louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02519647: Comparison of Intubation Conditions Between the Gliderite and the S-Guide
Official title: Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Lumbar Stenosis, Familial
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 50
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: Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.

Detailed description: Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.

The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.

Eligibility criteria: Inclusion Criteria:

* Surgery necessitating general anesthesia and orotracheal intubation

Exclusion Criteria:

* History or criteria of difficult intubation
* Patient refusal

Primary outcomes:
measure: Time necessary to intubate
timeFrame: 50 seconds
Secondary outcomes:
measure: Standardized questionnaire assessing injury after intubation
timeFrame: 50 seconds
measure: Standardized questionnaire assessing ease of use of the intubation
timeFrame: 50 seconds
measure: Subjective ease of use of the intubation assessed by questionnaire
timeFrame: 50 seconds
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Anesthesiology, University of Lausanne CHUV
state: VD
Study officials:
affiliation: University of Lausanne Hospitals
name: patrick Schoettker, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01090947: Data Aquisition for Optimization of Coronary Artery Disease Algorithm
Official title: Data Aquisition for Optimization of Coronary Artery Disease Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Acarix
Sponsor class: INDUSTRY
Collaborators: name: Rigshospitalet, Denmark
First posted: 2010-03-23
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to CAG.

Brief summary: The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

Detailed description: Acoustic information from the heart is obtained from patients suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Eligibility criteria: Inclusion Criteria:

* Age minimum 18 years
* Referred to CAG on suspicion of CAD
* Stabile angina without ACS
* Signed informed consent

Exclusion Criteria:

* ACS
* Previous bypass operation
* Previous heart transplant(incl. mechanical or artificial)
* Pregnancy
* Damaged skin on examination location

Primary outcomes:
measure: Sensitivity versus 1-specificity as a function of cut-off values on the 'Cardiac Noise Marker' scale here under Sensitivity by suitable cut-off value on the 'Cardiac Noise Marker' scale and Specificity with same cut-off value.
timeFrame: The first testday
Secondary outcomes:
measure: Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups.
timeFrame: The first testday
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Peter Clemmensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906147: Health ImprOvement Program of Bone in China
Official title: Health ImprOvement Program of Bone in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old

Brief summary: Fracture risk factors have long been identified as key factors in osteoporosis and fragility fractures. The WHO recommended Fracture risk assessmenttool (FRAX) applies clinical risk factors to assess the absolute risk of osteoporotic fractures in each individual. Our preliminary study suggests that FRAX estimates may underestimate the risk of fractures in the Chinese population. In order to optimize the risk prediction model of osteoporotic fractures, a treatment threshold and its optimal cutting point were initially established based on the data of the health management Center of the Second Xiangya Hospital of Central South University.


Eligibility criteria: Inclusion Criteria:

* Dual-energy X-ray bone mineral density measurement was performed in the health management center of our hospital in the physical examination subjects over 40 years old. Have independent civil capacity and agree to participate, and sign informed consent

Exclusion Criteria:

* Under 40 years of age， Patients who had undergone hip replacement or lumbar surgery and could not perform dual-energy X-ray BMD testing; Patients who have been treated with effective anti-osteoporosis drugs or have a history of malignant tumors.

Primary outcomes:
measure: bone mineral density bone mineral density
timeFrame: From 2021 to 2031
measure: Occurrence of fracture
timeFrame: From 2021 to 2031
measure: clinical risk factors of osteoporotic fracture
timeFrame: From 2021 to 2031
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Health Management Center, The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT00710047: Food Effect Study of a Single Dose of ZD4054 (Zibotentan)
Official title: A Randomised, Open-label, Single-centre, Crossover Study in Healthy Male Volunteers to Assess the Effect of Food on the Pharmacokinetics of a 10 mg Single Oral Dose of ZD4054 (Zibotentan)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ZD4054
Zibotentan
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Able to consume standard FDA specified high-fat breakfast.

Exclusion Criteria:

* Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
* Medical diagnosis of migraine with an attack during the 12 months prior to Screening
* Use of prescription medication within 2 weeks before dosing

Primary outcomes:
measure: PK variables
timeFrame: frequent sampling occasions during study days
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca, Medical Science Director
name: Thomas Morris
role: STUDY_DIRECTOR
affiliation: Parexel
name: David Wessels
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00929747: Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients
Official title: Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cataracts
Keywords: Cataract
Toric
IOL
AcrySof, LRI
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.


Eligibility criteria: Inclusion Criteria:

1. operable cataracts
2. good ocular health
3. 0.5 D to 2.0 D of corneal astigmatism

Exclusion Criteria:

1. \> 2.0 D astigmatism
2. irregular astigmatism
3. prior or ongoing corneal disease or scarring
4. history of ocular disease

Primary outcomes:
measure: Corneal aberration
timeFrame: 3 months
Secondary outcomes:
measure: Visual acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03310047: Intra-individual Reproducibility in Nerve Block Duration
Official title: Intra-individual Reproducibility in Nerve Block Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anesthesia, Regional
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2017-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will use a two-armed crossover design.

1. Day one; Right side low dose nerve block and left side high dose nerve block

   * Repeated after 24 hours Day three; Left side low dose nerve block and right side high dose nerve block
   * Repeated after 24 hours
2. Day one; Left side low dose nerve block and right side high dose nerve block

   * Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block
   * Repeated after 24 hours
Primary purpose: BASIC_SCIENCE

Brief summary: An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.

Detailed description: An interventional randomized controlled crossover trial, with the purpose to elucidate the reproducibility in nerve block duration on 20 healthy volunteers in Denmark.

There will be two trial arms:

1: Day one; Right side low dose nerve block and left side high dose nerve block. Repeated after 24 hours. Day three; Left side low dose nerve block and right side high dose nerve block. Repeated after 24 hours

2: Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours

All volunteers will receive two peripheral nerve blocking catheters adjacent to the common peroneal nerve and will be treated two times on each side with Lidocaine 0.5% 5 mL and 10 mL.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years
2. ASA classification ≤ II

Exclusion Criteria:

1. Allergy to local anaesthetics
2. Body weight 40 kg
3. Possible peripheral nerve injury or disease, including polyneuropathy and diabetes
4. Enrolment or recent participation in studies that may interfere with this study
5. Habitual use of any kind of analgesic medications
6. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion.
7. Pregnancy or breastfeeding

Primary outcomes:
measure: Duration of insensitivity towards cold
timeFrame: Up to 10 hours
Secondary outcomes:
measure: Onset time
timeFrame: Up to 30 minutes
measure: Degree of sensory nerve block
timeFrame: Up to 10 hours
measure: Degree of motor nerve block
timeFrame: Up to 10 hours
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed
state: Capital Region Of Denmark
Study officials:
affiliation: Nordsjaellands Hospital
name: Kai L Lange, MD, DMSci
role: STUDY_DIRECTOR
References:
Clinical trial NCT03259347: Eating Disorders Programs: An Indicated Trial
Official title: Eating Disorders Programs: An Indicated Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Image
Eating Disorders
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-08-23
Enrollment: 534
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of two body acceptance programs for women. Participants may experience reduction of eating pathology and prevention of future obesity and eating disorders; may derive a sense of altruism and contribution to furthering understanding of a public health problem.


Eligibility criteria: Inclusion Criteria:

* Participant indicates sub-threshold or threshold eating disorder.
* Participant is available to participate in the intervention sessions.
* Participants must be MRI eligible.

Exclusion Criteria:

* Participant does not indicate sub-threshold or threshold eating disorder.
* Participant is unable to attend intervention sessions.
* Participant cannot participate if MRI ineligible.

Primary outcomes:
measure: Change from Baseline Eating Disorder Diagnostic responses using the Eating Disorder Examination questionnaire at 8 weeks and 6 months
timeFrame: Measured at baseline, week 8, and Month 6
Secondary outcomes:
measure: Assessments using Ideal-Body Stereotype Scale-Revised
timeFrame: Measured at baseline, week 8, and Month 6
measure: Assessments using Satisfaction and Dissatisfaction with Body Parts Scale
timeFrame: Measured at baseline, week 8, and Month 6
measure: Assessments using Dutch Restrained Eating Scale
timeFrame: Measured at baseline, week 8, and Month 6
measure: Assessments using Positive Affect and Negative Affect Scale-Revised
timeFrame: Measured at baseline, week 8, and Month 6
measure: Assessments using Beliefs About Appearance Scale
timeFrame: Measured at baseline, week 8, and Month 6
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Austin
country: United States
facility: The University of Texas
state: Texas
Study officials:
References:
citation: Stice E, Rohde P, Shaw H, Gau JM. Randomized trial of a dissonance-based group treatment for eating disorders versus a supportive mindfulness group treatment. J Consult Clin Psychol. 2019 Jan;87(1):79-90. doi: 10.1037/ccp0000365.
Clinical trial NCT03228147: Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment
Official title: Sensory Evaluation of a New Oral Nutrition Supplement in Patients at Risk for Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagitis
Malignant Neoplasm
Mucositis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

Detailed description: PRIMARY OBJECTIVES:

I. To identify two products (one from the creamy shake category and one from the tea category) with the highest total average score that will be selected to move onto further testing.

OUTLINE:

Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires based on each sample in a single session over 60-90 minutes.

Eligibility criteria: Inclusion Criteria:

* Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy)
* At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia
* Within the first 3 weeks of initiation of a new type of therapy
* Able to read and write in English
* Able to provide written informed consent

Exclusion Criteria:

* Food allergy to any component of the supplement
* Inability to taste or smell due to medication or health condition

Primary outcomes:
measure: A creamy shake product with the highest total average nutrition supplement scores as assessed by questionnaires
timeFrame: Up to 1 year
measure: A tea product with the highest total average nutrition supplement scores as assessed by questionnaires
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Salma Jabbour
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04912947: EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
Official title: EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: Oxidative Stress
Glutathione
Immune system activity
Food supplement
Lead sponsor: Complife Italia Srl
Sponsor class: INDUSTRY
Collaborators: name: Macrofarm Srl
name: Icim International Srl
First posted: 2021-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to verify the effectiveness of Nutraceutical IMMU·SYSTEM Dietary supplement in reducing the levels of oxidative stress and inflammation in a sample of healthy adult subjects with high baseline levels of oxidative stress.


Eligibility criteria: Inclusion Criteria:

* Caucasian ethnicity;
* Age between 30 and 65 years;
* Smokers who have smoked at least 100 cigarettes in their lifetime and smoke at least 10 cigarettes a day;
* Sportsmen who have been playing sports for at least 6 months between 4 and 8 hours per week;
* Signature of informed consent.

Exclusion Criteria:

* Systemic pathologies;
* Active drug therapy;
* Estrogen-progestogen therapy;
* Pregnancy;
* Allergies to the components of the raw material under study.

Primary outcomes:
measure: Change in Erythrocytes GSH/GSSG ratio
timeFrame: Month 3
measure: Change in Erythrocytes GSH/GSSG ratio
timeFrame: Month 1
Secondary outcomes:
measure: Change in Immune system activity
timeFrame: Month 3
measure: Change in Immune system activity
timeFrame: Month 1
measure: Change in Immune system activity
timeFrame: Month 3
measure: Change in Immune system activity
timeFrame: Month 1
Other outcomes:
Locations:
city: Rende
country: Italy
facility: University of Calabria
state: CS
Study officials:
affiliation: DFSSN - UNICAL
name: Francesco Puoci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391347: Effects of Orange Oil Aromatherapy on the Pain and Anxiety
Official title: Effects of Orange Oil Aromatherapy on the Pain and Anxiety During Invasive Interventions in Patients With Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Transplantation
Bone Marrow Transplantation
Keywords: Hematopoietic stem cell transplantation
aromatherapy
pain
anxiety
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
Collaborators: name: Sinop University
name: Acıbadem Atunizade Hospital
First posted: 2022-05-25
Enrollment: 80
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: This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.

Detailed description: Introduction: Invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. This long and difficult treatment process causes anxiety and emotional disorders in most patients. Although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. This study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation.

Methods: This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old,
* without communication problems,
* without allergy and respiratory system problems,
* who agreed to participate in the study

Exclusion Criteria:

* severe hypotension
* other allergic complications that made it difficult for patients to continue the study

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 5 minutes before the aromatherapy
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 5 minutes before the aromatherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
References: