louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00437567: Prebiotics in the Prevention of Necrotizing Enterocolitis
Official title: Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Necrotizing Enterocolitis
Keywords: galacto-oligosaccharides
prebiotics
NEC
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 260
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of \<1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

Detailed description: Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls.

Preterm neonates, \<1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Preterm neonates
* \< 1750 gm birth weight

Exclusion Criteria:

* Infants who are deemed unlikely to survive
* Infants with significant congenital malformations
* Infants with other gastrointestinal problems

Primary outcomes:
measure: Incidence of Necrotizing Enterocolitis
timeFrame: yearly
Secondary outcomes:
measure: fecal calprotectin, urine IFABP
timeFrame: end of study
measure: NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement]
timeFrame: yearly
measure: Stool bifidobacteria
timeFrame: End of study
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. doi: 10.1016/j.jpeds.2005.03.054.
Clinical trial NCT04760067: Comparison of Sport Injury Anxiety of Athletes Doing Sports on Different Surfaces
Official title: Comparison of Sport Injury Anxiety of Athletes Doing Sports on Different Surfaces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Injuries
Keywords: Sports injuries
Anxiety
Surface
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy athletes with a history of injury

Brief summary: Due to its nature, sports are an activity in which injuries are common. Sports injuries have athletic and environmental reasons. In sports injuries, although the medical team is generally interested in the physiological aspect of the injury, in recent years, the psychological aspect of the injury has also started to be taken care of. One of these psychological aspects is anxiety. Athletes who develop sports injury anxiety are more prone to injury. One of the environmental reasons is the ground for sports. We could not find a study in the literature comparing the anxiety levels of those who do sports on different grounds in different sports branches. Our study will provide support to the literature in this direction.

Detailed description: The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer athletes between the ages of 18-35 without any known health problems will be included in the study after obtaining their informed consent.

150 athletes competing on turf, artificial turf and wooden parquet will be included in our study.

The data of our study will be collected by Google survey. After obtaining the demographic information of the athletes participating in our study, the data on injury anxiety will be collected with the Sports Injury Anxiety Scale.

Eligibility criteria: Inclusion Criteria:

* To be a healthy, previous injury athlete

Exclusion Criteria:

* Have an ongoing injury

Primary outcomes:
measure: Sports Injury Anxiety
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: KTO Karatay Üniversitesi
name: Hasan GERÇEK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04974567: Tear Based Sample Collection Breast Cancer Detection
Official title: Tear Based Sample Collection for Breast Cancer Detection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Tear
Breast Cancer Female
Keywords: preventative screening
protein biomarkers
lacrimal tear fluid
mammography
ELISA assay
CLIA laboratory
lab developed test
high complexity
tear collection
mammogram
improved patient outcomes
reduce gap in access
health equity
total cost of care
trust from patient
increased compliance
affordable
low cost
non-invasive
women's health and wellness
breast health
breast cancer screening test
Lead sponsor: Namida Lab
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Medical Branch, Galveston
First posted: 2021-07-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Tear Based Breast Cancer Detection study participants are all women, born biologically female, with a recent diagnosis of breast cancer, have not started treatment, and are between the ages of 18 to 100 years old.

Brief summary: This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

Detailed description: Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.

Eligibility criteria: Inclusion Criteria:

* Individual is an adult woman and has recently been diagnosed with breast cancer.

Exclusion Criteria:

* Individual is excluded if they have already started treatment for the breast cancer diagnosis.
* Age less than 18 or more than 100 years.

Primary outcomes:
measure: Number of participant tear samples collected.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: UTMB Health
state: Texas
Study officials:
affiliation: UTMB Health
name: Suzanne Klimberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745440: Belgian Infective Endocarditis Registry
Official title: Belgian Infective Endocarditis Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infective Endocarditis
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 300
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: Infective endocarditis

Brief summary: The objective of this prospective observational registry is to study patients di-agnosed with infective endocarditis (IE) and to gather comprehensive long-term outcome data, including mortality rates and IE-related complications (e.g., thromboembolic events, (hospitalization for) heart failure, valve surgery and IE recurrence) at one, three-, and five-years post-enrollment. Additionally, the registry will document epidemiological characteristics, clinical presentation at baseline, biochemical and microbiological profiles, relevant comorbidities and risk factors, diagnostic strategies, and therapeutic interventions, including an-timicrobial therapy and surgical procedures.


Eligibility criteria: \> 18 yo

Primary outcomes:
measure: Mortality
timeFrame: 5-years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05934240: The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy Young Individuals
Official title: The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Young Individuals
Keywords: Manual therapy
Respiratory function test
Physical activity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. The potential positive effects of thoracic manipulation on respiratory system diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been investigated and continue to be studied. Specifically, the results of studies investigating the physiological outcomes of this therapeutic approach in healthy adults are conflicting. The aim of this study is to investigate the short-term effects of thoracic manipulation and mobilization, as well as diaphragm mobilization, through a single session of manual therapy interventions on respiratory functions.

Detailed description: In this planned study, designed as a randomized controlled intervention trial, two groups will be formed: an experimental group and a control group. After completing these procedures, the intervention group will receive the method of "thoracic mobilization and manipulation with diaphragm mobilization," while the control group will receive a placebo thoracic mobilization method. All techniques will be applied by a physiotherapist.

Within 5 minutes after the completion of the intervention, a respiratory function test will be repeated, resulting in a total of two respiratory function tests: one before the intervention and one after the intervention. The changes in respiratory function criteria before and after the intervention will be compared in both groups

Eligibility criteria: Inclusion Criteria:

* be between the ages of 18-25,
* to be a studen

Exclusion Criteria:

* those who have any health problems
* those with orthopedic disorders
* those with systemic and cardiopulmonary diseases that would interfere with the evaluation

Primary outcomes:
measure: Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)
timeFrame: Change from before and 5 minutes after application
measure: Pulmonary Functions Test-FVC (Forced vital capacity)
timeFrame: Change from before and 5 minutes after application
measure: Pulmonary Functions Test- FEV1/FVC
timeFrame: Change from before and 5 minutes after application
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02395640: The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
Official title: The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer: An Open-label, Multi-center, Prospective and Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-03-23
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Detailed description: This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Eligibility criteria: Major inclusion criteria

* had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
* measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1
* an Eastern Cooperative Oncology Group performance status of 0 to 2
* adequate renal, hepatic, and hematologic function

Major exclusion criteria

* previous chemotherapy or radiotherapy (unless in the adjuvant setting)
* uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer
* accumulated dose of Epirubicin exceeds 300mg/m2
* HER2 positive and willing to use trastuzumab

Primary outcomes:
measure: progression free survival
timeFrame: 7 months
Secondary outcomes:
measure: overall survival
timeFrame: 10 months
measure: overall response rate
timeFrame: 2 months
measure: Number of Participants with Adverse Events
timeFrame: 2 months
measure: quality of life questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
References:
citation: Zhu XD, Huang MZ, Wang YS, Feng WJ, Chen ZY, He YF, Zhang XW, Liu X, Wang CC, Zhang W, Ying JE, Wu J, Yang L, Qin YR, Luo JF, Zhao XY, Li WH, Zhang Z, Qiu LX, Geng QR, Zou JL, Zhang JY, Zheng H, Song XF, Wu SS, Zhang CY, Gong Z, Liu QQ, Wang XF, Xu Q, Wang Q, Ji JM, Zhao J, Guo WJ. XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer: An open-labeled, multicenter, randomized, prospective phase III trial (EXELOX). Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.
Clinical trial NCT05644340: Feasibility and Safety Properties of Metabolic Flow Anesthesia Driven by Automated Gas Control in Pediatric Patients
Official title: Feasibility and Safety Properties of Metabolic Flow Anesthesia Driven by Automated Gas Control in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: pediatric anesthesia
metabolic flow anesthesia
low flow anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 130
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Low flow anesthesia was considered to be causing rebreathing, hypoxia and hypercarbia in the past. However, developing technologies made anesthesia ventilators safer. Low flow anesthesia is proved to be safe and cost-effective for almost a decade, and newer anesthetic machines with automated gas flow and metabolic flow anesthesia (\<0.3 L/min gas flow) features are now becoming prominent.

The literature still lacks of pediatric data regarding the cost analysis and safety profile of low flow and especially in metabolic flow anesthesia. In this study, it is aimed to observe inhaled agent expenditure of automated gas flow anesthesia which reaches metabolic flow limits in pediatric patients. For that, automated gas flow will be set to provide a desired end-tidal sevoflurane concentration during general anesthesia. Accordingly, inspired fraction of oxygen and air values will be recorded in 15-minute intervals. Primary outcome will be the inhaled agent (sevoflurane) amount wasted in milliliters for both inhaled agent maintenance speed (8-fast and 4-slow). Secondarily, delta value of set and detected inspired fraction of oxygen (DeltaFiO2=DetectedFiO2-SetFiO2) will be analyzed. DeltaFiO2 higher than 5 units will be accepted as "unsafe" gas mixture, and the incidence will be evaluated. Secondary outcomes will also include duration of emergence from anesthesia including both extubation and obeying verbal commands.


Eligibility criteria: Inclusion Criteria:

* Pediatric surgery patients
* Elective or Semielective surgeries
* Patients suitable for inhalation anesthesia

Exclusion Criteria:

* Emergency surgery
* Patients who are contraindicated for inhalation anesthesia

Primary outcomes:
measure: Total amount of sevoflurane consumed
timeFrame: up to 3 hours
Secondary outcomes:
measure: Time to extubation after inhalation anesthesia stop
timeFrame: Up to 45 minutes
measure: Time to cooperation after inhalation anesthesia stop
timeFrame: Up to 2 hours
measure: Delta Oxygen Concentration
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine
Study officials:
References:
Clinical trial NCT00809640: Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren
Official title: Active Management for Low Back Pain Taught to 6 to 8 Year Old Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
prevention
schoolchildren
education campaign
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.


Eligibility criteria: Inclusion Criteria:

* Students in randomly selected private, public and concerted Majorca schools
* Must be present in class on day of intervention and assessments

Exclusion Criteria:

* Absent from class on day of intervention and assessments

Primary outcomes:
measure: Assessment of the effectiveness of a prevention campaign promoting active management of low back pain in shifting beliefs in 6 to 8 year old schoolchildren.
timeFrame: 4 months
measure: Assessment of the effectiveness of a prevention campaign promoting active management on low back pain in 6 to 8 year old schoolchildren.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation,Palma de Mallorca, Spain
name: Mario Gestoso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04402840: Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Official title: Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
COVID-19
Keywords: Acute Respiratory Distress Syndrome
COVID-19
Autonomic Nervous System
Stellate Ganglion
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 infection.

Detailed description: Primary Aim:

• To determine safety of stellate ganglion block (SGB) in ARDS

Secondary Aim:

* To determine efficacy of SGB in slowing the progression of ARDS

Eligibility criteria: Inclusion Criteria:

* Subjects age 18 to 80
* Subjects with PCR documented diagnosis of COVID-19 ARDS requiring critical care and transfer to intensive care unit
* Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph

Exclusion Criteria:

* Subjects with pre-existing cardiac failure
* Hemodynamic Instability
* Subject on Extracorporeal membrane oxygenation (ECMO)
* Anatomical inability to do a stellate block

Primary outcomes:
measure: Adverse events related to SGB
timeFrame: 3 Months
measure: All Adverse events
timeFrame: 3 Months
measure: Death
timeFrame: 3 Months
Secondary outcomes:
measure: Assessment of respiratory/ pulmonary function
timeFrame: 3 Months
measure: Radiographic criteria
timeFrame: 3 Months
measure: Cardiac function
timeFrame: 3 Months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Rockefeller Neuroscience Institute
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Ali R Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References: