louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03115021: Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
Official title: Neurophysiological Effects of tPCS and tDCS on Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disorders of Consciousness
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims at comparing the effects of transcranial direct current stimulation and transcranial pulsed current stimulation on neurophysiological outcomes on patients with disorders of consciousness. This study also aims to evaluate the effects of these techniques on patients' level of consciousness.


Eligibility criteria: Inclusion Criteria:

* Fluent in English or French
* Legally authorized surrogate available to provide informed consent
* History of non-traumatic brain injury with loss of consciousness caused by stroke, cerebral hemorrhage, hypoxic ischemic insult, metabolic disorder or infection.
* Has been followed clinically on the CRS-R for a minimum two weeks and has undergone a minimum of 4 assessments with the CRS-R.
* Serial CRS-R scores show at least one subscale on which there is no behavioral sign of conscious awareness (ie, command following, visual fixation or pursuit, object localization or recognition, localization to noxious stimulation, object manipulation, automatic motor responses, functional object use, discernable speech, discernable yes no communication, based on clinically obtained scores contained in the medical record).
* CRS-R screening examination completed by research staff confirms the absence of a behavioral sign of consciousness on a least one CRS-R subscale.
* Medically stable (i.e., no systemic illness or disease) and capable of independent ventilation

Exclusion Criteria:

* History of developmental, neurologic, or major psychiatric disorder resulting in functional disability up to time of enrollment.
* Evidence or surrogate report of uncontrolled seizure disorder
* Metallic brain implant or implanted electronic brain medical devices or pacemaker
* Subjects with craniectomy
* History of cranioplasty in the frontal region or recent cranioplasty that has not yet fully healed
* Pregnancy

Primary outcomes:
measure: Signal coherence and EEG power as measured by Quantitative electroencephalographic analysis (qEEG)
timeFrame: It will be measured over the course of about 3 weeks
Secondary outcomes:
measure: Coma Recovery Scale Revised (CRS-R)
timeFrame: It will be measured over the course of about 3 weeks
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
References:
Clinical trial NCT00255021: Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Poliomyelitis
Haemophilus Infections
Pertussis
Keywords: Diphteria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
acellular
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 186
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.


Eligibility criteria: Inclusion Criteria:

* Aged 53 to 70 days inclusive on the day of inclusion

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past.
* Mother known as seropositive to HIV or hepatitis B
* Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin \[BCG\])
* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
* Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.

Primary outcomes:
measure: Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
timeFrame: 1 month post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06383221: Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy.
Official title: Evidence-based Pragmatism Re-design：Randomized Controlled Trial and Metabolomics Study of the Intervention Effect of "Self-help and Advanced On-site Referral" Stepped-care Models on Depression Symptoms During Pregnancy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Stepped Care
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 600
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: In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care.

Detailed description: The intervention group used the "Mental Fitness Boot Camp - Advanced Counseling" stepwise care model, which incorporated cognitive-behavioral therapy and mindfulness in both phases, with the Mental Fitness Boot Camp being a self-help learning experience and the Advanced Counseling being a perinatal clinic doctor guiding pregnant women in behavioral design.

Metabolic markers of perinatal depression and the mitigating effects of the stepped care model were explored by collecting blood and urine samples from the study participants during early, mid and late pregnancy, and 42 days postpartum, respectively, samples were collected and stored in a refrigerator at -80 degrees Celsius.

Eligibility criteria: Inclusion Criteria:

* Pregnant women; Informed consent, able to complete the questionnaire independently; Positive first depression screening (EPDS ≥ 10) in early, mid or late pregnancy; Intention to have children in this pregnancy.

Exclusion Criteria:

* Suffering from depression being treated with psychotherapy or medication; Positive screening for bi-directional affective disorder.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum
Secondary outcomes:
measure: Generalized Anxiety Disorder
timeFrame: 0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum
measure: World Health Organization Five-item Well-Being Index
timeFrame: 0, 3 weeks, 7 weeks, One week after delivery, 42 days postpartum
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00742521: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3
Official title: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: cortisol
catecholamines
Type 1 DM
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: It has been found that in some cases, when a person with Diabetes Mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. The purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

Detailed description: The SPECIFIC AIM of the study outlined in this proposal is to determine if hypoglycemia blunts counterregulatory responses during subsequent exercise in Type 1 Diabetes Mellitus due to physiologic increases in plasma cortisol.

Eligibility criteria: Inclusion Criteria:

* Males and females with Type 1 Diabetes Mellitus will be studied. Subjects recruited will be 18-50 years, with an HBA1c less than 9.5%, who have been diagnosed with diabetes for \>5 years, with no clinical evidence of diabetic tissue complications.

Exclusion Criteria:

* Subjects with known prior cardiac events will be excluded from the study. Additional exclusion criteria:

  1. all medical students (Vanderbilt policy)
  2. prior or current history of poor health
  3. abnormal results following blood and physical examination
  4. pregnancy

Primary outcomes:
measure: catecholamine measures
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Stephen N Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010321: Confocal Microscopy of Benign and Malignant Skin Tumors
Official title: Confocal Microscopy of Benign and Malignant Skin Tumors
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Skin Cancer
Keywords: skin lesion suspect as BCC or SCC or others
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women over the age of 18

- Skin lesion suspected to either BCC,SCC etc

Brief summary: The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.


Eligibility criteria: Inclusion Criteria:

* Men and women over the age of 18
* Skin lesion suspected to either BCC or SCC etc
* Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Exclusion Criteria:

* Pregnant women
* Children

Primary outcomes:
measure: efficacy of a confocal microscope as a diagnostic tool
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Aviv Barzilai, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05378321: Prevalence of NAFLD in ACS Patients
Official title: The Prevalence of Non-Alcoholic Fatty Liver Disease in Patients With an Acute Cardiac Event Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
ACS - Acute Coronary Syndrome
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Addressing CVD risk in patients with NAFLD is the aspect of the disease most amenable to medical management and so improving long-term clinical outcomes. Almost no studies have been done concerning the prevalence of NAFLD in CVD patients, most of the conducted studies have been done in already diagnosed NAFLD patients to estimate the risk of CVD development. Currently, there are no data available about the prevalence of NAFLD in CVD, more specifically patients with an acute cardiovascular event (ACE) in Belgium.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* having acute cardiovascular syndrome
* able to understand Dutch
* able to understand the informed consent

Exclusion Criteria:

* excessive alcohol abuse
* other liver disease
* secondary causes of steatosis

Primary outcomes:
measure: FibroScan® liver stiffness measurements
timeFrame: 4 years
measure: FibroScan® steatosis measurements
timeFrame: 4 years
measure: Liver ultrasound
timeFrame: 4 years
measure: Liver biopsy results
timeFrame: 4 years
measure: Aspartate transaminase (AST)
timeFrame: 4 years
measure: Alanine transaminase (ALT)
timeFrame: 4 years
measure: Gamma glutamyltransferase (GGT)
timeFrame: 4 years
measure: Lactate dehydrogenase (LDH)
timeFrame: 4 years
measure: Exclusion of other liver diseases
timeFrame: 4 years
measure: Wellbeing - BAECKE
timeFrame: 4 years
measure: Wellbeing - GAD-7
timeFrame: 4 years
measure: Wellbeing - PHQ-9
timeFrame: 4 years
measure: Wellbeing - WPAI-SHP
timeFrame: 4 years
measure: Wellbeing-SF-36
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT04652921: Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)
Official title: The Effects of 6-month Supplementation With Creatine and Guanidinoacetic Acid on Biomarkers of Sarcopenia in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive pathological facet of this condition, and this might be approached with targeted therapies in aim to restore creatine homeostasis in target tissues. Among potential therapeutic candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine mixture was found to be superior than creatine itself to effectively improves bioenergetics in the human brain and muscle in healthy humans, perhaps due to the unique transportability features of this combination. Here, we plan to evaluate does creatine-GAA supplementation affects various biomarkers of sarcopenia in elderly.


Eligibility criteria: Inclusion Criteria:

* Age \> 70 years
* Free of acute disorders

Exclusion Criteria:

* History of dietary supplement use during the past 4 weeks

Primary outcomes:
measure: Change in muscular strength
timeFrame: Baseline vs. 6 months post-intervention
Secondary outcomes:
measure: Change in muscle mass
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in muscle metabolites evaluated with MR spectroscopy
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in cognitive performance evaluated with Mini-Mental State Exam test
timeFrame: Baseline vs. 6 months post-intervention
measure: Change in serum creatine
timeFrame: Baseline vs. 6 months post-intervention
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
References:
Clinical trial NCT05334121: Safety Analysis of Chronic Intake of a β-alanine Supplement
Official title: Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Product Safety
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Single-center, double-blind, placebo-controlled clinical trial with two arms (product and placebo) to analyze the safety of beta-alanine consumption in active people.

Detailed description: After recruitment, subjects will be randomized and assigned to one of the two arms of the study: beta-alanine group or control group (placebo).

Subjects must be active people, and will take a dose of 15 g per day of the product for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Men between 18 and 40 years of age.
* Physically active people. They must train at least 3 sessions per week.
* Have been training continuously for at least one year.

Exclusion Criteria:

* Participant suffering from chronic illness.
* Serious or terminal illness.
* Suffering from a lasting injury that prevents him/her from training in the month prior to the intervention.
* Inability to understand the informed consent.
* Previous experience in the consumption of beta alanine.

Primary outcomes:
measure: Liver safety variables
timeFrame: Change in hepatic safety after 8 weeks of consumption
Secondary outcomes:
measure: Paresthesia test
timeFrame: Change after 8 weeks of consumption
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Fco Javier López Román
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00264121: The Incidence of Congenital Undescended Testis Among Dutch Infants
Official title: The Incidence of Congenital Undescended Testis Among Dutch Infants in the Medical Centre Alkmaar
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Undescended Testis
Keywords: congenital, high scrotal
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2005-12-12
Enrollment: 3000
Sex: MALE
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine the incidence of congenital undescended testis of mature boys, at one year of age, born in the Medical Centre Alkmaar (MCA).

Detailed description: The position of the testes of mature boys will be registered at birth and boys with a high-scrotal, non-scrotal or dubious position of the testis/ testes will be followed up (till the age of one year).

Eligibility criteria: Inclusion Criteria:

* mature newborns (\>/= 37 weeks)
* born in the Medical Centre Alkmaar

Exclusion Criteria:

* premature newborns (\< 37 weeks)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar (MCA)
state: Noord-Holland
Study officials:
affiliation: Department of Pediatrics, Medical Centre Alkmaar
name: W WM Hack, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06404021: Electronic Device Implantation Through Remote Guidance
Official title: Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Telemedicine
Heart Failure
Defibrillators
Keywords: electrophysiology
remote monitoring
technical support
device
Lead sponsor: University of Calabria
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients under 85 years
* Patients already implanted with defibrillator and admitted to cardiology division for others invasive procedures
* Patients undergoing defibrillator or cardiac resynchronization therapy defibrillator implantation
* Patients who signed written informed consent

Exclusion Criteria:

* Pacemaker dependent patients
* Patients who underwent generator replacement procedures

Primary outcomes:
measure: Feasibility of interventional cardiology procedures with remote assistance implementing certified specialized engineers
timeFrame: From enrollment to the end of treatment at 12 months
measure: Stability of interventional cardiology procedures results
timeFrame: From enrollment to the end of treatment at 12 months
measure: Radiation exposure
timeFrame: The time in minutes from the beginning up to the end of interventional cardiology procedures
measure: Electrophysiology laboratory occupancy
timeFrame: The time in minutes from the beginning up to the end of interventional cardiology procedures
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: "Magna Graecia" University of Catanzaro
Study officials:
affiliation: University of Calabria
name: Antonio Curcio
role: PRINCIPAL_INVESTIGATOR
References: