louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03126149: First in Human Study for PF-06667272
Official title: A Phase 1, Randomized, Double-blind (Sponsor-open), Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06667272 Under Fed And Fasted Conditions, In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-30.5 kg/m2;
* Body weight \>50 kg;

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
timeFrame: Baseline (Day 1, hour 0) up to 28 days after last dose of study medication
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Apparent Total Body Clearance (CL/F) for PF-06667272
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Apparent Volume of Distribution (Vz/F) for PF-06667272
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01779349: Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"
Official title: Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter" With Correlation to Pressure Flow Study and Uroflowmetry.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Bladder Outlet Obstruction
Keywords: benign prostatic hyperplasia (BPH)
acoustic vibration
Lead sponsor: P. Square Medical Ltd
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 45
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: Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study and to the standard free flowmetry test. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of benign prostatic hyperplasia (BPH)
* has indication for urodynamic evaluation
* Males 18 years and older
* Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.

Exclusion Criteria:

Any condition which, in the investigator opinion, makes the patient unsuitable

Primary outcomes:
measure: Efficacy of Holter to confirm or exclude of bladder outlet obstruction
timeFrame: One recording at the time of urodynamic testing. (approximatly one minute)
Secondary outcomes:
measure: Efficacy of Holter to supply the free flowmetry test curve & values.
timeFrame: One recording at the time of urodynamic testing. (approximatly one minute)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Urology Department Director, Tel Aviv Sourasky Medical Center
name: Haim Matzkin, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05272449: Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
Official title: Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea (Disorder)
Lead sponsor: CIDELEC
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 20
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: Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected obstructive sleep apnea

Exclusion Criteria:

* Lung infection
* Insomnia

Primary outcomes:
measure: Analyzable signal time
timeFrame: One night
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00114049: Dental Pain (Following Third Molar Tooth Extraction) Study
Official title: A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Pain
Surgery, Dental
Keywords: Dental Pain
Dental Surgery
Cox-2 inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

Detailed description: A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Eligibility criteria: Inclusion criteria:

* Scheduled for outpatient surgical removal of at least two third molar teeth.

Exclusion criteria:

* Subjects who do not achieve moderate to severe pain.
* Subjects who do not use acceptable contraception.
* Additional medical criteria will be assessed by the investigator.

Primary outcomes:
measure: Difference between treatments over time based on pain intensity and pain relief scores.
Secondary outcomes:
measure: Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments.
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05450549: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participant
Lead sponsor: Denali Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2022-07-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive
* BMI 18.5 to \<30 kg/m²
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception

Key Exclusion Criteria:

* History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* History of malignancy
* History of clinically significant stroke
* History of cognitive impairment
* Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding

Primary outcomes:
measure: Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 45 days
Secondary outcomes:
measure: PK Parameter: Maximum concentration (Cmax) of DNL919 in serum
timeFrame: Up to 45 days
measure: PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Up to 45 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research (CHDR)
state: South Holland
Study officials:
affiliation: Denali Therapeutics Inc.
name: Ana-Claire Meyer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03655249: Effects of AD on VI in Patients With CF
Official title: Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Multiple breath washout
Electrical impedance tomography
Lung clearance index
Chest physiotherapy
Autogenic drainage
Cystic fibrosis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants receive one of two interventions during the first day, and receive the alternative intervention the following day.

Interventions are : aerosoltherapy + autogenic drainage or aerosoltherapy alone
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

Detailed description: This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.

Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis diagnosis
* FEV1 \> 40%
* Able to sustain 30min of chest physiotherapy

Exclusion Criteria:

* Presence of Burkoldheria cepacia or non tuberculous mycobacteria
* Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
* Need for supplemental oxygen
* Cardiac pacemaker or internal cardiac defibrillator

Primary outcomes:
measure: Change in Lung Clearance Index
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Impedance variation
timeFrame: Up to 1 hour
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gregory Reychler, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04478149: A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
Official title: A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dementia
Lead sponsor: SafelyYou
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist control
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.


Eligibility criteria: Inclusion Criteria:

* Living in a participating assisted living facility and suffering from dementia

Exclusion Criteria:

-

Primary outcomes:
measure: Opt-in rate
timeFrame: through study completion, an average of 1 year
measure: Number of falls
timeFrame: through study completion, an average of 1 year
measure: Number of ER visits
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05640349: Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital
Official title: Evaluation of Bacteremia Epidemiology During the COVID Period in One French University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Catheter-Related Infections
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 4200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of University Hospital of Nice

Brief summary: The main objective of this retrospective cohort is to evaluate the impact of the first epidemic wave during lockdown on bacteremia epidemiology in one French University Hospital.


Eligibility criteria: o Inclusion criteria : Patients with positive blood culture recorded at the microbiology laboratory of University Hospital of Nice Aged 18 years

o Exclusion criteria : Patients with negative blood culture recorded at the microbiology laboratory of University Hospital of Nice

Primary outcomes:
measure: Epidemiology of bacteriemia,catheter-related infection and contamination
timeFrame: Day 0
Secondary outcomes:
measure: Characterization of community bacteremia
timeFrame: Day 0
measure: Determined therapeutic actions
timeFrame: Day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT03509649: Impact of Practitioner and Instructional Set on Subject Perceptions and Expectations of Cervical Spine Manipulation
Official title: The Impact of Practitioner and Instructional Set on Subject Expectations of Cervical Spine Manipulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 60
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: TREATMENT

Brief summary: Determine effects of perceptions and expectations on experience of cervical spine manipulation

Detailed description: The purpose of this study is to better understand how therapists may affect a patient's thoughts/ beliefs/ opinions on cervical spine (neck) manipulation. Current evidence suggests that patients who have a positive expectation about neck manipulation are more likely to report benefit from it, and we wish to determine if the perceived experience level of the therapist and the words they use to describe neck manipulation will affect the patient's perception.

Eligibility criteria: Inclusion Criteria:

1. age 18-65 years;
2. must report having no current episode of mechanical neck pain;
3. must be willing to participate;
4. must indicate they have not had their neck manipulated by a physical therapist, osteopath or chiropractor within the last 5 years.

Exclusion Criteria:

1. 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as: history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, heart disease, and stroke.
2. History of neck whiplash injury.
3. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) in both arms.
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands or face, muscle wasting in the hands, altered taste, and presence of abnormal reflexes.
5. Evidence of neurological signs suggesting nerve root entrapment (pinched nerve in the neck).
6. Prior surgery to your neck or upper back.
7. A medical condition which may change your sensation of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency).
8. Diagnosis from your physician of fibromyalgia syndrome.
9. Currently pregnant, or think you may be pregnant.

Primary outcomes:
measure: Global Perceived Effect Scale (GPE)
timeFrame: Immediate
Secondary outcomes:
measure: Perception of comfort scale
timeFrame: Immediate
measure: Beliefs about cervical spine manipulation
timeFrame: Immediate
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas - Department of Physical Therapy
state: Nevada
Study officials:
affiliation: Baylor University
name: Emilio J Puentedura, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161549: Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
Official title: Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRC
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 71
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects indicate for standard colonoscopy procedure (i.e., screening, diagnostic , surveillance)

Brief summary: Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.

The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.

Detailed description: 63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.

40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:

1. One head that irrigates and evacuates instead of two heads
2. Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
3. System adjustment to the above changes including updated software version.

Eligibility criteria: Inclusion Criteria:

* Subjects in the age range of 50-69 years
* Subjects who are considered for routine screening colonoscopy
* Subjects with BMI within the range of 18.5-30
* Subject is willing to sign informed consent form

Exclusion Criteria:

* History of G diseases or history of Colorectal cancer (personal or family)
* Previous major abdominal surgeries
* Medical status ASA grater or equal to 3
* Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
* Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
* Life-threatening condition
* Subjects who are unable or unwilling to cooperate with study procedures
* Severe Diverticula

Primary outcomes:
measure: Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
timeFrame: during colonoscopy procedure after cleansing with CleanUp System
Secondary outcomes:
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Clinica San Rafael
Study officials:
References: