louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00277225: A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris
Official title: A Phase I,Randomized, Double Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to determine the single-dose pharmacokinetics and immunogicity of BMS-188667 administered as a 1 hour intravenous infusion with extended pharmacokinetic sampling. Safety of all subjects will be assessed in a double blind fashion through the inclusion of placebo controls at each dose level.


Eligibility criteria: Inclusion Criteria:

* Subjects required to have a know diagnosis of psoriasis vulgaris involving 5-49% of total body surface area (BSA) for at least six months prior to randomization.
* Subjects clinically insignificant abnormal laboratory or ECG test results who were otherwise healthy and met all remaining eligibility criteria.

Exclusion Criteria:

* Evidence of active bacterial or viral infections at the time of enrollment, including any history of or clinical evidence of infection with Human Immunodeficiency virus (HIV) Hepatitis B or Hepatitis C.
* Any underlying metabolic, hematologic, pulmonary, cardiac, renal hepatic, infectious, psychiatric or gastrointestional condition, which in the opinion of the investigator, placed the subject at unacceptable risk from participation in a study with potentially immunosuppresive therapy.

Primary outcomes:
measure: Pharmacokinetics throughout study period
timeFrame: Until Day 43 or Day 120 depending on dose level
Secondary outcomes:
measure: Safety and Immunogenicity throughout study period.
timeFrame: Until Day 43 or Day 120 depending on dose level and duration of adverse events
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: California Institutional Review Board
name: Ralph D. Beasom, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03561025: Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis
Official title: Diagnostic Potential of PET/MRI in Cardiac Sarcoidosis: A Pilot Study Combining Advanced MRI and 18F-FDG and 18F-GE180 PET of the Myocardium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Cardiomyopathies
Keywords: Diagnostic Imaging
Positron Emission Tomography Computed Tomography
Magnetic Resonance Imaging
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University Hospital, Essen
First posted: 2018-06-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to find better and more specific non-invasive methods to diagnose and stage cardiac sarcoidosis with the use of advanced imaging modalities, simultaneous 3T MRI and PET. Cardiac sarcoidosis is a disease of possibly fatal outcome in young people. The use of a combined PET/MRI system with 18F-FDG and a new inflammation-tracer (18F-GE180) can become a future game changer.

Sarcoid induced focal inflammation in myocardium should show high 18F-GE180 uptake. 18F-GE180 PET scans will give reliable data about inflammatory sarcoidosis activity in the myocardium. 18F-GE180 PET is expected to improve diagnostic accuracy compared to 18F-FDG-PET and/or contrast enhanced MRI.


Eligibility criteria: Inclusion Criteria:

* Heart department: Suspicion of myocardial sarcoidosis after contrast enhanced cardiac MRI
* Lung department: Clinically verified lung and/or mediastinal sarcoidosis

Exclusion Criteria:

* Known malignancies
* Treatment for sarcoidosis started
* Severe arrhythmia
* Patients with pacemakers or defibrillator
* Claustrophobia
* Known alcohol or drug abuse
* Kidney failure (eGFR \< 30)
* Weight \> 120 kg
* Diabetes Mellitus type I and II
* Patients that take immunosuppressive or immunomodulatory medication for any reason

Primary outcomes:
measure: diagnostic accuracy of a combined 18F-FDG and 18F-GE-180 PET/MRI examination for diagnosing cardiac sarcoidosis
timeFrame: One day after the test
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav University Hospital, Dept Radiology and Nuclear Medicine
Study officials:
affiliation: St. Olavs Hospital
name: Edmund Søvik
role: STUDY_CHAIR
References:
Clinical trial NCT03254225: Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
Official title: Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Elderly
Resistance training
Heart rate variability
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2017-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.

Detailed description: This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks. Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.

Eligibility criteria: Inclusion Criteria:

* Hypertensives
* Age 60 to 80 years
* Nonactive

Exclusion Criteria:

* Orthopedic problems or other problem that prevented the exercises
* Change in drug treatment during protocol
* Absence in more than 25% of the exercise sessions

Primary outcomes:
measure: Blood pressure change due to resistance training
timeFrame: 16 weeks
Secondary outcomes:
measure: Heart rate variability - Time domain - change due to resistance training
timeFrame: 16 weeks
measure: Heart rate variability - Frequency domain - change due to resistance training
timeFrame: 16 weeks
measure: Heart rate variability - Non-linear methods - change due to resistance training
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Fabio Tanil Montrezol
state: Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Fabio T Montrezol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03897725: Evaluating The Acceptability and Uptake of Pre-Exposure Prophylaxis (PrEP) for Adolescent Women in The Deep South
Official title: Evaluating The Acceptability and Uptake of PrEP for Adolescent Women in The Deep South
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adolescent Behavior
HIV/AIDS
PrEP
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-04-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2) Determine the acceptability and preliminary effectiveness of a telehealth intervention to promote adherence in adolescents.


Eligibility criteria: Inclusion Criteria:

* Females between 15 to 21 years old
* Established patients at the Adolescent Health Center
* HIV negative

Exclusion Criteria:

* HIV positive patients
* patients weighing less than 35kg
* patients with creatinine clearance \<60 ml/min
* patients with documented osteopenia or osteoporosis or history of pathologic fractures
* patients with previous allergic reactions to either emtricitabine or tenofovir
* patients who are on post-exposure prophylaxis for HIV (they can become eligible after completion of therapy)
* patients with hepatic impairment
* For patients who become pregnant, they may be able to continue on PrEP after a discussion with their obstetrics/gynecology (OB/GYN) provider.

Primary outcomes:
measure: Adherence to PrEP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: William A. Daniel Adolescent Health Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birminghahm
name: Tina Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04789525: Physical Training and Diet for Childhood Obesity
Official title: Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With High Protein Diet in Childhood Obesity Following COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 76
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection


Eligibility criteria: Inclusion Criteria:

* A positive diagnosis of COVID-19
* Male children
* 5 - 12 years of age Body mass index (BMI).
* Between 85t h to 99th percentiles were considered for childhood obesity.

Exclusion Criteria:

* Subjects with a history of physical training
* Taking medications, recent surgeries.
* Fractures and joint problems in the lower extremity.
* Cardiac and respiratory problems.
* Neurological issues, major psychiatric problems.
* Any other systemic diseases, contraindications for physical training.

Primary outcomes:
measure: Body mass index
timeFrame: 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT02717325: 18842 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor (SPF) efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment DArkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01891825: Persistent Atrial Fibrillation Ablation Trial
Official title: Persistent Atrial Fibrillation Ablation Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Persistent atrial fibrillation
Atrial fibrillation ablation
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 50
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: Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.


Eligibility criteria: Inclusion Criteria:

* Symptomatic persistent or long-standing AF suitable for AF ablation.
* Age over 18 years old.
* Informed consent to participate in this study.

Exclusion Criteria:

* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
* Unable to undergo general anaesthesia for AF ablation.
* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Previous thoracic surgery.
* Participation in a conflicting study.
* Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
* Pregnancy
* Other cardiac rhythm disorders

Primary outcomes:
measure: Recurrence of persistent AF by 12 months after ablation
timeFrame: 12 months
Secondary outcomes:
measure: Change in AF burden after AF ablation
timeFrame: 12 months
measure: Time to first episode of symptomatic AF after ablation
timeFrame: 12 months
measure: Time to first episode of any AF after ablation
timeFrame: 12 months
measure: Total number of AF episodes after AF ablation
timeFrame: 12 months
measure: Total number of AF episodes lasting greater than 6 minutes after AF ablation
timeFrame: 12 months
measure: New MRI-detected subclinical cerebral embolic events
timeFrame: 3 months
Other outcomes:
measure: Quality of life changes after AF ablation
timeFrame: 12 months
measure: Change in exercise capacity assessed by cardiopulmonary exercise testing (CPET) after AF ablation
timeFrame: 12 months
measure: Change in echocardiographic left atrial dimensions and function after AF ablation
timeFrame: 12 months
measure: Change in cognitive function as assessed by the Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) instruments
timeFrame: 12 months
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne General Hospital
state: E Sussex
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: East Sussex
Study officials:
affiliation: Eastbourne General Hospital
name: Neil Sulke, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156025: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
Official title: Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis (Phase II Pilot Study, Multicentre, International, Randomised, Double-masked, Placebo-controlled, 2x40 Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Adenoviral Keratoconjunctivitis
Keywords: GV550
Acute adenoviral keratoconjunctivitis
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male or female aged from 18 to 80 years old
* Acute adenoviral keratoconjunctivitis

Exclusion Criteria:

* Active ocular allergy
* Ocular herpès disease
* History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit

Primary outcomes:
measure: efficacy of GV550
timeFrame: D0 to D4
Secondary outcomes:
measure: efficacy of GV550
measure: Ocular safety
measure: Systemic safety
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Medical Director
Study officials:
References:
Clinical trial NCT02184325: Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children
Official title: Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets, Comparing the Marketed Formula With an Improved One With a Reduced Mineral Amount, and a Comparator Product: a Double-blind, Controlled, Randomised, Three Arm Cross-over Study in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.


Eligibility criteria: Inclusion Criteria:

* Children of both sexes aged between 6 and 14 years, inclusive
* Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated
* Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations
* Pregnant children will not be excluded

Exclusion Criteria:

* Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
* Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug
* Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial
* Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug
* Has any serious disorder that may interfere with the participation to the trial
* Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes
* Increased calcium blood concentration, or an increased calcium-excretion
* Evident states of protein deficiency
* Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)

Primary outcomes:
measure: Incidence of total drug-related adverse events
timeFrame: up to 19 days
Secondary outcomes:
measure: Incidence of all individual drug-related adverse events
timeFrame: up to 19 days
measure: Assessment of overall tolerability and acceptance on a 4-point verbal rating scale
timeFrame: up to day 19
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03230448: Study of the Links Between Suicidal Intentionality and Acute Alcoholism
Official title: Study of the Links Between Suicidal Intentionality and Acute Alcoholism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide, Attempted
Keywords: Acute alcoholism
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people hospitalized in the emergency department after a suicide attempt by voluntary drug intoxication

Brief summary: There is a strong link between the alcohol consumption and the suicidal risk. Indeed there is an increase of the risk of suicide in case of chronic or acute alcohol consumption. However why the alcohol consumption increase the suicidal risk is unknown.

The hypothesis of this study is that the alcohol consumption induced disinhibition and facilitates the suicide attempt without premeditation

Detailed description: People hospitalized after a suicide attempt will answer to two questionnaires about the suicide intentionality and the acute alcohol consumption.

There is 2 arms:

people doing suicide attempt and with positive level of alcohol (up to 0.1g.L) people doing suicide attempt and with negative level of alcohol

110 patients will be included in this study so 55 in each arm.

Eligibility criteria: Inclusion Criteria:

* patient hospitalized in emergency department for a suicide attempt by voluntary drug intoxication
* speaking and understanding french

Exclusion Criteria:

* Patient who has used other psychoactive substances (attested by toxicological analyzes and / or interrogation)
* Known neurodegenerative pathology

Primary outcomes:
measure: compare the score of suicidal intentionality in patient presenting a positive or a negative alcohol level and doing suicide attempt
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Juliette SALLES, MD
role: PRINCIPAL_INVESTIGATOR
References: