louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04421261: Ventilation With Supraglottic Airway Devices
Official title: Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Masks Comparison
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals

Brief summary: Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.


Eligibility criteria: Inclusion Criteria:

* Adult female patients ASA I\&II.
* age: 18-55 years old.
* BMI\< 35.
* undergoing elective surgeries.

Exclusion Criteria:

* Patients with history of upper respiratory tract infections and obstructive sleep apnea.
* Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
* Patients with coagulation disorders.
* Patients with El-Ganzouri airway score ≥ 5 will.

Primary outcomes:
measure: oropharyngeal leak pressure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of anesthesia, Surgical ICU and Pain Management
Study officials:
References:
Clinical trial NCT00929461: Impact of Omega-3 Fatty Acids on Lactate
Official title: Do Omega-3 Fatty Acids Have Any Impact On Serum Lactate Levels After Major Gastric Cancer Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Surgery
Keywords: omega-3 fatty acids
lactate
surgery
gastric cancer
address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2009-06-29
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: Pre- and intra-operative nutritional support in patient undergoing major surgery results in decreased morbidity and mortality. Studies investigating the role of omega-3 fatty acids in these patients are increasing. Some are focused on perfusion at the cellular level. This study was undertaken to address the effect of postoperative administration of omega-3 fatty acids on cellular hypoperfusion associated with major gastric surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing major gastric cancer surgery

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University General Surgery Dep
Study officials:
References:
citation: 16. McNelis J, Marini CP, Jurkiewicz A, et al. Prolonged lactate clearance is associated with increased mortality in the surgical intensive care unit. Am J Surg 2001; 182: 481-5. 7. Smith I, Kumar P, Molloy S, et al. Base excess and lactate as prognostic indicators for patients admitted to intensive care. Intensive Care Med 2001; 27: 74-83. 8. Husain FA, Martin MJ, Mullenix PS, et al. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg 2003; 185: 485-91. 9. Skalski M, Goto M, Ravindranath T, et al. Omega-3 polyunsaturated fatty acid enriched diet attenuates stress induced lactacidemia in 10-day-old rats. Pediatr Int 2001; 43: 409-16. 11. Pscheidl EM, Wan JM, Blackburn GL, et al. Influence of omega-3 fatty acids on splanchnic blood flow and lactate metabolism in an endotoxemic rat model. Metabolism 1992; 41: 698-705. 22. Farolan LR, Goto M, Myers TF, et al. Perinatal nutrition enriched with omega-3 polyunsaturated fatty acids attenuates endotoxic shock in newborn rats. Shock 1996; 6: 263-6. 23. Pomposelli JJ, Flores EA, Blackburn GL, et al. Diets enriched with N-3 fatty acids ameliorate lactic acidosis by improving endotoxin-induced tissue hypoperfusion in guinea pigs. Ann Surg 1991; 213:166-76.
Clinical trial NCT02961361: the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
Official title: the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injury of Upper Limb
Keywords: dexmedetomidine
coracoid
brachial plexus block
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2016-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through intravenous infusion，in order to improved the quality of block in regional anesthesia. In this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed with ropivacaine in coracoid approach brachial plexus block.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II;
2. Aged 18-60 years;
3. The elbow, forearm, wrist or hand surgery

Exclusion Criteria:

1. History of allergy to local anesthetics;
2. Coagulation dysfunction, neuromuscular disease or local infection;
3. The operation time is longer than the local anesthetics effective time.

Primary outcomes:
measure: duration time
timeFrame: once per hour after surgery until 24 hours after surgery
Secondary outcomes:
measure: onset time
timeFrame: 5,10,15,20,25,30 min after injection
measure: Visual analogue scale
timeFrame: 2,6,12,24hour after injection
Other outcomes:
Locations:
Study officials:
affiliation: Hebei Medical University
name: wensheng he, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: He WS, Liu Z, Wu ZY, Sun HJ, Yang XC, Wang XL. The effect of dexmedetomidine in coracoid approach brachial plexus block under dual stimulation. Medicine (Baltimore). 2018 Sep;97(39):e12240. doi: 10.1097/MD.0000000000012240.
Clinical trial NCT05264961: Behavioral Abnormalities in Dysphonic Children
Official title: Behavioral Abnormalities in Dysphonic Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysphonia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: we will assess dysphonic children as regard presence of behavioral abnormalities and then receive voice therapy


Eligibility criteria: inclusion criteria :

* dysphonic children age 6-12 years

exclusion criteria:

* age less than 6 years and more than 12 years,
* hearing impaired,
* neurological abnormalities.

Primary outcomes:
measure: change in child behavior checklist
timeFrame: Baseline (before sessions) and after 3 months of sessions
measure: computerized speech lab.
timeFrame: Baseline (before sessions) and after 3 months of sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT04392661: Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up
Official title: Female Fertility Outcome Following Bariatric Surgery: Five Years Follow up, Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Fertility and Bariatric Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 197
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the LSG group, 14 patients (12.6%) suffered from infertility, and 24 patients (21.6%) were at pre-marriage stage. This is versus 15 patients (17.4%), and 26 patients (30.2%) in the LRYGB group respectively.

Brief summary: Maternal morbid obesity is an important risk factor in modern obstetrics, it has been associated with higher infertility rates and obstetrics complications. Bariatric surgery proven to achieve long term weight loss with improvement in all obesity related morbidities. This study was to compare the 5 years outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of fertility outcomes, breast feeding, weight loss, safety, and resolution of obesity related co-morbidity.

Detailed description: This study included 197 adult morbidly obese females, 111 underwent LSG (group I) and 86 LRYGB (group II). After 5 years follow up, the following were looked at: percentage excess weight loss (%EWL), comorbidity improvement or resolution, postoperative complications or mortality, fertility outcomes and breast feeding.

Eligibility criteria: Inclusion Criteria:

* Patients with primary goal of conceiving and complaining from infertility either primary or secondary as well as those who were seeking weight loss in preparation for marriage

Exclusion Criteria:

-

Primary outcomes:
measure: Measuring the number of females that got pregnant from79 females seeking pregnancy
timeFrame: Five years follow-up
measure: percentage excess weight loss after bariatric surgery
timeFrame: Five years follow-up
Secondary outcomes:
measure: comorbidity improvement or resolution after bariatric surgery
timeFrame: Five years follow-up
measure: postoperative complications or mortality after bariatric surgery
timeFrame: Five years follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01329861: Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
Official title: Guided Internet-based Cognitive Behavioural Treatment for Chronic Back Pain Reduces Catastrophizing:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Keywords: chronic back pain
internet based treatment
pain management programme
cognitive behavioural therapy
minimal therapist contact
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Uppsala University
First posted: 2011-04-06
Enrollment: 54
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: The aim of this study was to investigate whether an Internet-based cognitive behavioural intervention would have an effect on the symptoms of chronic back pain.

Detailed description: All participants were screened in a live, structured interview before inclusion. It´s a experimental design with a treatment and a control group measured before and after a treatment period.

Eligibility criteria: Inclusion Criteria:

* age between 18-65 years
* access to the Internet
* having been in contact with a physician
* back pain of chronic nature
* in current employment or on short-term sick leave(not longer than 6 months)

Exclusion Criteria:

* wheelchair user
* surgical treatment planned
* history of cardiovascular treatment
* severe depression

Primary outcomes:
measure: Coping Strategies Questionnaire - catastrophizing subscale (CSQ)
timeFrame: Two weeks pre treatment to two weeks post treatment
Secondary outcomes:
measure: Multidimensional Pain Inventory (MPI)
timeFrame: Change from baseline Two weeks pre treatment to two weeks post treatment
measure: Pain and Impairment Relationship Scale (PAIRS)
timeFrame: Change from baseline Two weeks pre treatment to two weeks post treatment.
measure: Hospital Anxiety and Depression Scale(HADS).
timeFrame: Change from baseline Two weeks pre treatment to two weeks post treatment.
measure: Quality of Life Inventory (QOLI)
timeFrame: Change from baseline Two weeks pre treatment to two weeks post treatment.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Monica Buhrman, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Elisabeth Nilsson-Ihrfelt, MSc
role: STUDY_CHAIR
affiliation: Linkoeping University
name: Maria Jannert, MSc
role: STUDY_CHAIR
affiliation: Livanda (private practice) Västerås
name: Lars Ström, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00691028: Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Official title: Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
Infliximab
TA-650
Remicade
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 327
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.


Eligibility criteria: Inclusion Criteria:

* Patients with active RA in spite of stable dose of MTX

Exclusion Criteria:

* Having received infliximab in the past
* Having a history of serious infection which caused hospitalization within 6 months before the registration
* Having an active tuberculosis
* Having a complication or a history of malignancy within 5 years before the registration

Primary outcomes:
measure: Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)
timeFrame: baseline and week 54
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)
timeFrame: 54 weeks
measure: Tender Joint Counts (TJC)
timeFrame: 54 weeks
measure: Swollen Joint Count (SJC)
timeFrame: 54 weeks
measure: CRP Level
timeFrame: 54 weeks
measure: Change From Baseline in DAS28
timeFrame: baseline and week 54
measure: Change From Baseline to Week 54 in HAQ
timeFrame: 54 weeks
measure: Change in Modified Total Sharp Score (mTSS) at week54 From Baseline
timeFrame: baseline and week 54
measure: Pharmacokinetics- Serum Concentration of Infliximab
timeFrame: 54 weeks
measure: Pharmacokinetics Positive- ATI
timeFrame: 54 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Takeuchi T, Miyasaka N, Inoue K, Abe T, Koike T; RISING study. Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis: results from the RISING study. Mod Rheumatol. 2009;19(5):478-87. doi: 10.1007/s10165-009-0195-8. Epub 2009 Jul 22.
citation: Takeuchi T, Miyasaka N, Inui T, Yano T, Yoshinari T, Abe T, Koike T. High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study. Arthritis Res Ther. 2017 Sep 2;19(1):194. doi: 10.1186/s13075-017-1401-2.
Clinical trial NCT03174028: Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty
Official title: Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorectal Malformation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Anorectal malformations are congenital malformations, in which the terminal part of the hindgut is abnormally placed and lies outside (partially or completely) the sphincter mechanism.

Detailed description: The incidence of anorectal malformation \~1 in 5,000 More common in Down's syndrome and Cat-eye syndrome. Male \>female (60:40).It is classified into many types according to the degree of descent of the rectal pouch in the pelvis, the fistula between the rectum and the urinary system in males and genital system in females. The most common type in males is high anorectal malformation with rectourethral fistula

There are many historical operations for the management of the high type, but the most popular operation now is the posterior sagittal anorectoplasty which was published for the first time in 1982. Children undergoing posterior sagittal anorectoplasty may have lifelong bowel management problems of constipation, incontinence, and encopresis.

After the introduction of laparoscopy in pediatric surgery, many surgeons hope that the use of laparoscopy instead of posterior sagittal anorectoplasty may reduce the complications of the complications of the big incision and disturbance of sphincter mechanism which occur in posterior sagittal anorectoplasty operation. In addition to its role in diagnosis in complex anomalies like cloaca which is well established now. So the question is to what extent can the laparoscopy replace usual surgery for anorectal malformation.

Eligibility criteria: Inclusion Criteria:

-all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done

Exclusion Criteria:

* all cases with low anomalies will be excluded.
* Female child with vestibular anus
* case with short distal pouch

Primary outcomes:
measure: stool continence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04888728: To Evaluate Drug-drug Interactions Between DWN12088 and Nebivolol or Paroxetine in Healthy Volunteers
Official title: An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between "DWN12088" and "Nebivolol" or "Paroxetine" in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and nebivolol or Paroxetine in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male adults aged ≥ 20 and ≤ 55 years at screening
* Subjects who voluntarily decided to participate in the study and provided written consent to follow study compliance requirements after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

* Subjects unable to have the standard meal provided at the study site
* Subjects who took (the day of taking the last dose) another investigational or bioequivalence study product within 180 days prior to the first dose

Primary outcomes:
measure: Cmax of Nebivolol
timeFrame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
measure: AUCt of Nebivolol
timeFrame: Day 1, Day 2, Day 3, Day 6, Day 7, and Day 8
measure: Cmax of DWN12088
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
measure: AUCt of DWN12088
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 9, Day 10, Day 11, and Day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Busan Paik Hospital
name: Jong-Lyul Ghim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01684228: Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease
Official title: Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: End stage renal disease
hemodialysis
breath test
volatile organic compound
dialysis adequacy
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients

Brief summary: End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over 5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems. The survival of these patients depends on renal replacement therapies, such as hemodialysis (HD), which artificially purifies the blood from toxins. The investigators assume that some of the uremic toxins are also present in the patient's exhaled breath, and could be detected by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by our collaborator Dr. Hossam Haick (Chemical Engineering, Technion).

In the current study, the investigators utilize this technology to identify VOCs in the exhaled breath of dialysis patients, and to characterize certain patterns of expression that could potentially help in future monitoring of HD adequacy. The investigators plan to collect 150 breath samples from patients before and during dialysis, and from healthy subjects. All participants provide a signed informed consent. Subsequently, analysis of samples will be done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters extracted from each sensor response.


Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* End stage renal disease receiving hemodialysis

Exclusion Criteria:

* Age under 18
* Pregnancy
* Malignancy
* Infectious diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Department of Nephrology, Rambam-Health Care Campus
name: Suheir Assady, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: