louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04518254: Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
Official title: Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: L-tyrosine
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is composed of 4 arms:

1. Tyrosine treatment without stress exposure
2. Tyrosine treatment with stress exposure
3. Placebo treatment without stress exposure
4. Placebo treatment with stress exposure

Every participants will participate in the 4 arms in a random order.
Primary purpose: PREVENTION

Brief summary: L-tyrosine is a chemical precursor of dopamine. Under specific conditions, tyrosine administration can increase brain dopamine levels and therefore several studies have explored whether tyrosine supplementation can have a beneficial effect on cognitive and behavioural performance that is dependent on dopaminergic function. However, the effects of tyrosine supplementation are mixed: some studies show positive effects while others do not. Stress leads to an increase in dopaminergic activity and turnover in the brain, resulting in a decrease in brain dopamine levels. We propose to study the contribution of tyrosine to decision making and more particularly to the processes of response selection (mediated by the prefrontal cortex and under the influence of the dopaminergic system) in stressful situations.


Eligibility criteria: Inclusion Criteria:

* From 18 to 65 years of age

Exclusion Criteria:

* Tyrosine intake within the previous 15 days
* History of neurological or psychiatric disorder
* History of nephrological or endocrine disorder or liver failure
* Hereditary tyrosinemia

Primary outcomes:
measure: Reaction Time
timeFrame: At day 9 (9 days after enrollment)
measure: Number of incorrect responses
timeFrame: At day 9
Secondary outcomes:
measure: Error negativity
timeFrame: At day 9
measure: Correlation coefficient between anxiety level and tyrosinemia
timeFrame: At day 9
measure: Correlation coefficient between anxiety level and plasma tyrosine
timeFrame: At day 9
measure: Correlation coefficient between cortisolaemia and melatoninaemia
timeFrame: At day 9
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT03740854: The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.
Official title: The Effects of Two Different Ventilation Strategies on Lung Ventilation in Patients Undergoing Robotic Radical Prostatectomy: Ultrasonographic Evaluation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: lung ultrasonography
mechanical ventilation
pressure controlled ventilation
volume controlled ventilation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.


Eligibility criteria: Inclusion Criteria: 18-75 age

* Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
* Patient with ASA (American Society of Anesthesiologists) Score 1-3

Exclusion Criteria:

* Patients with ASA Score above 3
* Patients with obstructive (FEV1\<%60) or restrictive pulmonary disease (FVC\<%60)
* Patients with intrathoracic operation history
* Heavy smokers (\>25 cigarettes/day)

Primary outcomes:
measure: The difference between LUS Scores at T5 in patients ventilated with VCV and PCV
timeFrame: (T5) 60 minutes after patients come to the recovery room.
Secondary outcomes:
measure: The difference between LUS Scores at T2 in patients ventilated with VCV and PCV
timeFrame: (T2) 5 minutes after intubation
measure: The difference between LUS Scores at T3 in patients ventilated with VCV and PCV
timeFrame: (T3) 5 minutes after the surgical procedure is finished
measure: The difference between LUS Scores at T4 in patients ventilated with VCV and PCV
timeFrame: (T4) 5 minutes after taking the patient to supin position
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medical Faculty of Cerrahpasa
Study officials:
affiliation: Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty
name: Fatis Altintas, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00282854: Genetics of Rolandic Epilepsy
Official title: Genetics of Rolandic Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
Rolandic epilepsy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-01-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.

Detailed description: Rolandic epilepsy (RE) is the most common type of childhood epilepsy-affecting more than 50,000 children in the United States-and has a complex genetic inheritance. The seizure prognosis is relatively benign, however, many children with RE also have problems with speech and language, reading, and motor coordination. Symptoms of the disorder overlap with more severe types of epilepsy.

The purpose of this study is to find the genes that influence RE and its related traits. Identifying genetic causes for the variants would improve diagnosis and allow for early intervention.

Researchers will enroll 1000 children with RE and 3000 controls for participation in the study. The scientists will request medical histories and (salivary) DNA samples from the participants. Participation can be completed by mail and telephone.

Results from this study should provide important information regarding diagnosis and prognosis of RE, may be useful in clinical management, and, eventually, may lead to a cure for this and other forms of epilepsy.

Eligibility criteria: Inclusion:

* typical history of focal seizures
* EEG centrotemporal sharp waves
* age of onset 3-12 years
* no previous epilepsy type (febrile seizures OK)
* normal development
* normal neurological examination
* normal MRI/CT (if done)

Exclusion:

* only history of secondary generalized seizures
* atypical history/semiology
* history and EEG inconsistent
* abnormal EEG background
* very early (\<3yrs) or late (\>12yrs) onset
* global neurodevelopmental deficit
* deviant neurodevelopment
* structural imaging abnormality

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mailman School of Public Health, Columbia University Medical Center, 722 West 168th St, 6th Floor
state: New York
Study officials:
affiliation: Associate Research Scientist, Mailman School of Public Health, Columbia University Medical Center
name: Deb K. Pal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710054: Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools
Official title: Recording Cyclist Crashes and Long-term Injury Consequences by New Smart Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brief Description of the Focus of the Study: Number of Injuries to Bicyclists and Micro Mobility Users
Keywords: bicyclist injuries bicyclist accidents
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Oslo University Hospital
First posted: 2024-11-29
Enrollment: 322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cyclists with recent accident in our well defined region

Brief summary: Recording Cyclist Crashes and Long-term Injury Consequences by new Smart Tools

Detailed description: The ReCyCLIST project is a collaboration between research institutes from the health and transport sciences, public authorities, medical expertise and web-tool developers, and end-user organisations, and as such an excellent example of a project that promotes and supports cooperation between research groups and users of the research.

Three major research questions are addressed in the ReCyCLIST project:

1. What are the numbers, characteristics and locations of accidents and injuries among cyclists and e-scooter/micro mobility device users in a representative county (Agder) in Norway?
2. What are the consequences of injuries in terms of social and individual costs including long-term consequences with respect to recovery, disability rates etc.?
3. What are the overall health impacts of cycling, when including the more comprehensive set of positive and negative effects; and what are the economic impacts from increased cycling (in terms of cost-benefit ratios)? To answer these research questions, the investigators will develop a new digital registration tool to record accidents and injuries among cyclists and users of micro mobility devices in Agder county in Norway. Patients will be followed up and data on medical rehabilitation, recovery and general conditions will be collected by use of questionnaires after three and twelve months. To map long-term consequences of injuries (\> 1 year), a retrospective study will be applied based on linking data from different registers containing information about health, welfare benefits and injuries.

Eligibility criteria: Inclusion Criteria:

* All cyclist (including micromobility devices), with recent accidents submitted to out- and in patient clinics in a well defined region of 310 000 inhabitants

Exclusion Criteria:

* No informed consent
* "Patients" not eligible for follow up within our region

Primary outcomes:
measure: Time to recover
timeFrame: From the inclusion of bicycle accidents to 12 months after the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
Study officials:
References:
Clinical trial NCT05456854: Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Official title: Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Metabolic Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Detailed description: Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.

During the inpatient study, the subjects will

Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp

Eligibility criteria: * over the age of 17
* normal pubertal development
* regular menstrual cycles
* stable weight for previous three months
* normal body mass index
* blood pressure systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg
* normal hemoglobin
* hemoglobin A1C \< 6.5%
* BUN, creatinine not elevated
* AST, ALT \< 3x upper limit of normal
* negative serum pregnancy test

Exclusion Criteria:

* active illicit drug use,
* history of a medication reaction requiring emergency medical care,
* difficulty with blood draws.
* history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
* history of chronic disease that has required hospitalization
* recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
* history of diabetes in a first degree relative
* hyperlipidemia by fasting lipid panel

Primary outcomes:
measure: First Phase Insulin Secretion
timeFrame: 10 minutes
measure: Second Phase Insulin Secretion
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margaret Lippincott
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328454: Clinical Characteristics and Prognostic Factors of Patients With COVID-19
Official title: Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Chibi People's Hospital, Hubei Province
First posted: 2020-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19

Brief summary: As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Detailed description: As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

Eligibility criteria: Inclusion Criteria:

* Adult aged \>=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.

Exclusion Criteria:

* Near-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.

Primary outcomes:
measure: Time to negative conversion of severe acute respiratory syndrome coronavirus 2
timeFrame: 1 month
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 1 month
measure: Survival
timeFrame: 1 month
measure: Intubation
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02119754: Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
Official title: Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Infection
Keywords: Wound
Ulcer
Infected
Infection
Lead sponsor: PluroGen Therapeutics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Arkios BioDevelopment International
First posted: 2014-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.


Eligibility criteria: Inclusion Criteria:

* Subjects who have failed treatment on Protocol PGN-1300X

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical Response
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ledesma Foot and Ankle
state: Arizona
city: Los Angeles
country: United States
facility: Foot & Ankle Clinic
state: California
city: Oakland
country: United States
facility: Samuel Merritt University
state: California
city: Hamden
country: United States
facility: ASAP Urgent-Care
state: Connecticut
city: Miami Lakes
country: United States
facility: Sweet Hope Research Specialty, Inc.
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Miami
country: United States
facility: Miami Center for Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Unlimited Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Med Research of Florida, LCC
state: Florida
city: Des Plaines
country: United States
facility: Weil Foot & Ankle Institute
state: Illinois
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc
state: Pennsylvania
city: Arlington
country: United States
facility: AllCare Foot & Ankle, PA
state: Texas
city: Virginia Beach
country: United States
facility: Coastal Podiatry Group
state: Virginia
Study officials:
References:
Clinical trial NCT06231433: Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis
Official title: Effect of Factional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Systemic Sclerosis
Vulvovaginal Signs and Symptoms
Sexual Function Disturbances
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days.

At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion Criteria:

* gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy

Primary outcomes:
measure: 1-5 Likert Scale
timeFrame: Six months follow up
Secondary outcomes:
measure: 0-10 Visual Analogue Scale
timeFrame: Six months follow up
measure: Female Sexual Function Index
timeFrame: Six months follow up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
References:
Clinical trial NCT01375933: A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
Official title: A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: Smoking
NicVAX
Smoking vaccine
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine.
* History of clinically significant allergic reactions.
* Use of systemic steroids.
* Cancer or cancer treatment within 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence.
* Required treatment for depression within the past 12 months.
* Body mass index ≥ 30 \[calculated as weight (kg)/height2 (m)\].
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 30 weeks.

Primary outcomes:
measure: Immunogenicity
timeFrame: At Week 14
Secondary outcomes:
measure: Safety
timeFrame: Through Week 16
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: NicVAX Investigator
state: Alabama
city: San Diego
country: United States
facility: NicVAX Investigator
state: California
city: Melbourne
country: United States
facility: NicVAX Investigator
state: Florida
city: Peoria
country: United States
facility: NicVAX Investigator
state: Illinois
city: South Bend
country: United States
facility: NicVAX Investigator
state: Indiana
city: Rockville
country: United States
facility: NicVAX Investigator
state: Maryland
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Medical Monitor
role: STUDY_DIRECTOR
References: