louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02660671: Behavioral Economic Approaches to Increase Colorectal Cancer Screening
Official title: Behavioral Economic Approaches to Increase Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Colon
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 2250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening through email outreach, including usual email communication, active choice, and active choice + financial incentive.

Detailed description: This is an RCT aimed at testing different population-based approaches to increasing colorectal cancer screening. The investigators will randomize a cohort of employees between the ages of 50-64 to 3 arms of email communications: a.) Usual email communication; b.) Active choice- usual care + the ability to pre-commit directly through a web form; c.) Financial incentive- usual care + active choice + financial incentive for completion.

Eligibility criteria: Inclusion Criteria:

* Male and female employees of the University of Pennsylvania Health System who live within 30 miles of a health system endoscopy center.

Primary outcomes:
measure: Colonoscopy participation
timeFrame: 3 months
Secondary outcomes:
measure: Email engagement
timeFrame: 3 months
measure: Scheduling of colonoscopy
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Feingold J, Vandertuyn M, Niewood T, Cox C, Doubeni CA, Volpp KG, Asch DA. Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial. Gastroenterology. 2017 Nov;153(5):1227-1229.e2. doi: 10.1053/j.gastro.2017.07.015. Epub 2017 Jul 20.
Clinical trial NCT04969471: NATURE (EnVast As an Adjunct PPCI in Subjects Presenting with STEMI)
Official title: An Interventional, Prospective, Randomized, Multi-Center, Assessor-Blinded Study Designed to Assess the Safety and Effectiveness of the EnVast Coronary Thrombectomy System As an Adjunctive Measure to Conventional Intervention in Subjects Presenting with ST-segment Elevation Myocardial Infarction (STEMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 148
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 study is designed to compare the safety and effectiveness of blood clot (thrombus) removal in subjects presenting with ST-segment elevation myocardial infarction (STEMI) with the enVast coronary system versus conventional intervention.

Detailed description: A prospective, multi-center, randomized clinical trial designed to assess the safety and effectiveness of the enVast coronary thrombectomy system as an adjunctive measure to conventional intervention in subjects presenting with ST-segment elevation myocardial infarction (STEMI).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Chest pain for \> 20 min with an electrocardiographic ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads or an infero-lateral myocardial infarction (MI) with ST segment depression of ≥ 1 mm in ≥ 2 of leads V1-3 with a positive terminal T wave.
3. TIMI Thrombus Grade ≥ 3 in the infarct related artery. In cases where TIMI Thrombus Grade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI Thrombus Grade of at least 3 has to be re-confirmed with AWI. Patients showing TIMI Thrombus Grade of less than 3 upon AWI are no longer eligible for randomization.
4. Start of intervention within 8 h of symptom onset
5. Subject is willing and able to provide informed consent prior to the intervention

Exclusion Criteria:

1. Unconscious patients
2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
3. Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s)
4. Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
5. Women of child-bearing potential (e.g. below 55 years of age, who have not undergone tubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12 months)
6. Stent thrombosis as culprit lesion
7. Previous myocardial infarction in the same territory (i.e. same target vessel)
8. Participation in another interventional clinical trial

Primary outcomes:
measure: Infarct size
timeFrame: three days post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
Study officials:
References:
Clinical trial NCT00214071: Immunological Consequences of Obstructive Sleep Apnea
Official title: Influence of Obstructive Sleep Apnea on Humoral and Cell-Mediated Vaccine Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in recognition and awareness. OSA is associated with the development of hypertension and other cardiovascular diseases (1,2). OSA has pathophysiologic characteristics that are known to negatively impact immune function. Both sleep deprivation and hypoxia, hallmarks of OSA, impair immune responses (6,8,11). In addition, patients with OSA are frequently obese and obesity may be associated with increased chance of infections and immune impairment (14,15). Adipose cells are known to secrete cytokines and hormones that are involved in the immune response such as leptin, tumor necrosis factor alpha and interleukin-6 (16-19). Thus, it seems very likely that OSA may impact antigen-specific immune responses. Although it is known that characteristics of OSA impact immune function, it is not known what effects clinical OSA has on immunity.

The central hypothesis of this application is that that patients with obstructive sleep apnea will have attenuated cell-mediated and humoral immune responses to influenza vaccine compared to matched control subjects. Our hypothesis has been formulated on the basis that patients with OSA are sleep deprived and experience repeated hypoxemia that negatively impact both humoral and cell-mediated immune responses.


Eligibility criteria: Inclusion Criteria:

* Absence of any immunocompromising diseases or medical conditions
* Not taking any immune modifying medications or supplements
* Significant obstructive sleep apnea as verified by complete overnight polysomnography with apnea-hypopnea index (AHI) \> 15 events per hour (sleep apnea subjects)
* Free of sleep disordered breathing verified by complete overnight polysomnography (AHI \< 5 events per hour) or oximetry (\< 5 desaturations per hour) (control subjects)

Exclusion Criteria:

* Documented history of allergy to influenza vaccine or any of its components

Primary outcomes:
measure: The primary outcome variable will be mean lymphocyte interferon- ÿ (IFN- ÿ) production at 14 days (measured by ELISA)
Secondary outcomes:
measure: Mean influenza antibody concentrations (pre- and post-immunization) with standard deviations will be calculated and compared between sleep apnea and control patients.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: John M Dopp, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668471: U/S Guided vs. Traditional Palpation for Radial Artery Cannulation
Official title: Ultrasound-guided Compared With Traditional Palpation Radial Artery Cannulation in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.

Detailed description: Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients. There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication. Recently no setting published in pediatric intensive care unit.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit

Exclusion Criteria:

* Wound at area of cannulation
* Can not palpate or weak radial artery pulse

Primary outcomes:
measure: first attempt success rate of radial artery catheter insertion
timeFrame: 5 minute
Secondary outcomes:
measure: time to success of radial artery catheter insertion
timeFrame: 15 minute
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatric,Ramathibodi Hospital
Study officials:
References:
citation: Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
Clinical trial NCT06442371: Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training in Obese Adults
Official title: Additional Effects of Quranic Listening Meditation in Combination With High Intensity Interval Training on Cardiovascular Fitness and Mental Health in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the additional effects of Quranic listening meditation, in combination with High-Intensity Interval Training on cardiovascular fitness and mental health in obese adults.


Eligibility criteria: Inclusion Criteria:

* Obese adults (BMI ≥ 30)
* Age range: 18-45 years
* No previous experience with Quranic listening meditation since last 4 weeks.
* No contraindications for engaging in high-intensity physical activity
* Able to attend regular sessions at clinic and follow the study protocol.
* Willingness to undergo pre and post-assessments for cardiovascular fitness and mental health measures.

Exclusion Criteria:

* Individuals with a history of the medical condition being studied
* Those who are currently taking medication that may affect the study
* Participants with a history of mental health disorders
* Individuals who are pregnant or breastfeeding
* Those who have previously participated in a similar study
* Participants with a history of substance abuse or addiction

Primary outcomes:
measure: Modified BORG Scale
timeFrame: 6 week
measure: 6 Min walk test (Distance in meters)
timeFrame: 6 week
measure: Peak VO2 with formula
timeFrame: 6 week
measure: Body Mas Index
timeFrame: 6 week
measure: Heart Rate recovery
timeFrame: 6 week
measure: Depression Anxiety and Stress Scale
timeFrame: 6 week
measure: Systolic and diastolic blood pressure
timeFrame: 6 week
measure: Change in blood lipid profile
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: physiotherapy department, Jinnah international hospital
state: Khyber PkahtoonKhwa
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706871: Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia
Official title: Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Keywords: transcutaneous auricular vagus nerve stimulation
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 90
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: Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve stimulation (taVNS) for the functional dyspepsia (FD).

Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index, Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate the therapeutic effects.

A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* 1. Age \>=18 and Age \<=65. 2. Clinical diagnosis of functional dyspepsia.

Exclusion Criteria:

* 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of gastrointestinal surgery. 3. Pregnant or lactating women.

Primary outcomes:
measure: Mean change from Baseline in the FD Symptoms Index at 16 Weeks
timeFrame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
measure: Mean change from Baseline in the FDQOL at 16 Weeks
timeFrame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Secondary outcomes:
measure: Mean change from Baseline in the HAMA at 16 Weeks
timeFrame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
measure: Mean change from Baseline in the HAMD at 16 Weeks
timeFrame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
measure: Mean change from Baseline in the SDS at 16 Weeks
timeFrame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT02245971: A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastric Adenoma and Early Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD.

Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).


Eligibility criteria: Inclusion Criteria:

1. Over 19 years old
2. Patients with gastric adenoma or early gastric cancer

Exclusion Criteria:

1. Patients who has undergone subtotal gastrectomy
2. Patients who has undergone gastrostomy
3. Patients with local recurred gastric adenoma or early gastric cancer

Primary outcomes:
measure: Procedure time
timeFrame: Within 5 mins after the procedure
Secondary outcomes:
measure: En bloc resection rate
timeFrame: Within 7 days after the procedure
Other outcomes:
measure: complete resection rate
timeFrame: Within 7 days after the procedure
Locations:
city: Seoul
country: Korea, Republic of
facility: Sevrance hospital
Study officials:
References:
Clinical trial NCT03438071: Impact of Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants (VISIO-NEONAT)
Official title: Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infants
Parent-Child Relations
Parental Stress
Post Partum Depression
Neonatal Intensive Care Units
Videoconferencing
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 preterm infants and their parents (15 in each group)

Brief summary: The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).


Eligibility criteria: Inclusion Criteria:

* Parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our NICU during recrutment period
* Which agreed participating to the study after having complete information about it and sign a consent.

Exclusion Criteria:

* Parents with a preterm child with another pathology than prematurity or with a lenght of stay in the NICU less than 7 days
* Parents refusing to participate to the study
* Parents not having videoconference equipment or internet access at home
* Parents not understanding or speaking good enough French.

Primary outcomes:
measure: Level of stress of the mothers
timeFrame: From date of inclusion until the date of discharge, assessed up to 1 month
Secondary outcomes:
measure: Level of stress of the fathers
timeFrame: From date of inclusion until the date of discharge, assessed up to 1 month
measure: Parental stress evolution
timeFrame: From the date of inclusion until the date of discharge, assessed up to 1 month
measure: Post-partum depression rate of the mothers
timeFrame: Through study completion, an average of 2 months
measure: Quality of the relationship between the parents and their child
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Denis Oriot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220671: Measles Vaccination at Health System Contacts
Official title: Health Effects of Utilising Curative Health System Contacts to Provide Measles Vaccination - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Measles Vaccine
Hospital Admission
Mortality
Non-specific (Heterologous) Effects of Vaccines
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 5400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In addition to protecting against measles infection, measles vaccine (MV) strengthens the individual's ability to combat infections in general - MV has beneficial non-specific effects (NSE) lowering the risk of death and admissions by around 30%.

In Guinea-Bissau 30% of children do not receive a routine MV scheduled at 9 months of age, putting both the individual child's health and measles eradication at risk. WHO recommends vaccination at health system contacts, including those for curative services. At the paediatric ward of the national hospital in Guinea-Bissau, there are more than 2600 yearly contacts with measles-unvaccinated children aged 9-59 months, but no vaccines are given. In a randomised controlled trial, we will assess the effect of providing MV vs placebo to 5400 children at hospital contacts (at discharge or after an out-patient consultation) to test the hypothesis that MV reduces the risk of admission or death (composite outcome) by 25% over the subsequent 6 months.


Eligibility criteria: Inclusion Criteria:

* Measles-unvaccinated children
* 9-59 months with a hospital contact (discharged or outpatient consultation) at the paediatric ward at the national hospital Simao Mendes.

Exclusion Criteria:

* Axil temperature \>38.0
* Mid upper arm circumference \<110 mm

Primary outcomes:
measure: Non-accident mortality or admission (Composite outcome)
timeFrame: 6 months
Secondary outcomes:
measure: Non-accidental mortality
timeFrame: 6 and 12 months
measure: Non-accidental hospital admission with an overnight stay in any health facility
timeFrame: 6 months
measure: Cause specific hospital admissions at the national hospital.
timeFrame: 6 months
Other outcomes:
measure: Adverse events
timeFrame: 2 weeks
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
affiliation: Bandim Health Project
name: Ane Fisker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisker AB, Martins JSD, Jensen AM, Martins C, Aaby P, Thysen SM. Health effects of utilising hospital contacts to provide measles vaccination to children 9-59 months-a randomised controlled trial in Guinea-Bissau. Trials. 2022 Apr 23;23(1):349. doi: 10.1186/s13063-022-06291-z.