louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03377062: CVA in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
Official title: Cerebrovascular Accident (CVA) in Patients Suffering From Decreased Consciousness, Confusion or Headaches to an Emergency Room
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CVA
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 120
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: Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness

Brief summary: A CVA occurs when there is a sudden interruption of blood supply to the brain. Fast identification of CVA is crucial in order to refer the patient to an appropriate medical center as well as to direct him/her to a suitable treatment upon arrival to the Medical Center, in order to minimize the permanent damage to the brain. In this study, we are evaluating a tool for detecting CVA based on EEG (electroencephalograph) data analysis using innovative algorithm. The system is comprised of four electrodes, reference electrode and earphones for auditory stimulation. In the study, 120 patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness will be monitored for five-minute each, with EEG accompanied with auditory stimulation. The EEG analysis will be performed based on the synchronization of the front and back hemispheres. During CVA, specific hemisphere is damaged, therefore desynchronization is expected. The purpose of this study is to develop a tool for identifying CVA in patients who have no clear CVA related signs.


Eligibility criteria: Inclusion Criteria:

Patients arriving to the emergency room with decreased consciousness, severe headaches or dizziness

Exclusion Criteria:

Pregnant women

Primary outcomes:
measure: Desynchronization Index
timeFrame: 1 day
Secondary outcomes:
measure: EEG variablity
timeFrame: 1 day
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References:
Clinical trial NCT03313362: Detecting PNES With Single-channel sEMG
Official title: Detecting PNES With Single-channel sEMG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy, Motor Partial
Psychogenic Seizures
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 71
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.


Eligibility criteria: Inclusion Criteria:

1. Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or Female between the ages 22 to 99.
4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

* Intracranial EEG electrodes are being used.

Primary outcomes:
measure: Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
timeFrame: 1 year
Secondary outcomes:
measure: To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North Carolina
name: Aatif Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, Virginia
name: Alan Towne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas
name: David Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02866162: Screening for Genes in Patients With Congenital Neutropenia
Official title: Identification of the Molecular Bases of Syndromic Congenital Neutropenia With Development Anomalies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Neutropenia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with syndromic congenital neutropenia with development anomalies

Brief summary: Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. Most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. A large number of genes still have to be identified in these syndromic forms.

The aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.


Eligibility criteria: Inclusion Criteria:

* Persons who have provided written consent
* Patients with congenital neutropenia and mental retardation and/or a development anomaly (malformation, facial dysmorphism)
* Patients who accept a clinical evaluation, and to give at least one blood sample
* Screening for chromosomal microrearrangements by normal array-CGH

Exclusion Criteria:

* Persons without national health insurance cover
* Patients who do not meet the clinical and/or biological criteria
* Refusal to give written consent to take part in the study
* Refusal to give a blood sample
* Blood samples from parents not available

Primary outcomes:
measure: Identification of a gene or genes responsible for congenital neutropenia syndromic
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05533762: The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
Official title: The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flatfoot, Flexible
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.

Detailed description: Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.

Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.

In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

Eligibility criteria: Inclusion Criteria:

* Children presenting symptomatic flexible flatfoot only

Exclusion Criteria:

* Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.

Primary outcomes:
measure: Change in Functional Reach Test(FRT) from pre to post-intervention.
timeFrame: up to 10 minutes
measure: Pediatric Berg Balance Scale
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Change in Center of pressure (CoP) from pre to post-intervention.
timeFrame: up to 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Wang Fang Hospital, Taipei Medical University
name: YenTing LIU, Master
role: STUDY_CHAIR
References:
Clinical trial NCT04851262: Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
Official title: Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of the proposed project is to improve muscle strength in older adults with possible sarcopenia by promoting home-based progressive resistance exercise. The target population for health talks is community-dwelling older adults. A Three monthly home-visits and weekly phone calls will be made. A waitlist randomised controlled trial will be conducted to evaluate effectiveness, and qualitative feedback will be collected from participants. A pilot study will be conducted first.


Eligibility criteria: The inclusion criteria are:

* Aged 65-89;
* Possible sarcopenia (defined by AWGS 2019);
* No cognitive impairment (Abbreviated Mental Test score ≥8); and
* No communication problems.

The exclusion criteria are:

* having engaged in a structured exercise programme in the past 6 months or planning to do so within the intervention period;
* mobility-limiting injury of the hands or lower limbs, surgery or hospitalisation within the intervention period;
* contraindications such as musculoskeletal/cardiorespiratory disorders, or any advanced diseases that inhibit them from exercising.

Primary outcomes:
measure: Change in lower-limb muscle strength at 12 weeks from baseline
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: Change in lower-limb muscle strength at 24 weeks from baseline
timeFrame: 24 weeks after baseline
Other outcomes:
measure: Change in handgrip strength at 12 weeks from baseline
timeFrame: 12 weeks after baseline
measure: Change in handgrip strength at 24 weeks from baseline
timeFrame: 24 weeks after baseline
measure: Status of possible sarcopenia at 12 weeks from baseline
timeFrame: 12 weeks after baseline
measure: Status of possible sarcopenia at 24 weeks from baseline
timeFrame: 24 weeks after baseline
measure: Sarcopenia risk score at 12 weeks from baseline
timeFrame: 12 weeks after baseline
measure: Sarcopenia risk score at 24weeks from baseline
timeFrame: 24 weeks after baseline
Locations:
city: Hong Kong
country: Hong Kong
facility: Community
Study officials:
References:
Clinical trial NCT06629662: Robotic Versus Laparoscopic Sleeve Gastrectomy
Official title: Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Robotic Surgery
Keywords: Robotic surgery
Sleeve Gastrectomy
Bariatric surgery
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
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: Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.

Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.


Eligibility criteria: Inclusion Criteria:

* According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines

Exclusion Criteria:

* Previous bariatric or abdominal surgery

Primary outcomes:
measure: Operative time
timeFrame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Secondary outcomes:
measure: Intraoperative bleeding
timeFrame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
measure: Postoperative bleeding
timeFrame: From the end of the procedure to postoperative day 30
measure: Conversion to Laparoscopy
timeFrame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
measure: Conversion to Laparotomy
timeFrame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
measure: Postoperative Leak
timeFrame: From the end of the procedure to postoperative day 30
measure: Postoperative Bowel Obstruction
timeFrame: From the end of the procedure to postoperative day 30
measure: Postoperative nausea
timeFrame: From the end of the procedure to postoperative hour 24
measure: Postoperative vomit
timeFrame: From the end of the procedure to postoperative hour 24
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT02335762: Dietary Conjugated Linoleic Acid (CLA) Intake Among Students in Italy
Official title: Dietary Intake of Conjugated Linoleic Acid in a Cohort of Healthy Students in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CLA Intake From Different Food Sources
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 healthy students

Brief summary: 40 healthy subjects were recruited using advertisements posted at the Catholic University of Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a Gima scale) of each subject were measured and the body mass index (BMI) was calculated (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all food and drink consumed daily for 3 days using a diary previously used in the Italian National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate as best their habits. They were educated to report also the place, time, number and quantity of serving portions consumed. If they were not able to weight exactly each portion, a photographic atlas developed for the Italian component of the European Prospective Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days the food diaries were checked and for each subject the energy intake was estimated.


Eligibility criteria: Inclusion Criteria:

* self-reported healthy
* not suffering disorders of lipid metabolism and from eating disorders.

Exclusion Criteria:

* pregnant or breast-feeding,
* subjects consuming an energy-restricted diet
* vegan or vegetarians.

Primary outcomes:
measure: CLA intake (food questionnaire crossed with data on CLA amount in foods)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00445562: Blood Sample Collection and Health Information Collection From Patients With Invasive Breast Cancer and Their Brothers and Sisters
Official title: Breast Cancer Siblings Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: male breast cancer
recurrent breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-03-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: RATIONALE: Collecting blood samples and health information from patients with invasive breast cancer and from their brothers and sisters over time may help the study of cancer in the future.

PURPOSE: This study is collecting blood samples and health information over time from patients with invasive breast cancer and from their brothers and sisters.

Detailed description: OBJECTIVES:

* Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.

OUTLINE: Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.

Patients and their siblings are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 1,000 patients and siblings will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Pathologically confirmed invasive breast cancer (patient)

    * No ductal carcinoma in situ
  * Affected OR unaffected sibling

    * Affected sibling must have had (or currently has) breast cancer only
    * Unaffected sibling must be female
    * No deceased siblings
    * Must be a full-blood related sibling
* Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Collection of blood samples and medical and background information
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: GenBasix Incorporated
state: California
Study officials:
affiliation: GenBasix Incorporated
name: Richard A. Shapiro, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00406562: Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.
Official title: Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Acellular Pertussis
Keywords: uncontrolled
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.


Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 6-8 years of age at the time of vaccination,
* Written informed consent obtained from the parent or guardian of the subject,
* Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,

Exclusion Criteria:

* subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate
* Subjects with history of diphtheria, pertussis or tetanus diseases can not participate

Primary outcomes:
measure: Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Suining
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.