louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01291979: The Effect of Intravenous Lidocaine on Pain After Tonsillectomy
Official title: Intravenous Lidocaine for Effective Pain Relief After Tonsillectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Pain
Preemptive
Lidocaine
Intravenous
Tonsillectomy
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 62
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: This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.

A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility criteria: Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics

Primary outcomes:
measure: Visual analogue scale 4hour
timeFrame: post op 4hour
Secondary outcomes:
measure: visual analogue scale 12 hour
timeFrame: Post op 12 hour
measure: visual analogue scale 24hour
timeFrame: Post op 12 hour
measure: Visual analogue scale 48hour
timeFrame: Post Op 48hour
measure: Opioid consumption 4hour
timeFrame: Post Op 4hour
measure: Opioid consumption 24hour
timeFrame: Post op 24 hour
measure: Opioid consumption 12 hour
timeFrame: Post Op 12 hour
measure: Opioid consumption 48hour
timeFrame: Post Op 48 hour
measure: FPB 4 hour
timeFrame: Post Op 4 hour
measure: FPB 12 hour
timeFrame: post op 12 hour
measure: FPB 24 hour
timeFrame: Post Op 24 hour
measure: FPB 48 hour
timeFrame: Post Op 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChungAng University
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, Ph.D.
role: STUDY_CHAIR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: KyungSoo Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857179: Study of Bariatric Surgery
Official title: Prospective Cohort Study Monitoring Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Keywords: bariatric surgery
follow-up
weight loss
complications
comorbidities evolution
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients (BMI \> 30) or patients admitted for a bariatric surgery complication

Brief summary: The aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. The investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.


Eligibility criteria: Inclusion Criteria:

* History of bariatric surgery procedure

Exclusion Criteria:

* Patients \< 16 years
* Patients \> 80 years

Primary outcomes:
measure: Weight loss in kg
timeFrame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
measure: Weight loss in kg/m²
timeFrame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
measure: Excess Weight Loss
timeFrame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
measure: % weight loss
timeFrame: Before surgery (Day 0) and After surgery (every year, up to 25 years or loss to follow-up)
Secondary outcomes:
measure: type of surgical procedure
timeFrame: at the time of surgery (Day 1)
measure: age
timeFrame: before surgery (Day 0)
measure: gender
timeFrame: before surgery (Day 0)
measure: Type of comorbidities
timeFrame: before surgery (Day 0)
measure: surgical complications
timeFrame: per and postoperative (up to 25 years or loss to follow-up)
measure: dose of insulin
timeFrame: after surgery (up to 25 years or loss to follow-up)
measure: number of oral medications
timeFrame: after surgery (up to 25 years or loss to follow-up)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon
Study officials:
affiliation: Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon
name: Maud ROBERT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iceta S, Tardieu S, Nazare JA, Dougkas A, Robert M, Disse E. An artificial intelligence-derived tool proposal to ease disordered eating screening in people with obesity. Eat Weight Disord. 2021 Oct;26(7):2381-2385. doi: 10.1007/s40519-020-01076-2. Epub 2021 Jan 2.
Clinical trial NCT06151379: Muscle Parameters and Pathological Response in Breast Cancer Patients
Official title: The Relation Between the Initial Value of the Skeletal Mass Index and Pathological Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoadjuvant Chemotherapy
Keywords: operable breast cancer
skeletal mass index
neoadjuvant chemotherapy
pathologic response
L3 vertebra
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 69
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

Brief summary: The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Detailed description: In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

Exclusion Criteria:

* Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Primary outcomes:
measure: Sarcopenic index
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Body mass index
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Residual cancer burden
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Istanbul
country: Turkey
facility: AcıbademAH
Study officials:
affiliation: Acıbadem Atunizade Hospital
name: Aysun Isiklar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065779: FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs.

Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).


Eligibility criteria: Inclusion Criteria:

* Participants who are treated with FOSAMAX PLUS / FOSAMAX PLUS D within label for the first time

Exclusion Criteria:

* Participants who have a contraindication to FOSAMAX PLUS / FOSAMAX PLUS D according to the current local label

Primary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to ~ 16 weeks and 14 days after treatment discontinuation
measure: Number of Participants With Unexpected Adverse Events
timeFrame: Up to ~ 16 weeks and 14 days after treatment discontinuation
measure: Number of Participants With Non-Serious AEs
timeFrame: Up to ~ 16 weeks and 14 days after treatment discontinuation
measure: Number of Participants With Improved, Unchanged, or Worsened Disease
timeFrame: Baseline and end of Treatment (Up to ~ 16 weeks)
measure: Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment
timeFrame: Baseline and End of Treatment (Up to ~ 16 weeks)
measure: Change From Baseline in Serum Osteocalcin at End of Treatment
timeFrame: Baseline and End of Treatment (Up to ~ 16 weeks)
measure: Change From Baseline in Urine Deoxypyridinoline at End of Treatment
timeFrame: Baseline and End of Treatment (Up to ~ 16 weeks)
measure: Change From Baseline in Alkaline Phosphatase at End of Treatment
timeFrame: Baseline and End of Treatment (Up to ~ 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02318979: What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Official title: What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation, Traumatic
Traumatic Amputation of Lower Extremity
Wounds and Injuries
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2014-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.


Eligibility criteria: Inclusion Criteria:

* bilateral or unilateral transtibial amputation
* at least one year of running experience using running-specific prostheses
* 18-55 years old
* no current problems with their prosthesis or residual limb
* at a K4 Medicare Functional Classification Level

Exclusion Criteria:

* Cardiovascular, pulmonary, or neurological disease or disorder

Primary outcomes:
measure: Biomechanics
timeFrame: 4-10 days
Secondary outcomes:
measure: Metabolic Demand
timeFrame: 4 days
measure: Top Speed
timeFrame: 4-10 days
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System
name: Alena M Grabowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348979: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns
Official title: Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: restoration fracture
CAD/CAM resin composite endocrowns
lithium disilicate endocrowns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.


Eligibility criteria: Inclusion Criteria:

* Endodontically treated molar teeth indicated for endocrown.
* Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free

Exclusion Criteria:

* ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.

  * Severe periodontal problems

Primary outcomes:
measure: clinical Fracture
timeFrame: change from baseline and months: 3, 6, 12
Secondary outcomes:
measure: clinical performance marginal adaptation
timeFrame: change from baseline and months: 3, 6, 12
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02078479: rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy
Official title: Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignancy
Keywords: Malignancy
VAS
LANSS
VDS
Neuropathic pain
rTMS
motor cortex
analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10 second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80% of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1 month after the end of treatment. ic pain.


Eligibility criteria: Inclusion Criteria:

All patients within age group 18-65 years with malignant lateralized neuropathic pain resistant to medical treatment for at least 2 months or associated with significant adverse effects from medication were involved in this study.

Exclusion Criteria:

Patients with intracranial metallic devices Patients with pacemakers or any other device. Patients with recent myocardial ischemia, unstable angina Patients known to have history of epilepsy.

Primary outcomes:
measure: Neuropathic pain improvement
timeFrame: one month
Secondary outcomes:
measure: Reduction of depression manifestation
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01849679: Post Extubation Dysphagia
Official title: The Effect on Time After Extubation on Aspiration Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severity of Aspiration in Post-extubated Subjects
Keywords: Dysphagia
extubation
aspiration
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.

Brief summary: The investigators hypothesize that aspiration will be more prevalent at two to four hours post-extubation but will resolve in the majority of patients by 24 to 26 hours post-extubation.

The purpose of the research is to investigate whether there is a difference in swallow function two to four hours after extubation (removal of breathing tube) compared to 24 hours after extubation. This information will help healthcare providers decide if it is necessary for people to wait 24 hours after extubation before they start eating and drinking.


Eligibility criteria: Inclusion Criteria:

* Patients that were intubated for more than 48 hours.
* Adults, 18 and over
* All races
* Males and females
* Approval to participate in the study by the treating physician

Exclusion Criteria:

* Patients with a history of oropharyngeal dysphagia.
* Patients with neurological disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
* Patients with a history of head and neck cancer or laryngeal surgery.
* Patients that are not candidate for FEES because of facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk (patients on therapeutically dosed anticoagulant infusion or injection, platelet count less than 50,000, INR greater than 2.0, partial thromboplastin time greater than 1.5 times normal), decreased level of arousal/alertness, significant agitation, or inability to tolerate room air or nasal cannula oxygen for duration of FEES.
* Patients who are extubated after 1400 or on weekends (Friday, Saturday, or Sunday).
* Non-English Speakers will be excluded

Primary outcomes:
measure: Severity of Aspiration per Evaluation
timeFrame: post-extubation at 2-4 hours and possibly 24-26 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Univeristy of Wisconsin
name: Stevie Marvin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042079: Endoscopic Full Thickness Resection With Laparoscopic Assistance
Official title: Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastric Subepithelial Tumor
Keywords: Endoscopic full-thickness resection
gastric subepithelial tumor
hybrid-NOTES
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2014-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.

Detailed description: The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.

Eligibility criteria: Inclusion Criteria:

* Gastric subepithelial tumor
* Invasion of muscularis propria on Endoscopic ultrasound
* Tumor size 1.5cm-5cm or increasing size during follow-up

Exclusion Criteria:

* Bleeding tendency,
* Inappropriate condition for surgery with general anesthesia
* Refuse to be enrolled to study

Primary outcomes:
measure: En-bloc resection and successful closure
timeFrame: 3 months after surgery
Secondary outcomes:
measure: number of troche
timeFrame: during surgery
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Chan G Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: