louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00238654: A Study to Evaluate Readiness to Self-inject on Adherence and Compliance to Copaxone® Therapy
Official title: A Multicenter, Open-Label, Two-Arm Prospective Study to Evaluate the Impact of Patient Readiness to Self-Inject on Outcomes When Using the Copaxone® Prefilled Syringes [The "READY" Trial]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RRMS patient with treatment-naïve or treatment-experienced

Brief summary: This study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. In addition, patients will have their self-injection observed and evaluated on up to three visits


Eligibility criteria: Inclusion Criteria:

1. Male or Female, 18 years of age or older, with diagnosis of RRMS
2. Naive to treatment or previously treated with an IFN.

Exclusion Criteria:

1. Not eligible for treatment based on clinical criteria and current indication.
2. Unable to respond to surveys or provide informed consent.

Primary outcomes:
measure: Adherence of self-injection assessed by self-report at each follow-up visit
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: MerriKay Oleen-Burkey, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01270854: Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
Official title: Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Multiple Trauma
Disorder of Fluid Balance
Keywords: Normal saline
Plasmalyte
Intravenous fluid
Traumatic injury
Fluid resuscitation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-01-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline."

Detailed description: Electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. Although Normal Saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. Plasmalyte A is a solution that more closely matches physiologic electrolyte levels. In this study, we will evaluate whether Plasmalyte A results in less disturbance of the base deficit 24 hours following traumatic injury than does Normal Saline.

Eligibility criteria: Inclusion Criteria:

* Triaged upon arrival to the hospital as severely injured
* At least 18 years of age
* Meets at least one of the following criteria:

  1. Intubated or likely to become intubated within 60 minutes of arrival at the hospital
  2. Likely to need an operation within 60 minutes of arrival
  3. Received or likely to receive a blood transfusion within 60 minutes of arrival

Exclusion Criteria:

* Greater than 60 minutes since arrival at the hospital
* Death likely within 48 hours
* Transfer from another hospital
* Pre-existing renal failure requiring dialysis
* Pregnancy
* Prisoner status

Primary outcomes:
measure: Change in the base deficit
timeFrame: 24 hours after randomization
Secondary outcomes:
measure: Mortality
timeFrame: Hospital discharge
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Garth H. Utter, MD
role: STUDY_DIRECTOR
affiliation: University of California, Davis
name: Lynette A. Scherer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young JB, Utter GH, Schermer CR, Galante JM, Phan HH, Yang Y, Anderson BA, Scherer LA. Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial. Ann Surg. 2014 Feb;259(2):255-62. doi: 10.1097/SLA.0b013e318295feba.
Clinical trial NCT06151054: Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age
Official title: Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study and in this context, who had an assessment of arterial stiffness by applanation tonometer

Brief summary: Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Detailed description: In the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . Arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . This study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study
* Patient with an assessment of arterial stiffness by applanation tonometer

Exclusion Criteria:

* patients without an assessment of arterial stiffness by applanation tonometer

Primary outcomes:
measure: to etablish a relationship inflammation of aortic wall and arterial stiffness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Anne-Sophie HUE, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05477654: Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients
Official title: TwinBrain Parkinson's Disease Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Motor Disorders
Cognitive Impairment
Lead sponsor: Science and Research Centre Koper
Sponsor class: OTHER
Collaborators: name: Technische Universität Berlin
name: University of Geneva, Switzerland
name: University of Trieste
name: University Maribor
First posted: 2022-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include healthy age-matched controls and patients with an early diagnosis of Parkinson's disease.

Brief summary: Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the healthy older participants will be:

* no diagnosis of cognitive or movement disorder,
* score \> 7 for the Short Physical Performance Battery (SPPB),
* living independently in the community,
* age range between 55 and 70 years,
* no color blindness.

Inclusion criteria for the early-stage PD patients:

* diagnosed according to the last MDS criteria (2015),
* duration of the disease less than 5 years,
* positive DATSCAN,
* diagnosed akinetic-rigid or mixed phenotype,
* score of 1 or maximally 2 on the Hoehn and Yahr scale (Hoehn \& Yahr, 1967),
* MoCA score ≥ 24 points,
* score \> 7 for the SPPB,
* age range between 50 and 75 years,
* no color blindness
* living independently in the community.

Exclusion Criteria:

* advanced stages of PD (Hoehn and Yahr score \> 2)
* any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression
* MoCA score \< 24 points,
* severe disabling tremor,
* recurrent falls,
* impaired vision that is not corrected with e.g., glasses,
* low SPPB score

Primary outcomes:
measure: dual-task costs while walking
timeFrame: Day 1
measure: dual-task costs while standing
timeFrame: Day 1
measure: dual-task costs while execution of isometric task
timeFrame: Day 1
Secondary outcomes:
measure: The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Koper
country: Slovenia
facility: Science and research centre Koper
Study officials:
References:
Clinical trial NCT00004854: The Safety and Efficacy of Adjunct Carvedilol in Children With Moderate Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Diseases
Keywords: moderate heart failure
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-03-09
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase ejection fraction of the heart under echo. All interpretation of data will be sent to Boston Children's Hospital to be reviewed, which is the primary research center in this study. There are 5 hospitals participating in this study. The population targeted are children with moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome after placing them on Carvedilol is to change their ejection fraction on echo. The patients will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose. Secondary outcome is to increase quality of life, exercise tolerance and decrease their symptom scores as noted on their questionnaires.


Eligibility criteria: Inclusion Criteria:

* Etiology of heart failure in Group 1 or Group 2
* Moderate heart failure as evidenced by ventricular shortening fraction \<= standard deviations below the mean, or ejection fraction \<= 40% d) documented shortening fraction or ejection fraction that meet criteria for greater than 3 months
* Standard medical therapy include ACE inhibitors plus or minus diuretics plus or minus digoxin; all efforts will made to maximize therapy prior to entry. Medication doses must be stable for 3 months prior to entry
* Willingness to comply with followup testing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT04277754: Motor and Visual Development in 2 Year Olds
Official title: Correspondence Between Motor and Road Development in 2-year-old Children With Typical Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development, Child
Motor Skills Disorders
Visual Disorder
Keywords: developmet
motor
visual
infant
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: two-year-old children with typical development

Brief summary: It is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age.


Eligibility criteria: Inclusion Criteria:

* typical development
* be enrolled in a nursery school of the University of Seville

Exclusion Criteria:

* visual deficit
* developmental disorder

Primary outcomes:
measure: Motor development
timeFrame: Up to two weeks
measure: Motor development
timeFrame: Up to two weeks
Secondary outcomes:
measure: Visual acuity
timeFrame: Up to two weeks
measure: Visual axis alignment
timeFrame: Up to two weeks
measure: Three dimensional vision capability
timeFrame: Up to two weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Elena Piñero Pinto
Study officials:
References:
Clinical trial NCT05265754: The Effect of Sujok Therapy on Cancer Symptoms
Official title: The Effect of Sujok Therapy on Pain, Fatigue, Insomnia, Nausea and Vomiting Experienced by Patients With Gastrointestinal System Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Pain
Insomnia
Fatigue
Nausea and Vomiting
gastrointestinal system cancer.
sujok therapy
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 sessions in 2 weeks in total of sujok therapy will be applied to the interventional group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of Sujok therapy on Pain, Fatigue, Insomnia, Nausea and Vomiting experienced by patients with gastrointestinal system cancer.

Detailed description: The aim of this study is to determine the effect of Sujok treatment on Pain, Fatigue, Insomnia, Nausea and Vomiting experienced by patients with gastrointestinal system cancer. Intervention and control groups will be determined by randomization. The scales to be used in the measurement will be applied to the individuals included in the study. Then, sujok therapy will be applied to the intervention group. After 6 sessions in weeks in total, measurement tools will be applied and evaluated again.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* Fatigue Severity Measurement - Visual Analogue Scale (VAS) fatigue score of 3 and above,
* Pain Severity Measurement - Visual Analogue Scale (VAS) pain score of 3 and above,
* Measurement of Nausea and Vomiting Severity - Patients with a Visual Analogue Scale (VAS) nausea and vomiting score of 3 and above will be included.

Exclusion Criteria:

* Loss of sensation, amputation, injury, colostomy, etc., which will prevent practice in hands. patients will be excluded from the study.

Primary outcomes:
measure: Sujok Therapy's Positive Change in Pain Experienced by Gastrointestinal System Cancer Patients
timeFrame: 2 weeks
measure: Sujok Therapy's positive change in Fatigue Experienced by Patients with Gastrointestinal System Cancer
timeFrame: 2 weeks
measure: Sujok Therapy's positive cahange in insomnia Experienced by Patients with Gastrointestinal System Cancer
timeFrame: 2 weeks
measure: Sujok Therapy's positive cahange in nausea and vomiting Experienced by Patients with Gastrointestinal System Cancer
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Universty
Study officials:
References:
Clinical trial NCT03158454: Capsula Closure vs. Non-Capsula Closure: Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
Official title: Capsula Closure Versus Non-Capsula Closure During Hip Arthroscopy in Danish Patients With Femoroacetabular Impingement (FAI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Injuries
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate whether patients undergoing surgical treatment (hip arthroscopy) of FAI syndrome will positively benefit from capsular closure, in terms of higher scores in validated patient reported outcome measurements, compared to a Group of patients with FAI syndrome where the capsule is left open at the end of the surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Radiological and symptomatic Femoroacetabular Impingement, where surgery is indicated. Preoperatively a minimum of 3 months of relevant physiotherapeutic treatment should have been performed.

Exclusion Criteria:

* Previous hip surgery in either hip
* Malignant disease
* Recent hip or pelvic fractures
* Arthritic disease
* Hip joint dysplasia
* Legg-Calvé-Perthes
* Slipped Capital Femoris Epiphysis
* Recent (within 6 weeks) medical treatment with corticosteroids
* Language problems of any kind

Primary outcomes:
measure: Change in patient reported outcome scores (Hagos)
timeFrame: From baseline to 2 year after the operation
Secondary outcomes:
measure: Change in patient reported outcome scores (Ihot12)
timeFrame: From baseline to 2 year after the operation
measure: Change in patient reported outcome scores (NRS)
timeFrame: From baseline to 2 year after the operation
measure: Change in patient reported outcome scores (EQ5D
timeFrame: From baseline to 2 year after the operation
measure: Reoperation
timeFrame: Up to 2 years after surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Division of Sports Trauma, Tage-Hansens Gade 2b
Study officials:
References:
citation: Dippmann C, Kraemer O, Lund B, Krogsgaard M, Holmich P, Lind M, Briggs K, Philippon M, Mygind-Klavsen B. Multicentre study on capsular closure versus non-capsular closure during hip arthroscopy in Danish patients with femoroacetabular impingement (FAI): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 10;8(2):e019176. doi: 10.1136/bmjopen-2017-019176.
Clinical trial NCT04151433: Conservative Endometrioma Surgery
Official title: BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis Ovary
Endometrioma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: GZA Ziekenhuizen Campus Sint-Augustinus
name: Centre Hospitalier Régional de la Citadelle
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2019-11-05
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.

The 2 conservatives techniques used are:

1. The combined technique
2. CO2 laser vaporization only

Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.


Eligibility criteria: Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.

Inclusion Criteria:

* Age: 18 - 40 years (both inclusive)
* Unilateral endometriotic cysts with a mean diameter of \>=2.5cm and ≤8 cm, measured in 3 dimensions.
* Presence of a contralateral endometrioma of ≤ 2cm is allowed
* Complaining of infertility and/or pain
* BMI ≤35
* Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery

Exclusion Criteria:

* Incomplete surgery for the pelvis
* Contra-indication for the use of contraception (combined or Progesteron only)
* Use of GnRH analogues preoperatively and in the first 3 months postoperatively
* (History of) hysterectomy
* Prior unilateral oophorectomy
* Pituitary/hypothalamic disorders
* Suspected malignancy
* Contralateral endometrioma of \>2 cm
* AMH \<0.7 preoperatively
* Pregnancy

Primary outcomes:
measure: AMH levels 3 months postoperatively
timeFrame: 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: GZA Sint-Augustinus
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-LUC (UCL)
city: Leuven
country: Belgium
facility: UZLeuven
city: Liège
country: Belgium
facility: CHR La Citadelle
Study officials:
affiliation: Leuven University Fertility Center
name: Carla Tomassetti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: