy in Doms Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Musculoskeletal Diseases
Lead sponsor: Studi Fisioterapici di Montagna
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of hand massage, switched on diathermy or sham/switched off diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.

Detailed description: This study examine DOMS in athletes following a ski mountaineering race, pain measured with numbering pain rating scale NPRS and perceived global improvement (PGIC) after treatment have been measured after a massage treatment, a diathermy treatment and a sham diathermy treatment.

Eligibility criteria: Inclusion Criteria:

- Healthy patients who complaints about D.O.M.S. after a skimountaneering race

Exclusion Criteria:

- Patient who complain of pathology such trauma or declaring consuming drugs for pain management where excluded from the study.

Primary outcomes:
measure: Numering pain rating scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Aosta
country: Italy
facility: Studi fisioterapici di Montagna
Study officials:
affiliation: Studi Fisioterapici di Montagna
name: LORENZO VISCONTI, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022879: Topical Anesthesia in Small Gauge Vitrectomy
Official title: Pain Scale in the Use of Topical Anesthesia in Small Gauge Vitrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Pain scale of pain
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of topical anesthetics is a non invasive option avoiding local or general anesthesia in small gauge vitrectomy without causing intolerable pain


Eligibility criteria: Inclusion Criteria:

* Pseudofaquic or faquic,
* male or female,
* 18 to 80 years,
* primary vitrectomy

Exclusion Criteria:

* Combined surgery
* Non cooperative patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Maria A Martinez-Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977584: Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease
Official title: Tau PET Longitudinal Substudy Associated With: A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-randomized, Placebo-treated Non-carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Banner Alzheimer's Institute
name: National Institute on Aging (NIA)
First posted: 2019-06-06
Enrollment: 114
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352). Participants will receive up to three intravenous (IV) injections of \[\^18F\] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of \[18\^F\]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD).


Eligibility criteria: Inclusion Criteria:

- Enrolled in main Study NCT01998841 (GN28352).

Exclusion Criteria:

- Contraindication to PET scan procedures, possibly including, but not limited to current, past, or planned participation in studies involving radioactive agents, including the main Study NCT01998841 (GN28352) and this Tau PET substudy, such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.

Primary outcomes:
measure: Annualized Rate of Change in Tau Burden
timeFrame: Baseline up to Week 149
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Grupo Neurociencias de Antioquia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00947284: Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
Official title: Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 40
* In stable health
* Speak, read, understand English language
* If female, must be non-lactating and not pregnant

Exclusion Criteria:

* Heat pain detection thresholds above 47 ºC/116.6 ºF
* Inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit
* Serious psychiatric psychopathology (psychotic disorder, substance abuse)
* Tattoos in the area of measurements
* Allergy to study drugs (nalbuphine, naloxone, or capsaicin)
* Current or recent use opioids

Primary outcomes:
measure: Change in Skin Sensitivity as Measured by a Visual Analog Scale
timeFrame: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jon D Levine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: