louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04502485: Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
Official title: Reduce Patient Discomfort With Water Exchange Method During Upper Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Diagnostic EGD
Keywords: water exchange
upper endoscopy
discomfort
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study was to evaluate the application of water exchange method to upper endoscopy. We hypothesize that water exchange during upper endoscopy could reduce patient discomfort. The primary outcome will be the patient discomfort score during upper endoscopy. The secondary outcomes will include cleanliness score, techniques adequacy score, findings of the EGD, and willing to repeat the procedure, as well as the patient and endoscopist satisfaction score with the method.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will include those anticipated to undergo EGD , aged 20 to 65 at the time of enrollment

Exclusion Criteria:

* a therapeutic EGD
* sedation with other agents
* American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
* age less than 20 years or more than 65 years
* pregnancy
* refusal to provide written informed consent. All participants signed written informed consents

Primary outcomes:
measure: Discomfort during the procedure
timeFrame: 5 minutes after the procedure
Secondary outcomes:
measure: patient satisfaction score
timeFrame: 5 minutes after the procedure
measure: mucosa cleanliness score
timeFrame: 1 minutes after the procedure
measure: technique adequacy score
timeFrame: 1 minutes after the procedure
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
References:
citation: Abraham N, Barkun A, Larocque M, Fallone C, Mayrand S, Baffis V, Cohen A, Daly D, Daoud H, Joseph L. Predicting which patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest Endosc. 2002 Aug;56(2):180-9. doi: 10.1016/s0016-5107(02)70175-2.
citation: Meining A, Semmler V, Kassem AM, Sander R, Frankenberger U, Burzin M, Reichenberger J, Bajbouj M, Prinz C, Schmid RM. The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam. Endoscopy. 2007 Apr;39(4):345-9. doi: 10.1055/s-2006-945195. Epub 2007 Feb 7.
Clinical trial NCT00501085: LAP-BAND AP Early Experience Trial (APEX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-13
Enrollment: 521
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: Community sample

Brief summary: The purpose of this study is to evaluate the LAP-BAND AP System in severely obese patients.

Detailed description: The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting. Effectiveness was assessed through the collection of weight loss data, as well as other secondary effectiveness measurements. Safety was assessed by the incidence and severity of adverse events (AEs) related to treatment.

Eligibility criteria: Inclusion Criteria:

* Patient is scheduled to receive the LAP-BAND AP System
* Willingness to follow protocol requirements, including: the Informed Consent Form (ICF), Health Insurance Portability and Accountability Act (HIPAA) forms, follow-up schedule, completion of patient questionnaires.

Exclusion Criteria:

* Per the LAP-BAND AP System Directions For Use (DFU)

Primary outcomes:
measure: Change in Percent Excess Weight
timeFrame: Baseline to 5 Years
Secondary outcomes:
measure: Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation
timeFrame: Baseline to 5 years
measure: Subject Reported Satiety
timeFrame: Baseline to 5 Years
measure: Subject Reported Quality of Life
timeFrame: Baseline to 5 Years
measure: Subject Reported Sleepiness (Epworth Sleepiness Scale)
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Austin
country: United States
facility: Apollo Endosurgery
state: Texas
Study officials:
affiliation: Apollo Endosurgery, Inc.
name: Apollo Endosurgery
role: STUDY_DIRECTOR
References:
citation: Ponce J, Taheri S, Lusco V, Cornell C, Ng-Mak DS, Shi R, Okerson T. Efficacy and safety of the adjustable gastric band - pooled interim analysis of the APEX and HERO studies at 48 weeks. Curr Med Res Opin. 2014 May;30(5):841-8. doi: 10.1185/03007995.2013.874992. Epub 2014 Jan 16.
citation: Fusco M, James S, Cornell C, Okerson T. Weight loss through adjustable gastric banding and improvement in daytime sleepiness: 2 year interim results of APEX study. Curr Med Res Opin. 2014 May;30(5):849-55. doi: 10.1185/03007995.2013.874991. Epub 2014 Jan 17.
citation: Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP(R) adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561.
Clinical trial NCT01424085: Antibiotic Prophylaxis Before Percutaneous Gastrostomy
Official title: Antibiotic Prophylaxis Before Percutaneous Gastrostomy: A Randomized, Controlled Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anyone referred to Interventional Radiology for percutaneous gastrostomy is in the study population (with inclusion and exclusion criteria below).

Brief summary: The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to receive antibiotics or placebo before the procedure, and the rates of skin infection after the procedure will be determined between the two groups. This has never been studied in our population of patients undergoing the procedure. However, antibiotics are routinely given despite the lack of evidence. The investigators hypothesize that patient receiving prophylactic antibiotics will have a decreased number of infections compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Anyone over the age of 18 years who is not currently on antibiotics for other reasons

Exclusion Criteria:

* Anyone on antibiotics for the treatment of other infections.
* Anyone under the age of 18 years
* Pregnant patients

Primary outcomes:
measure: Rate of infection
timeFrame: Within one month of the procedure (antibiotic dose, if given)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References:
citation: Ahmad I, Mouncher A, Abdoolah A, Stenson R, Wright J, Daniels A, Tillett J, Hawthorne AB, Thomas G. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy--a prospective, randomised, double-blind trial. Aliment Pharmacol Ther. 2003 Jul 15;18(2):209-15. doi: 10.1046/j.1365-2036.2003.01684.x.
Clinical trial NCT06629285: Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery
Official title: Effectiveness Comparison Between Continuous Cryotherapy and Ice Pack Therapy After Anterior Cruciate Ligament Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain, Acute
Anterior Cruciate Ligament Injuries
Cryotherapy Effect
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial study conducted by comparing the VAS score, swelling condition, knee ROM and patient's satisfactory score between applying ice pack cold therapy and applying continuous compressive cryotherapy in a postoperative three-day period of anterior cruciate ligament reconstruction surgery patients.


Eligibility criteria: Inclusion Criteria:

* Having anterior cruciate ligament reconstruction
* Agree to be enrolled in study

Exclusion Criteria:

* Complex knee injury
* Raynard's disease
* Sensitive to low temperature
* Do not want to use cryotherapy
* Have vascular disease

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 3 days postoperative
measure: Knee effusion
timeFrame: 3 days postoperative
measure: Knee range of motion
timeFrame: 3 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center, Ho Chi Minh city
state: Ho Chi Minh
Study officials:
References:
Clinical trial NCT00550485: Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene
Official title: Blood-brain-barrier Permeability of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene: Effect on Sleep and Procedural Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 79
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively transports substrates out of the intracellular compartment. One of the major sites of its action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial cells and involved in limiting the access of substrates such as antidepressants to the central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently identified showing a different treatment response to antidepressant drugs depending on the genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP will be associated with significantly different brain levels of the antidepressant escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy subjects with different genotypes of the above mentioned SNP will be differently affected after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression in lymphocytes and metabolic changes will be assessed.


Eligibility criteria: Inclusion Criteria:

* healthy males 20-30 years

Exclusion Criteria:

* any medication

Primary outcomes:
measure: Time spent in rapid-eye-movement (REM) sleep assessed by polysomnography.
timeFrame: after 6 days of intake of escitalopram
Secondary outcomes:
measure: Sleep stages
timeFrame: after 6 days of intake of escitalopram
measure: Sleep continuity
timeFrame: after 6 days of intake of escitalopram
measure: ABCB1 gene expression
timeFrame: baseline and after 6 days of intake of escitalopram
measure: Metabolic changes
timeFrame: baseline and after 6 days of intake of escitalopram
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Axel Steiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04892485: Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF
Official title: Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult CF patients and healty age sex matched controls

Brief summary: 31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. A dynamometer was used to measure each subjects handgrip strength.


Eligibility criteria: Inclusion Criteria:

* CF diagnosed
* Age 18 and above

Exclusion Criteria:

* Having a pulmonary flare up within the previous month
* Pregnancy

Primary outcomes:
measure: Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
affiliation: Marmara University
name: Berrin Ceyhan, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02291185: Prediction of Fluid Responsiveness Using Dynamic Preload Indices During Arthroscopic Shoulder Surgery in the Beach Chair Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Arthroscopy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing shoulder arthroscopic surgery in the beach chair position

Brief summary: The beach chair position (BCP) has been commonly used for shoulder arthroscopic surgery. Hemodynamic instability is frequently encountered problem associated with BCP. In addition, high rates of cerebral desaturation events have been reported during surgery in BCP. Although fluid loading could alleviate hypotension associated with BCP, it may lead to volume overload. As an alternative to static indices, dynamic preload indices such as pulse pressure variation (PPV) and stroke volume variation (SVV) were reported to be sensitive predictors of fluid responsivness in several surgical condition. The investigators will examine the abilities of PPV and SVV to predict fluid responsivness during shoulder arthroscopic surgery in BCP. Using transesophageal echocardiography (TEE), the investigators will directly estimate the change of cardiac output during BCP.


Eligibility criteria: Inclusion Criteria:

1. Above 20 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. shoulder arthroscopy under Beach-chair position

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. cerebrovascular disease 4. Pregnancy

Primary outcomes:
measure: The changes between dynamic preload indices (SVV and PPV) and stroke volume index during beach chair position. We will measure them to evaluate the effect of beach chair position on PPV and SVV.
timeFrame: The participants will be followed up to 5 minutes after fluid challenge.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06373185: Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children
Official title: Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urogenital Diseases
Nerve Block
Pain, Postoperative
Keywords: sacral erector spinae plane block
caudal block
nerve block
anesthesia, general
urogenital surgery
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double blind study
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

Detailed description: The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

Eligibility criteria: Inclusion Criteria:

* Patients aged 1-7 years undergoing paediatric urogenital surgery
* Patients in American Society of Anesthesiologist (ASA) class I-II

Exclusion Criteria:

* Patients whose parents do not give consent
* Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
* Patients with known local anaesthetic allergy
* Patients for whom regional anaesthesia is contraindicated
* Known neurological or muscular disease

Primary outcomes:
measure: Face, Leg, Activity, Cry, Consolability (FLACC) score
timeFrame: baseline ,and 24 hours
Secondary outcomes:
measure: Analgesic requirement
timeFrame: baseline, and 24 hours
measure: Satisfaction of the patient's parents
timeFrame: 24. hours
measure: Satisfaction of the surgeons
timeFrame: 24.hours
Other outcomes:
Locations:
city: Gi̇resun
country: Turkey
facility: Giresun Research and Training Hospital
state: Central
Study officials:
affiliation: Giresun University
name: Bilge Olgun Keleş
role: PRINCIPAL_INVESTIGATOR
affiliation: Giresun University
name: Dilek Yeniay
role: STUDY_CHAIR
affiliation: Giresun University
name: Elvan Tekir Yılmaz
role: STUDY_CHAIR
affiliation: Giresun University
name: İlke Tamdoğan
role: STUDY_CHAIR
affiliation: Giresun University
name: Mehmet Değermenci
role: STUDY_CHAIR
References:
Clinical trial NCT01091285: Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Official title: Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Birth
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.

160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.

Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy above week 37
* Indication to induce birth
* Unripe cervix
* Term date set by US before week 21

Exclusion Criteria:

* Ripe cervix
* Prematurity (\<37w)
* IUFD
* Letal malformations
* Low lying placenta
* Multiple pregnancies
* Breakage of amniotic fluid
* The woman does not understand norwegian

Primary outcomes:
measure: Cervix dilatation >= 3cm
timeFrame: At cather removal
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Womens Hospital, Haukeland University Hospital
Study officials:
References:
Clinical trial NCT01577485: LGG/BB12-pastille Study
Official title: LGG/BB12-pastille Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Probiotics
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: The Forsyth Institute
First posted: 2012-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.


Eligibility criteria: Inclusion Criteria:

* Subjects healthy, 20-30 yrs of age

Exclusion Criteria:

* Subjects not healthy, too old/young

Primary outcomes:
measure: Counts of mutans streptococci
timeFrame: 4 weeks
Secondary outcomes:
measure: Amount of plaque
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Institute of Dentistry
Study officials:
affiliation: Associate Professor
name: Eva M Söderling
role: PRINCIPAL_INVESTIGATOR
References: