louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01172756: A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
Official title: Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension
Left ventricular dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction


Eligibility criteria: Inclusion Criteria:

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction

Exclusion Criteria:

* Types of pulmonary hypertension other than group 2.2 of Dana Point Classification

Primary outcomes:
measure: Pulmonary artery mean pressure at rest
timeFrame: Peak change from baseline within 6 hours after a single dose of study drug
Secondary outcomes:
measure: Adverse event collection
timeFrame: until 30 days after study drug treatment
measure: Plasma concentrations to obtain pharmacokinetic profile of Riociguat
timeFrame: Within 24 hours after study drug treatment
Other outcomes:
Locations:
city: Linz
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Graz
country: Austria
state: Steiermark
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Praha 2
country: Czech Republic
city: Köln
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.
Clinical trial NCT01487356: Factors Associated With Short Withdrawal Time and Polyp Detection Rate During Colonoscopy
Official title: Factors Associated With Short Withdrawal Time and Polyp Detection Rate During Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Keywords: Colonoscopy
quality assurance
withdrawal time
polyp detection rate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 802
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.

Brief summary: Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study. By collecting data on hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.

Detailed description: Background:

Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study.

Objective:

To identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.

Design:

Data were prospectively collected (05/08-06/09) on 802 colonoscopies conducted by 9 blinded endoscopists, including patient age and sex, indication, colonoscope insertion and withdrawal time, biopsies performed, number/size of polyps and method of resection, bowel preparation quality, time of day, day of week, endoscopist, position of the procedure within the endoscopist's slate, and call status of the endoscopist.

Setting:

This study was conducted at a single tertiary care hospital, St. Paul's Hospital, in Vancouver, British Columbia.

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.

Exclusion Criteria:

* Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Rob Enns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05495256: Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Official title: Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Copd
Lead sponsor: Pulmonary Critical Care Associates of Baltimore
Sponsor class: OTHER
Collaborators: name: Gerresheimer
First posted: 2022-08-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients are screened, consented, and all go through the inhaler training.
Primary purpose: DIAGNOSTIC

Brief summary: To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.

Detailed description: Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.

This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
* Patients must be willing and able to provide informed consent to participate in the the study.
* Patients must be able to use a metered dose inhaler

Exclusion Criteria:

* Contraindication to inhaler use
* Tracheostomy
* Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
* Unable to understand informed consent (e.g. non-English speakers)

Primary outcomes:
measure: Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device
timeFrame: 2 weeks
Secondary outcomes:
measure: Describing baseline pressurized metered-dose inhaler (pMDI) technique
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates Of Baltimor
state: Maryland
Study officials:
References:
Clinical trial NCT05479656: A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
Official title: A Better Trunk and Lower Limb Control for a Better Mobility: Assessment of a Re-entrainment Program in Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Muscular Dystrophy Canada
First posted: 2022-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This exploratory study used a pre-post test design. The supervised rehabilitation program was performed three times a week for 8 weeks (two sessions at a rehabilitation gym and one pool session). Outcome measures included Ottawa sitting scale, 30-Second Chair Stand test, Berg Balance Scale, 10-Meter Walk Test, 6-minute Walk Test, modified Activities-specific Balance Confidence Scale and SARA scale. 10 participants will complete the training program. They will be evaluated at baseline, at week 4 (miway) and after the program.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent

Exclusion Criteria:

* Having other medical diagnosis causing physical limitations

Primary outcomes:
measure: Change in the Scale for the assessement and rating of ataxia (SARA)
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
measure: Change in walking speed
timeFrame: Baseline, week 4, week 8
measure: Change in the number of sit-to-stand performed in 30 seconds
timeFrame: Baseline, week 4, week 8
measure: Change in the balance confidence
timeFrame: Baseline, week 4, week 8
measure: Change in balance
timeFrame: Baseline, week 4, week 8
measure: Change in sitting balance
timeFrame: Baseline, week 4, week 8
measure: Change in the level of independence to perform daily living activities
timeFrame: Baseline, week 4, week 8
Other outcomes:
Locations:
city: Saguenay
country: Canada
facility: Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
state: Quebec
Study officials:
affiliation: Sherbrooke University
name: Cynthia Gagnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233256: Measurements of Water in Breath and Saliva
Official title: Rapid Measurements of Water Isotopes in Human Breath and Saliva for Doubly Labeled Water Analysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Human Energy Expenditure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy adults (18-45 yrs.) will be recruited from the local Denver area. The investigators have elected to study a relatively homogenous sample to limit the impact of age, weight, and chronic disease on isotope fractionation in breath.
Primary purpose: DIAGNOSTIC

Brief summary: This study proposes to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath by comparing the natural abundances of 2H:1H and 18O:16O in saliva and urine of un-dosed humans.

Detailed description: The scientific premises for this line of research are 1) challenges related to costs, the complexity of sample collection and preparation, and the level of technical skills required for Isotope-ratio mass spectrometry (IRMS) analysis have limited the adoption of the doubly labeled water (DLW) method; and 2) the investigators preliminary data demonstrates that Off-Axis Integrated Cavity Output Spectroscopy (OA-ICOS) provides a valid, more rapid, and less technically challenging approach to isotopic analysis of human samples.

Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women, aged 18-45 yrs

Exclusion Criteria:

* Obesity (body mass index (BMI) \> 30 kg/m2)
* Pregnant or lactating women
* Self-reported acute or chronic disease (diabetes, heart diseases, thyroid diseases)

Primary outcomes:
measure: Natural abundances of 2H:1H and 18O:16O in humans
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Edward Melanson
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Edward L Melanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03833856: Incidence and Clinical Course of Colonoscopy Related Perforation
Official title: Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforation Colon
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients undergoing colonoscopy who end up with perforation.

Brief summary: This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.

Detailed description: In each endoscopy unit from participating hospital, there is a alarm system focusing on the development of perforation. Therefore, perforation cases will not be missed from the registry.

Eligibility criteria: Inclusion Criteria:

* Patients who have a perforation after colonoscopy

Exclusion Criteria:

* Patients who refuse to be registered.

Primary outcomes:
measure: Operation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Eun Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209856: Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?
Official title: Vitamin D Supplementation in Vitamin Deficient Women Undergoing ICSI Cycles: Does it Affect the Fertility Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.

Detailed description: The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.

Eligibility criteria: Inclusion Criteria:

* Vitamin D deficient females undergoing first ICSI trial
* Age from 20 to 35 years

Exclusion Criteria:

* Women undergoing ICSI trials who are vitamin D sufficient

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: It will be calculated 1 year after enrollment of the first patient in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Eman Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944956: Swallowing Sound in Preterm Infant Evaluation of Feeding Maturation
Official title: Swallow Maturation in Preterm and Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Preterm Infants
Keywords: Maturation
preterm infants
sucking and swallowing
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 94
Sex: ALL
Minimum age (years): 26
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants (\< 37 gestational weeks) and term infants (\>=37 gestational weeks)

Brief summary: Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were used as reference values.

Detailed description: Successful transition to full oral feeding in preterm infants is important for safe discharge from hospital and for facilitating the mother-infant bond. Preterm infants were evaluated weekly for sucking and swallowing performance (i.e., feeding performance) from the time they began oral feeding (frequency 1-2 oral feedings/day) until they reached independent oral feeding (frequency 8 oral feedings/day) at postmenstrual 38-40 weeks. For the term infants, we evaluated a single oral feeding during the first week of life.

The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis. Each swallowing-sound recording was 2 minutes long and was captured in a quiet environment by the same investigator. The feeding parameters generated from the recordings were as follows: total number of swallows (S), total number of rhythmic swallows (RS), total number of resting intervals (RI), average time between resting intervals (ATRI), average time between swallows (ATS), average time between rhythmic swallows (ATRS), maximum number of rythymic swallows (MRS), and volume of milk ingested (VM) during the 2-minute evaluation.

Eligibility criteria: Inclusion Criteria:

* Preterm infants (\< 37 gestational weeks) and term infants (\>=37 gestational weeks)

Exclusion Criteria:

- The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis.

Primary outcomes:
measure: swallow count
timeFrame: Participants will be followed up until postmenstrual 38-40 weeks, an expected avarage of 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baskent University
name: Deniz Anuk Ince, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ince DA, Ecevit A, Acar BO, Saracoglu A, Kurt A, Tekindal MA, Tarcan A. Noninvasive evaluation of swallowing sound is an effective way of diagnosing feeding maturation in newborn infants. Acta Paediatr. 2014 Aug;103(8):e340-8. doi: 10.1111/apa.12686. Epub 2014 May 29.
Clinical trial NCT04509856: Teach-Back Educational Method On Diabetes Knowledge Level
Official title: The Impact Of Teach-Back Educational Method On Diabetes Knowledge Level And Clinical Parameters In Type 2 Diabetes Patients Undergoing Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Empowerment
Keywords: diabetes
education
teach-back
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It was aimed to research the effect of teach-back educational method on diabetes knowledge level and clinical parameters in type 2 diabetes patients undergoing insulin therapy. This is a randomized-controlled trial. Teach-back method will used for intervention group, routin diabetes education will used for control group. The primary outcome is diabetes knowledge levels (DKL), and secondary outcome is clinical patameters (fasting blood glucose, HbA1c, blood pressure). DKL and clinical parameters will measured and compared between two groups before and three months after the interventions.


Eligibility criteria: Inclusion Criteria:

* To have Type 2 Diabetes
* To be over 18 years old
* Not have any barriers in understanding and speaking Turkish
* Who started insulin treatment for the first time

Exclusion Criteria:

* Patients with a diagnosis of dementia
* To have vision or hearing loss

Primary outcomes:
measure: Diabetes knowledge level (DKL)
timeFrame: 3 months
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 3 months
measure: HbA1c
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Hospital
Study officials:
affiliation: Ataturk University
name: Yasemin Cayir, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877156: Local Potential Measurement In PFA: A Pilot Study
Official title: Unipolar Signal Local Potential Measurement in Pulsed Field Ablation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
Collaborators: name: Fabrio Pharma
First posted: 2025-03-14
Enrollment: 10
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: Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.

Brief summary: This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.


Eligibility criteria: Inclusion Criteria:

* Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.

Male or non-pregnant female aged ≥18 years.

Able and willing to provide written informed consent prior to any clinical investigation related procedure

Exclusion Criteria:

* Pregnant or nursing subjects.
* Current participation in another investigational drug or device study that interferes with this study.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Patients who have had a prior ablation procedure
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy is less than 12 months, in the opinion of the investigator
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Primary outcomes:
measure: PFAnalyzer output
timeFrame: From enrollment to hospital discharge typically 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: