louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01547247: Cap-assisted Water Immersion Versus Water Immersion Colonoscopy
Official title: Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
cap-assisted colonoscopy
water immersion colonoscopy
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.


Eligibility criteria: Inclusion Criteria:

* outpatient diagnostic colonoscopy
* bowel prep with macrogolum
* initial 2 mg of midazolam i.v.
* signed informed consent form

Exclusion Criteria:

* planned therapeutic intervention
* colorectal surgery in history
* known inflammatory bowel disease or colorectal cancer
* refusal of sedation

Primary outcomes:
measure: Cecal Intubation Time
timeFrame: 3 months
Secondary outcomes:
measure: Patient Comfort During Insertion Phase of the Colonoscopy
timeFrame: 3 months
measure: Success Rate of Minimal Sedation Colonoscopy
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vitkovice Hospital
Study officials:
affiliation: Digestive Diseases Center, Vitkovice Hospital
name: Premysl Falt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5.
Clinical trial NCT04992247: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Official title: A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid19
long haul
post-acute covid
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a randomized, placebo-controlled study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

Detailed description: This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise.

COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility criteria: Inclusion Criteria:

* Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
* Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinically improving pulmonary status over the month prior to screening
* Undergone a previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Primary outcomes:
measure: Change in 6-Minute Walk Distance (6MWD) at Day 60
timeFrame: Baseline to Day 60
Secondary outcomes:
measure: Change in 6MWD at Day 30
timeFrame: Baseline to Day 30
measure: Relief of symptoms on Day 30 and Day 60
timeFrame: Baseline to Day 30 and Day 60
measure: Change in Pulmonary Function
timeFrame: Baseline to Day 30 and Day 60
measure: Change in oxygenation
timeFrame: Baseline to Day 30 and Day 60
measure: Change in biomarker levels
timeFrame: Baseline to Day 60
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02355847: Cultural Competency, Risk Management, and Patient Safety Internet-Based Curriculum for OB/GYN Resident Physicians
Official title: Cultural Competency, Risk Management, and Patient Safety Internet-Based Curriculum for OB/GYN Resident Physicians and Adverse Patient Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Additional educational training lectures were provided to healthcare workers. Outcome measure of cultural competency was completed to assess patient safety, risk management, and cultural competency of healthcare providers in an urban academic Labor and Delivery Unit.

Detailed description: Introduction: Patient safety, risk management, and cultural competency are essential topics for healthcare provider mastery in a high stakes, urban academic Labor and Delivery Unit.

Methods: A prospective cross sectional pilot study was performed with IRB exempt status to examine the effect of an internet based educational curriculum on topics including patient safety, risk management and cultural competency over 6 months amongst OB/GYN and Family Medicine medical students, nurses, and physicians. 76 healthcare providers participated. Assessments took place before and after curriculum implementation. Primary outcome measures were cultural competency as measured by the Tucker-Culturally Sensitive Health Care Inventory (TCSHCI) Provider Form, Pascal Metrics of Patient Safety survey for healthcare providers, patient satisfaction measured by the Press Ganey patient survey scores, and poor Labor and Delivery Outcomes. The curriculum intervention included five online lectures lasting 30-60 minutes pertaining to cultural competency, risk management, patient safety, and Team STEPPS training.

Eligibility criteria: Inclusion Criteria:. Inclusion criteria were OB/GYN medical students, Labor and Delivery nurses, and resident/ attending physicians in OB/GYN, Pediatrics, Anesthesia, and Family Medicine.

-

Exclusion Criteria:

* .Exclusion criteria were those providers that refused participation, or those that did not complete the course by June 2013.

Primary outcomes:
measure: Tucker-Culturally Sensitive Health Care Inventory (TCSHCI) Provider Form
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03087747: Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes
Official title: Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cholecystitis, Acute
Elderly Infection
Drain Abscess
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute cholecystitis

Brief summary: In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some radiology aspects and correlate with clinical patient outcomes in patients with acute cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).


Eligibility criteria: Inclusion Criteria:

* clinical markers of acute cholecystitis
* diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US).

Exclusion Criteria:

* clinical diagnosis was not confirmed with imaging.

Primary outcomes:
measure: C-reactive protein (CRP)
timeFrame: Up to 8 weeks.
Secondary outcomes:
measure: Drainage duration (expressed in days)
timeFrame: Up to 16 weeks.
measure: White blood cells (WBCs) count
timeFrame: Up to 8 weeks.
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split, School of Medicine
Study officials:
affiliation: University Hospital Split
name: Liana Cambj Sapunar, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03895047: ICCAC-ToNF & Tinnitus
Official title: Multifocal Tomographic Neurofeedback for Treating Chronic Tinnitus in Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 36
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: TREATMENT

Brief summary: Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive oscillatory changes in auditory as well as non-auditory regions of the brain such as the insula and the anterior cingulate cortex which are known to be key points within the salience and distress networks of the brain.Thus, we are conducting a clinical trial by implementing those auditory as well as non-auditory regions into a tomographical neurofeedback Training (ToNF) -protocol.

Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants using standardized Low Resolution Electromagnetic Tomography Software (sLORETA, Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance imaging (sMRI) in order to identify potential structural markers for training success (e.g. cortical thickness).

Training success will be measured by oscillatory change via EEG before and after the training period as well as by means of follow-up measures. Furthermore, a comprehensive battery of behavioral and psychometric standardized self-report questionnaires will be applied.

Based on this multifocal (Insula, dorsal anterior cingulate cortex \& auditory cortex) ToNF we expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived loudness and distress.


Eligibility criteria: Inclusion Criteria:

* chronic tinnitus (\>6 months)
* Age 40 to 80
* Informed Consent
* Fluent in German language
* mentally \& physically fit

Exclusion Criteria:

* ferromagnetic implants
* cochlear implants
* average hearing loss over 50 dB
* claustrophoby
* addiction to alcohol or drugs
* intake of anesthetics, tranquilizers, neuroleptics or antiepileptics
* acute suicidal

Primary outcomes:
measure: Change from Baseline in Tinnitus symptoms assessed by questionnaires
timeFrame: Time Frame: at 1, 3, 6 month follow up
measure: Change from Baseline in frequency band EEG-activity in the auditory cortex, insula & dorsal anterior cingulate cortex
timeFrame: Time Frame: at 1, 3, 6 month follow up
Secondary outcomes:
measure: brain structure (volume, surface area) of the three regions of interest as predictor for training success.
timeFrame: Baseline (measurement before training)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Otorhinolaryngology ORL
state: ZH
Study officials:
References:
Clinical trial NCT01409447: Repair of Articular Osteochondral Defect
Official title: Repair of Articular Osteochondral Defect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondritis Dissecans
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Matrix-associated autologous chondrocyte implantation (MACI) has been recently used to treat cartilage defects. The investigators had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. The investigators further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.

Detailed description: Methods: Ten patients with symptomatic isolated osteochondritis at the femoral condyle were treated by replacing the pathological tissue with autologous chondrocyte-laden biphasic cylindrical plug of DL-poly-lactide-co-glycolide, with its lower body impregnated with -tricalcium phosphate as the osseous phase. The osteochondral lesion was drilled to fashion a pit of identical size and shape as the plug. The chondrocyte-laden plug was press-fit to fill the pit. Outcome of repair was examined by KOOS scale at 3, 6 and 12 months postoperatively, and tissue sample was collected with second-look arthroscopic needle-biopsy at 12 months. The primary outcome parameter was the postoperative change of KOOS; and the secondary outcome parameter was the regeneration of cancellous bone and hyaline cartilage at the repair site.

Eligibility criteria: Inclusion Criteria:

* Age: 18 \~ 60 years
* Articular cartilage defect of the knee
* Diagnosis by X-ray and/or MRI, Arthroscopy
* Confined area: diameter \< 3 cm
* Full layer cartilage damage

Exclusion Criteria:

* Pregnancy
* Nonunion of fracture around the knee
* Diffuse degenerative arthropathy of the knee
* Diffuse cartilage pathology due to
* Rheumatism: rheumatoid, psoriatic, ...
* Metabolic disorder: gouty, hemorrhagic, ...
* Stiff knee from any reason
* Flexion \< 130˚
* Extension loss \> 20˚

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Chuan Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368847: Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
Official title: Optimizing and Validating the Clinical Algorithm for Diagnosing Urinary Tract Infections in Older Persons Admitted to a Psychogeriatric Ward
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Aged
Psychiatric Hospitals
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Urinary tract infections are one of the most common types of infections in older persons. The general aim of this study is to improve the epidemiological knowledge and develop a better diagnostic algorithm for urinary tract infections in older institutionalized individuals in order to reduce excessive prescribing of antibiotics and prevent antimicrobial resistance.


Eligibility criteria: Inclusion Criteria:

* Older (65+ years) persons admitted to a gerontopsychiatric ward

Exclusion Criteria:

* Patients not understanding Dutch or not willing to participate (no informed consent)

Primary outcomes:
measure: Serious infection
timeFrame: 2 months
Secondary outcomes:
measure: Reliability of the uricult dipslide in a population of institutionalized older patients
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Jan De Lepeleire, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05681247: Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Official title: Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemias
Keywords: Ezetimibe Tablet, Bioequivalence, Pharmacokinetics
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic proﬁles of ezetimibe tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age
* The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).
* The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion Criteria:

* any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
* hepatic/renal impairment
* abnormal vital signs
* drug or alcohol abuse
* smoking ≥5 cigarettes per day ,
* donation(≥300ml) o
* enrollment in other clinical trials during the 3 months prior to screening
* allergic to ezetimibe or its excipients
* any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
* lactating or pregnant women

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
timeFrame: 80 days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 80 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Clinical Research Center
state: Shandong
Study officials:
References:
Clinical trial NCT00422747: Early Diagnosis of Asthma in Young Children
Official title: Early Diagnosis of Asthma in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
transient wheezing
early diagnosis
exhaled air
nitrogen monoxide
airway resistance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Netherlands Asthma Foundation
name: Stichting Astma Bestrijding, The Netherlands
First posted: 2007-01-17
Enrollment: 202
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements


Eligibility criteria: Inclusion Criteria:

* Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
* Children aged 2-3 years, with no or minor respiratory symptoms

Exclusion Criteria:

* Mental retardation
* Cardiac anomalies
* Congenital malformations
* Other diseases of the lungs/airways
* Chronic systemic inflammatory diseases like M. Crohn
* The inability to perform lung function measurements and/or exhaled air collection

Primary outcomes:
measure: - definite asthma diagnosis - biomarkers in exhaled breath
timeFrame: 6 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Dept. of Paediatric Pulmonology, Maastricht University Medical Centre
name: Edward Dompeling, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klaassen EM, van de Kant KD, Jobsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med. 2015 Jan 15;191(2):201-7. doi: 10.1164/rccm.201408-1537OC.
citation: van de Kant KD, van Berkel JJ, Jobsis Q, Lima Passos V, Klaassen EM, van der Sande L, van Schayck OC, de Jongste JC, van Schooten FJ, Derks E, Dompeling E, Dallinga JW. Exhaled breath profiling in diagnosing wheezy preschool children. Eur Respir J. 2013 Jan;41(1):183-8. doi: 10.1183/09031936.00122411.
citation: van de Kant KD, Koers K, Rijkers GT, Lima Passos V, Klaassen EM, Mommers M, Dagnelie PC, van Schayck CP, Dompeling E, Jobsis Q. Can exhaled inflammatory markers predict a steroid response in wheezing preschool children? Clin Exp Allergy. 2011 Aug;41(8):1076-83. doi: 10.1111/j.1365-2222.2011.03774.x. Epub 2011 May 30.
citation: van de Kant KD, Klaassen EM, Jobsis Q, Nijhuis AJ, van Schayck OC, Dompeling E. Early diagnosis of asthma in young children by using non-invasive biomarkers of airway inflammation and early lung function measurements: study protocol of a case-control study. BMC Public Health. 2009 Jun 29;9:210. doi: 10.1186/1471-2458-9-210.