louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04127201: En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity
Official title: En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Keywords: "online therapy"
"weight loss control program"
Internet
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 305
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: A randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group

Detailed description: This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65 years) with overweight type II (27-29.9 kg/m2) or obesity type I (30-34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent.

Eligibility criteria: Inclusion Criteria:

1. Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
2. Age between 18 and 65 years old
3. Compliance with all evaluation phases.

Exclusion Criteria:

1. Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
2. Presence of several psychological problem, i.e. depression, anxiety
3. Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
4. Use of drugs, i.e. slimming, anovulatory or psychotropic
5. Pregnancy or planned pregnancy for the next six months
6. Following another weight control program at the time of selection.

Primary outcomes:
measure: Weight loss
timeFrame: 4 months
measure: Maintenance of weight loss 1 month follow-up
timeFrame: 1 month follow-up
measure: Maintenance of weight loss 3 months follow-up
timeFrame: 3 months follow-up
measure: Maintenance of weight loss 6 months follow-up
timeFrame: 6 months follow-up
measure: Maintenance of weight loss 12 months follow-up
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Adherence
timeFrame: 4 months
measure: Drop out
timeFrame: 4 months
measure: Quality of life test measures
timeFrame: 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Unidad de Terapia de Conducta, University of Barcelona
Study officials:
References:
citation: Varela C, Saldana C. En_Linea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial. BMC Public Health. 2019 Nov 21;19(1):1552. doi: 10.1186/s12889-019-7928-1.
Clinical trial NCT01596101: Circadian Rhythm of Melatonin in Burns
Official title: Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Burns
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2012-05-10
Enrollment: 86
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric burn patients

Brief summary: Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.


Eligibility criteria: Inclusion Criteria:

* 5-18 years old

Exclusion Criteria:

* anoxic brain injury
* preexisting neurological disorder
* pre-existing sleep disorder
* no informed consent or HIPAA release

Primary outcomes:
measure: sleep status
timeFrame: 48hrs
Secondary outcomes:
measure: urinary melatonin
timeFrame: every 2 hours for 48 hrs
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
References:
Clinical trial NCT02806401: Ultrasound Guided Axillary Venous Cannulation in Pediatrics
Official title: Real-time Ultrasound-guided Axillary Venous Catheterization in Pediatric Patients: Comparison With the Landmark Technique Subclavian Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Guided Central Venous Cannulation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 132
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists.

Detailed description: Objective: Subclavian vein catheterization may cause various complications. The investigators will compare the real-time ultrasound-guided axillary venous access vs. the landmark method- subclavian venous access in pediatric paticipants. (the needle insertion point of ultrasound-guided axillary venous is axillary vein. and the needle insertion point of landmark method is infraclavicular subclavian vein)

Design: Prospective randomized study.

Setting: Operating room of a tertiary medical center.

Interventions: The investigators will compare the ultrasound-guided axillary vein cannulation (66 paticipants) vs. the landmark method (66 pa- ticipants).

Eligibility criteria: Inclusion Criteria:

* surgery under general anesthesia require central venous catheterization

Exclusion Criteria:

* hematoma in central vein central vein anomaly catheterization site infection

Primary outcomes:
measure: 2nd access success rate
timeFrame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
Secondary outcomes:
measure: 1st access success rate
timeFrame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
measure: 3rd access success rate
timeFrame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
measure: total time
timeFrame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT03605901: Dosing of Methadone for Spine Surgery
Official title: Dosing of Methadone for Spine Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Post-operative pain
Spine surgery
Methadone
Opioid
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares two methods of dosing methadone for complex spine cases

Detailed description: Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.

Eligibility criteria: Inclusion Criteria:

1. Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
2. At or between the ages 18 to 75 years.
3. Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

Exclusion Criteria:

1. Methadone or buprenorphine use.
2. Morbid obesity with BMI\>40 Kg/m2.
3. Chronic renal failure with creatinine\>2.0 mg/dL.
4. Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
5. Current or historical alcohol abuse.
6. Current or historical drug abuse.
7. Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females.
8. Patients with ASA status IV or V.
9. Surgical diagnosis including spine tumor, infection, or trauma.
10. In the Principal Investigator's opinion is not a candidate for the study.
11. Unwilling to sign the informed consent form.

Primary outcomes:
measure: Change in opioid requirement for complex spine surgery patients
timeFrame: Changes from baseline (pre-op) up to 72 hours post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Christoph Seubert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
Clinical trial NCT05805267: To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC
Official title: To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer who have previously received or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy

Brief summary: Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent


Eligibility criteria: Inclusion Criteria:

* 1)≥18;
* 2) advanced non-small cell lung cancer confirmed by histopathology;
* 3) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
* 4) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case

Exclusion Criteria:

* 1) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
* 2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods

Primary outcomes:
measure: PFS
timeFrame: 2 year
Secondary outcomes:
measure: ORR
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References:
Clinical trial NCT01359267: Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
Official title: A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.


Eligibility criteria: Inclusion Criteria:

* Treatment naive patients with histologically proven cancer of the head and neck
* T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)
* At least one measurable site of disease
* At least 18 years of age
* Karnofsky performance status \> or = 70% or ECOG \<2
* Able to tolerate SPECT/CT imaging
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Written consent from patients
* Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study

Exclusion Criteria:

* Diabetics with insulin dependence or blood sugar levels \>200 mg/dL prior to imaging
* Patient weight above the SPECT/CT table weight limit
* Pregnant and/or lactating female
* Unequivocal demonstration of metastatic disease
* Patients unwilling to or unable to comply with protocol

Primary outcomes:
measure: Persistent Disease within 6 months of CRT
timeFrame: 6 months
Secondary outcomes:
measure: Persistent Disease within 2 years of CRT
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Everett Vokes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636167: Construction of Computerized Intraoperative Keratometer and Experimental Study
Official title: Construction of Computerized Intraoperative Keratometer and Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Astigmatism
Orientation
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Detailed description: The study is designed to construct a computerized intraoperative keratometer to analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery.

Eligibility criteria: Inclusion Criteria:

* Cornea astigmatism from -1.0 D to -4.0D;

Exclusion Criteria:

* any significant corneal disease
* Other eye diseases induces impaired vision ,such as retinal detachment,keratoconus,pterygium,glaucoma,choroidal detachment,vitreous hemorrhage,congenital cataract,lens dislocation,anterior uveitis ,pupil deformation and so on;
* Previous corneal or intraocular surgery;
* Refuse surgery;

Primary outcomes:
measure: axis of astigmatism
timeFrame: day 1
Secondary outcomes:
measure: axis of implantation
timeFrame: day 1
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: YU A YONG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05911867: Muscle Energy Technique and Mulligan's Mobilization in Breast Cancer Surgery Patients
Official title: The Combined Effect of Mulligan and Muscle Energy Techniques on Shoulder Kinematics and Postural Changes After Breast Cancer Surgery With Axillary Dissection: A Prospective, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mobility Limitation
Muscle Relaxation
Kinematics
Postural; Defect
Breast Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 108
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, single-blinded, and randomized clinical trial
Primary purpose: TREATMENT

Brief summary: A recent study aimed to examine the combined effect of Mulligan and muscle energy techniques on postural changes and shoulder kinematics among women who had undergone breast cancer surgery with axillary dissection.

Detailed description: 90 female patients who had undergone breast cancer surgery with axillary dissection were recruited and randomly assigned to three groups. Group A received Mulligan and muscle energy technique, group B received Mulligan technique only, and group C received muscle energy technique. The study measured shoulder kinematics and postural changes using a digital inclinometer for range of motion, PAS/SAPO for cervical angle, and the horizontal alignment of acromions and quick DASH for upper extremity activities. Outcome measurements were taken at three different time points: baseline, six weeks post-intervention, and eight weeks after the intervention during a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* female
* between 50 and 65 years
* limited shoulder range of motion

Exclusion Criteria:

* having metastases
* lymphedema
* traumatic or musculoskeletal disorders affecting the arm
* not taking anticoagulants
* not having undergone bilateral breast cancer surgery
* not having a locoregional recurrence
* not having vascular disorders in the affected arm

Primary outcomes:
measure: digital inclinometer
timeFrame: 6 weeks
Secondary outcomes:
measure: Postural Assessment Software (PAS/SAPO)
timeFrame: 6 weeks
Other outcomes:
measure: Quick DASH scale
timeFrame: 6 weeks
Locations:
city: Cairo
country: Egypt
facility: Hany Mohamed Elgohary
Study officials:
affiliation: Delta University for Science and Technology, Gamasa, Coastal Road
name: Hany M Elgohary
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elgohary HM, Eladl HM, Soliman AH, Soliman ES. Effects of Ultrasound, Laser and Exercises on Temporomandibular Joint Pain and Trismus Following Head and Neck Cancer. Ann Rehabil Med. 2018 Dec;42(6):846-853. doi: 10.5535/arm.2018.42.6.846. Epub 2018 Dec 28.
Clinical trial NCT06661967: Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate
Official title: Topical Oral Anesthesia Adjuncts in Conventional Intubation: A Randomized Controlled Trial Evaluating the Impact of Topical Oral Anesthesia on First-pass Success Rate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unrecognized Condition
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The participants are randomized into two groups. The first group receives lidocaine oral spray during preoxygenation while the latter will receive NSS spray as placebo.
Primary purpose: TREATMENT

Brief summary: This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.

Detailed description: In Thailand, conventional intubation or sedation without paralysis is still the most common method of intubation due to the lack of emergency physicians at primary care centers. A pilot study had shown that topical oral anesthesia can improve the first-pass success rate in conventional intubation by direct laryngoscopy. This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.

Eligibility criteria: Inclusion Criteria:

* Patients in emergency department that have indication for conventional intubation
* Age \> 18 yr

Exclusion Criteria:

* Patient who undergo RSI
* Patient who falls in cardiac arrest airway algorithm
* Patient who is currently pregnancy
* Known allergy to lidocaine

Primary outcomes:
measure: First-pass success rate
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
state: Chonburi
Study officials:
References:
Clinical trial NCT01109667: Differences in Coagulation Test Kits
Official title: The Effects of Different Reagents on Coagulation Tests: Innovin Versus Thromborel-S.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Different Reagents.
Oral Anticoagulant Therapy
Keywords: Thromboplastin, Prothrombin, Diagnostic Reagent Kits, International Normalized Ratio, Laboratory Tests.
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving and not receiving oral anticoagulant therapy

Brief summary: The aim of this study is to assess the effect of Innovin® reagent on laboratory results when compared with the Thromborel® S.

Detailed description: Thromboplastins are the screening tests which are used in the diagnosis of acquired or inherited disorders of the coagulation system but still, alterations between various thromboplastin preparations in the measurements remains a problem.Blood samples are going to drawn from patients receiving and not receiving oral anticoagulant therapy (OAT) during their routine laboratory tests. Samples are subjected to analysis by using Thromborel® S and Innovin® reagents. Mean International Normalized Ratio (INR), prothrombin time and fibrinogen values are going to compared. To further study the importance of this phenomenon the cohort will be divided into three subgroups according to the INR values as Group I: Patients not receiving OAT, Group II: Patients under OAT and INR values in good therapeutic range and Group III: Patients under OAT and INR values over the therapeutic range.

Eligibility criteria: Inclusion Criteria:

Routine control patients receiving and not receiving oral anticoagulant therapy

Exclusion Criteria:

Hemolytic and/or lipemic samples were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Hospital
Study officials:
References: