louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03698214: Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury
Official title: Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: systolic blood pressure
reversed shock index
traumatic brain injury
mortality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 1216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. We excluded patients younger than 18 or older than 65 years of age. Patients were grouped and analyzed according to RSI (\< 1 or ≥ 1).

Brief summary: A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor condition in trauma patients. In such scenarios, the reversed shock index (RSI) is \<1, as calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be used to identify high-risk adult patients with isolated traumatic brain injury (TBI).


Eligibility criteria: Inclusion Criteria:

* Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included

Exclusion Criteria:

* Patients with incomplete registered data were also excluded

Primary outcomes:
measure: in-hospital mortality
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02793414: Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malaria
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any participant above the age of 5 years fulfilling the inclusion criteria and attending the study hospital is eligible to participate in the study.

Brief summary: This is a diagnostic efficacy study to evaluate a set of biomarkers in human breath indicative of an acute malaria infection. The investigators plan to enroll 75 malaria patients and 175 febrile non-malaria patients in Ethiopia.

Upon enrollment, blood for malaria RDT, microscopy and PCR will be collected as well as a breath sample to assess the presence of biomarkers at a reference center. Malaria patients identified by microscopy are revisited at day 2 and 7 to collect a further samples. G6PD testing will be performed concurrently to identify prevalent G6PD variants.


Eligibility criteria: Malaria cohort

* Age ≥5 years of age
* Malaria microscopy and / or Malaria RDT confirmed malaria infection
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Written informed consent Febrile controls
* Age ≥5 years of age
* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Absence of a malaria episode confirmed by malaria microscopy
* Written informed consent

Primary outcomes:
measure: Performance of the VOC breathalyser
timeFrame: 7 days
Secondary outcomes:
measure: Correlation of malaria parasite density with VOC concentrations
timeFrame: 7 days
measure: G6PD variants
timeFrame: 1 day
measure: G6PD activity in U/gHb
timeFrame: 1 day
measure: Performance characteristics of qualitative and quantitative G6PD test formats.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03031314: Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Keywords: Joint Replacement
Knee Replacement
Wound Healing
Hip Replacement
Lead sponsor: Washington Hospital Healthcare System
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.

The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.

Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).

Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.


Eligibility criteria: Inclusion Criteria:

* primary joint replacement

Exclusion Criteria:

* no prior joint surgery
* no infection

Primary outcomes:
measure: Number of soft tissue infections
timeFrame: 12 weeks
measure: use of antibiotics to treat infection, recorded by number
timeFrame: 12 weeks
measure: measurement of incision drainage, measured in grams and mm surface area
timeFrame: 2 weeks
measure: assessment of quality of incision closure, recorded by time and number
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06174714: Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders
Official title: Effectiveness of Indo-SURFT in Reducing Addictive Substance Use in Women With Substance Use Disorders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Relapse in women was associated with depression, interpersonal stress, and relationship conflict with others when compared with men. The differences in gender profiles with substance use disorders (SUD) leads to the need for management strategies that are sensitive to each gender. This is a challenge to build a new module that can be applied continuously by collaborating CBT and several other psychosocial interventions, such as motivational enhancement therapy. The investigators compiled Indonesia Substance Use Reduction for Female Therapy (Indo-SURFT). By implementing this module, it is hoped that it can provide short and long term effects and reduce the relapse rate in women with SUD.


Eligibility criteria: Inclusion Criteria:

* women aged 18-59 years old
* diagnosed with substance use disorders based on DSM-V or ICD-10

Exclusion Criteria:

* subjects with severe mental disorder or intellectual disability

Primary outcomes:
measure: Abstinence from Substance Use
timeFrame: post-intervention (week 13)
measure: Decrease in Addiction Severity
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
measure: Improvement in Motivation to Change
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
measure: Improvement in Substance Craving
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
Secondary outcomes:
measure: Improvement in Psychological Distress
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
measure: Improvement in Social Performance
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
measure: Improvement in Quality of Life
timeFrame: pre-intervention (week 0), and post-intervention (week 13)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06381414: Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion
Official title: Childhood Early Oral Aging Syndrome: Prevalence, Associated Etiological Factors, and Consequences on Vertical Dimension of Occlusion (VDO): A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 183
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic

Brief summary: The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05.


Eligibility criteria: Inclusion Criteria:

* Children from three to six years of age with complete deciduous teeth;
* Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic

Exclusion Criteria:

* Children with amelogenesis or dentinogenesis imperfecta
* Children undergoing orthodontic treatment
* Children with a genetic syndrome

Primary outcomes:
measure: Assessment of Tooth Wear and Dental Management
timeFrame: Baseline
measure: Presence of Enamel Defects
timeFrame: Baseline
measure: Vertical Dimension of Occlusion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
state: SP
Study officials:
References:
Clinical trial NCT01648114: A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
Official title: A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Pregnancy
Keywords: breastfeeding
pregnancy
antenatal
exclusive breastfeeding
education
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 472
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.

Detailed description: The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding.

Eligibility criteria: Inclusion Criteria:

1. singleton pregnancy,
2. primiparous
3. 18 years of age or older,
4. at least 36 weeks of gestation,
5. Cantonese speaking,
6. Hong Kong resident,
7. no serious medical or obstetrical complications,
8. staying in Hong Kong for at least 6 months after delivery, and
9. intention to breastfeed.

Exclusion Criteria:

Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).

Primary outcomes:
measure: Exclusive Breastfeeding Rate
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Median Duration of Breastfeeding
timeFrame: 6 months postpartum
measure: Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum
timeFrame: 6 Months Postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tsan Yuk Hospital
Study officials:
affiliation: The University of Hong Kong
name: Marie Tarrant, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong KL, Tak Fong DY, Yin Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-968. doi: 10.1097/AOG.0000000000000481.
Clinical trial NCT01385514: Staphylococcus Aureus Skin and Soft Tissue Infections
Official title: Evaluating Strategies to Prevent Staphylococcus Aureus Skin and Soft Tissue Infections in Soldiers During Infantry Training
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 1050
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the population of the study will be selected from infantry training bases in the IDF

Brief summary: The purpose of this study is to evaluate strategies to prevent Staphylococcus aureus skin and soft tissue infections in soldiers during infantry training.

This study will be conducted on three different bases among groups of male recruits to IDF training base. They will provide nasal swabs to detect Staphylococcus aureus carriage in two time points: 1. before mixing and training in confined settings, reflecting carriage acquired before entering 2. After 14-30 days. All soldiers will be under surveillance for skin infection until the end of the training program.


Eligibility criteria: Inclusion Criteria:

* new recruit for a combat training unit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel aviv
country: Israel
facility: Israeli Defense Forces
Study officials:
affiliation: International Diabetes Federation
name: Michael Hartal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03391414: Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Official title: Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: thick mucus
obstructive lung disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2018-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Detailed description: This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Eligibility criteria: Inclusion Criteria:

1. FEV1 greater than 50% predicted.
2. Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
3. Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.

Exclusion Criteria:

1. Reactive airway disease
2. Use of inhaled hypertonic saline in the past 28 days
3. Use of IV antibiotics in the past 4 weeks
4. Changes in CF-related medications in the four weeks prior to study screening
5. SpO2 \< 94% on room air or use of supplemental oxygen.
6. Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux symptoms in cases of treated GERD more than three times per week.
7. Pregnant or nursing females.

Primary outcomes:
measure: Exhaled breath condensate pH change
timeFrame: two time points (baseline and four (4) hours)
Secondary outcomes:
measure: Expectorated sputum change
timeFrame: two time points (Baseline and four (4) hours)
measure: Spirometry
timeFrame: two time points (baseline and four (4) hours)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Fallk Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Joseph M PIlewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411214: Decisional Process in Male Fertility Preservation
Official title: Fertility Preservation in the Male Pediatric Population: a Patient and Parent Perspective of Factors Influencing the Decisional Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Quality of Life
Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 348
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013 and their parents

Brief summary: The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on

1. patient and parent feelings about fertility preservation counselling
2. influence of the emotional state of patients and parents on fertility preservation acceptance
3. support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations

Detailed description: Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.

Three different questionnaires, for children (\<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.

Eligibility criteria: Inclusion Criteria:

* prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013

Exclusion Criteria:

* none

Primary outcomes:
measure: factors improving the decision-making process for fertility preservation
timeFrame: less than 1 year
Secondary outcomes:
measure: patient and parent feelings about fertility counseling
timeFrame: less than 1 year
measure: influence of the emotional state of parents and patients on fertility preservation acceptance
timeFrame: less than 1 year
measure: support of medical staff and family
timeFrame: less than 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Wyns C, Collienne C, Shenfield F, Robert A, Laurent P, Roegiers L, Brichard B. Fertility preservation in the male pediatric population: factors influencing the decision of parents and children. Hum Reprod. 2015 Sep;30(9):2022-30. doi: 10.1093/humrep/dev161. Epub 2015 Jul 3.
Clinical trial NCT02315014: Daily Protein Intake Distribution and MPS (ARCIII)
Official title: Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 20
Sex: MALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis


Eligibility criteria: Inclusion Criteria:

* Overweight/obese (BMI 27-40 kg/m2)
* Non-smokers
* Non-diabetic
* No history of hyperlipidemia
* Not taking medications thought to interfere with study
* Considered generally healthy

Exclusion Criteria:

* Efforts to lose weight in previous 16 weeks
* Hyperlipidemia
* Blood pressure ≥ 140/90 mmHg
* Smoking
* Heart and other organ disease
* Type 2 diabetes
* Gastrointestinal disease
* Orthopedic injury interfering with exercise
* Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Primary outcomes:
measure: muscle protein synthesis
timeFrame: up to 4 weeks
Secondary outcomes:
measure: body composition is evaluated using DEXA
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Stuart Phillips, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: