louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02534740: A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
Official title: A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Primary outcomes:
measure: Area under the concentration-time Curve (AUC)
timeFrame: 120 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 120 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 120 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 120 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 120 hours
measure: Area Under the Curve from Time zero to infinity
timeFrame: 120 hours
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 NCT00479440: Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult subjects.


Eligibility criteria: Inclusion criteria:

* Men and women of nonchildbearing potential aged 18 to 45 years
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours and, grapefruit, grapefruit-containing products is prohibited 72 hours before study day 1.

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03251040: Fibrin Sealant in Esophageal Surgery
Official title: Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anastomotic Leak
Keywords: Esophagogastric anastomosis
Fibrin sealant
Sealing
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: PREVENTION

Brief summary: Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.


Eligibility criteria: Inclusion Criteria:

* Aged 18 - 90 years
* Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).
* physical status (American Society of Anesthesiologists) of 3 or lower

Exclusion Criteria:

* Other malignancies
* Previous esophageal surgery were excluded

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 30-day morbidity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Freek Daams, MD PhD
role: STUDY_DIRECTOR
References:
citation: Plat VD, Bootsma BT, van der Wielen N, van der Peet DL, Daams F. Autologous Activated Fibrin Sealant for the Esophageal Anastomosis: A Feasibility Study. J Surg Res. 2019 Feb;234:49-53. doi: 10.1016/j.jss.2018.08.049. Epub 2018 Sep 27.
Clinical trial NCT04578340: Long Term Outcomes Following Hernia Repair With Mesh
Official title: Long Term Outcomes Following Hernia Repair With Mesh
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Hernia
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-10-08
Enrollment: 4700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multihospital system inclusive of all abdominal hernia repairs using mesh

Brief summary: The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

Detailed description: This is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Eligibility criteria: Inclusion Criteria:

* abdominal hernia repair using mesh

Exclusion Criteria:

* less than 18 years old

Primary outcomes:
measure: Hernia recurrence rate
timeFrame: Within 5 years of initial hernia repair
measure: Patient quality of life
timeFrame: Up to 5 years postopertively
Secondary outcomes:
measure: Postoperative infection rate
timeFrame: Up to 5 years postoperatively
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
References:
Clinical trial NCT00740740: Biomarkers of Aneurysm Wall Strength
Official title: Biological and Biochemical Markers of Aneurysm Wall Degradation; Towards Non-Invasive Wall Strength Analysis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Keywords: Aneurysm
Rupture
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care clinic. Patients scheduled for transbadominal aortic surgery

Brief summary: The purpose of this study is to identify possible in vivo biochemical and biological markers related to aortic wall strength.

Detailed description: Rupture of an Abdominal Aortic Aneurysm (AAA) is potentially lethal. prophylactic surgical repair is therefore warranted when the risk of rupture exceeds the risk of complications following surgery. Aneurysm rupture occurs when the forces (stress) acting on the aneurysm wall surpass aneurysm wall strength. Information on both wall stress and strength might therefore improve rupture risk assessment and patient selection for prophylactic repair. Although aneurysm wall stress calculations are possible, no in vivo method exists to determine aneurysm wall strength. This study was designed to identify possible biomarkers of aneurysm wall strength

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for transabdominal aortic surgery

Exclusion Criteria:

* Patient characteristics and aneurysm anatomy suitable for endovascular repair
* Previous aortic surgery

Primary outcomes:
measure: Aneurysm wall strength
timeFrame: Post-operative
Secondary outcomes:
measure: Extra Cellular Matrix components (Glucoaminoglycans)
timeFrame: post-operative
measure: Biochemical blood analysis
timeFrame: post-operative
measure: MMP content
timeFrame: post-operative
measure: Degree of inflammation
timeFrame: Post-operative
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep, Rijnstate Hospital
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Jan Blankensteijn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03206840: Neural Correlates of Self
Official title: The Neural Correlates of the " Self " in Altered States of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: mindfulness meditation
hypnosis
meta-awareness
absorption
consciousness
self
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. This study aims to identify the neural correlates of self-consciousness in meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy participants combined with detailed first-person experiential accounts and behavioural tasks. This study will provide important clues about the widely reported effects of mindfulness meditation and hypnosis and shed light on the neural correlates of the conscious experience of self.


Eligibility criteria: Inclusion Criteria:

* aged 18-70
* Body mass index between 18.5 and 30
* Covered by health insurance
* motivated to participate
* signed informed consent
* normal or corrected-to-normal eyesight
* sufficient command of French to be able to follow the instructions

Exclusion Criteria:

* history of neurological or psychiatric conditions
* chronic pain or another medical condition altering pain perception
* use of medication that affects the central nervous system
* use of opioids or antidepressant medication
* severe auditory loss
* consumption of alcohol or intoxicants on the day of the experiments and the day preceding the experiments
* pregnancy, breastfeeding or having given birth \<6months ago
* any contra-indication to Magnetic Resonance Imaging (metal implants or foreign bodies), agitation, claustrophobia

Primary outcomes:
measure: Reaction time (minutes)
timeFrame: at day 1
measure: Brain activation with IRM
timeFrame: At day 3
Secondary outcomes:
measure: personality trait with questionnaires
timeFrame: at day 2
measure: Scores during behavioural tasks
timeFrame: at day 1
measure: Scores during behavioural tasks
timeFrame: at day 3
measure: salivary volume (millimeter)
timeFrame: at day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon Hôpital le Vinatier/Inserm
Study officials:
affiliation: Lyon Neuroscience Research Center
name: Antoine LUTZ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145740: Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury
Official title: The Effect of Intensive Facial Oral Tract Therapy (F.O.T.T.®) on Swallowing Function in Patients After Acquired Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Unfallkrankenhaus Berlin
First posted: 2017-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial (RCT). Patients after severe acquired brain injury (ABI) were randomised in addition to the individual daily rehabilitation program to intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment: washing face, brushing teeth, without facilitating swallowing (control group).

The duration of the intervention period was 15 working days (3 weeks). The intervention in both groups was twice a day.

Detailed description: The F.O.T.T.® approach uses structured tactile input and facilitation techniques in meaningful everyday life context, aiming for improving function in the face and oral tract that is as normal as possible. The goal is maximum participation in daily life. The treatment encourages learning of helpful functional movements or patterns of movement for safe swallowing, protection of airway, oral hygiene, eating, drinking, breathing, voice and articulation.

Eligibility criteria: Inclusion Criteria:

* Patients with dysphagia caused by severe ABI

Exclusion Criteria:

* congenital brain damage, psychiatric diagnosis, history of head and neck cancer, agitated behaviour, need for tracheostomy tube

Primary outcomes:
measure: Change in swallowing frequency of saliva.
timeFrame: Change from baseline frequency of swallowing at three weeks.
measure: Change in swallowing quality of saliva (speed of laryngeal elevation)
timeFrame: Change from baseline quality of swallowing at three weeks.
measure: Change in swallowing quality of saliva (Range of movement of laryngeal elevation during swallowing)
timeFrame: Change from baseline quality swallowing at three weeks.
measure: Change in swallowing quality of saliva (time of pharyngeal closure during swallowing)
timeFrame: Change from baseline quality of swallowing at three weeks.
measure: Change in swallowing quality of saliva (pumping jaw movements before swallowing)
timeFrame: Change from baseline quality of swallowing at three weeks.
Secondary outcomes:
measure: Severity of Dysphagia
timeFrame: Baseline and three weeks
measure: Ability to eat and drink
timeFrame: Baseline and three weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03798340: Vibratory Perturbation-based Pinch Task Training for Stroke Patients
Official title: Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: stroke
perturbation-based training
task-specific motor training
recovery of function
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of unilateral cerebral infarction or hemorrhage
2. Be able to perform a pinch task with the thumb and index finger
3. With premorbid right-handedness

Exclusion Criteria:

1. Subject has a uncontrolled hypertension
2. Subject has major cognitive-perceptual deficits
3. Subject has other brain disease

Primary outcomes:
measure: Change in the result of Fugl-Meyer assessment for UE motor function
timeFrame: baseline, endpoint (6 weeks) and follow up (18 weeks)
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, endpoint (6 weeks) and follow up (18 weeks)
measure: Change in the result of Box and blocks test
timeFrame: baseline, endpoint (6 weeks) and follow up (18 weeks)
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, endpoint (6 weeks) and follow up (18 weeks)
measure: Change in the result of Motor Activity Log
timeFrame: baseline, endpoint (6 weeks) and follow up (18 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
citation: Hsu HY, Kuan TS, Tsai CL, Wu PT, Kuo YL, Su FC, Kuo LC. Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):811-818. doi: 10.1016/j.apmr.2020.11.004. Epub 2020 Dec 2.
Clinical trial NCT06511440: Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database
Official title: Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Crystalvue Medical Coporation
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 285
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: The objective of this study is to establish the Reference database of Vision-700.

Detailed description: The objective is to collect and establish the Reference database of Vision-700, which is expected to recruit subjects with normal vision to collect the optical coherent tomography measurement data.

Eligibility criteria: Inclusion Criteria:

1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes bilaterally
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better bilaterally

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging.
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images.
3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%
4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits."
5. History of leukemia, dementia or multiple sclerosis.
6. History of hydroxychloroquine or chloroquine use.
7. Subjects with photosensitivity.
8. Subject having Photodynamic therapy (PDT) within 6 months.
9. Subjects taking photosensitivity drug currently.

Primary outcomes:
measure: The reference OCT data
timeFrame: 2022/09/01
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Tri-Services General Hospital
Study officials:
affiliation: Tri-Services General Hospital
name: Liang I-Chia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602640: Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit
Official title: Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: sedation
critical care
morphine
fentanyl
analgesic based sedation
Lead sponsor: Clínica de Los Andes IPS
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.


Eligibility criteria: Inclusion Criteria:

* Adults admitted to ICU requiring mechanical ventilation Informed consent

Exclusion Criteria:

* Less than 18 years old
* Consent denial

Primary outcomes:
measure: Time from sedation discontinuation to first T-Tube time from sedation
timeFrame: 12-120 hours
Secondary outcomes:
measure: Time from sedation discontinuation to extubation time from sedation
timeFrame: 12-180 hours
Other outcomes:
Locations:
city: Tunja
country: Colombia
facility: Clinica de los Andes IPS
state: Boyaca
Study officials:
affiliation: Clinica de los Andes IPS
name: Efrain Riveros, Principal investigator
role: PRINCIPAL_INVESTIGATOR
References: