louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04612400: Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
Official title: Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Stable Isotopes
Validation
Whole-body protein metabolism
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blinded, randomized, crossover pilot study
Primary purpose: OTHER

Brief summary: To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.

Detailed description: This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.

Eligibility criteria: Inclusion Criteria:

* Aged 21-40 years.
* Body weight of ≤ 80kg.

Exclusion Criteria:

* History Chronic kidney disease.
* History of dairy allergy or intolerance.
* History of gastric reduction/bypass surgery.

Primary outcomes:
measure: Whole-body Protein Net Balance
timeFrame: 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Center of Translational Research in Aging and Longevity
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Arny A Ferrando, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05031000: Blood Glucose Monitoring Systems: Discounter Versus Brand
Official title: Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.


Eligibility criteria: Inclusion Criteria:

* Male or female, with clinical indication for blood glucose measurement
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02020200: The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder
Official title: A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BD
Keywords: Bipolar Disorder
Methylphenidate
Cognitive Function
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.

Detailed description: Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.

Eligibility criteria: Inclusion Criteria:

* Hebrew Speakers
* Age 21-50
* Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID).

Exclusion Criteria:

* Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study.
* BD patients diagnosed with an acute manic episode at screening, as established by YMRS\>8. It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history.
* Participants for whom there exists a contra-indication for consuming Ritalin.
* Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study.
* Drug use in the previous 6 weeks according to participants' self report
* Electroconvulsive therapy (ECT) in the previous 6 months

Primary outcomes:
measure: Cognitive function.
timeFrame: Within 4 hours of intervention.
Secondary outcomes:
measure: Creativity abilities.
timeFrame: Within 4 hours of intervention.
Other outcomes:
Locations:
city: Hod HaSharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Shalavata MHC
name: Yechiel Levkovitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05148000: Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
Official title: Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Canthal Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
Primary purpose: TREATMENT

Brief summary: This study to assess aesthetic improvement following treatment with QM1114-DP.

Detailed description: This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Eligibility criteria: Inclusion Criteria:

* Male or Female 18 years or older
* Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
* Moderate to severe GL at maximum frown as assessed by the Investigator

Exclusion Criteria:

* Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
* Female who is pregnant, breast feeding or intends to conceive a child during the study.
* Known allergy to hypersensitivity or any component of the Investigational product

Primary outcomes:
measure: Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1
timeFrame: 1 month
measure: Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Galderma Research Site
state: New York
Study officials:
References:
Clinical trial NCT01636700: Tramadol Infiltration for Tonsillectomy
Official title: Comparative Study of Analgesic Effect and Serum IL-6 With Tramadol Infiltration or Intravenous After Tonsillectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Tramadol infiltration
Analgesic effect
Serum IL-6
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.

Detailed description: The study will be prospective, double-blind, randomized study of 40 children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy under general anesthesia.

Patients will be allocated into two groups. Group 1 patients will receive tramadol 2 mg / kg intravenously and saline 0.9% infiltration in tonsils; group 2, will receive tramadol 2 mg / kg infiltration and intravenous saline.

There will be evaluated: postoperative pain intensity by facial scale, supplementary analgesics and interleukin-6. For statistical analysis of the results will be used parametric and nonparametric tests, taking into account the nature of the variables. The level of statistical significance will be set at \< 0.05.

Eligibility criteria: Inclusion Criteria:

* children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion Criteria:

* coagulopathy,
* cancer,
* hepatic or renal alteration

Primary outcomes:
measure: Analgesic effect
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata
role: STUDY_DIRECTOR
References:
Clinical trial NCT05350800: A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants
Official title: A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food the Bioavailability of BMS-986369 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: BMS-986369
Healthy Volunteer
CC-99282
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
* Must have a normal or clinically-acceptable 12-lead ECG at screening
* Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1

Exclusion Criteria:

* Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
* History of major surgery within 8 weeks before the first dose administration

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Day 1
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Day 1
measure: Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 336 hours after dose administration
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: From the date of having consented until 30 days after completion of study treatment
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 15
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 15
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 15
measure: Effect of BMS-986369 on ECG parameters - Part 1
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01604200: Dental PROBE (Dental Practice suRvey of Office Blood Pressure mEasurement)
Official title: A Mixed Methods Study to Assess How to Engage Dentists in Blood Pressure Screening
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Focus of Study is on Dentist's Attitudes Toward BP Measures
Keywords: hypertension
dentistry
blood pressure
measurement
screening
qualitative research
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian dental faculties and regulators. Canadian dentists. Canadian dental patients. Canadian dental experts

Brief summary: 20% of Canadians are hypertensive with approximately 200,000 new cases each year. Early detection of hypertension affects outcomes, reducing the risk for heart attack, stroke, kidney disease, and dementia. Screening strategies are required to identify the more than one third of Canadians with unrolled high blood pressure, in particular, younger men unaware of their condition, women over sixty years old, and underserved groups.

A collaborative practice model linking dentists to other healthcare providers in a reporting network is a promising model for hypertension detection and management. There are 20,129 licensed dentists in Canada who graduate with the ability to measure blood pressure, and 74% of the population visits a dentist each year. This represents an opportunity, but information is required on Dental attitudes toward screening for hypertension before attempting to initiate a screening model. To engage dentists in hypertension detection requires an understanding of the practice environment and the factors that shape their beliefs, attitudes and behaviours regarding routine hypertension screening in their practices.


Eligibility criteria: Inclusion Criteria:

* Dentists in practice

Exclusion Criteria:

* Unwilling to participate in study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT00990600: QoL and Adherence to One-pill Once-a-day HAART
Official title: Adherence to a One Pill, Once-a-day Antiretroviral Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
HIV Infections
Keywords: adherence
Qol
virologic efficacy
immunologic efficacy
patients' preference
once-daily
HAART
treatment experienced
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective of the study is:

To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Informed consent signed
* Effective ongoing treatment (HIV-RNA \< 50 copies/ml) for at least three months
* Being on a stable HAART regimen based either on two possible drug associations:

  * 3TC/FTC + TDF + EFV
  * FTC/TDF (fixed dose combination) + EFV
* No previous documented virologic failure

Exclusion Criteria:

* Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
* Any ongoing grade 4 laboratory abnormality

Primary outcomes:
measure: Proportion of adherence to HAART
timeFrame: 6 months
Secondary outcomes:
measure: QoL (VAS scale) preferences of patients virologic and immunologic outcomes
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ospedali Riuniti, Bergamo
name: Franco Maggiolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447900: Marker Guided Breathhold Radiotherapy in NSCLC
Official title: Proof of Concept Study Evaluating Safety and Performance of a Gel Marker (BioXmark) Used for Image Guidance in Deep Inspiration Breathhold Radiotherapy (DIBH IGRT) in Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-05-19
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: Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)


Eligibility criteria: Inclusion criteria

* Age \> 18 years old
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Stage T1-4N1-3M0
* Performance status ≤ 2
* Inoperable
* FEV1 ≥ 1 l
* Ability to hold deep inspiration breathhold for \> 15 seconds
* Accepting treatment at Rigshospitalet
* Eligible for concomitant chemo-radiotherapy
* If a woman is of childbearing potential, a negative pregnancy test must be documented
* Ability to understand the given information
* Signed written consent for inclusion into the study

Exclusion criteria

* Prior thoracic radiotherapy
* Allergy to Iodine or iodine based contrast
* In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons

Primary outcomes:
measure: Visibility of the injected gel marker during the course of radiotherapy delivery
timeFrame: 3 months
measure: Number of pneumothoraxes in relation to placement procedure of the gel
timeFrame: 0-1 week after placement of gel
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Denmark
Study officials:
References:
Clinical trial NCT01567800: Prostate Hypoxia FAZA
Official title: A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how prostate cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.


Eligibility criteria: Inclusion Criteria:

* Age =\> 18 years
* Histologic diagnosis of adenocarcinoma of the prostate
* Bulky intermediate risk, high risk or metastatic prostate cancer

Bulky intermediate risk: cT1-2 with \>50% of diagnostic biopsy cores containing cancer and Gleason 6 or 7 and prostate specific antigen (PSA) \>10 and ≤20 OR

High risk:

cT1-2 with Gleason score ≥8; or cT1-2 with PSA \>20; or cT3 OR N+ and/or M1 disease OR Newly diagnosed hormone-refractory prostate cancer - Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy

* Intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the Princess Margaret Genitourinary Site policies.
* Previous or concurrent anti-cancer therapy for the PET FAZA target lesion allowed
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Inability to lie supine for more than 60 minutes
* Patients taking the drug disulfiram (Antabuse)
* Contraindications for MRI: only applicable in cases where the PET FAZA target lesion is identified as the prostate gland. Patients with target lesions at other anatomic sites will not undergo MR imaging.
* Patients weighing \> 136 kg

Primary outcomes:
measure: Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with prostate cancer prior to treatment with radiotherapy +/- concurrent and adjuvant hormonal therapy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: