louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06670170: A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF TWO FORMULATIONS OF PF-07976016 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Participants
Healthy Subjects
Human Volunteers
Normal Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.


Eligibility criteria: Key Inclusion Criteria:

* Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
* Willing to provide consent and follow study requirements
* Total body weight \>110lbs (50kg)

Key Exclusion Criteria:

* Any condition affecting drug absorption, clinically significant laboratory values
* HIV, HepB \& HepC
* Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or non-prescription drugs within a specified timeframe prior to the first dose of study intervention
* positive urine drug test at screening/admission
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Primary outcomes:
measure: Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
timeFrame: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events - TEAEs
timeFrame: From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00405899: Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Official title: Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis
Keywords: Allergy
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Pennsylvania Allergy and Asthma Research Foundation
First posted: 2006-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and Female patients aged 6 to 18 years being treated for allergies.

Brief summary: The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care.

Detailed description: This study will consist of five visits. Visit 1 will occur after subjects complete an initial clinical evaluation for allergy at this site. Subjects will select their treatment (allergy immunotherapy as compared to standard medical care) prior to enrollment in this study.

Visit 1 will include informed consent, review of inclusion and exclusion criteria and phlebotomy for the determination of serum interferon-gamma levels. At the end of this visit, diary cards to capture the frequency of symptoms of viral respiratory infections will be distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include review/exchange of diary cards, and phlebotomy for determination of serial serum interferon-gamma levels.

Eligibility criteria: Inclusion Criteria:

* Age 6-18 years of age
* History of allergic rhinitis as confirmed by previous allergy skin testing conducted within the past year
* Subjects assigned to the allergy immunotherapy must be prescribed therapy according to national recommendations using FDA-approved allergy extracts supplied by Greer Laboratories

Exclusion Criteria:

* Concurrent difficult to control asthma or an underlying immune deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Deborah Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00359099: Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening
Official title: Proposal for Retrospective Review of the Prevalence of Hepatitis C Infection in Adult Patients Who Underwent Congenital Heart Surgery Before Screening
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Keywords: Hepatic Medicine
Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-08-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: This is a retrospective chart review. We hypothesize that patients who have undergone congenital heart surgery, prior to screening of blood products have a significant risk of hepatitis C infection and all such patients would benefit from screening for hepatitis C.

Detailed description: The Adult Congenital Clinic at Emory Hospital routinely screens all patients who have had congenital heart surgery prior to 1992 for hepatitis C antibodies. It is currently not the practice norm for all congenital heart patients to receive hepatitis screening unless they are at a specialized clinic that has implemented a system. The question of hepatitis C serology is particularly important for this population as many of these patients develop heart failure and may require heart transplantation and immunosuppression.

This is a retrospective analysis examining the prevalence of hepatitis C in the Adult Congenital Clinic at The Emory Clinic. The current practice is to screen all adult congenital heart disease patients for hepatitis C. All Emory clinic charts reviewed will be of patients who had congenital heart surgery. Only information on patients who had surgery prior to 1992 will be used for this study. We will review approximately 1000 charts for this study.

Eligibility criteria: Inclusion Criteria:

* patients seen at Emory Adult Congenital Clinic
* patients \> 18 years of age
* underwent surgery for congenital heart disease prior to 1992

Exclusion Criteria:

* history of known hepatitis prior to congenital heart surgery
* history of intravenous drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: William T Mahle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02946099: Comparison Between Reciproc and Protaper Next
Official title: Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Necrosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.

Detailed description: Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.

Eligibility criteria: Inclusion Criteria:

* Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis

Exclusion Criteria:

* Patients on medication for chronic pain
* Patients with pre-operative pain.
* Patients having significant systemic disorders.
* Patients with two or more adjacent teeth requiring root canal therapy
* teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.

Primary outcomes:
measure: Post operative pain assessed with the Numerical Rating Pain Scale
timeFrame: Up to 48 hours post-instrumentation
measure: Post-obturation pain assessed with the Numerical Rating Pain Scale
timeFrame: up to 24 hours following obturation
Secondary outcomes:
measure: Time required to complete instrumentation
timeFrame: From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
citation: Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.
citation: Burklein S, Schafer E. Apically extruded debris with reciprocating single-file and full-sequence rotary instrumentation systems. J Endod. 2012 Jun;38(6):850-2. doi: 10.1016/j.joen.2012.02.017. Epub 2012 Apr 6.
Clinical trial NCT06940999: An Innovative Image-Based Method for Extensibility Assessment
Official title: Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertrophic Scar
Keywords: Image-based assessment
Scar extensibility assessment.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed-method design combining quasi-experimental and instrument validation approaches
Primary purpose: OTHER

Brief summary: This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.

Detailed description: 1. Quasi-experimental, single-group pre-post intervention:

   Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method.
2. Methodological validation approach: The image-based method will be tested for:

   * Reliability (test-retest, inter-rater)
   * Validity (concurrent validity against established tools and construct validity)

Eligibility criteria: Inclusion Criteria:

* History of clinically diagnosed scar contracture following thermal burns.
* Presence of scars (≥6 months post-burn) to ensure stability for accurate assessment.
* Scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities.
* Willingness to undergo a standardized physical therapy intervention.
* Ability to provide informed consent and comply with all study procedures.

Exclusion Criteria:

* Active infection, unhealed wounds, or unstable scars at the assessment site.
* Diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes).
* History of experimental or non-standard scar treatment within the last 3 months.
* Severe cognitive impairments or communication barriers that interfere with understanding or participation.
* Pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism.
* Concurrent participation in other physical therapy or rehabilitation studies targeting scar management.

Primary outcomes:
measure: Vancouver Scar Scale (VSS)
timeFrame: Baseline and three months after the intervention
measure: Firmness and pliability at the scar site
timeFrame: Baseline and three months after the intervention
measure: Proposed Image-Based Method
timeFrame: Baseline and three months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaimaa Mohamed Ahmed Elsayeh
state: New Cairo
Study officials:
affiliation: Cairo University
name: Shaimaa MA Elsayeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04779099: Trial of a Brief Psychological Intervention for Suicidal Patients with Borderline Personality Disorder in the Emergency Department
Official title: Pilot Randomized Controlled Trial of a Brief Psychological Intervention for Suicidal Patients with Borderline Personality Disorder in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Suicide and Self-harm
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When in crisis, people with borderline personality disorder (BPD) frequently seek care in emergency departments (EDs) often presenting with suicide and self-harm behaviour. There is no established evidence-based brief intervention for patients with BPD in ED settings, however a 4-session psychotherapeutic intervention for people with personality disorders in ED settings was tested in Australia and showed promising results in reduced health care utilization. The proposed pilot randomized controlled trial will assess the feasibility of delivering this 4-session intervention in the ED for people with BPD who present with suicidal ideation or self-harm with the aim of reducing health care utilization.


Eligibility criteria: Inclusion Criteria:

1. aged 16 or older
2. presenting to ED with self-harm and/or suicidal ideation; and
3. meeting criteria for BPD on the Structured Clinical Interview for DSM-5 Personality Disorders

Exclusion Criteria:

1. unable to give informed consent;
2. meeting DSM-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder I mania based on the Structured Clinical Interview for DSM-5 (28); and/or
3. IQ \< 70 based on the Wechsler Test of Adult Reading

Primary outcomes:
measure: Primary clinical outcome measure - Emergency Department Visits
timeFrame: 1, 3 and 6 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References:
Clinical trial NCT00741299: A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder
Official title: Association Between Tobacco Smoking and Bipolar Affective Disorder.Clinico-epidemiological, Cross-sectional, Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: bipolar affective disorder, Smoking
Lead sponsor: Tirat Carmel Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2008-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample will consist of all patients ascertained in database of Tirat Carmel Mental Health Center and Psychiatric Outpatients Clinic, Rambam Medical Center

Brief summary: The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)

Detailed description: An association exists between smoking and schizophrenia, independent of other factors and related to psychotic symptomatology. Only a few small descriptive studies have examined the prevalence and correlates of tobacco use among bipolar patients with conflicting results. Patients who smoke score higher on rating scales for psychotic symptoms than their non-smoking peers. While the association of smoking with psychotic symptomatology in schizophrenia is established, such association according to bipolar affective disorder has been reported in a few studies and remains unclear. Also a few studies reported about association of smoking with depressive and manic symptoms, and with suicidal behavior in bipolar patients. Thus further investigation of these issues is warranted.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 male or female
* DSM -IV criteria for bipolar I affective disorder
* Ability and willingness to sign informed consent for participation in the study

Exclusion Criteria:

* Unwillingness or inability to participate in the study

Primary outcomes:
measure: Relationship between smoking and other factors including: bipolar subtype, current and past clinical status, illness severity,history of a suicide attempts, age of bipolar onset, gender, education, social class, economic status.
timeFrame: One interview session
Secondary outcomes:
Other outcomes:
Locations:
city: Tirat HaCarmel
country: Israel
facility: Tirat Carmel Mental Health Center
Study officials:
affiliation: B. Rappaport Faculty of Medicine, Technion, Haifa
name: Anatoly Kreinin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreinin A, Novitski D, Rabinowitz D, Weizman A, Grinshpoon A. Association between tobacco smoking and bipolar affective disorder: clinical, epidemiological, cross-sectional, retrospective study in outpatients. Compr Psychiatry. 2012 Apr;53(3):269-74. doi: 10.1016/j.comppsych.2011.04.063. Epub 2011 Jun 12.
Clinical trial NCT00932399: Longitudinal Study of Weight Change Following Lower Limb Amputation
Official title: Weight Change, Physical Activity and Health Promotion in Veteran Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation Wound
Traumatic Amputation of Toe
Dysvascular Amputation of Lower Limb
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-07-03
Enrollment: 4549
Sex: MALE
Minimum age (years): 27
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Veterans who received care at a VISN20 medical facility between 1997 and 2008

Brief summary: The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.


Eligibility criteria: Inclusion Criteria:

"Exposed" cohort:

* incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20
* \>= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)
* \>=1 weight measured post amputation (2 months to 42 months post amputation)

"Unexposed" (comparison) cohort:

* no lower limb amputation during the study period
* no prior history of amputation
* \>= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").
* Alive at least 18 months after "baseline"

Exclusion Criteria:

* female (due to small number of women with lower limb amputations)
* lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)

Primary outcomes:
measure: % Weight Change From Baseline
timeFrame: At ~3 years after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Alyson J. Littman, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouldin ED, Thompson ML, Boyko EJ, Morgenroth DC, Littman AJ. Weight Change Trajectories After Incident Lower-Limb Amputation. Arch Phys Med Rehabil. 2016 Jan;97(1):1-7.e1. doi: 10.1016/j.apmr.2015.09.017. Epub 2015 Oct 8.