louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06251960: Demineralized Dentin Graft in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement
Official title: Comparison of Autogenous Completely Demineralized Dentin Graft Versus Partially Demineralized Dentin Graft Used in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Socket Preservation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 30
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: Thirty patients will be selected from outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking for extraction of non-restorable mandibular posterior teeth For the 1st group: the socket will be grafted with completely demineralized dentin graft after 3 days of extraction, followed by delayed implant placement after 4 months.

For the 2nd group: the socket will be grafted with partially demineralized dentin graft in in the same day of extraction, followed by delayed implant placement after 4 months.


Eligibility criteria: Inclusion Criteria:

* Patient medically free from systemic diseases.
* Patient with good oral hygiene.
* Age above 18 years.
* Presence of non-restorable mandibular premolar tooth due to caries, root resorption, roots fracture, etc.
* No acute infection is present.
* No history of bruxism.
* Patients prepared to comply with the follow-up and maintenance program.

Exclusion Criteria:

* Patients with systemic diseases that interfere with dental implant insertion.
* Pregnancy.
* Immunocompromised patients.
* Existence of non-treated generalized progressive periodontitis.

Primary outcomes:
measure: Histomorphometric evaluation:
timeFrame: 4 monhs
measure: Histomorphometric analysis
timeFrame: 4 months
measure: Bone density:
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Elsheikh
Study officials:
References:
Clinical trial NCT02719860: High Tea Consumption on Smoking Related Oxidative Stress
Official title: A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking Related Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer Prevention
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-03-25
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.


Eligibility criteria: Inclusion Criteria:

* FEV1 \< 85% and at least 25 pack-years of current or former smoking history.
* No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
* Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
* Not be pregnant or intending to get pregnant during the study period (women participants).
* Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
* Willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months)
* Willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months).
* Subjects cannot take mega-doses of vitamins during the trial. This is defined as more than 400 IU of vitamin E, 200 ug of selenium, or 1 gm of vitamin C per day, or more than the tolerable upper limits of any other supplement as defined in the Dietary Reference Intake panels developed by the Food and Nutrition Board under the Institute of Medicine. Such vitamin therapy must be discontinued at least 2 weeks prior to study entry.

Exclusion Criteria:

* Subjects immunosuppressed by virtue of medication or disease.
* Serious concurrent illness that could interfere with study regimen.
* Subjects with a history of invasive cancer within the past 5 years.
* Subjects who are drinking more than 5 cups of non-herbal tea per week.
* Subjects who cannot or are unwilling to consume caffeinated beverages.
* Subjects unable to perform forced expiratory maneuver during spirometry testing.
* More than one acute emphysema exacerbation within the last 6 month -period .
* Subjects on oxygen.
* Women with positive urinary pregnancy test.

Primary outcomes:
measure: Post-intervention change in urinary 8-hydroxydeoxyguanosine
timeFrame: Baseline and 6 months
measure: Post-intervention change in urinary 8-F2-isoprostanes
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00846560: Involvement of Lymphocyte Type B in Amyotrophic Lateral Sclerosis (ALS)
Official title: Involvement of Lymphocyte Type B in Amyotrophic Lateral Sclerosis (ALS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Amyotrophic lateral sclerosis and Healthy subjects

Brief summary: The involvement of Lymphocyte type B in Amyotrophic lateral sclerosis (ALS) patients will be compared to lymphocyte in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* ALS patients who could sign ICF.

Exclusion Criteria:

* No ALS patients age less than 18 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical center, Neurology Department
Study officials:
References:
Clinical trial NCT01802476: A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)
Official title: A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PD-0332991
Absolute Bioavailability Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)

Exclusion Criteria:

1. Any condition which could possibly affect drug absorption.
2. Pregnancy or actively nursing females, or females of childbearing potential.
3. A positive urine drug screen.

Primary outcomes:
measure: Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0 to 144 hours
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0 to 144 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 144 hours
measure: Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 to 144 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 to 144 hours
measure: Dose-Normalized Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 to 144 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 to 144 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 to 144 hours
measure: Systemic Clearance (CL)
timeFrame: 0 to 144 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0 to 144 hours
measure: Apparent Volume of Distribution after an Oral Dose (Vz/F)
timeFrame: 0 to 144 hours
measure: Volume of Distribution at Steady State after an IV Infusion (Vss)
timeFrame: 0 to 144 hours
Other outcomes:
Locations:
city: NOttingham
country: United Kingdom
facility: Pfizer Investigational Site
state: Nottinghamshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04254276: Musculoskeletal Pain of Neck and Shoulder Area in Female Office Workers: Relations Between Muscle Tone, Stiffness, Pain-pressure Threshold, Self-reported Pain Intensity and Physical Activity.
Official title: Musculoskeletal Pain of Neck and Shoulder Area in Female Office Workers: Relations Between Muscle Tone, Stiffness, Pain-pressure Threshold, Self-reported Pain Intensity and Physical Activity.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Pain
Neck Pain
Shoulder Pain
Keywords: Musculoskeletal pain
Muscle tone
Muscle stiffness
Pain-pressure threshold
Neck
Shoulder
Office work
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50-100 subjects are anticipated, all female, aged 20-60. Office work of at least 4 days per week with over 50% of time working with a computer is required.

Brief summary: The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity in female office workers. 50-100 participants aged 20-60 are anticipated.

Detailed description: The objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity.

Participants: 50-100 subjects, all female, aged 20-60 are anticipated.

Methods: Skeletal muscle tone and stiffness are measured using myotonometry. Pain-pressure threshold is measured using algometry. Prevalence of neck and shoulder area musculoskeletal pain is recorded using Nordic questionnaire. Self-reported pain intensity is measured using VAS scale. Self-reported physical activity is recorded using Baecke physical activity questionnaire.

Eligibility criteria: Inclusion Criteria:

* Office work (at least 4 day per week, 8 hours a day with over 50% working with a computer)

Exclusion Criteria:

* Prior neck trauma, neurological or oncological conditions, recent use of muscle relaxants or painkillers, obesity (BMI of \>30)

Primary outcomes:
measure: Relationship between muscle tone, stiffness and self-reported pain
timeFrame: March 1st 2020 - May 1st 2021
Secondary outcomes:
measure: Relationship between muscle tone, stiffness and pain-pressure threshold
timeFrame: March 1st 2020 - May 1st 2021
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00746876: Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
Official title: Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Hip
Fracture
Femoral neck
Hemiarthroplasty
Bipolar
Unipolar
Displaced femoral neck fractures
Lead sponsor: Sykehuset Asker og Baerum
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
First posted: 2008-09-04
Enrollment: 28
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Detailed description: Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* Displaced femoral neck fracture
* 70 years or older
* Ambulatory status: No walking aids
* No mental illness or impaired cognitive function

Exclusion Criteria:

* Pathological fracture (malignant disease)
* Ongoing systemic or local infection
* Radiologically presence of acetabular wear (osteoarthrosis)

Primary outcomes:
measure: Acetabular wear measured with radiostereometry
timeFrame: 24 months
Secondary outcomes:
measure: Harris hip score
timeFrame: 24 months
measure: Health-related quality of life (eq-5d)
timeFrame: 24 months
Other outcomes:
Locations:
city: Baerum
country: Norway
facility: Asker and Baerum Hospital
state: Rud
Study officials:
affiliation: Asker and Baerum hospital, Norway
name: Asbjørn Hjall, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05539976: A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Official title: An Open-label Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of healthy volunteers who are qualified based on training and experience in performing taste evaluations.

Brief summary: The purpose of this study is to develop taste profiles of iberdomide and mezigdomide drug substances and oral formulation prototypes in order to develop a pediatric oral form of iberdomide and mezigdomide.


Eligibility criteria: Inclusion Criteria:

* Participant is qualified based on training and experience.
* Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling.
* Participant is qualified based on training and experience.
* Senopsys LLC will provide all participants.
* Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling.

Exclusion Criteria:

* Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might confound the results of the study or places the participant at unacceptable risk if he or she were to participate in the study.
* Participant has a known hypersensitivity to mezigdomide, iberdomide, thalidomide, lenalidomide, or pomalidomide.
* Participant is a female that is pregnant, breastfeeding, or is a women of childbearing potential (WOCBP).

Primary outcomes:
measure: Taste Evaluation - Aromatic Identity
timeFrame: Up to 3 Months
measure: Taste Evaluation - Amplitude
timeFrame: Up to 3 Months
measure: Taste Evaluation - Mouthfeel
timeFrame: Up to 3 Months
measure: Taste Evaluation - Off-notes
timeFrame: Up to 3 Months
measure: Taste Evaluation - Aftertaste
timeFrame: Up to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Local Institution - 0001
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03167476: Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma
Official title: Comparative Study of microRNA Changes in Patients With Reactive Lymphoid Hyperplasia and Malignant Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Hyperplasia Lymphoid Reactive
Keywords: miRNA
biomarker
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
Collaborators: name: Chengdu Nuoen Biotechnologies, Inc.
name: Sichuan Cancer Hospital and Research Institute
First posted: 2017-05-30
Enrollment: 200
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: This research project will recruit a cohort of observational lymphoma patients. Diagnosis and immunophenotyping should be performed on FFPE tissues according to the WHO-classification system and reviewed by an in-house pathologist. Reactive hyperplasia controls will also be recruited to demonstrate the physiological level of different body-tissue miRNAs.

Brief summary: The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

The objectives are to:

1. validate a panel of tissue-specific miRNAs that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma.
2. investigate the physiological range of the miRNA panel in lymphoma and reactive hyperplasia subjects.
3. investigate the dysregulation of miRNA panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia.

This trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. The investigators will develop panels of miRNAs that are specific biomarkers of lymphoma, and assist clinical outcomes with these miRNAs.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years and above
* Has condition related to lymphoma or reactive lymphoid hyperplasia

Exclusion Criteria:

* Age below 18 years
* Known pregnancy
* lymph tissue cannot be accessed

Primary outcomes:
measure: The concentration of miRNA expression quantitated in absolute copy numbers and their correlation in patients with reactive hyperplasia and lymphoma.
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Jian Huang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01918176: Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
Official title: A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib In Healthy Subjects To Investigate The Potential Effect Of Antacid Treatment On The Pharmacokinetics Of A Single Oral Dose Administered Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Palbociclib
PD-0332991
Proton Pump Inhibitor
DDI
Healthy Volunteers
Pharmacokinetics
Rabeprazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.


Eligibility criteria: Inclusion Criteria:

* Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.

Exclusion Criteria:

* A positive urine drug screen, urine cotinine test or alcohol breath test.
* Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0-120 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-120 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0-120 hours
measure: Area Under the Curve from Time Zero to 72 hours
timeFrame: 0-72 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 0-120 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0-120 hours
measure: Time For the Last Quantifiable Concentration (Tlast)
timeFrame: 0-120 hours
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0-120 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0-120 hours
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: