louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03271008: Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice
Official title: Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* over 18 years of age
* elective intervention
* no anticipated difficult airway or intubation
* preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II

Exclusion Criteria:

-

Primary outcomes:
measure: Intubation time
timeFrame: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Secondary outcomes:
measure: Laryngoscopy time
timeFrame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
measure: Percentage of glottic opening (POGO) score
timeFrame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
measure: Tube insertion time
timeFrame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
measure: Primary intubation attempt success rate
timeFrame: Measured once after intubation. Up to 120 seconds following the start of intubation attempt.
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Dept. of Anaesthesia and Intensive Care
state: Baranya county
Study officials:
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
name: Bálint Nagy, MD PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
name: Szilárd Rendeki, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
name: Lajos Bogár, MD PhD DSc
role: STUDY_CHAIR
References:
citation: Rendeki S, Keresztes D, Woth G, Merei A, Rozanovic M, Rendeki M, Farkas J, Muhl D, Nagy B. Comparison of VividTrac(R), Airtraq(R), King Vision(R), Macintosh Laryngoscope and a Custom-Made Videolaryngoscope for difficult and normal airways in mannequins by novices. BMC Anesthesiol. 2017 May 26;17(1):68. doi: 10.1186/s12871-017-0362-y.
Clinical trial NCT04238208: The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy
Official title: The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Patients With Diabetic Peripheral Neuropathic Pain: a Randomized, Placebo-controlled Study of South Asian Male Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nerve Problems
Diabetic Neuropathy
Diabetic Complications Neurological
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 290
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This present study was a double blinded, placebo controlled, parallel group study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Detailed description: The aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south Asian male patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study

Eligibility criteria: Inclusion Criteria:

* Males aged 40 - 60
* Type 2 diabetes of \>10 years duration
* Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)

Exclusion Criteria:

* Diabetic foot ulcer
* Deformed or contracted foot
* Neurological complications
* Presence of neurological disease
* Presence of cardiovascular or peripheral vascular disease,
* Usage of topical analgesics or implanted medical device six weeks prior to the study

Primary outcomes:
measure: Outcome 1 Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores
timeFrame: 24 weeks
measure: Outcome 2 Patient Global Impression of Change score
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Zainab Khan
state: Punjab
Study officials:
References:
Clinical trial NCT02523508: Does Passive Spinal Mobilization Improve Lower Limbs Strength and Function
Official title: Does Passive Spinal Mobilization Improve Lower Limbs Strength and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies have shown that peripheral muscles weakness or inhibition is related to spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle weakness. The purpose of the study was to assess the effect of spinal mobilization on the maximal muscle strength of the hip flexors and motor function.


Eligibility criteria: Inclusion Criteria:

* Healthy adults have no active back or hip pain

Exclusion Criteria:

* Subjects with active back or hip pain

Primary outcomes:
measure: Hip flexor strength
timeFrame: 10 minutes after the intervention
Secondary outcomes:
measure: Running speed
timeFrame: 10 minutes after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chi Ngai Lo, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675908: Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
Official title: Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Jaundice
Pancreatic Cancer
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: University of Maryland, Baltimore
First posted: 2012-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Detailed description: Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Eligibility criteria: INCLUSION CRITERIA:

1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
2. Patients 19 yrs of age and older
3. Serum bilirubin \> 2mg/dl
4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

EXCLUSION CRITERIA:

1. Karnofsky score \< 60
2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication
3. Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
4. Ongoing or planned neoadjuvant therapy
5. Cholangitis at presentation or coagulopathy needing reversal medication
6. Post-surgical anatomy
7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Primary outcomes:
measure: Complications related to stent dysfunction
timeFrame: 30 days
Secondary outcomes:
measure: Procedural complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: Florida Hospital Center for Interventional Endoscopy
name: shyam varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305108: Fascial Manipulation in Patients With Hip Osteoarthritis
Official title: Evaluation of the Efficacy of Treatment of the Soft Tissues With Fascial Manipulation for Patients That Are Waiting for Total Hip Arthroplasty in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. The aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.


Eligibility criteria: Inclusion Criteria:

* patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by Numeric Rating Scale ≥ 5 and that live in Bologna

Exclusion Criteria:

* arthroplasty revision or substitution. Patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)

Primary outcomes:
measure: pain is measured by numeric rating scale
timeFrame: 3 weeks before surgery
Secondary outcomes:
measure: performance measurement assessed with Oxford Hip Scale, 30 second chair stand test, 10 meters walking test, Iova level of assistance.
timeFrame: a month after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Bo
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Andrea Cotti, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299608: Rapid Analysis of Infections by Spectrometry of Exhaled Breath
Official title: Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Tract Infections
Hematologic Diseases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation

Brief summary: To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18y at start of study
* One of the following diagnoses:

  * De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
  * De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
  * Aplastic anemia requiring ATG therapy
  * Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
  * Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
* Written informed consent obtained from the patient

Exclusion Criteria:

* Hematological disease beyond the specified inclusion criteria
* Signs of active respiratory infection
* If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Through study completion (i.e. 6 weeks after diagnosis)
Secondary outcomes:
measure: Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
timeFrame: 2 weeks after diagnosis
measure: Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
timeFrame: 6 weeks after diagnosis
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT00946608: To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets
Official title: Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Sandoz Inc. and Schering (Claritin) 10 mg Loratadine Tablets In Healthy Adult Male Volunteers Under Fed and Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Antihistamine
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Loratadine 10 mg tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 54 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Early Clinical Research
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507208: Dynasplint Therapy for Trismus in Head and Neck Cancer
Official title: Dynasplint Therapy for Trismus in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trismus
Keywords: trismus
head and neck cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Dynasplint Systems, Inc.
First posted: 2007-07-26
Enrollment: 53
Sex: ALL
Minimum age (years): 19
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 compare the use of the Dynasplint Trismus System to routine trismus treatment in improving the ability of opening the mouth in a randomized trial. This study will also determine what effects, good and/or bad, this procedure has on the participant. Participants will be randomly assigned to the Dynasplint Trismus System or to routine treatment with tongue depressors.

Detailed description: This trial is a single-institution, randomized study to evaluate the effectiveness of the Dynasplint Trismus System (DTS) for patients with trismus. Improvement of mouth opening and quality of life of participants using DTS will be compared to improvement of mouth opening and quality of life of participants using standard therapy. Standard therapy will be the use of tongue depressors. Crossover from standard therapy to DTS will be implemented if at three months there is no improvement in mouth opening when using tongue depressors.

Eligibility criteria: Inclusion Criteria:

1. Patients with \<= 30mm mouth opening who have undergone treatment for head and neck cancer. (If the patient is edentulous then mouth opening must be \<= 40mm.)
2. Patients who are receiving or have completed treatment for head and neck cancer (surgery, radiation, chemotherapy alone or in any combination).
3. Patients must be completely recovered from any radiation induced oral mucositis.
4. Age =\>19 years.
5. Patients must sign informed consent.

Exclusion Criteria:

1. Severe periodontal or gum disease that has caused teeth to be loose.
2. Any systemic disease that causes blistering of the oral mucosa.
3. Any condition that renders the patient unable to understand the informed consent.
4. Participants who are not able to comply with protocol activities.

Primary outcomes:
measure: Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Otolaryngology
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06878508: DuoCor Ventricular Assist System Early Feasibility Study
Official title: Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2025-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.


Eligibility criteria: Inclusion Criteria:

1. Requiring a biventricular mechanical circulatory support, defined by either of the following criteria:

   * Persistent total heart failure despite under optimal medical management based on current heart failure practice guidelines. OR
   * Development of refractory right heart failure following left ventricular assist device (LVAD) implantation, unresponsive to pharmacological interventions for right heart failure.
2. Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.

Exclusion Criteria:

1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
2. Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators.
3. Pregnancy.
4. Age \> 75 years.
5. Presence of an active, uncontrolled infection.
6. Brain death.
7. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
8. Irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and DuoCor VAS management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.

Primary outcomes:
measure: Composite of survival at 3 months post-implantation
timeFrame: 3 months
Secondary outcomes:
measure: Hospital redmission rate
timeFrame: 3 months
measure: Adverse Events.
timeFrame: 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00578708: Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Membranous Ventricular Septal Defects
Keywords: membranous
ventricular
septal
defect
VSD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.


Eligibility criteria: Inclusion Criteria:

* Patients with hemodynamically significant Perimembranous ventricular septal defects

Exclusion Criteria:

* Patients \< 8 kg
* Supracristal ventricular septal defects
* Left ventricle to right atrium shunting
* Prolapse of the aortic valve
* Right to left shunting through the defect
* Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
* Patients with \<2mm aortic rim
* Sepsis (local/generalized)
* Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
* Patients who are ASA intolerant
* Unable to be followed for the duration of the clinical trial
* Inability to obtain informed consent

Primary outcomes:
measure: Closure of perimembranous Ventricular Septal Defects
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital UN/CU)
state: Nebraska
city: New York
country: United States
facility: Columbia University
state: New York
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: