louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00874016: Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway
Official title: A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: intubation
Airtraq
pediatric
airway
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children.

Detailed description: 50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.

Eligibility criteria: Inclusion Criteria:

* elective surgery requiring endotracheal intubation

Exclusion Criteria:

* predicted difficult bag-mask ventilation
* predicted difficult intubation
* rapid sequence induction
* emergency endotracheal intubation
* hemodynamic instability
* emergency surgery
* non-english speaking caregivers/parents

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Percentage of glottic opening seen
timeFrame: 1 day
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Department of Pediatric Anesthesia, IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Arnim Vlatten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8. doi: 10.1111/j.1365-2044.2007.05316.x.
citation: Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
Clinical trial NCT04533516: Additional Manual Therapy Over Inspiratory Muscle Training in COPD
Official title: Effectiveness of 12-Weeks Inspiratory Muscle Training With Manual Therapy in Patients With COPD: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Severe
Muscle Weakness
Keywords: copd
manual therapy
inspiratory muscle therapy
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be limited.There is need for further research in new and complementary modalities to improve IMT efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new approach that has not yet been investigated in COPD.

Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD patients.

Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease
* Being clinically stable
* Having FEV1/FVC ratio of ≤ 50% of the predicted value after bronchodilator drugs.

Exclusion Criteria:

* Having an acute bronchitis,
* Having a pneumonia,
* Having an exacerbation of COPD,
* Having thoracic spinal scoliosis,
* Having substantial chest wall deformity, or acute rib or vertebral fracture.
* Unable to perform the pulmonary function test because of cognitive or physical impairments.

Primary outcomes:
measure: Pulmonary Function Test
timeFrame: 12 weeks
measure: respiratory muscle strength
timeFrame: 12 weeks
measure: 6 minute walk test
timeFrame: 12 weeks
measure: Dyspnea perception
timeFrame: 12 weeks
measure: Fatigue perception
timeFrame: 12 weeks
measure: St.George Respiratory Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstinye University
Study officials:
References:
Clinical trial NCT02738216: Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby
Official title: Efficacy of a Prenatal Yoga Intervention for Antenatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a series of educational workshops focused on perinatal health, the Mom and Baby Wellness Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Detailed description: In this randomized controlled trial, eligible women will be randomly assigned to either a 9-week Prenatal Yoga Program (PYP) vs. a 9-week health education control group, the Mother-Baby Wellness Workshop (MBWW). Follow up assessments will take place at multiple points during the study. The primary study outcome will be severity of prenatal depression assessed by a blind interviewer. The investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, \& pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).

Eligibility criteria: Inclusion Criteria:

1. Healthy singleton pregnancy, 12-27 weeks gestation
2. Medically cleared for moderate exercise
3. Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; \[119\]) score between 8-20
4. English-speaking
5. Aged 18 or older

Exclusion Criteria:

1. New or unstable depression treatment
2. Currently a regular yoga practitioner
3. Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
4. Current hazardous drug or alcohol use
5. Acute suicidality

Primary outcomes:
measure: Quick Inventory of Depression Symptoms - Clinician Rating
timeFrame: Baseline to 9-week end point
Secondary outcomes:
measure: Edinburgh Postnatal Depression Screen
timeFrame: Baseline to 9-week endpoint
measure: State-Trait Anxiety Inventory
timeFrame: Baseline to 9-week endpoint
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline to 9-week endpoint
measure: Maternal & Neonatal Outcomes Checklist (MNOC)
timeFrame: 30 days postpartum
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Cynthia Battle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800916: Safety and Performance of New 1-piece Ostomy Product
Official title: Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Keywords: ileostomy
Subjects
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Detailed description: The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the bags themselves.
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Currently use a 1-piece flat ostomy appliance with open bag.
7. Use minimum 1 ostomy appliance every second day.
8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
9. Must be able to use a custom cut ostomy appliance.
10. Accept to test three 1-piece ostomy appliances in the investigation.
11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. Currently using ostomy belt.
7. Currently using extended wear product.
8. Known hypersensitivity towards any of the test products
9. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -

Primary outcomes:
measure: Degree of Leakage
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Holtedam 3
Study officials:
affiliation: Coloplast A/S
name: Birte Jakobsen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03025516: Performance Evaluation of TB Breath- and Cough-testing Platforms
Official title: Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary TB
Diagnoses Diseases
Lead sponsor: Find
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
name: University of Cape Town
First posted: 2017-01-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who have symptoms consistent with pulmonary TB presenting to health facilities during study period. Patients will be asked by study or non-study clinicians or staff if they would be interested in participating in the study. Interested individuals will be referred to study personnel for additional information and screening, if appropriate, samples will be obtained following the informed consent process.

Brief summary: This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.


Eligibility criteria: Inclusion Criteria:

* Symptoms suggesting pulmonary TB, i.e. persistent cough (generally \> 3 weeks or as per local definition of TB suspect) and at least one other finding listed below:

  1. Persistent cough
  2. Fever
  3. Malaise
  4. Recent weight loss
  5. Night sweats
  6. Contact w/ active case
  7. Hemoptysis
  8. Chest pain
  9. Loss of appetite
  10. Other \[specify\]
* Provision of informed consent to sample collection, banking and HIV and breath-based assay testing
* Production of adequate quantity of sputum (sputum induction whenever possible)
* Adult age (\>18 years old)

Exclusion Criteria:

* Participants receiving any anti-tuberculosis medication, including fluoroquinolone and aminoglycosides in the 60 days prior to enrolment.
* Participants with ONLY extra-pulmonary disease will be excluded.
* Participants for whom complete follow-up and a clear final diagnosis are judged to be difficult (e.g. residents elsewhere or about to move).

Primary outcomes:
measure: Microbiological TB Diagnosis
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Nolungile Clinic, University of Cape Town
Study officials:
affiliation: Find
name: Timothy C Rodwell, MD, PhD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02505516: BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS
Official title: BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS ON METFORMIN THERAPY IN A WEST AFRICA SUB-REGION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bladder Cancer
Diabetes
Keywords: pathology
Lead sponsor: University of Cape Coast
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: patients om metformin from diabetic clinic were checked for bladder cancer


Eligibility criteria: Inclusion Criteria:

* 150 people attending diabetic clinic

Exclusion Criteria:

Primary outcomes:
measure: Number of diabetic patients on metformin therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Coast
country: Ghana
facility: Universty of Capecoast
Study officials:
References:
Clinical trial NCT04462016: Effects of Calamansi on Blood Glucose
Official title: Blood Glucose Response to a Calamansi Drink in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose Response
Keywords: calamansi
glycaemic index
post-prandial blood glucose
Lead sponsor: University Malaysia Sarawak
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: It is important to bring the blood glucose levels of those with type 2 diabetes mellitus (T2DM) back to normal levels as this can stop the condition from worsening and prevent other conditions that are related to T2DM from developing. One way to maintain healthy blood glucose level is the use of the glycaemic index (GI), which ranks food according to how the body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood glucose levels. Since beverages from calamansi are available and diabetes is a health concern in the community, it is important to investigate the effect of consuming this drink. Finger prick blood were tested in order to obtain the blood glucose levels for calculating the GI for the calamansi drink.


Eligibility criteria: Inclusion Criteria:

* non-smoker
* BMI between 18.5 and 24.99 kg/m2
* waist circumference less than 102 cm
* random blood glucose less than 7.8 mmol/L
* negative urine dipstick result
* not on any medications
* no family history of inherited diseases
* no heart conditions (angina, arrhythmia or heart failure)
* no history of acute medical or surgical event within the past 6 months.

Exclusion Criteria:

* pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes mellitus, kidney disease, blood disorders (such as thalassaemia)

Primary outcomes:
measure: Change from baseline blood glucose levels
timeFrame: 30, 60, 90, 120 min after drinking
Secondary outcomes:
measure: Change from baseline urinary glucose levels
timeFrame: 30, 60, 90, 120 min after drinking
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Faculty of Medicine and Health Sciences
state: Sarawak
Study officials:
affiliation: Universiti Malaysia Sarawak
name: Angela Siner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siner A, Sevanesan MS, Ambomai T, Abd Wahab Z, Lasem L. Blood glucose response to a calamansi drink in healthy adults: a non-randomised study. BMC Res Notes. 2020 Aug 28;13(1):404. doi: 10.1186/s13104-020-05250-8.
Clinical trial NCT03129516: Turkish Version of the Movement Imagery Questionnaire-3
Official title: Reliability and Validity of the Turkish Version of the Movement Imagery Questionnaire-3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Image, Body
Keywords: imaginary
Turkish version
motor imagery
reliability
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Motor imagery is the mental representation of movement without any body movement. According to recent studies motor imagery contains three strategies to mentally simulate the movements: internal visual, external visual and kinesthetic imagery. Motor imagery is associated with cortical reorganization and functional improvements and it does not only related with motor performance, it also influces cognitions. Movement Imagery Questionnaire-3 (MIQ-3) is the recent, modified version of the Movement Imagery Questionnaire-Revised, Second Edition and measures imagery ability in terms of ease of imagery.

The aim of this study is to translate MIQ-3 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.


Eligibility criteria: Inclusion Criteria:

* age above 18, consenting, with no limitation in mobility or movement disorder

Exclusion Criteria:

* refuse to attend to the study

Primary outcomes:
measure: Cronbach's Alpha coefficient
timeFrame: 2 years
measure: MIQ-3 total score
timeFrame: 2 years
Secondary outcomes:
measure: MIQ-3 subscale score
timeFrame: 2 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT03364816: Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis
Official title: Evaluation on Efficacy of Total Artificial Disc Replacement (TDR) of Cervical Spondylosis: a Cohort Prospective Follow-up for 5 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylosis
Keywords: cervical spondylosis
artificial disc replacement
complications
photographic indicators
functional efficacy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. The range of participants is from 20-65 years;
2. conservative treatment of 6 months is invalid;
3. never had cervical operations;
4. operation on one to three segments.

Brief summary: To evaluate the efficacy of 3 different types of cervical disc prosthesis (Prodisc-C, Mobi-C and Prestige-LP) in the treatment of cervical spondylosis.

Detailed description: A cohort, retrospective analysis will be performed of 150 patients who were in implementation of artificial disc replacement in our department from 2008 to 2012 and accepted a regular postoperatively follow-up up to 5 years, the sample will be divided into 3 groups according to prosthesis and 50 people in each group. The outcome will be measured among 3 groups respectively on the operation (such as operation time, intraoperative bleeding.), postoperative complications (such as prosthesis sinking, displacement and prolapse, adjacent segments degeneration and heterotopic ossification), photographic indicators and functional efficacy analysis and then a comparison for self-contrast pre- and post-operatively.

Eligibility criteria: Inclusion Criteria:

1. Patients was diagnosed as cervical spondylosis based on imaging and symptomology;
2. patients were purely underwent TDR within the three kinds of prosthesis;
3. the range of participants is from 20-65 years;
4. conservative treatment of 6 months is invalid;
5. never had cervical operations.

Exclusion Criteria:

1. Patients suffered from cervical trauma or congenital malformations;
2. non-artificial cervical disc replacement or hybrid surgery;
3. ones who refused to be followed up.

Primary outcomes:
measure: JOA score
timeFrame: 5 years
Secondary outcomes:
measure: prosthesis sinking
timeFrame: 5 years
measure: range of motion (ROM)
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of spinal surgery
name: Zhenqi Zhu
role: PRINCIPAL_INVESTIGATOR
References: