louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050751: Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets
Official title: Open-Label, Randomized, 2-Way Crossover Study To Estimate The Pharmacokinetics And Bioavailability Of Lersivirine (UK 453,061) Administered As A Single 750 Mg Tablet And 3 X 250 Mg Tablets In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Bioavailability
Bioequivalence
Lersivirine
UK-453
061
Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 12
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: This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Treatment with an investigational drug within 30 days or 5 half-lives or local regulation (whichever is longer) preceding the first dose of study medication.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* History of regular alcohol consumption exceeding 14 drinks/week for women and 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).

Primary outcomes:
measure: To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.
timeFrame: 7 days
Secondary outcomes:
measure: To investigate the safety and tolerability of both single oral 750 mg (3 x 250 mg and 1 x 750 mg) dose of lersivirine.
timeFrame: 7 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01425151: The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Device Success Rate
Device Performance
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Age 1.5-6 years

Exclusion Criteria:

* known or predicted difficult airway
* body mass index \> 35 kg m-2
* risk of aspiration

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 10 Minutes
Secondary outcomes:
measure: Insertion success rate
timeFrame: 1 Minute
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Klinik für Anästhesie und Allgemeine Intensivmedizin
city: Zürich
country: Switzerland
facility: Christian Keller
Study officials:
affiliation: Schulthess Klinik
name: Christian Keller, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03637751: Temporal Genomics Mechanisms Underlying Disease and Aging
Official title: Temporal Genomics Mechanisms Underlying Disease and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gene Expression in Response to Acute Stress
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Given the salient role of early-life adversity and the resulting biological embedding in disease risk, there is a critical need to understand the mechanisms operating at multiple levels of analysis in order to promote effective clinical treatments and intervention efforts for survivors. An example for such an effort could be to utilize models of dynamic cellular markers as individual-level factors to account for variation in intervention response and clinical outcomes. Results of this study will lead to new knowledge about specific gene expression pathways in response to stress, and whether the response is moderated by previous exposure to early adversity, shorter telomere length (a marker of cellular aging) and self-report mental-health measures. Thus, the long-term effects of this study will advance our understanding on stress-related transcriptomic changes that play a downstream role in disease susceptibility and accelerated aging, with the goal of targeting specific pathways and genes for potential intervention studies and pharmacological treatments to reverse the effects of exposure to early adversity. For example, considering high failure rates for depression treatments, and in order to tailor individual interventions, identifying objective changes in stress-induced gene expression may help to predict intervention efficacy in clinical and non-clinical settings, as seen, for example, in breast and leukemia cancers. Thus, findings will have a range of impacts for basic science, intervention studies and clinical practice that will influence treatments to match the specific cellular processes operating within an individual.


Eligibility criteria: Inclusion Criteria:

* Age 18-25
* Without significant medical illness or endocrine illness (for example, asthma, diabetes, thyroid disease or pituitary gland disorders)
* Currently non-smokers
* Not pregnant and had not given birth in the past year
* Not using medication on a regular basis besides oral contraceptives to allow generalizability to adult women.

Exclusion Criteria:

* Recent infection or illness
* Use of abused drugs
* Immune disease, ascertained during the phone interview.

Primary outcomes:
measure: Gene expression via RNAseq
timeFrame: Gene expression over 5 hours in response to stress or a no-stress condition
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Biobehavioral Health Building
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01239251: GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
Official title: Feasibility of Using the GlowCap Reminder System in Patients With Early Stage Breast Cancer Receiving Adjuvant Endocrine Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: GlowCap
adjuvant endocrine therapy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 8
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer Medicine practice outpatients

Brief summary: The purpose of this study is to test the ease of using a new device, called the GlowCap that reminds the patient to take their breast cancer hormone pill. The study will collect information about the experience with this device and what the patient thinks of its role in the daily pill taking routine.


Eligibility criteria: Inclusion Criteria:

* Early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane).
* Age ≥ 60 years
* Must have broadband internet access at home (to enable the base for the system to communicate to the Vitality server).
* Must have a landline or mobile phone

Exclusion Criteria:

* Non-English speaking patients

Primary outcomes:
measure: Assess the usability of the GlowCap system by patients
timeFrame: 2 years
Secondary outcomes:
measure: Measure the acceptance and satisfaction of the GlowCap reminder system
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tiffany Traina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417451: Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Official title: Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

Detailed description: The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.

Eligibility criteria: Inclusion Criteria:

* women with histologically confirmed stage 0, I, II, or III breast cancer
* who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
* are currently receiving adjuvant endocrine therapy
* are able to read and speak English
* with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms

Exclusion Criteria:

* have self-reported hospitalization for psychiatric illness within the past 2 years
* have a bleeding disorder
* physically or cognitively unable to complete the study procedures
* pregnant women

Primary outcomes:
measure: PROMIS Pain Interference
timeFrame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
measure: PROMIS Fatigue
timeFrame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
measure: PROMIS Sleep Disturbance
timeFrame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Secondary outcomes:
measure: PROMIS Depression
timeFrame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
measure: PROMIS Anxiety
timeFrame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago College of Nursing
state: Illinois
Study officials:
References:
Clinical trial NCT05546151: A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
Official title: A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986322
Japanese descent
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.


Eligibility criteria: Inclusion Criteria:

* Participant must be of Japanese descent (both biological parents are ethnically Japanese).
* In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
* Women should be of non-childbearing potential.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
* Any major surgery within 90 days of study drug administration.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 7 weeks
measure: Number of participants with adverse events (AEs) leading to discontinuation
timeFrame: Up to 7 weeks
measure: Number of deaths
timeFrame: Up to 7 weeks
measure: Number of participants with AEs
timeFrame: Up to 7 weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 7 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 7 weeks
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 7 weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 7 weeks
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Day 1 and Day 14
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Day 1 and Day 14
measure: Area under the concentration-time curve within a dosing interval (AUC[TAU])
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04680351: Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
Official title: Evaluation of the Hemodynamic Effects of Transvenous Phrenic Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Mechanical ventilation is a cornerstone in the management of severe forms of pneumonia, acute respiratory distress syndrome. It provides essential oxygen to patients, ventilates the lungs but also has deleterious effects like any treatment, in particular by reducing cardiac output by reducing venous return. Mechanical ventilation also has effects on the diaphragm: diaphragmatic dysfunction. It is explained by a prolonged inactivity of this muscle with a reduction of muscle fibers that can settle down quickly, after only a few days of mechanical ventilation. This dysfunction results in a reduction in the latter's ability to generate intrathoracic pressure necessary for ventilation, slows the withdrawal of mechanical ventilation and lengthens the duration of stay in intensive care unit. To reduce this dysfunction, phrenic stimulation has been proposed as an alternative to remuscler the diaphragm thanks to electrodes located on a central venous catheter, also used to deliver the usual therapies in intensive care unit.

The HEMOSTIM study is interested in the effects of phrenic stimulation on regional ventilation, cardiac output and cerebral perfusion: investigator hypothesize that diaphragmatic stimulation allows an improvement of these parameters.


Eligibility criteria: Inclusion Criteria:

* Patient included in RESCUE 3 study, interventional arm with phrenic stimulation
* Patient or family consent

Exclusion Criteria:

* Patient not affiliated or not benefiting from a social security scheme

Primary outcomes:
measure: measurement of integral time speed by cardiac transthoracic ultrasound
timeFrame: 1 minute
measure: Measurement of increased venous return gradient in percentage (variation between the value before phrenic stimulation and the value after phrenic stimulation)
timeFrame: 1 minute
Secondary outcomes:
measure: variation in ventilation distribution before and after phrenic stimulation measured in electrical impedance tomography
timeFrame: 1 minute
measure: Measurement of diaphragmatic stimulation on cerebral oxygenation evaluated by the Near infrared spectrometry technique
timeFrame: 1 minute
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Paris
country: France
facility: APHP La Pitié-Salpêtrière
city: Paris
country: France
facility: APHP La Pitié-Salpêtrière
Study officials:
References:
Clinical trial NCT06053151: Cloud Platform Integration Model for Pregnant Women Exercise Consultation
Official title: Cloud Platform Integration Model for Pregnant Women Exercise Consultation: Development, Construction and Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Pregnancy Related
Keywords: exercise counselling
pregnancy
women
platform
physical activity
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 154
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To construct the platform for exercise counseling for pregnant women, and evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

Detailed description: This study will develop and construct an exercise counseling model with using cloud platform for women during pregnancy. In addition, we will evaluate the effects of that telecare platform integration model for exercise consultation on exercise behaviors and prenatal health outcomes among pregnant women during pregnancy.

Eligibility criteria: Inclusion Criteria:

* pregnant women who less than 17 gestation and able to understand basic technologies such as smartphone and computer

Exclusion Criteria:

* women who had a diagnosis of pregnancy related compliactions and absolute limited exercise, such as preterm contraction, ruputer of menbrance, evidence of intrauterus growth retardation, heart and lung disease, cervical incompetence and/or medical conditions that influence exercise.

Primary outcomes:
measure: increase physiacl activity
timeFrame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)
measure: decrese symptom distress
timeFrame: The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)
measure: decrease pregnancy related complications
timeFrame: The data were collectedbefore the intervention to childbirth: <16 week gestation, second trimester (24-26 weeks) and third trimester (34-36 weeks)
Secondary outcomes:
measure: construct exercise counseling model
timeFrame: The data will be collected from pregnant women and experts perspectives; From date of first participant attend the focus group until the date of the last experts meeting , assessed up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Mackay Medical College
name: Ching Fang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786651: Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
Official title: Task Switching Behavior Between Target Templates During Visual Search in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive each level of visual information (target or distractor)
Primary purpose: BASIC_SCIENCE

Brief summary: In this line of research, the researchers having participants engage in task switching between tasks which require a positive (target) template, negative (distractor) template, or neutral (non-informative) template to the cognitive control factors associated with each template type during visual search. This is a basic science study.

Detailed description: The researchers will have participants engage in task switching between tasks which require a positive (target) template, negative (distractor) template, or neutral (non-informative) template to the cognitive control factors associated with each template type during visual search. Looking for impacts of task switching helps to identify the components of the cognitive control system that overlap between different types of attentional templates. This is a basic science study.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: One day (during testing)
measure: Button Press Accuracy
timeFrame: One day (during testing)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04450251: Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection
Official title: Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy Tracker
Owlet Band
Owlet
Wearable Tech
Lead sponsor: Owlet Baby Care, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 500 pregnant women 24 weeks gestation and up in the second or third trimester of pregnancy will be screened into the study.

Brief summary: Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman, 18 years of age and up.
* Singleton or twin pregnancy.

Exclusion Criteria:

* Self-reported substance abuse problems.
* Anyone unable or unwilling to give informed consent.

Primary outcomes:
measure: The objective of this study is to collect observational fetal ECG readings with a novel wearable device
timeFrame: Up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lehi
country: United States
facility: Owlet Baby Care, Inc.
state: Utah
Study officials:
affiliation: Owlet Baby Care, Inc.
name: Kenneth Ward, MD
role: PRINCIPAL_INVESTIGATOR
References: