louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02811562: Learning Curves of Intubation for Simulated Difficult Airway Scenarios by Manikin: Comparison of Combined Pentax Airwayscope-fiberoptic Bronchoscope and Fiberoptic Bronchoscope Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Airway
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown that there is a wide variation in the learning curves of residents and the number of attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative. So, the aim of this study is to compare the number of attempt to achieve proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.


Eligibility criteria: Inclusion Criteria:

* resident in Department of anesthesiology

Exclusion Criteria:

* resident who has an experience of successful fiberoptic bronchoscopic intubation in difficult case

Primary outcomes:
measure: trial number to achieve 'proficient' in terms of cumulative sum analysis
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou universiry hospital
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: Dae Hee Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03669562: The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers
Official title: The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lower Extremity Arterial Occlusive Diseases
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conducted in Chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers are at least 18 years of age and no older than 40.
* BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The male weight is greater than or equal to 50kg.The female weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion.
* Subjects with normal medical history,vital signs,physical examination and clinical examination (routine blood,routine urine,blood chemistry,coagulation function and ECG,X-ray,intraocular pressure and so on).
* A negative hepatitis B surface antigen,hepatitis C,HIV or syphilis test result.
* Subjects with the ability to communicate with investigators.Besides,subjects must be willing to remain at the study center as required per protocal to complete all visit assessments.

Exclusion Criteria:

* Subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators.
* Subjects with a history of psychiatric disease or drug dependence.
* Subjects with a medical history about cardiac,liver,renal,digestive system or neurological.
* Subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma.
* Subjects significantly abuse alcohol or tobacco.
* Drink in 24 hours before post-dosing of study drug.
* Subjects who had taken medications within 2 weeks.
* Subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded.
* Subjects who participate in other clinical trials within 3 months will be excluded.
* History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
* Subjects with a history of fainting.
* Subjects who had infected for unknown reason.
* Subjects with interstitial pneumonia.
* Subjects with glaucoma or intraocular pressure with hyperthyroidism.
* Women who are pregnant or lactating.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xuhuiqu central hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04558762: Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Official title: Ten Years Follow-up, Efficacy and Complications, After Insertion of a MUS Due to Stress Urinary Incontinence, According to the Swedish National Quality Register of Gynecological Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Urinary Incontinence
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2020-09-22
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women who underwent MUS surgery in Sweden 2006-2010 due to stress urinary incontinence.

The controlgroup will consist of women who did not undergo this surgery but are matched in age with the women who underwent surgery.

Brief summary: The investigators intend to investigate the long-term complications and the subjective well-being among women who underwent insertion of a MUS due to stress urinary incontinence 2006-2010.


Eligibility criteria: Inclusion Criteria:

* Underwent a MUS in Sweden 2006-2010 due to stress urinary incontinence.
* Were registered in The Swedish National Quality Register of Gynecological Surgery.

Exclusion Criteria:

* Did not undergo MUS surgery in Sweden 2006-2010 due to stress urinary incontinence, except those constituting the control group.

Primary outcomes:
measure: Stress urinary incontinence
timeFrame: +10 years after surgery
Secondary outcomes:
measure: Number of participants with late post operative complications
timeFrame: +10 years after surgery
measure: Number of patients with pelvic pain
timeFrame: +10 years after surgery
measure: Number of participants with groin pain
timeFrame: +10 years after surgery
measure: Number of participants with dyspareunia
timeFrame: +10 years after surgery
measure: Number of participants that has had a reoperation
timeFrame: Up to 14 years after first surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Obstetrics and Gynecology, Stockholm South General Hospital
Study officials:
affiliation: Karolinska Institutet
name: Marion Ek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242162: Establishment of a Non-invasive and Indirect Measure of Volitional Pimax
Official title: Establishment of a Non-invasive and Indirect Measure of Volitional Pimax
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Respiratory Failure
Keywords: phrenic nerves magnetic stimulations
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neuromuscular diseases

Brief summary: Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.


Eligibility criteria: Inclusion Criteria:

* Neuromuscular disease
* Pimax evaluation indication

Exclusion Criteria:

* pregnant women
* usual contre-indications for nuclear magnetic resonance

Primary outcomes:
measure: magnetic stimulation pressure measure( Pstim)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital R Poincaré
Study officials:
affiliation: Hopital R Poincaré
name: frederic Lofaso, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00613262: A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
Official title: A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Adenomatous Polyp
Neoplastic
Keywords: Narrow Band Imaging
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.


Eligibility criteria: Inclusion Criteria:

* referral for screening or surveillance colonoscopy
* the ability to provide informed consent

Exclusion Criteria:

* prior surgical resection of any portion of colon
* prior history of colon cancer
* history of inflammatory bowel disease
* use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
* poor general condition or any other reason to avoid prolonged procedure time
* history of polyposis syndrome or Hereditary Non-polyposis colon cancer
* inability to give informed consent

Primary outcomes:
measure: The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
Study officials:
affiliation: Kansas City VA Medical Center
name: Amit Rastogi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610362: Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
Official title: Human Rabies Immunoglobulin (HRIG)- Dosage Determination and Interference With the Active Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rabies
Keywords: rabies
immunoglobulin
dosage
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dosage of rabies immune globulin was calculated from the victim's body weight, then the amount of rabies immune globulin would be injected as much as possible to all of the wounds. Increase dosage of rabies immune globulin was needed in situation of multiple severe bite-wounds especially among children whose had lower body weight than adults. Our study would be conducted in order to determine whether the increase dosage of rabies immune globulin would interfere with the protective antibody levels against rabies.

Detailed description: * Controlled trial study.
* All 50 volunteers who had never had rabies immunization would be enrolled and designated into 2 groups.

group 1 : 15 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 20 IU/kg of human rabies immune globulin (HRIG).

group 2 : 35 Healthy volunteers age 18 - 60 yr receive 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of human rabies immune globulin (HRIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28 and 90 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers age 18-60 years.

Exclusion Criteria:

* received prior rabies immunization
* pregnancy
* immunocompromised conditions

Primary outcomes:
measure: Rabies Neutralizing antibody titers in volunteers who receive HRIG 40 IU/kg
timeFrame: Change from baseline of Rabies Neutralizing Antibody Titers at 3 - month period
Secondary outcomes:
measure: Number of participants who have Rabies Neutralizing antibody titers above protective levels.
timeFrame: Number of participants who have Rabies Neutralizing antibody titers above protective levels at 3-month period..
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Saovabha Memorial Institute, Thai Red Cross Society
Study officials:
affiliation: Queen Saovabha Memorial Institute, Thai Red Cross Society
name: Suda Sibunruang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07010562: A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization
Official title: A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Acorai AB
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled for a right heart catheterization procedure as part of their standard of care.

Brief summary: Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.

This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age at the time of screening.
* Subject is willing and physically able to comply with the specified evaluations as per the protocol.
* Subject is referred for invasive hemodynamic assessment with right heart catheterization.
* Subject has provided written informed consent using the approved consent form.

Exclusion Criteria:

* Discretionary exclusion when the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the study.

Primary outcomes:
measure: Evaluation of the ML's performance to estimate pressure
timeFrame: Day 0 to Day 90
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01423162: Iron Bioavailability of Fortified Oat Drink
Official title: Iron Bioavailability Study Of Fortified Oat Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Absorption
Keywords: Iron absorption
Oats
fortified oat beverages
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: Food and Nutrition Research Institute, Philippines
First posted: 2011-08-25
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.


Eligibility criteria: Inclusion Criteria:

* 6 year old children (inclusive)
* Normal BMI for age (WHO standard: 15.3-15.5 kg)
* Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
* No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
* Parents demonstrate an understanding of the given information and ability to comply with the study procedure
* Obtained parental or legal representative's informed consent

Exclusion Criteria:

* Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
* Children taking medication
* Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
* Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study

Primary outcomes:
measure: Percent Iron Absorption
timeFrame: 14 days after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Taguig City
country: Philippines
facility: Food and Nutrition Research Institute
Study officials:
affiliation: FNRI
name: Trinidad P Trinidad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01882062: Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington Disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2013-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.


Eligibility criteria: Inclusion Criteria:

* 5 \< UHDRS \< 50
* Age \> 18 years
* Ability to undergo MR scanning
* Covered by french social security

Exclusion Criteria:

* Evidence of psychiatric disorder
* Attendant neurological disorder
* Contraindications to MRI (claustrophobia, metallic or material implants)
* Severe head injury
* Unable to understand the protocol
* Pregnancy
* Failure to give informed consent
* Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
* Unwillingness to be informed in case of abnormal MRI

Primary outcomes:
measure: Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr
timeFrame: visit 1 (baseline), visit 2 (after 1 month of treatment)
Secondary outcomes:
measure: Correlation Between Primary Outcome Measure and Clinical Parameters
timeFrame: visit 1 (baseline), visit 2 (after 1 month of treatment)
Other outcomes:
Locations:
city: Paris
country: France
facility: Brain and Spine Institute
Study officials:
References:
citation: Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
Clinical trial NCT00601562: Bioequivalency Study of Zidovudine Under Fed Conditions
Official title: A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinical trial within 30 days prior to study initiation.
* Positive blood screen for HIV or Hepatitis B and C.
* History of allergic or adverse responses to zidovudine.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Three day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References: