louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02552485: Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions
Official title: Prospective, Monocentric Study for the Evaluation of Latent Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions Lost to Follow-up.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Septal Defects
Ventricular Septal Defects
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent congenital heart defect closure before the age of 18 years and who are lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Brief summary: Prospective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.

Detailed description: Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR). This causes pressure overload in the right heart, and thereby right ventricular (RV) and right atrial (RA) dysfunction, which may implicate considerable morbidity and even mortality. Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced (partially irreversible) stage and treatment is often initiated too late.

Dismissal from follow-up after a surgical correction of simple CHD was customized in the seventies and eighties. There is no literature available that learns us whether these patients really need follow-up or not. A substantial number must have insidiously developed PAH or mild pulmonary vascular disease (PVD) and still are prone to develop PAH later in life. It is relevant to recall these patients dismissed from follow-up in the past, because they might carry a lot of useful information on the natural history of PAH development. Focus will lie mainly on patients with simple shunt lesions, as atrial septal defect (ASD) and ventricular septal defect (VSD).

Eligibility criteria: Inclusion Criteria:

* Previous repair for secundum ASD, VSD

Exclusion Criteria:

* Other congenital heart disease
* Chronic lung disease or total lung capacity \< 80% of predicted value
* History of pulmonary embolism

Primary outcomes:
measure: Mortality
timeFrame: From date of birth until date of study inclusion (up to 100 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Werner Budts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503785: Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Official title: Esophageal Impedance and Manometry Measurements and Dysphagia Symptom Scoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dysphagia, Esophageal
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be recruited from patients who were referred by their physicians to the GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

Brief summary: Comparison of manometry measurements and EndoFlip Balloon measurements in patients with dysphagia and a known esophageal diagnosis

Detailed description: Gastrointestinal (GI) motility problems are very common in the general population. Dysphagia, difficulty swallowing, is one of the most common issues in gastroenterology. In many patients, esophageal obstruction is not identified despite workup with upper endoscopy or barium swallow x-ray. Patients are often referred to the Motility Laboratory for evaluation of non-obstructive dysphagia. Transnasal esophageal manometry-impedance is a diagnostic test to measure the pressures and coordination of the esophagus during swallowing. The Endolumenal Functional Lumen Imaging Probe (EndoFLIP) is another instrument used to measure the lumen distensibility of the esophagus and pylorus. Both tests are FDA-approved and are currently being used in clinical practice. However, correlation of the results obtained from these tests with clinical syndromes and symptoms is not clearly understood. Furthermore, the relationship between esophageal impedance-manometry and EndoFLIP results has never been defined.

The primary Aim is to develop a registry of patients undergoing esophageal manometry-impedance and Endoflip from the GI Motility Lab at the IU University Hospital

Eligibility criteria: Inclusion Criteria:

* All patients who presented to GI Motility Lab at IU University Hospital for esophageal manometry-impedance and/or EndoFLIP

Exclusion Criteria:

* Age \<18 yrs old
* Unable to communicate verbally with the staff

Primary outcomes:
measure: Endoflip parameters for gastroparesis
timeFrame: 5 years
Secondary outcomes:
measure: Correlation between endoflip parameters and gastric scintigraphy
timeFrame: 5 years
measure: Correlation between endoflip parameters and symptom severity
timeFrame: 5 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: John M Wo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02539485: Heating Precondition of Streamlined Liner of the Pharynx Airway Decrease the Incidence of Sore Throat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Artificial Airway
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated.


Eligibility criteria: Inclusion Criteria:

* Hysteroscopic surgery
* General anesthesia

Exclusion Criteria:

* Upper respiratory disease
* Communication disfunction

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 5 minutes
measure: postoperative sore throat
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetric & Gynecology Hospital
state: Shanghai
Study officials:
affiliation: obstetric & gynecology hospital
name: Guiqi Geng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geng G, Chen Y, Liu H. Preheating of streamlined liner of pharyngeal airway (SLIPA) reduced the related complications: a randomized control study. J Clin Monit Comput. 2017 Jun;31(3):547-550. doi: 10.1007/s10877-016-9875-z. Epub 2016 Apr 8.
Clinical trial NCT04250285: Academic Self-regulation, Parenting Dimensions and Academic Procrastination
Official title: University of Bojnord
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self-regulation
Parenting
Procrastination
Lead sponsor: University of Bojnord
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 278
Sex: MALE
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: male students in age range of 9 to 13 years old in Garmeh city(Iran)

Brief summary: the method was the correlational way. The statistical population of the was all of the boy students of the second-period elementary school in Garmeh city (Iran). the sample size was 278. The age of participants was in the range of 9 to13 years old.


Eligibility criteria: Inclusion Criteria:

be the male student, having the age of 9 to 13 years, having the ability of reading and writing

Exclusion Criteria:

* be female, no be student, no having age of 9 to 13 years, disability of reading and writing, having psychotic disorders

Primary outcomes:
measure: Self-Regulation
timeFrame: 2 days
measure: Procrastination
timeFrame: 2 days
measure: parenting
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bojnourd
country: Iran, Islamic Republic of
facility: Malahat Amani
state: North Khorasan
Study officials:
References:
Clinical trial NCT03454685: The Role of Microbiota on the Development of Lung Cancer
Official title: The Role of Microbiota on the Development of Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC, Stage I
NSCLC, Stage II
NSCLC, Stage III
NSCLC Stage IV
Healthy Subjects
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Just confirmed non-small cell lung cancer patients

Brief summary: Relationship between human microbiota and epidemiology of lung cancer

Detailed description: In this study,We aim to find some kinds of human microbiota , which were associated with development of non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer patients

Exclusion Criteria:

* long-term workers in the polluted environment, Patients who had used antibiotics within 1 month before sampling,

Primary outcomes:
measure: Relationship Between Human Microbiota and Epidemiology of Lung Cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital
state: Hubei
Study officials:
affiliation: china government
name: dong xiaorong, Dr
role: STUDY_DIRECTOR
References:
citation: Lu H, Gao NL, Tong F, Wang J, Li H, Zhang R, Ma H, Yang N, Zhang Y, Wang Y, Liang Z, Zeng H, Chen WH, Dong X. Alterations of the Human Lung and Gut Microbiomes in Non-Small Cell Lung Carcinomas and Distant Metastasis. Microbiol Spectr. 2021 Dec 22;9(3):e0080221. doi: 10.1128/Spectrum.00802-21. Epub 2021 Nov 17.
Clinical trial NCT01464385: Nutrition Beverage Tolerance Study
Official title: Nutrition Beverage Tolerance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Volunteers
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 121
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the sensations experienced by subjects consuming a nutritional beverage.


Eligibility criteria: Inclusion Criteria:

Subject ≥ 45 years of age.

If female, subject is either postmenopausal for at least 1 year or surgically sterile

Subject reports that he/she has not participated in a research study in the last three months.

Exclusion Criteria:

Subject has active metabolic or endocrine disease

Subject has an autoimmune disorder

Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months.

Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products

Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening

Primary outcomes:
measure: Proportion of subjects experiencing neurologic adverse event(s)
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Proportion of subjects experiencing any adverse event(s).
timeFrame: 2-3 Weeks
Other outcomes:
Locations:
city: Livermore
country: United States
facility: The National Food Lab
state: California
Study officials:
affiliation: Abbott
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02707185: Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training
Official title: Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: METHODS:

Subjects:

All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy.

Study Assessment Tool:

An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills (attachment A).

Design:

* Phase I: In groups of five to six subjects, residents and nurses will undergo baseline assessment in CPR techniques in the simulation lab. Subject will be presented with a clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by observers based on the previously described assessment tool and will be video recorded.
* Phase II: All study subjects who completed phase I assessment will undergo standardized debriefing and demonstration of proper CPR techniques after reviewing their individual baseline videotape followed by repeated demonstration in CPR techniques during a clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention will be assessed periodically.
* Phase III: Rates of survival to hospital discharge and survival at 24 hours in hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA department longitudinally for one year after completion of project training (phase II) will be reviewed and compared to the same period one year earlier (CPR outcome data are being collected since 2005 at St. Luke's-Roosevelt Hospitals).


Eligibility criteria: Inclusion Criteria:

* Physicians in training and nurses

Exclusion Criteria:

* Physicians in training and nurses refusing to have their data included in final analysis

Primary outcomes:
measure: Performance scale
timeFrame: Baseline and 1 year
measure: Rates of survival
timeFrame: 1 year
Secondary outcomes:
measure: Survey questionnaire
timeFrame: Baseline and 1 year
measure: Perceptions of preparedness
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: NYC
country: United States
facility: St. Luke's Roosevelt Roosevelt
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Hassan Khouli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732885: Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes
Official title: Crestal Maxillary Sinus Floor Elevation Using Osseodensification Drills (Densah Burs) Versus Summers Osteotomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implant Tissue Failure
Keywords: Sinus
Stability
Bone gain
Osseodensification
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.


Eligibility criteria: Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
* both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Primary outcomes:
measure: implant stability
timeFrame: 6 months after surgery
Secondary outcomes:
measure: bone gain
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sohaib M Elsheikh
Study officials:
References:
Clinical trial NCT00056485: Treatment of Depression in Nursing Homes
Official title: Behavioral Intervention for Depression in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Nursing homes
Aging
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a pilot feasibility study; the first part was a single group; the second part was a two-group randomized design.
Primary purpose: OTHER

Brief summary: This study will implement a treatment for depression in a nursing home setting.

Detailed description: Depression in long-term care facilities is a significant public health issue. Up to 50% of nursing home residents are affected by significant depressive symptoms. The decreased health and limited cognitive ability of many nursing home residents makes treatment and research extremely challenging. This study will attempt to identify and implement treatments for depressed nursing home residents.

Participants are randomly assigned to receive either an active intervention or treatment as usual for 6 weeks. The active intervention is followed by 4 weeks of maintenance. The intervention is implemented primarily by existing nursing facility staff and focuses on increasing opportunities for residents to experience pleasant events through increased levels of activity and positive affect. The maintenance treatment involves incorporation of protocol-based activities into patient care plans. Patients have a follow-up visit 12 weeks after the study. Psychiatric evaluations, depression and mood rating scales, observed affect and activity participation, behavior problems, and staff burden are assessed.

Eligibility criteria: Inclusion Criteria:

* Nursing home residents
* DSM-IV criteria for major depressive disorder or dysthymia or Research Diagnostic Criteria for minor depressive disorder with current Geriatric Depression Scale scores \> 11 and Mini Mental State scores \>= 14

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Suzanne Meeks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02217085: Colorectal Polyp Resection Adequacy
Official title: Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyp Resection Adequacy
Keywords: Colorectal Cancer Screening
Colon Cancer Screening
Polyps
Colonoscopy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 288
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for colorectal adenomatous polyps.

Brief summary: The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.


Eligibility criteria: Inclusion Criteria:

* Age 40-80

Exclusion Criteria:

* Coagulopathy (international normalized ratio \>2)
* Inflammatory bowel disease or other active colitides
* Polyps of index colonoscopy that were felt not to be completely resected or pedunculated
* Familial adenomatous polyposis or hereditary polyposis
* Potential hereditary cancer syndrome (Lynch Syndrome)

Primary outcomes:
measure: The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
timeFrame: Between 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: