louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03033979: Prolonged Laryngeal Mask Airway ProSealTM Use
Official title: Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We describe the use of the LMA ProSealTM in seven patients in a variety of clinical situations for procedures lasting more than 5 hours.

Brief summary: The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

Detailed description: There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

Eligibility criteria: Inclusion Criteria:

* ASA 1 - 3
* Age 19-85 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35

Primary outcomes:
measure: Feasibility of the LMA ProSealTM for prolonged use
timeFrame: 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Christian Keller MD, M.Sc.
Study officials:
References:
Clinical trial NCT06514079: Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
Official title: Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Disorder
Esophageal Diseases
Esophageal Stricture
Keywords: Esophageal stricture
Steroid injection
Esophageal dilatation
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections were included in our study
Primary purpose: TREATMENT

Brief summary: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.

Detailed description: Background and study aims: Benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. This study investigates the efficacy and safety of intralesional steroid injections (ISIs) in addition to dilation in patients with refractory benign esophageal strictures.

Methods: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged less than 14 years
* with refractory benign esophageal strictures
* received a dilatation therapy without triamcinolone injections

Exclusion Criteria:

* failure to pass a guide wire secondary to pharyngeal stenosis
* tracheo-esophageal fistula
* those who received triamcinolone injections at early dilatation

Primary outcomes:
measure: Maximum dilatation size
timeFrame: 12 months
Secondary outcomes:
measure: dysphagia score
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohammad Daboos
state: Select
Study officials:
affiliation: Department of pediatric surgery, faculty of medicine , Al-Azhar University
name: Mohammad Daboos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01841879: Mumbai Worksite Tobacco Control Study
Official title: Mumbai Worksite Tobacco Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Healis-Sekhsaria Institute for Public Health
name: Carelon Research
name: Dana-Farber Cancer Institute
First posted: 2013-04-29
Enrollment: 6880
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are designing and testing the effectiveness of an integrated tobacco control and occupational health (OH) intervention aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies in 20 manufacturing worksites in the greater Mumbai region of India.

Detailed description: Through 6 health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use.

Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced.

Eligibility criteria: Inclusion Criteria:

* Manufacturing worksites located in the Mumbai, Thane, or Raigad districts of India
* Employ at least 60% production workers/40% administrative staff OR at employ at least 200 production workers on staff. NOTE: We are defining "workers" as anyone who is on the company roster, regardless of whether they're permanent or contractual
* Companies must be autonomous decision-makers and allow us to function at their worksite
* Companies must be willing to provide us with a current employee roster

Exclusion Criteria:

* Employees do not speak English, Hindi, or Marathi

Primary outcomes:
measure: Tobacco use cessation
timeFrame: 6-month post intervention
Secondary outcomes:
measure: Changes in company tobacco policy
timeFrame: 6-month post intervention
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Healis-Sekhsaria Institute for Public Health
state: Maharshtra
Study officials:
affiliation: Harvard School of Public Health, Dana-Farber Cancer Institute
name: Glorian Sorensen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen G, Pednekar M, Cordeira LS, Pawar P, Nagler EM, Stoddard AM, Kim HY, Gupta PC. Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial. Tob Control. 2017 Mar;26(2):210-216. doi: 10.1136/tobaccocontrol-2015-052671. Epub 2016 Feb 16.
Clinical trial NCT00688779: Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Official title: A Double Blind, Placebo Controlled, Randomised, First Time In Man. Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD8848 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out Of Season
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Allergic Rhinitis
Keywords: Healthy male
allergic rhinitis
tolerability
safety
intranasally
Healthy subjects
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate safety/tolerability after a single dose intranasal administration of AZD8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season


Eligibility criteria: Inclusion Criteria:

* History of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years
* Body mass index (BMI) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of asthma

Primary outcomes:
measure: Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
timeFrame: During the study
Secondary outcomes:
measure: Clinical chemistry, haematology, urinalysis
timeFrame: During the study
measure: Nasal symptoms and peak nasal inspiratory flow
timeFrame: During the study
measure: Pharmacokinetics
timeFrame: During the study
measure: Biomarkers nasal lavage and blood
timeFrame: During the study
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: Department of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine on University Hospital Lund, Sweden
name: Edward Högestätt
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Lund
name: Leif T Eriksson
role: STUDY_DIRECTOR
References:
citation: Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.
Clinical trial NCT03327779: World Bleeding Disorders Registry
Official title: World Bleeding Disorders Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemophilia A
Hemophilia B
Von Willebrand Diseases
Lead sponsor: World Federation of Hemophilia
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of participating Hemophilia Treatment Centres with Hemophilia A or B, or von Willebrand Disease.

Brief summary: The WBDR is an international observational disease registry of patients with hemophilia. It will provide a platform for a network of hemophilia treatment centres (HTCs) around the world to collect uniform and standardized patient data and guide clinical practice. With informed consent from the patient, the WBDR stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.

Detailed description: The WBDR is a prospective, global registry of patients diagnosed with hemophilia A and B. Following the success of a pilot study, implementation of the full scale WBDR is underway. The goals are to enroll at least 200 HTCs from more than 50 countries, and at least 10,000 people with hemophilia, during the first five years, aiming for representation of patients from around the world and from all levels of access to care. Minimal criteria for participation of HTCs include access to reliable internet, human resources for data entry and commitment to long-term enrolment and follow-up of patients. The WBDR database is being developed through a collaboration between the WFH, Karolinska Institute and Health Solutions.

By combining data from countries around the world, the WBDR will provide a large amount of real world data, on which researchers can address important scientific and clinical issues. The World Bleeding Disorders Registry (WBDR) is intended to fill existing gaps in knowledge by collecting real world data on the patient clinical experience around the globe.

Eligibility criteria: Inclusion Criteria:

* Patients of participating Hemophilia Treatment Centres with Hemophilia A or B, or von Willebrand Disease

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants recruited
timeFrame: 5 years
measure: Number of participating Hemophilia Treatment Centres
timeFrame: 5 years
measure: Number of participating countries
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: World Federation of Hemophilia
state: Quebec
Study officials:
References:
Clinical trial NCT00298779: Open-Label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of VELCADE in Patients With Either Advanced Solid Tumors or Non-Hodgkin's Lymphoma.
Official title: An Open-Label Study to Assess the Effect of Omeprazole Administration on the Pharmacokinetics of VELCADE in Subjects With Either Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Non-Hodgkins's Lymphoma
Keywords: patients with advanced solid tumors or Non-Hodgkins's Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2006-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, multiple-dose, multicenter Pharmacokinetics drug-drug interaction study in patients with advanced solid tumors, including non-Hodgkin's lymphoma, who are in need of anti-tumor therapy. In addition, the impact of omeprazole on the pharmacodynamics of VELCADE will also be evaluated.


Eligibility criteria: Inclusion Criteria:1) Male or female at least 18 y/o 2)Weigh \>/= 50 kg (110lbs) and a BMI of \</= 28kg/m2;3)life expectancy \>/= 3 mos; 4)Karnofsky Performance Status \>/=70%; 5)Women must be menopausal. 3)Men must agree to use an acceptable method of contraception for the duration of the study.4)Must sign an informed consent document indicating understanding of the purpose and procedures required for the study;5)informed consent for genetic testing 6)Subjects have advanced solid tumor (including non-Hodgkin's lymphoma).7)resolution of reversible toxicities considered related to any prior antineoplastic therapies before entry; 8)must be able to swallow capsules whole; -

Exclusion Criteria:1)Prior exposure to VELCADE.2)Has known hypersensitivity or intolerance to omeprazole, boron, mannitol or heparin. 3)Medical history of of liver or renal insufficiency; significant cardiac, vascular, pulmonary, GI, endocrine, neurologic, rheumatologic, pyschiatric or metabolic disturbances. 4)Uncontrolled diabetes. 5)history of hypotension or decreased blood pressure;6)Uncontrolled or severe cardiovascular disease incl. myocardial infarction within 6 mos of enrollment; 7)History of alcohol/drug abuse. 8)Presence of HIV antibodies, hepatitis C antibodies or hepatitis B. 9)active systemic infection requiring treatment; 10)Pregnant or breastfeeding' 11)neuropathy \>/= Gr.1; 12)transfusion dependence; 12)pre-planned surgeries or procedures that would interfere with conduct of study

-

Primary outcomes:
measure: The investigator will determine the patient's response to VELCADE treatment following completion of Cycle 2 (Day 21).
timeFrame: completion of cycle 2 - Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
References:
Clinical trial NCT04222179: One Brand-new Maneuver to Place Nasoenteric Tube
Official title: Tzu-chi General Hospital,Hualien County,Taiwan,ROC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrient Intake Disorder
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.

Detailed description: Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.

Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.

Eligibility criteria: Inclusion Criteria:

1. Esophageal obstruction
2. Gastric outlet obstruction
3. Duodenal obstruction
4. Pancreatitis
5. Gastroparesis -

Exclusion Criteria:

* (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance

Primary outcomes:
measure: procedure time
timeFrame: wıthın 20 mınutes
Secondary outcomes:
measure: the tıme of naso-enterıc tube usage
timeFrame: within 90 days
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Tzu-chi Hospital
state: Hua-lien County
Study officials:
affiliation: Buddhist Tzu Chi General Hospital
name: Jen S Lin, VS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06989879: Knowledge of Students About Vitamin A and Assessment of Eye Manifestations in Quranic Schools (Khalwai) Khartoum State, Sudan 2022
Official title: Knowledge of Students About Vitamin A and Assessment of Eye Manifestations in Quranic Schools (Khalwai) Khartoum State, Sudan 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin A Deficiency
Night Blindness
Keywords: Vitamin A deficiency
Night blindness
Quranic boarding school
knowledge
nutrition
Lead sponsor: University of Khartoum
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Khalwa (Quranic boarding school) dormitory residents are either dedicated teachers, students, or those who teach and study at the same time. The study participants were those who lived in the dormitory regardless of their status. Those in the last category were counted as students.

The study was conducted in traditional Quran centers in East Nile Province, Khartoum.

Brief summary: This is an observational study that aims to study vitamin A deficiency status, knowledge, and nutritional assessment among Khalwa (Quran boarding school) individuals. we want to assess the magnitude of the problem and put appropriate recommendations for it.


Eligibility criteria: Inclusion Criteria:

* All Khalwa (Quranic-boarding-school) dormitory residents of in East-Nile province, Khartoum State

Exclusion Criteria:

* Anyone who refuses to participate in the study.
* Those who live with their families

Primary outcomes:
measure: Prevalence rate of night blindness
timeFrame: At enrollment
measure: Vitamin A knowledge score
timeFrame: At enrollment
measure: Prevalence rate of vitamin A deficiency signs
timeFrame: At enrollment
measure: Prevalence rate of respiratory tract infection
timeFrame: At enrollment
measure: Prevalence rate of diarrhea
timeFrame: At enrollment
measure: Food specific (milk, vegetables, fruits, etc.) prevalence rate of eating/drinking from outside dormitory
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Faculty of Medicine, University of Khartoum
Study officials:
References:
Clinical trial NCT04040179: A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide
Official title: A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging of Anatomical Structures
Lead sponsor: Medaphor Limited
Sponsor class: INDUSTRY
Collaborators: name: IntelligentUltrasound Limited
First posted: 2019-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

Detailed description: The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:

* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary
* ESP
* PECS
* Interscalene

Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.

The videos will be segmented by hand to identify the relevant anatomical regions for each category.

The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:

   * Adductor canal
   * Popliteal fossa
   * Fascia Iliaca
   * Rectus sheath
   * Axillary
   * ESP
   * PECS
   * Interscalene
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Model development
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Medicentre
Study officials:
References: