louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02472444: Gustatory Evoked-related Potentials in Humans
Official title: Etude du contrôle hédonique de la Prise Alimentaire Par l'Analyse Des Potentiels évoqués Gustatifs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gustatory Evoked Potentials
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy young volunteers

Brief summary: Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory receptors by a primary flavour. GEP are non invaisve, painless and safe.

The aims were to establish a reliable recording of GEP in Humans and to determine physiological variations of the gustatory evoked cerebral activity, by recording gustatory evoked potentials in different physiological situations (different intensities of taste solutions, after feeding or fasting, with different taste...). Healthy volunteers were included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system), in front of the primary and the secondary gustatory cerebral areas, referenced against ear lobes.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* non smoker

Exclusion Criteria:

* diabetes mellitus
* treatment interfering with taste
* history or current neurological problem

Primary outcomes:
measure: latencies of the gustatory evoked potentials
timeFrame: during a 20 minutes taste stimulus
measure: amplitudes of the gustatory evoked potentials
timeFrame: during a 20 minutes taste stimulus
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jacquin-Piques A, Gaudillat S, Mouillot T, Gigot V, Meillon S, Leloup C, Penicaud L, Brondel L. Prandial States Modify the Reactivity of the Gustatory Cortex Using Gustatory Evoked Potentials in Humans. Front Neurosci. 2016 Jan 5;9:490. doi: 10.3389/fnins.2015.00490. eCollection 2015.
Clinical trial NCT04458844: Strength and Fundamental Movement Skill (FMS) Training in Children
Official title: Integrated Strength and Fundamental Movement Skill (FMS) Training in Children: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fundamental Movement Skill Competence
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Cluster randomised control trial.
Primary purpose: TREATMENT

Brief summary: Competence in Fundamental movement skills (FMS) is essential to enable children to be physical active. The aim of this study was to investigate the effects of integrated FMS skill training (balancing and stabilisation skills, locomotor skills \[e.g. run, hop, jump, crawl\] and object control / manipulation \[e.g. dribbling, rolling, striking, kicking and catching i.e. a ball\] with strength training on FMS performance in children.


Eligibility criteria: Inclusion Criteria:

* Age 10 - 11 years in a participating primary school (cluster) for which the Head Teacher has provided consent.
* Parental consent received

Exclusion Criteria:

* No parental consent

Primary outcomes:
measure: Change in product-process assessment of FMS via the Canadian agility and movement skills assessment (CAMSA)
timeFrame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Secondary outcomes:
measure: Change in product assessment of FMS
timeFrame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
measure: Change in strength
timeFrame: Baseline data was collected mid-June 2018 at the primary schools, one week prior to the intervention. Post testing data collection was in the week immediately after the final week of the four week intervention.
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
state: England
Study officials:
References:
Clinical trial NCT01124344: Safety and Pharmacology Study of BMS-866949
Official title: Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Major Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable


Eligibility criteria: Inclusion Criteria:

* Panels 1-6: Healthy Male Subjects
* Panel 7: Females
* Ages 21 to 55, inclusive
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP \<21 mmHg)
* History or family history of psychiatric disorder
* Current treatment with prescription medication
* Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Primary outcomes:
measure: Assessment of safety by evaluating incidence of adverse events (AE)
timeFrame: Over a period of 28 days (+/- 2 days) of first dose
Secondary outcomes:
measure: Assessment of pharmacokinetics by evaluating plasma concentration versus time data
timeFrame: Over a period 28 days (+/- 2 days) of first dose
measure: Assessment of pharmacodynamics by evaluating brain transporter occupancy
timeFrame: Over a period 28 days (+/- 2 days) of first dose
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02261844: Resveratrol and Human Hepatocyte Function in Cancer
Official title: Resveratrol and Human Hepatocyte Function in Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Keywords: Hepatocellular carcinoma
Metastatic colorectal cancer
Metabolism
Hepatic function
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.

Detailed description: Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling pathway proteins will be measured using western blot analysis for protein expression and polymerase chain reaction for gene expression. Activation of signaling pathways in both native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on transcription factors that may be important in gene expression will be analyzed by transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell metabolism will be analyzed by proteomic analysis.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective liver resection for liver cancer

Exclusion Criteria:

* Inability to speak or read English
* Sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure
* History of daily alcohol intake
* Presence of human immunodeficiency virus
* Presence of significant renal dysfunction as defined by baseline serum creatinine \> 2.0 mg/dl or need/impending need for chronic dialysis therapy
* Known allergy to the study medication
* Pregnancy, lactating women, women contemplating pregnancy during the study period

Primary outcomes:
measure: Improved metabolic profile of liver cells
timeFrame: 36 months
Secondary outcomes:
measure: Decreased cell growth and proliferation
timeFrame: 36 months
measure: Decreased hepatic inflammation
timeFrame: 36 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Brian G Harbrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965640: Treatment of Male Pattern Baldness With Botulinum Toxin
Official title: A Prospective, Single Center, Open Label, Proof of Principle Study to Assess the Efficacy and Safety of 150 Units of Botulinum Toxin-A Intra-Muscular Injection in the Prevention of Hair Loss in Men With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Pattern Baldness
Keywords: male pattern baldness
androgenetic alopecia
hair loss
Lead sponsor: The Crown Institute
Sponsor class: OTHER
First posted: 2009-08-25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: SCREENING

Brief summary: This proof of concept study seeks to demonstrate that Botulinum toxin injections are a safe and effective method for treating this form of hair loss.


Eligibility criteria: Inclusion Criteria:

* Male pattern baldness
* Norwood II-VI

Exclusion Criteria:

* Treatment with Botulinum toxins or other hair growth interventions with past year

Primary outcomes:
measure: Hair Growth
timeFrame: 1 year
Secondary outcomes:
measure: Hair Loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Pickering
country: Canada
facility: Crown Institute
state: Ontario
Study officials:
affiliation: Crown Institute
name: Brian Freund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freund BJ, Schwartz M. Treatment of male pattern baldness with botulinum toxin: a pilot study. Plast Reconstr Surg. 2010 Nov;126(5):246e-248e. doi: 10.1097/PRS.0b013e3181ef816d. No abstract available.
Clinical trial NCT05429840: Safety & PK of Single Doses of MT1980
Official title: A Two-part, Single Dose, Randomized, Single Blinded, Placebo Controlled, Phase I Study to Assess the Safety and Pharmacokinetics of Oral MT1980 in Healthy Volunteers When Dosed in the Fasted State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuroinflammatory Response
Keywords: pharmacokinetics
neuroinflammation
Lead sponsor: Monument Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: MT1980 is being developed as a treatment for neuroinflammation (an inflammatory response in the brain and/or spinal cord). Much research has focused on the central role of neuroinflammation in the pathogenesis of many conditions relating to the CNS, including eg, traumatic brain injury, stroke, Alzheimer's disease, post-operative cognitive decline (POCD)/perioperative neurocognitive disorder, and now even long-term cognitive side effects from severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Current anti-inflammatories do not easily cross the blood-brain barrier from the systemic circulation to the brain, making neuroinflammation a difficult condition to treat.

This will be a Phase 1, single dose, randomized, placebo-controlled study in healthy subjects. The study will provide information on the safety of MT1980, the systemic bioavailability of the active drug, and levels of the active drug in the CSF. The study will be conducted in two parts. In Part 1, subjects will be randomized to receive a single oral dose of MT1980 or placebo in a parallel design. An interim PK and safety data analysis will be performed after Part 1 prior to dose selection in Part 2. In Part 2 subjects will be randomized to receive either placebo or a single oral dose of MT1980 at one of 2 strengths in a parallel design.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with good physical and mental health
* Body Mass Index 18 to 30 kg/m2
* Men \& women of child-bearing potential must agree to use adequate contraception
* Willing \& able to provide written informed consent and to communicate and participate in the study

Exclusion Criteria:

* Clinically significant abnormal biochemistry, haematology, urinalysis results
* Results of screening liver function or kidney function tests outside of normal ranges
* Heavy daily smoking or use of nicotine containing substances

Primary outcomes:
measure: Treatment-related adverse events
timeFrame: Day 1 to Day 11
Secondary outcomes:
measure: Systemic bioavailability of MT1980
timeFrame: 72 hours post dose
measure: Level of MT1980 in CSF
timeFrame: up to 7 hours post dose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Icon Early Development Services
Study officials:
affiliation: Icon Early Development Services
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942240: Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects
Official title: A Phase I, Double-Masked, Multiple Rising Dose Study of ACU-4429 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2009-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 25
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 evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.


Eligibility criteria: Inclusion Criteria:

* males or females, between 25 and 55 years of age, inclusive
* within BMI range 19 to 32 kg/m2 at Screening
* in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs;
* clinical laboratory evaluations (including serum for Chem-20 \[fasted at least 10 hours\], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
* Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study.
* able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

* significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator);
* history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed;
* history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
* participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in;
* Is currently using, or has recently received treatment with a medication disallowed by the Protocol.

Primary outcomes:
measure: Safety as measured by adverse events, physical exam, ECG, vital signs, laboratory tests and visual tests
timeFrame: 20 days
Secondary outcomes:
measure: Pharmacokinetics as measured by plasma ACU-4429 drug levels
timeFrame: 16 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Texas
Study officials:
affiliation: Covance
name: William Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05594940: Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Official title: Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Keywords: CardioMEMS
iQ+
Home
CHF
B-Lines
Lead sponsor: Butterfly Network
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CHF patients with CardioMEMS devices

Brief summary: The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.

Detailed description: Feasibility study to compare an investigational Artificial Intelligence (AI) Auto B-line tool measurement on Lung Ultrasound (US) images acquired with an AI assisted guidance tool by novice ultrasound clinicians and heart failure (HF) patients, to standard of care heart failure monitoring of pulmonary artery pressure measured by the Abbott CardioMEMS system.

Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of heart failure at least three months prior to the date of consent
2. HF currently managed with the Abbott CardioMEMS device
3. Able to read and write in English.
4. At least 18 years of age or older on the date of consent.
5. Willing and able to provide written consent to participation
6. Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements
7. Access to WiFi or cellular data connection at home
8. In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures.

Exclusion Criteria:

1. Previous experience using an ultrasound device on themselves or others
2. Women who are pregnant or plan to become pregnant during the study

Primary outcomes:
measure: Patients Image Quality
timeFrame: Study Completion (91 days)
measure: Novice Image Quality
timeFrame: Study Completion (91 days)
measure: B-Line count CardioMEMS comparison
timeFrame: Study Completion (91 days)
Secondary outcomes:
measure: Ease of use
timeFrame: Study Completion (91 days)
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health Hospital, Concord Medical Center
state: California
city: Walnut Creek
country: United States
facility: John Muir Health Hospital, Walnut Creet Medical Center
state: California
Study officials:
References:
Clinical trial NCT05360940: Concomitant Infection of Intestinal Parasites and Helicobacter Pylori
Official title: Concomitant Infection of Intestinal Parasites and Helicobacter Pylori in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspepsia Abdominal Burning Pain Diarrhea Dysentery
Keywords: Helicobacter pylori Intestinal Parasites
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Samples will be collected from outpatients complaining of dyspepsia, abdominal burning pain, diarrhea,and dysentery with persons of any age or sex groups from different locations (cities and villages)

Brief summary: Intestinal parasitic infections such as Giardia lamblia, Entamoeba histolyica and Enterobius Vermicularis are among the most common infections worldwide.So parasitic infections are considered one of the major health problems in the world especially in developing countries.

Helicobacter pylori is a gram-negative,helical-shaped,motile bacillus bacterium,which colonizes the gastric mucosa.

H.pylori bacterium secretes urease,a special enzyme that converts urea to ammonia.

Ammonia reduces the stomach's acidity .This risk factor allows pathogenic intestinal protozoa such as G.lamblia to take the opportunity to cross through the stomach's increased pH and cause disease.


Eligibility criteria: Inclusion Criteria:

* patients complaining of dyspepsia , abdominal burning pain,diarrhea,dysentery,of persons of any age or sex group.

Exclusion Criteria:

* patients taking antibiotics within the previous four weeks, proton pump inhibitors within the previous two weeks, or anti-parasitic drugs within the previous two weeks.

Primary outcomes:
measure: Compare the prevalence of intestinal parasitic infections among positive and negative H.pylori infected outpatients in Sohag University Hospital
timeFrame: 18 weeks following the start point of the study
Secondary outcomes:
measure: Evaluate the prevalence of intestinal parasitic infection among H.pylori infected outpatients in Sohag University Hospital
timeFrame: 18 weeks following the start point of the study
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Asmaa Nabil Abouzeid
Study officials:
References: