louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04467008: Covid-19 Rapid Diagnostic Tests on Blood Drop
Official title: Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid 19
Diagnostic
Biosynex
Blood drop
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed COVID-19 pneumonia (using RT-PCR) who required hospitalization in intensive care unit.

Brief summary: This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

Detailed description: The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.

Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).

As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 diagnosis with at least one positive RT-PCR

Exclusion Criteria:

* None

Primary outcomes:
measure: Positivity of the rapid diagnostic test
timeFrame: Immediate, up to 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
Study officials:
affiliation: CMC Ambroise Paré
name: Lee Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897308: Best Treatment Modality of Frozen Shoulder
Official title: Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Adhesive Capsulitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .


Eligibility criteria: Inclusion Criteria:

* gross limitation of passive shoulder movement
* pain interfering with daily activities
* painful restiction of active and passive movement of shoulder

Exclusion Criteria:

* presence of degenerative pathology
* fracture
* contraindication to steroid injection
* deformity affecting upper limb
* history of previous shoulder injection in the past 4 weeks

Primary outcomes:
measure: Improvement in range of motion of shoulder joint
timeFrame: 12 weeks efter intervention
measure: Improvement in pain
timeFrame: 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty
Study officials:
References:
Clinical trial NCT04182308: Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult
Official title: Anatomic Characteristics of Lisfranc Ligament in Vietnamese Adult
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lisfranc Injury
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam

Brief summary: Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament

Detailed description: Goal: the aim of this study is to determine the anatomic characteristic of lisfranc ligament, including components, thickness, height, and width, origins as well as relationship of center point of origin with neighbor structures in Vietnamese adults

Eligibility criteria: Inclusion Criteria:

* above ankle amputation samples at Cho Ray hospital, HCM city, Vietnam

Exclusion Criteria:

* foot injuries
* foot infection

Primary outcomes:
measure: Some anatomic characteristic of lisfranc ligament
timeFrame: 2 years
Secondary outcomes:
measure: relative position with neighbor structures
timeFrame: 2 years
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray hospital
state: Ho Chi Minh
Study officials:
affiliation: Cho Ray Hospital
name: Hung P Do, professor
role: STUDY_DIRECTOR
References:
citation: Johnson A, Hill K, Ward J, Ficke J. Anatomy of the lisfranc ligament. Foot Ankle Spec. 2008 Feb;1(1):19-23. doi: 10.1177/1938640007312300..
Clinical trial NCT03683108: Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
Official title: Efficacy and Safety of a New Medical Device Based on Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention:

A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group, receiving saline solution.

Each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.

Detailed description: Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days).

Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days.

Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.

Eligibility criteria: Inclusion Criteria:

* common cold syndrome

Exclusion Criteria:

* main comorbidities

Primary outcomes:
measure: Canadian Acute Respiratory Illness and Flu Scale (CARIFS)
timeFrame: enrollment, after 48 hours and after 7 and 30 days
Secondary outcomes:
measure: Detection of Rinovirus in the nasal secretions
timeFrame: after 48 hours and 7 days
measure: 30-day relapses
timeFrame: 30-day after treatment
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Study officials:
References:
Clinical trial NCT06566508: Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
Official title: Effectiveness of Asiaticoside as Intracanal Medication on Infectious/Inflammatory Contents in Teeth With Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Intracanal Medication
Keywords: Inflammation
Asiaticoside
Pulpal necrosis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate \&#34;clinically\&#34; the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Detailed description: This study investigate \&#34;clinically\&#34; the effectiveness of Asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Eligibility criteria: Inclusion Criteria:

• Single-rooted with pulp necrosis and apical periodontitis.

Exclusion Criteria:

Receiving antibiotic treatment within the preceding 3 months.

* Reporting systemic disease.
* Teeth that could not be isolated with rubber dam.
* Teeth with periodontal pockets deeper than 3 mm.

Primary outcomes:
measure: counting the number of colonies forming units of bacterial cells Microbiology cell culturing (manual counting technique to the bacterial cells) [Time Frame: up to 7 months]
timeFrame: up to 7 months
Secondary outcomes:
measure: using enzyme-linked immunosorbent assay (ELISA test) to measure the amount of Inflammatory Cytokines (TNF-α), (IL-1β) and (PG2) ELISA test to measure the amount of tumor necrotizing factor (TNF-α), interleukin 1β(IL-1β) and prostaglandin E2 (PG2)
timeFrame: up to 25 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Faculty of Dentistry Mansoura University
name: Amany Bader, prof
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry Mansoura University
name: Youssry Elhawary, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01289808: Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
Official title: Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant
Newborn Diseases
Keywords: Glucose
analgesic
newborns
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2011-02-04
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Detailed description: Pain in the newborn and young infant is a source of stress for the infant, family and care providers.

During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.

Pain experienced during the neonatal period is known to have long term effects on the baby.

The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant.

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Eligibility criteria: Inclusion Criteria:

* Full term above 37 weeks gestation.
* Normal birth-weight, healthy infants
* Males and Females
* Whose parents have signed the informed consent form

Exclusion Criteria:

* Premature born below 37 weeks
* Chromosomal abnormalities or congenital malformation.
* Suffering neurological imbalance
* Inability of oral feeding

Primary outcomes:
measure: Reduced infant response to a routine care procedure after glucose 25% analgesia
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Neonatal Department, The Baruch Padeh Medical center - Poria
name: Shay Barak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795208: Lung Recruitment Improves Right Ventricle Performance
Official title: Lung Recruitment Improves Right Ventricle Performance After Cardio-Pulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lead sponsor: Hospital Privado de Cordoba, Argentina
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
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 test whether a lung recruitment maneuver improves the right ventricle performance after cardiopulmonary bypass. Half of the patients received an standard protective ventilation and the other half the same ventilatory pattern after a lung recruitment maneuver.

Detailed description: Atelectasis is developed in 90% of anesthetized patients after surgery.

Protective ventilation with low tidal volumes and positive-end expiratory pressure (PEEP) promotes atelectasis with the potential right ventricle dysfunction induced by the increment in afterload (activation of the pulmonary hypoxic vasocontriction reflex).

Lung recruitment can improve the right ventricle performance caused by atelectasis because the pulmonary hypoxic vasocontriction reflex desapear in a normal aerated lungs.

Eligibility criteria: Inclusion Criteria:

* cardiovascular surgery with cardiopulmonary bypass.
* Patients with a New York Heart Association (NYHA) class I-II,
* Pre-operative left ventricular ejection fraction ≥ 50 %.
* Euroscore ≤ 6.

Exclusion Criteria:

* TEE contraindications.
* Hemodynamically unstable
* Needi for inotropic support

Primary outcomes:
measure: Right ventricle assessment by transesophageal echocardiography
timeFrame: intraoperative
Secondary outcomes:
measure: Atelectasis assessment by transesophageal echocardiography
timeFrame: intraoperative
measure: PaO2 and respiratory compliance
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Privado de Córdoba
name: Silvina Longo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339208: TREAT (Telemedicine for Reach, Education, Access, and Treatment)
Official title: TREAT (Telemedicine for Reach, Education, Access, and Treatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-04-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.

Detailed description: This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia

Eligibility criteria: Inclusion Criteria:

* Age 18 or older with type 2 diabetes
* Referral by a primary care provider.
* HbA1c equal or greater than 7.0%.

Exclusion Criteria:

* Type 1 diabetes
* Gestational Diabetes

Primary outcomes:
measure: Change in HbA1c % from baseline
timeFrame: 3 and 6 month
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 month
Other outcomes:
Locations:
city: Seneca
country: United States
facility: UPMC Northwest
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Frederico Toledo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toledo FG, Ruppert K, Huber KA, Siminerio LM. Efficacy of the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model for diabetes care. Diabetes Care. 2014 Aug;37(8):e179-80. doi: 10.2337/dc13-1909. No abstract available.
Clinical trial NCT05838508: Effect of Physical Activity Pattern on Cardiometabolic Health
Official title: Effect of Physical Activity Pattern on Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Life Style
Keywords: exercise
circadian system
physical activity
glucose tolerance
blood pressure
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to understand the interaction between the circadian system and physical activity.

Participants will:

* complete 2 inpatient stays
* perform moderate exercise
* be provided with identical meals
* have frequent blood draws
* provide urine and saliva samples

Detailed description: The endogenous circadian system (i.e., an internal biological rhythm) plays an important role in regulating blood glucose, blood pressure, and energy expenditure. Physical activity improves health and reduces the risk for cardiovascular diseases and type 2 diabetes. The goal of this study is to understand the interaction between the circadian system and physical activity. We aim to test whether such relationship between the circadian system and physical activity can be used to enhance the health benefits of physical activity.

Eligibility criteria: Inclusion Criteria:

* 18-45 yr old
* Body mass index (BMI) 18.5 - 34.9 kg/m2
* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
* Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

* Currently smoking/vaping or 5 or more years of smoking/vaping
* Currently pregnant or breastfeeding
* History of drug or alcohol dependency
* History of psychiatric illness or disorder
* Any hospitalization due to COVID-19
* Inability to exercise for any reason
* Any known contraindication to exercise testing based on current ACSM guidelines

Primary outcomes:
measure: glucose level
timeFrame: 24-hour test period after exercise
measure: mean arterial pressure
timeFrame: 24-hour test period after exercise
Secondary outcomes:
measure: insulin sensitivity index
timeFrame: about 12 and 24 hours after exercise
measure: beta-cell function index
timeFrame: about 12 and 24 hours after exercise
measure: total peripheral resistance
timeFrame: 24-hour test period after exercise
measure: autonomic nervous system activity
timeFrame: 24-hour test period after exercise
Other outcomes:
measure: resting energy expenditure
timeFrame: 24-hour test period after exercise
measure: respiratory exchange ratio
timeFrame: 24-hour test period after exercise
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jingyi Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06527508: Construct Validity and Intra-Observer Reliability of the SDQ
Official title: Construct Validity and Intra-Observer Reliability of the Self-Report Version of Strengths and Difficulties Questionnaire in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
Strength and Difficulties Questionnaire
validity
reliability
Lead sponsor: Bingol University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 120
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included children aged 11-17 years who were diagnosed with CP by health science boards at the government or education and research hospitals.

Brief summary: The aim of the observational study is to investigate the validity and reliability of a self-report version of the Strength and Difficulties Questionnaire (SDQ) for 11-17 years in children with cerebral palsy (CP). That is, the current study explore if the self-report version of the SDQ would be valid and reliable in children with CP to report their mental health problems themself


Eligibility criteria: Inclusion Criteria:

* A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability

Exclusion Criteria:

* the presence of an inability to comprehend items on the SDQ and involuntary attendance of a possible re-test after two weeks (i.e., for re-test reliability)

Primary outcomes:
measure: Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week
timeFrame: Baseline and Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Bingöl
country: Turkey
facility: Bingöl University
Study officials:
References:
citation: Downs J, Blackmore AM, Epstein A, Skoss R, Langdon K, Jacoby P, Whitehouse AJO, Leonard H, Rowe PW, Glasson EJ; Cerebral Palsy Mental Health Group. The prevalence of mental health disorders and symptoms in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018 Jan;60(1):30-38. doi: 10.1111/dmcn.13555. Epub 2017 Sep 15.
citation: Anthoine E, Moret L, Regnault A, Sebille V, Hardouin JB. Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures. Health Qual Life Outcomes. 2014 Dec 9;12:176. doi: 10.1186/s12955-014-0176-2.