louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01149824: Placebo Controlled Study of Sublingual Salvinorin A
Official title: A Double Blind Placebo Controlled Ascending Dose Pharmacodynamic and Tolerability Study of 100 to 4000 µg of Sublingual Salvinorin A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmaceutical Preparations
Keywords: Salvia divinorum
Salvinorin A
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose, placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and 4000µg) will be single-blind.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 21-45
* Experienced with hallucinogenic amounts of SA
* Good physical and mental health
* Able to give adequate informed consent

Exclusion Criteria:

* Any medical or psychiatric condition which, in the investigators' opinion, would preclude safe or consistent participation
* Significant acute or chronic medical disease
* Female who is pregnant, lactating, or plans to become pregnant during the study period and within one month after study drug administration

Primary outcomes:
measure: To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: California Pacific Medical Center
name: John Mendelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01971424: Assessment of Physical Performance After Oral Supplementation of Magnesium in a Sample of Old Women in Good Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Muscle Loss
Keywords: magnesium
SPPB
strength
physical performance
24 hour magnesuria
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Magnesium deficiency is associated also in the elderly with low physical performance; nevertheless trials about the effect of supplementation of magnesium on physical performance are not available in old people. The aim of our study is to investigate whether 12-weeks of oral magnesium supplementation improves physical performance in healthy elderly women


Eligibility criteria: Inclusion Criteria:

* People over 65 years, not residents in nursing home, in good health

Exclusion Criteria:

* previous supplementation of calcium, potassium or magnesium
* use of pump proton inhibitors or digitalis
* important co-mordidities such renal failure

Primary outcomes:
measure: Changes in short physical performance battery (SPPB)
timeFrame: Baseline and after 12 weeks
Secondary outcomes:
measure: Changes in appendicular skeletal mass (ASMMI)
timeFrame: Baseline and after 12 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Geriatrics Division, Department of Medicine
Study officials:
References:
citation: Dominguez LJ, Barbagallo M, Lauretani F, Bandinelli S, Bos A, Corsi AM, Simonsick EM, Ferrucci L. Magnesium and muscle performance in older persons: the InCHIANTI study. Am J Clin Nutr. 2006 Aug;84(2):419-26. doi: 10.1093/ajcn/84.1.419.
citation: Veronese N, Berton L, Carraro S, Bolzetta F, De Rui M, Perissinotto E, Toffanello ED, Bano G, Pizzato S, Miotto F, Coin A, Manzato E, Sergi G. Effect of oral magnesium supplementation on physical performance in healthy elderly women involved in a weekly exercise program: a randomized controlled trial. Am J Clin Nutr. 2014 Sep;100(3):974-81. doi: 10.3945/ajcn.113.080168. Epub 2014 Jul 9.
Clinical trial NCT01005524: Brain Computer Interface for Communication in ICU: a Feasibility Study
Official title: A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetraplegia
Guillain-Barre Syndrome
Keywords: brain computer interface
P3Speller
P300
Event Related potential
tetraplegia
Guillain barre syndrome
Feasibility
Speed of spelling
Accuracy
Lead sponsor: University of Versailles
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Quadriplegia, also known as tetraplegia, is paralysis caused by illness or injury to a human that results in the partial or total loss of use of all of their limbs and torso; paraplegia is similar but does not affect the arms. The loss is usually sensory and motor, which means both sensation and control are lost.

Brief summary: The main objective of this study is to evaluate the usability of a system to assist verbal communication based on BCI system using the P300 wave in patients with tetraplegia who can no longer communicate because of severe engine damage (tetraplegia) and respiratory damage requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal communication.


Eligibility criteria: Inclusion Criteria:

* Admitted in the ICU
* Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h

Exclusion Criteria:

* Acute respiratory failure.
* Visual disorder
* Cognitive disorder
* Illiterate patient
* Mother tongue other than french

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Service de reanimation, Hopital Raymond Poincare
Study officials:
References:
Clinical trial NCT03786224: Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence
Official title: Pilot Trial on the Efficacy of Contingency Management for Six Months of Cannabis Abstinence Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Adolescent Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.


Eligibility criteria: Inclusion Criteria:

* Male and female adolescents actively enrolled in a middle or high school in the Boston area who are between the ages of 13 and 19 (inclusive);
* Average use of cannabis at least 3 times per week during the 3 months prior to study enrollment;
* Cannabis use reported within 7 days of study enrollment;
* No immediate plan to discontinue cannabis use;
* Have a parent or legal guardian who is competent and willing to provide written informed consent for the active study phase (if under the age of 18);
* Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
* Competent and willing to provide written informed consent (if age 18 or older);
* Able to communicate in English language;
* Have a parent/guardian who can communicate in English language;
* Able to commit to 27 study visits in approximately 6 months;
* Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.

Exclusion Criteria:

- Any severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).

Primary outcomes:
measure: Continuous Abstinence Via Progressive Declines in Urine THCCOOH
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Randi M Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886024: Evaluation of Serum Ages Levels in Patients With Endometriosis
Official title: The Serum Ages Levels in Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: AGES (Advanced Glycation End Products)
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18-45 diagnosed with endometriosis (surgery or ultrasound)

Brief summary: Serum AGES (Advanced Glycation End Products) levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Detailed description: Serum AGES (Advanced Glycation End Products) levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. The energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since AGES (Advanced Glycation End Products) gives information about the energy metabolism of the people.

Eligibility criteria: Inclusion Criteria:

* diagnosed with endometriosis (Surgery or ultrasound)
* Women without endometriosis

Exclusion Criteria:

* Women without endometriosis women who are only suspected endometriosis

Primary outcomes:
measure: Serum Advanced Glycation End Products (AGEs) levels in women with endometriosis
timeFrame: 8 months
Secondary outcomes:
measure: Comparison of the relationship between serum Serum Advanced Glycation End Products (AGEs) level and endometriosis stage
timeFrame: 8 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT05435924: Turkish Version of The Upper Limb Hypermobility Assessment Tool
Official title: Turkish Version of The Upper Limb Hypermobility Assessment Tool : Reliability and Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypermobility, Joint
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - The study will be carried out by young adults and adults in the Kutahya Health Science University

Brief summary: Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the upper extremities. The Upper Limb Hypermobility Assessment Tool (ULHAT) has been reported to be one of the most appropriate scoring methods for assessing upper extremity hypermobility in the literature. The aim of this study is to adapt ULHAT to Turkish and measure its validity and reliability.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged between 18 to 35

Exclusion Criteria:

* Using assistive devices or orthoses for the upper extremity
* Surgery history of the upper extremity
* Pain located on the upper extremity in the last 6 months
* Previous trauma that might restrict normal range of motion.
* Having degenerative or inflamatuar disease

Primary outcomes:
measure: The Upper Limb Hypermobility Assessment Tool (ULHAT)
timeFrame: 15 minutes
measure: The Beighton Score
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Sciences University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086124: Objective Systolic Function Recuperation Assessed by Echocardiography
Official title: Objective Systolic Function Recuperation Assessed by Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Left Ventricular Systolic Dysfunction
Anterior Akinesis
Apical Akinesis
Keywords: echocardiography
ST elevation myocardial infarction
Heart failure
Coronary artery disease
Cardiovascular diseases
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to teaching hospital or sent from community hopitals to teaching hospital for primary PCI

Brief summary: The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* ST elevation myocardial infarction treated with primary PCI
* Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction)
* Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory

Exclusion Criteria:

* Known left ventricular systolic dysfunction before myocardial infarction
* Left bundle branch block
* Vital prognosis less than 6 months
* Cardiogenic shock
* Rescue PCI
* Sub-optimal echocardiographic imaging (contrast use is allowed)
* Significant valvular heart disease (moderate or severe)
* Surgical revascularization
* Pregnancy or breastfeeding
* Incapacity to provide informed consent

Primary outcomes:
measure: Left ventricular ejection fraction recuperation 1 month post myocardial infarction
timeFrame: 1 month post myocardial infarction
Secondary outcomes:
measure: Anterior and apical akinesis recuperation 1 month post myocardial infarction
timeFrame: 1 month post myocardial infarction
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Paul Farand, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02672124: A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microswimup Procedure Efficacy
Lead sponsor: Cervesi Hospital, Cattolica, Italy
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included couples submitted to in vitro fertilization treatment at the Unit of Physiopathology of Reproduction (Cervesi Hospital, Cattolica, RN, Italy).

Brief summary: The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.


Eligibility criteria: Inclusion Criteria:

* at least 8 oocytes retrieved at pickup
* oocyte insemination with ICSI technique
* only elective single embryo transfer (eSET) at blastocyst stage
* sperm concentration ≥ 1 X 106 /ml
* absence of antibiotic treatment in the previous four weeks for male patients

Exclusion Criteria:

* recurrent miscarriages
* more than three in vitro fertilization treatment
* azoospermia

Primary outcomes:
measure: microbiological test
timeFrame: 3 months
Secondary outcomes:
measure: semen treatment efficacy
timeFrame: 6 months
Other outcomes:
measure: euploid status
timeFrame: 6 months
Locations:
city: Cattolica
country: Italy
facility: Cervesi Hospital IVF Unit
state: Rimini
city: Cattolica
country: Italy
facility: Primiterra Mariangela
state: Rimini
Study officials:
References:
Clinical trial NCT00208624: Rhythm Disturbances After Ventricular Septal Defects
Official title: Rhythm Disturbances After Ventricular Septal Defects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Block After Surgery
Keywords: arrhythmia
pediatrics
cardiac
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: We would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient:

Patient Date of Birth Date of the surgical procedure

Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful)

We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up.

Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.


Eligibility criteria: Inclusion Criteria:

Patients with heart block after surgery -

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Kevin Maher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371524: A Prospective RegistrY of Cardiac Echographic Loops
Official title: A Prospective RegistrY of Cardiac Echographic Loops
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Calcified Aortic Valve
Lead sponsor: Cardiawave SA
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 90
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: Patients with diagnosed calcified aortic stenosis.

Brief summary: CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.

Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.

The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.

ARYEL is a prospective, multicenter, non-interventional study.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 y.o
* Patients with a confirmed diagnosis of Aortic valve calcification on native valve or bioprosthesis
* Patients with planned cardiac transthoracic echography for 'Aortic valve calcification' follow-up
* Patients who have signed Informed Consent Form
* Patients affiliated to French social security or equivalent

Exclusion Criteria:

* Patients allergic to echographic gel
* Patients with "hostile thorax": serious cutaneous irradiation injury or major thoracic deformity.
* Low echogenicity
* Patients with mild or high abundance pericardic effusion

Primary outcomes:
measure: Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Rouen
country: France
facility: Hôpital Charles Nicolle
Study officials:
References: