louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963858: Effect of Functional Relaxation on Patients Undergoing Colonoscopy
Official title: Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Relaxation
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is the most common reason for low acceptance of colonoscopy. Several methods have been used to minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to participate in administration of medication. Although a potential benefit from some of these methods has been suggested, no clear recommendations have been made so far. We hypothesized functional relaxation reduces discomfort during colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Previous colorectal resection

Primary outcomes:
measure: Patient's abdominal pain during colonoscopy
timeFrame: 1 day
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 day
Other outcomes:
measure: State Trait Anxiety Inventory (STAI)
timeFrame: 1 day
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's hospital, Catholic university of Korea
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital, The Catholic University of Korea
Study officials:
References:
Clinical trial NCT02084758: Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
nitrate supplementation
metabolic efficiency
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-03-12
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: Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.


Eligibility criteria: Inclusion Criteria:

* COPD
* Indication metabolic inefficiency

Exclusion Criteria:

* Sodium intake limitation
* Long-term oxygen therapy
* Severe renal impairment
* Use of medications that may interact with nitrate
* Contra-indications for performing (sub)maximal cycle ergometry

Primary outcomes:
measure: Change in metabolic efficiency during exercise
timeFrame: Baseline, day 7, day 14 and day 21.
Secondary outcomes:
measure: Change in blood pressure during exercise
timeFrame: Baseline, day 7, day 14 and day 21.
measure: Change in dyspnea during exercise
timeFrame: Baseline, day 7, day 14 and day 21.
measure: Change in cycle endurance time during exercise.
timeFrame: Baseline, day 7, day 14 and day 21.
measure: Change in oxygen uptake (VO2 mL/min) during exercise
timeFrame: Baseline, day 7, day 14 and day 21
measure: Change in Resting Energy Expenditure (REE)
timeFrame: Baseline, day 7, day 14 and day 21
measure: Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin
timeFrame: Baseline, day 7, day 14 and day 21
Other outcomes:
measure: VO2max and Wmax
timeFrame: Baseline
measure: height, body weight and body mass index (BMI)
timeFrame: Baseline
measure: Fat free mass and fat mass
timeFrame: Baseline
measure: Lung function
timeFrame: Baseline
measure: Physical activity
timeFrame: During the two supplementation periods
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Annemie Schols, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04660058: Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer
Official title: Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer: A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Reflux
Gastric Cancer
Precancerous Lesion
Keywords: bile acid
gastric microbiota
Gastric Cancer
precancerous lesion
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients are from Xijing Hospital

Brief summary: To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer

Detailed description: This study is a case-control study. Patients, according to the pathological results, will be consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group. The serum and gastric juice bile acid profiles, gastric microbial composition of each group patients will be detected.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years old, gender is not limited;
2. No history of antibiotic or probiotic use for 8 weeks;
3. No preoperative chemotherapy or radiation therapy prior to the examination;
4. Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.
5. Voluntary testing for H. pylori

Exclusion Criteria:

1. had undergone upper gastrointestinal and colon surgery;
2. Previous diagnosis of Malignant Tumors;
3. Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;
4. Recent use of drugs that affect gastrointestinal motility;
5. Presence of contraindications to endoscopy;
6. pregnant and lactating women;
7. Those with mental disorders;
8. Refusal to sign the informed consent form.

Primary outcomes:
measure: corelation between the bile acid profile and gastric mucosa diseases
timeFrame: up to 6 months
measure: corelation between the bile acid profile and gastric microbiota in different groups
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
References:
Clinical trial NCT02130258: Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Official title: Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Lower Extremity Radicular Pain
Keywords: Radicular
Pain
Epidural Steroid Injection
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators hypothesize that there may exist different quantitative sensory profiles between radicular pain patients who respond and those who do not respond to the standard therapy of epidural steroid injections (ESI).

Detailed description: The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and conditioned pain modulation (CPM) as measured by Quantitative Sensory Testing (QST) between subjects with a radicular pain condition. The investigators are comparing those who respond and those who do not respond to standard therapy (ESI) before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
* scheduling an epidural steroid injection (ESI)

Exclusion Criteria:

* a major psychiatric disorder requiring a recent (within one month) hospitalization, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis
* subject is taking illicit or recreational drug detected through a urine toxicology screen
* subject has had an interventional pain management procedures within the last eight weeks that may alter QST responses including neuraxial or local anesthetic block
* subject had a change in dosage of neuromodulatory pain medication (including gabapentin, pregabalin, cymbalta, amitriptyline, nortriptyline, trileptal, etc) in the past two weeks
* subject is pregnant
* subject has pending litigation involving the current pain condition being treated and studied.

Primary outcomes:
measure: Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results
timeFrame: Baseline measurement before the epidural injection
measure: Post-epidural Continued Pain Modulation (CPM)
timeFrame: 4 weeks after the epidural injection
measure: Post-epidural Cold Pain Threshold QST Results
timeFrame: 4 weeks after the epidural injection
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Center for Translational Pain Research
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yi Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02781363: Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
Official title: Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pneumonia
Keywords: thoracic ultrasound
children
efficacy
emergency service
Lead sponsor: Hospital Universitari General de Catalunya
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Thoracic ultrasound is a safer and sensitive technique than conventional radiography because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions. The main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled personnel in the emergency service prdiatricas to diagnose pneumonia in children.

Detailed description: Diagnostic test evaluation.The sample collected sequentially until an exact size . Given the safety of the technique, which involves no risk to patient management and the possibility of generating a type II error by premature study discontinuation , we have no plans to make any interim analyzes .

Eligibility criteria: Inclusion Criteria:

* fever above 38 degrees
* tachypnea
* Difficulty breathing
* Side tip pain
* pathological auscultation

Exclusion Criteria:

* \< 3 months\> 14 years
* Background of Prematurity
* Rewalizados imaging studies in the last 7 days
* Any chronic respiratory process
* congenital heart diseases
* hemodynamic instability
* Diagnosis of pneumonia in the last 3 months
* Refusal of relatives to participate in the study

Primary outcomes:
measure: coincidence between the ultrasound image and conventional radiography
timeFrame: 1 day
Secondary outcomes:
measure: additional workload
timeFrame: 1 day
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Hospital UNiversitari General de Catalunya
state: Catalonia
Study officials:
References:
Clinical trial NCT02774863: How to Collect the Expression of Psychological Suffering of Children Under Two Years?
Official title: Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Emotional Neglect
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty children and their families (parents / guardians) will be included in the research in the department of Loire-Atlantique, coming visit to the Mother and Child Protection within the first two years of their child.

Brief summary: Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.

This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.

The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.


Eligibility criteria: Inclusion Criteria:

* Families say vulnerable falling M.Heaman selection criteria associated with two significant items of Q-Sort, agreeing to participate in the research project.
* Patient 24 months or less at the time of the first consultation PMI.
* Parents / legal representatives agreeing to participate in the research project.

Non inclusion Criteria:

* Serious genetic and somatic pathologies resulting deficiency, physical pain,
* Non-French speaking families.
* Families whose baby is monitored as part of the network grow together because of their prematurity.
* Minor or major Parents Trust

Primary outcomes:
measure: Comparison of the sensitivity of the Global Printing-scale gravity relative to the Development Quotient (reference) between the 2 supported (Group A versus Group B).
timeFrame: up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Medical-social Center Dalby Millet
city: Nantes
country: France
facility: Medical-Social center Bellevue
city: Nantes
country: France
facility: Medical-social center Pilotière
city: Nantes
country: France
facility: Medical-Social center Port Boyer
city: Saint-Herblain
country: France
facility: Medical-social Saint-Servan
city: St-Etienne de Montluc
country: France
facility: Medical-social St-Etienne de Montluc
Study officials:
References:
Clinical trial NCT05937763: ED Adaptive Staffing Study
Official title: Feasibility and Evaluation of an Adaptive STaffing Model in a Community Emergency Department (FAST-ED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergency Medicine
Well-Being, Psychological
Lead sponsor: Oak Valley Health
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 5917
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will use a convenience sampling method, given that patients brought in by ambulance are at random and non-predictive.

Brief summary: Emergency Departments (EDs) across Ontario are being inundated with unprecedented high patient volumes and a staffing shortage that directly impacts patient care and flow. An area of concern among EDs is the offload zone where patients are brought in by ambulance. EMS offload time is the time it takes paramedics to transfer a patient to the appropriate area within an emergency department and give hospital staff a summary of what concerns the patient is seeking care for. There are multiple factors that may delay this time, including limited staff in the offload area to complete the transfer process due to competing patient care responsibilities. The adaptive staffing model study will look to add a primary care paramedic (PCP) or a registered nurse (RN) in the offload zone during times of high ambulance volume (August to January) to help with patient care within the offload zone. This single-centered community hospital study will evaluate the benefits of having a PCP or RN, compared to the current model, on ambulance offload times, patient safety outcomes, patient treatment times, and staff well-being using three different models of staffing.


Eligibility criteria: Inclusion Criteria:

* Patients brought in by ambulance to hospitals emergency department offload area

Exclusion Criteria:

* Patients not arriving to the hospitals emergency department offload area

Primary outcomes:
measure: Triage Time
timeFrame: 6 months
measure: Return to Service
timeFrame: 6 months
Secondary outcomes:
measure: Time to provider assessment
timeFrame: 6 months
measure: Provider Feedback Survey
timeFrame: 6 months
measure: Time to treatment
timeFrame: 6 months
measure: Time to disposition
timeFrame: 6 months
measure: Number of incident reports
timeFrame: 6 months
measure: Case costing
timeFrame: 6 months
measure: Well-being Index (questionnaire)
timeFrame: 6 months
Other outcomes:
Locations:
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT03125135: Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility criteria: Competent non-smoking adults

Inclusion Criteria:

* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.

Primary outcomes:
measure: Accuracy of Sensor
timeFrame: 1-5 hours
measure: Accuracy of Sensor during motion
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Corporation
state: California
Study officials:
References:
Clinical trial NCT00097435: A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Official title: A Multi-Center, Randomized, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-24
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.


Eligibility criteria: Major Inclusion Criteria:

* Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
* Have previously failed to respond to treatment with any interferon alfa (IFNa) product
* Have compensated liver disease with the following minimum criteria: white blood cell count \> 3,000/mm3, absolute neutrophil count (ANC) \> 2,000/mm3, platelets \> 125,000/mm3, and hemoglobin (Hb) \> 13 g/dL for males or \> 12 g/dL for females.

Major Exclusion Criteria:

* Evidence of decompensated cirrhosis or portal hypertension.
* Pregnant or lactating female.
* History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
* A current drug or alcohol addiction

Primary outcomes:
measure: The major safety endpoints are the common side effects of IFNa therapy including flu-like symptoms, depression, and hematologic abnormalities.
Secondary outcomes:
measure: Sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy. The primary efficacy assessment is HCV RNA level.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Gainesville
country: United States
facility: University of Florida CRC
state: Florida
city: Jacksonville
country: United States
facility: University of Florida at Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: