louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04961346: RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair
Official title: Sublay Technique With Retromuscular Mesh Augmentation for Incisional Hernia Repair - A Prospective Randomized Multicentre Trial Comparing "Lightweight" Versus "Heavyweight" Meshes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 188
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.


Eligibility criteria: Inclusion Criteria:

* fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter

Exclusion Criteria:

* hernia of other location
* recurrent hernia
* incarcerated hernia
* emergency surgery
* patients with a malignancy or chemotherapy within the last 3 months
* pregnancy
* participation in other studies
* patients with a wound infection
* missing informed consent

Primary outcomes:
measure: foreign body sensation
timeFrame: 12 month after surgery
Secondary outcomes:
measure: postoperative seroma
timeFrame: 24 month
measure: wound infection
timeFrame: 24 month
measure: haematoma
timeFrame: 5 days
measure: hematoma requiring surgery
timeFrame: 5 days
measure: chronic pain
timeFrame: 24 month
measure: hernia recurrence
timeFrame: 24 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Surgery, University Hospital Aachen
state: NRW
Study officials:
affiliation: Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany
name: Ralf D Hilgers, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02311946: A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
Official title: A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib (pd-0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.

Detailed description: This will be a 6 cohort study investigating one experimental formulation of palbociclib in each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days, and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood sampling up to 120 hours post-dose.

Eligibility criteria: Inclusion Criteria:

* Healthy Male or Female of non-childbearing potential,
* Having a body weight \>50 kg
* Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A positive urine drug or cotinine test
* A known history of hypersensitivity to palbociclib
* A supine systolic blood pressure \>140 mmHg, or a QTc \>450 msec.

Primary outcomes:
measure: AUCinf
timeFrame: Pre-dose to 120 hours post-dose
measure: Cmax
timeFrame: Pre-dose to 120 hours post-dose
Secondary outcomes:
measure: AUClast
timeFrame: Pre-dose to 120 hours post-dose
measure: CL/F
timeFrame: Pre-dose to 120 hours post-dose
measure: Tmax
timeFrame: Pre-dose to 120 hours post-dose
measure: Vz/F
timeFrame: Pre-dose to 120 hours post-dose
measure: t1/2
timeFrame: Pre-dose to 120 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: MRA Clinical Research - Phase 1
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, LLC
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research, LLC
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02673346: Employee Wellness Survey
Official title: Assessing Tobacco Use and Treatment Preferences Among Alaska Yukon-Kuskokwim Health Corporation Employees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Yukon Kuskokwim Health Corporation
name: University of Minnesota
First posted: 2016-02-03
Enrollment: 467
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: Employees at a health corporation in Western Alaska

Brief summary: The aims of this study are 1) To assess the prevalence of tobacco use and cessation treatment preferences among YKHC employees, 2) To assess employee's current levels of perceived stress, engagement in physical activity, and feelings of resiliency to inform future tobacco cessation interventions, and to examine the relationship between these factors and tobacco use, and 3) To assess YKHC employees' perceptions and opinions of the hospital's current workplace tobacco policy and expansion of these regulations to all YKHC properties.

Detailed description: All employees at YKHC will be invited to complete an online survey that took approximately 10-15 minutes to complete. All employees will receive information via email, which includes an overview of the project, information regarding privacy and consent, and a link to the survey. Those who wish to do so were able to print a copy of the information for their reference. Employees who wish to participate did so by clicking on the survey link. Those who do not wish to participate could simply delete the email. Participants will be given two weeks to complete the online survey. Individuals who do not respond within the first week, will be sent an automated email reminder. All employees who participate will received a small incentive (approximately $10 in value).

Eligibility criteria: Inclusion Criteria:

* YKHC employee
* aged 18 years or older
* provides consent

Exclusion Criteria:

* None

Primary outcomes:
measure: current tobacco use
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03162146: Team Elements Associated With Mortality in Intensive Care
Official title: Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit Stay
Death
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 43378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to intensive care unit

Brief summary: The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.


Eligibility criteria: Inclusion Criteria:

* All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016

Exclusion Criteria:

* Patients admitted in pediatrics intensive care units and in specialized burns units

Primary outcomes:
measure: Patient mortality
timeFrame: At the time of intensive care unit discharge up to a maximum of 6 years since admission
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Réanimation médicale, Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT00018746: Transcranial Magnetic Stimulation in Depression
Official title: Efficacy of Threshold vs. Subthreshold TMS in the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study examines efficacy of repetitive transcranial magnetic stimulation in treating severely depressed patients who are medicated.

Detailed description: Medicated, treatment resistant, depressed patients are randomized to active or sham repetitive transcranial magnetic stimulation (rTMS). Responding patients go into a six months follow-up period.

Eligibility criteria: severe treatment-resistant depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
name: Ralph Hoffman
name: Dan Oren
References:
citation: Wu NQ, Gao Z, Zheng Y, Li W, Li JN, Xu HY, Cheng XS, Wu Y, Wang Y, Wang ZJ, Yang JG, Yang YJ; China Acute Myocardial Infarction Registry Study Group. [Status of intra-aortic balloon pump application and related factors in Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2018 Jan 24;46(1):26-31. doi: 10.3760/cma.j.issn.0253-3758.2018.01.005. Chinese.
citation: Fu R, Yang YJ, Dou KF, Yang JG, Gao XJ, Xu HY, Wu Y, Li W, Wang Y, Jia YL, Jin C; China Acute Myocardial Infarction Registry. [Age-related differences in the clinical symptoms and triggering factors among Chinese patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2016 Apr 24;44(4):298-302. doi: 10.3760/cma.j.issn.0253-3758.2016.04.005. Chinese.
Clinical trial NCT04752046: Scapular Flap Versus Obturator
Official title: Is the Maxillectomy Patient's Quality of Life Affected by Palatal Defect Reconstruction Via Scapular Free Flab or Obturator? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Defect Reconstruction
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 30
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 aim of this study was to evaluate and compare quality of life (QoL) outcomes of scapular island flap versus maxillary obturator reconstruction after partial maxillectomy. patients indicated for maxillectomy were allocated randomly to two equal-sized groups. Control group patients underwent reconstruction with a surgical obturator, while intervention group patients underwent scapular island flap reconstruction


Eligibility criteria: Inclusion Criteria:

* n0 lymph node
* older than 18ys

Exclusion Criteria:

* patients who recived radiotherapy

Primary outcomes:
measure: patient quality of life
timeFrame: 6month
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT03067246: A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel
Official title: A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Supraglottic device
Fibre optic scope
Endotracheal intubation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.

Detailed description: This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation widely used at present. The company responsible for the manufacture of this product is VBM Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the use of these newer generation devices and this has been the incentive to conduct this project. These newer generation supraglottic devices have an additional feature which is an extension of the mask with a balloon that sits in the oesophagus. The trial is investigating ease of placement of these devices, ventilatory pressures, leak pressure and ease of intubation through the VBM device compared to I-Gel. The position of the supraglottic device on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A follow up will take place on the same day and after 24 hours for symptoms of a sore throat postoperatively.

Eligibility criteria: Inclusion Criteria:

1. Any patient between the age of 18 - 70
2. Any patient having the capacity to consent
3. Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.

Exclusion Criteria:

1. Patient refusal
2. Patients involved in another research project
3. Patients who require endotracheal intubation immediately after induction of anaesthesia
4. Patients who are systemically unwell/unstable
5. Patients at risk of aspiration

Primary outcomes:
measure: Time in seconds required for placement of supraglottic device
timeFrame: Through study completion, an average of 30 minutes
Secondary outcomes:
measure: Seal pressure measured in cmH2O
timeFrame: Through study completion, an average of 30 minutes
measure: Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals
timeFrame: Through study completion, an average of 30minutes
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Imran Ahmad, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller DM. Third generation supraglottic airways: is a new classification needed? Br J Anaesth. 2015 Oct;115(4):634-5. doi: 10.1093/bja/aev310. No abstract available.
Clinical trial NCT02097446: Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy
Official title: Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy : A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Genital Diseases, Female
Keywords: cystectomy
Lead sponsor: Genewel Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: * Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
* Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
* Primary Outcome Measure : Anti-adhesion Rate
* Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)


Eligibility criteria: Inclusion Criteria:

1. The patients who sign the written informed consent
2. Women aged between 18 and 44
3. The patients who are able to participate in clinical trial during the period of study
4. The patients without abnormal figures at the screening laboratory examination
5. The patients expecting ovarian cystectomy for benign ovarian tumor(mature cystic teratoma, Mucinous cystadenoma, serous cystadenoma)

Exclusion Criteria:

1. The patients who took treatments with medical products which might be barrier to evaluate the effectiveness
2. The patients who took medicine like other anti-adhesion, absorbable hemostat and dose of steroid, immunosuppressants
3. The patients with severe drug allergy
4. The patients with infectious disease on abdominal or pelvic cavity
5. The patients who previously participated in another clinical trials within the past 30 days
6. The patients considered inappropriate for the study
7. The pregnant
8. The patients with severe renal disease
9. The patients with severe systemic diseases

Primary outcomes:
measure: Anti-Adhesion Rate
timeFrame: Post-Operative Day+4weeks(Second - look)
Secondary outcomes:
measure: Score
timeFrame: Post-Operative Day+4weeks(Second-look)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Joong Sub Choi, Ph.D
role: STUDY_DIRECTOR
affiliation: Severance Hospital
name: Seong Hun Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546246: Water Method in Patients With Incomplete Colonoscopy
Official title: Water Method With Water Exchange Versus Air Insufflation in Patients With Incomplete Colonoscopy: a Prospective Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Failed or Difficult Intubation
Adenoma
Pain
Keywords: colonoscopy
water
incomplete
failed
unsedated
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Colonoscopy has been considered the gold standard procedure in screening for colorectal disease. However, 5-10% of colonoscopies are incomplete due to patient discomfort, difficult anatomy and prior abdominal or pelvic surgery. The investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with immediately failed colonoscopy.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with incomplete colonoscopy. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* Patients with incomplete colonoscopy

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable

Primary outcomes:
measure: Cecal intubation success rate
timeFrame: up to two years
Secondary outcomes:
measure: Adenoma detection rate
timeFrame: up to two years
measure: Pain Scores on the Visual Analog Scale
timeFrame: up to two years
measure: Cecum intubation time
timeFrame: up to two years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References: