louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05600712: A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem
Official title: A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Performance
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2022-10-31
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants who have been implanted with REDAPT Sleeved Stem
Primary purpose: OTHER

Brief summary: Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.

Detailed description: The purpose of this study is to assess performance and safety of the Smith \& Nephew REDAPT Sleeved Stem by collecting retrospective 2 year post-op with PROMs or prospective 2 year post-op with PROMs.

Eligibility criteria: Inclusion Criteria:

* Primary and revision surgery for hip degenerative joint disease including osteoarthritis, avascular necrosis, and traumatic arthritis.
* Rheumatoid arthritis, congenital dysplasia, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, and fracture-dislocation of the hip.

Exclusion Criteria:

* Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriate size implant (blood supply limitations, osteoporosis/metabolic disorders, infections)
* Mental or neurological conditions impairing or precluding cooperation with post-operative protocols and proper response to PROMs.
* Skeletal immaturity.

Primary outcomes:
measure: Harris HIp Score (HHS)
timeFrame: 2 years
measure: Hip Disablity and Osterarthritis Outcome Score (HOOS)
timeFrame: 2 year
measure: HOOS Jr.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
Study officials:
References:
Clinical trial NCT02917512: Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
Official title: A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

* age over 19
* Corneal staining score(Oxford grading) \> 2 or Schirmer test \< 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test \> 3mm/5min)
* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause
* Volunteer who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* The patients with systemic or ocular disorders affected the test result
* Being treated with systemic steroid
* Wearing contact lenses within 3 days of screening visit
* Pregnancy or Breastfeeding

Primary outcomes:
measure: change from Baseline of Corneal staining score - Oxford grading
timeFrame: Week 12
Secondary outcomes:
measure: change from Baseline of Corneal staining score - Oxford grading
timeFrame: Week 4, 8
measure: change from Baseline of Strip meniscometry assessment
timeFrame: Week 4, 8, 12
measure: change from Baseline of Tear film break-up time
timeFrame: Week 4, 8, 12
measure: change from Baseline of Standard patient evaluation of eye dryness questionnaire
timeFrame: Week 4, 8, 12
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Huons
state: Gyeonggi-do
Study officials:
affiliation: Huons Co., Ltd.
name: Seung-il Baek
role: STUDY_DIRECTOR
References:
citation: Shin J, Rho CR, Hyon JY, Chung TY, Yoon KC, Joo CK. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021 Jan-Feb;37(1):4-11. doi: 10.1089/jop.2020.0104.
Clinical trial NCT03007212: Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess the outcomes after TACE in patients with branch PVT regarding Child classification, radiological response and 1 year survival.

Detailed description: Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions, triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival analysis was performed using Kaplan-Meier estimations.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed HCC,
* Child class A and
* Portal vein branch tumoral thrombus (proved by imaging)
* written informed consent

Exclusion Criteria:

* patients with Child class B and C,
* main Portal vein thrombosis,
* previous management for HCC,
* Arterio-portal shunt
* refused to be enrolled

Primary outcomes:
measure: changes in Radiological Response in the (CT/ MRI) after the intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01989312: The Simultaneous Use of Supraclavicular and Distal Blocks
Official title: Can we Gain an Advantage by Combining Distal Median, Radial and Ulnar Nerve Blocks With Supraclavicular Block? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Orthopaedic Disorders
Nerve Block
Anaesthesia
Keywords: ultrasound
peripheral nerves
anesthetics
local
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.

Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.


Eligibility criteria: Inclusion Criteria:

* 18 and 80 years old patient
* American Society of Anesthesiologists (ASA) physical status I-III
* Scheduled for elective hand and forearm surgery

Exclusion Criteria:

* patient refusal
* preexisting neuropathy
* coagulopathy
* allergy to agents used
* pregnancy
* body mass index \> 35 kg/m2
* chronic obstructive pulmonary disease
* infection or previous surgery in the supraclavicular area
* systemic infection

Primary outcomes:
measure: The time required after a supraclavicular block alone or a supraclavicular block combined with distal blocks, to achieve a sensory and motor block needed for surgery.
timeFrame: All patients will be followed up during the block procedure and during the surgery. Also, after the surgery patients will be followed up to 7 days postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Ibni Sina Hospital colonoscopy lab
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Basak Ceyda Meco, MD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06317012: Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery
Official title: Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Le Fort; I
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.


Eligibility criteria: Inclusion Criteria:

* Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy.
* Patients with good oral hygiene.
* Class II or III malocclusion.
* Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment

Exclusion Criteria:

* Patients with acute infection at the surgery site.
* Patient with Systemic disorders contraindicating surgery.
* Smokers.
* Alcohol or drug abuse is prohibited.
* patients who suffered from craniofacial syndrome;
* patients who had previous orthognathic surgery;
* patients who had previous maxillary or mandibular trauma

Primary outcomes:
measure: Change in pain
timeFrame: 2nd and 7th days
measure: change in edema
timeFrame: 2nd and 7th days
measure: Change in post operative osteotomy position
timeFrame: Immediate post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02814812: Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery
Official title: Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatectomy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.


Eligibility criteria: Inclusion Criteria:

Will be included in this study, patients:

* Having an indication of pancreatic surgery
* In scheduled surgery
* Agreeing to participate in the research (ie who signed the informed consent to research participation)
* \>18yo

Exclusion Criteria:

Will not be included in this study, patients:

* With emergency surgery
* Protected by law
* Under 18 years
* Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)

Primary outcomes:
measure: detection of undiagnosed postoperative complication by CT scan
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04602312: How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Healthy Sample)
Official title: Online RCT Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Coronavirus-related Catastrophizing in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catastrophizing Coronavirus (COVID-19)
Keywords: Coronavirus-related Catastrophizing
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: University of California, San Diego
First posted: 2020-10-26
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 x (2) mixed design, with training (mindfulness vs specific sham mindfulness vs general sham mindfulness vs book listening control, between subjects) and time (pre-treatment vs post-treatment, within-subjects) as factors.
Primary purpose: TREATMENT

Brief summary: Both mindfulness meditation and expectancy effects are known to reduce anxiety, stress and catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Able to read and understand English

Exclusion Criteria:

* Recurrent pain (two or more days in the last month)
* Chronic pain (pain most days in the last three months)
* Incomplete or invalid data (response time \< 32 minutes, failing attention checks)
* Completing the 20-minute training module in \< 18 minutes or \> 90 minutes

Primary outcomes:
measure: Coronavirus-related catastrophizing
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
measure: Expectancy
timeFrame: 40 minutes
measure: Reappraisal
timeFrame: 40 minutes
measure: Mindful observing
timeFrame: 40 minutes
measure: Mindful non-reactivity
timeFrame: 40 minutes
measure: State Mindfulness
timeFrame: 40 minutes
measure: State Decentering
timeFrame: 40 minutes
Locations:
city: Brisbane
country: Australia
facility: Health and Behavioural Sciences
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Melissa Day, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03831412: Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy
Official title: CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Nightmare
Trauma
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 13
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: The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.


Eligibility criteria: Inclusion Criteria:

* experiences at least one nightmare per week for the past month
* having previously experienced a traumatic event
* difficulty falling or staying asleep
* suicidal ideation
* actively under the care of another health care provider

Exclusion Criteria:

* untreated obstructive sleep apnea
* acute or apparent psychosis
* untreated or unstable bipolar disorder
* past history of seizure disorder or neurological disorder
* intellectual disability
* current substance dependence or in past 6 months

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
measure: Change in Insomnia Severity Index
timeFrame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
measure: Change in Sleep log
timeFrame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
measure: Change in Sleep log
timeFrame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
measure: Change in Beck Suicide Scale
timeFrame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Lorton Hall
state: Oklahoma
Study officials:
References:
Clinical trial NCT03609112: Neurocognitive Risks in Children With Solid Tumors
Official title: Neurocognitive Risks in Children With Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor in Children
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 6 to 16 years and 11 months during the study period

Brief summary: The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.

Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)


Eligibility criteria: Inclusion Criteria:

* Patient aged 6 to 16 years and 11 months during the study period
* Type of pathology: solid tumor
* Place of treatment and follow-up: Gustave Roussy
* Minimum time from the end of the initial treatment:
* For patients who have not received treatment with methotrexate: 6 months
* For patients being treated with methotrexate: none
* Obtaining the non-opposition of parents / legal representatives
* Affiliation to a social security scheme.

Exclusion Criteria:

* Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
* Patients lost to follow-up
* Deceased patients
* Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
* Non-French speaking patients

Primary outcomes:
measure: Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
timeFrame: Up to 60 months
measure: Univariate analysis to identify risk factors related to cognitive disorders.
timeFrame: Up to 60 months
measure: Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors.
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT00608712: Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Official title: Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Bariatric Surgery
Keywords: bariatric surgery
ulcer prevention
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction


Eligibility criteria: Inclusion Criteria:

* Written informed consent signed and dated
* BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
* Indication for gastric bypass surgery
* Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
* Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery

Exclusion Criteria:

* Contraindication for gastric bypass surgery
* Contraindication to use Omeprazole and derivatives
* Patients carriers of gastrinoma or having hypergastrinemia
* Patients contraindicated to perform UDE
* Patients with previous esophagogastroduodenal surgery

Primary outcomes:
measure: To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
Secondary outcomes:
measure: To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.
Other outcomes:
Locations:
Study officials:
References: