louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06546800: SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
Official title: SPECIAL INVESTIGATION FOR ABRYSVO INTRAMUSCULAR INJECTION -INVESTIGATION IN INDIVIDUALS AGED 60 YEARS OR OLDER-
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Syncytial Virus Infection
Keywords: Respiratory syncytial virus infection
RSV Vaccine
Individuals aged 60 years or older
Post Marketing Study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 1100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time.

Brief summary: This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.


Eligibility criteria: Inclusion Criteria:

1. Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Those who have previously participated in the clinical trials of this product will be excluded.
2. Vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study.

Exclusion Criteria:

-There are no exclusion criteria for this study.

Primary outcomes:
measure: Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination.
timeFrame: From the day of vaccination up to 28 days after vaccination.
measure: Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination.
timeFrame: From the day of vaccination up to 28 days after vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03233100: FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Official title: FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation - Functional
Depressive Symptoms
Anxiety Symptoms
Gut-Brain Disorders
Keywords: FMT
gut microbiota
gut-brain disorder
constipation
depression
anxiety
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled.
* Age ≥ 18 years
* Body mass index of 18-25 kg/m2.
* HAMA ≥ 14 and/or HAMD (17 items) ≥ 17

Exclusion Criteria:

* History of sever mental disorders such as schizophrenia and bipolar disorder
* History of organic intestinal disorders
* History of gastrointestinal surgery
* Pregnant or breast-feeding women
* Infection with enteric pathogen
* Usage of probiotics, prebiotics, antibiotics within the last month
* Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota.
* Patients who could not complete the follow-up

Primary outcomes:
measure: CSBMs per week
timeFrame: 12 weeks after treatment
measure: HAMA
timeFrame: 12 weeks after treatment
measure: HAMD
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: Wexner
timeFrame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
measure: PAC-SYM
timeFrame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
measure: Bristol Bristol PAC-SYM
timeFrame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
measure: PAC-QOL
timeFrame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Other outcomes:
measure: Gut microbiota analysis
timeFrame: pre, 4 weeks, 12 weeks
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00471900: Six Months DHEA Treatment in Female Adrenal Failure
Official title: Physiolocal Effects of 6 Months DHEA Substitutional Therapy in Female Adrenal Failure in a Randomised, Placebo Controlled and Overcrossed Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-05-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects of physiologically DHEA substitution is investigated in the model of female adrenal failure.


Eligibility criteria: Inclusion Criteria:

* Female,
* Adrenal insuficiency,
* Stable and safe anticonception,
* Stable hydrocortison substituation treatment.

Exclusion Criteria:

* Neoplastic and thromboembolic disease,
* Diabetes mellitus.

Primary outcomes:
measure: Quality of life parameteres, cardiovascular parameters, bodycomposition, exercise parameters, hormonal and serological parameters, fuel metabolisme.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical Dept. M, Aarhus University Hospital
name: Jens S Christiansen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04317300: Feasibility of Treatment for Vaping Cessation
Official title: The Feasibility of Treatment for Vaping Cessation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Vaping
Keywords: electronic cigarettes
vaping
e-cigarettes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 weeks of varenicline
Primary purpose: TREATMENT

Brief summary: Researchers are gathering information on the feasibility of treating e-cigarette users with 12-weeks of varenicline (Chantix®) in assisting with stopping the use of e-cigarettes.

Detailed description: Because the process of developing nicotine dependence and the reinforcing mechanisms of nicotine delivered in high concentrations are similar between tobacco cigarettes and newer generation electronic cigarettes, the investigators hypothesize that evidence based treatment approaches used in treating tobacco dependence should be effective in treating dependence on electronic cigarettes. Since there is no existing evidence base for treatment of electronic cigarette dependence, preliminary evidence is needed from feasibility and open label studies to guide in the development of future randomized clinical trials. In this study, vaping participants will be treated with a 12 week course of varenicline as well as have nicotine dependence counseling through a certified tobacco treatment specialist followed up 12 weeks post end of medication.

Eligibility criteria: Inclusion Criteria:

* ≥18 years and ≤65 years of age;
* No use of tobacco in any form (except E-cigarettes) in the past 3 months;
* currently using e-cigarettes

Exclusion Criteria:

* Current moderate or severe depression
* Use of any treatments for tobacco dependence within the past 30 days;
* Recent history (past 3 months) of abuse of, or dependence on, a substance other than nicotine;
* Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase, or a male who is able to father a child, and are not willing to use a reliable form of contraception,
* Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty; or d) an untreated cardiac dysrhythmia;
* Subject currently has cancer \[excluding non-melanoma skin cancer\] not in remission;
* Known allergy to varenicline;
* Subject has a medical condition deemed by the investigators to be exclusionary to the study.

Primary outcomes:
measure: Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Jon Ebbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02681900: Exploring Whether Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
Official title: Exploring Whether Experimentally Manipulated Self-affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Health Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Sussex
Sponsor class: OTHER
Collaborators: name: Economic and Social Research Council, United Kingdom
First posted: 2016-02-15
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health message detailing the risks of alcohol consumption, (ii) engagement with the health message and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete a self-affirmation manipulation, where they reflect on their most important values, whereas the other half complete a control equivalent, where they reflect on their least important values. Immediately post-intervention, all participants then receive information about the risks of alcohol consumption and complete measures of message acceptance and engagement with the materials. Seven days after intervention, participants self-report their alcohol consumption in the previous 7 days.


Eligibility criteria: Inclusion Criteria:

* Female
* Drinkers

Exclusion Criteria:

* Male
* Non-drinkers

Primary outcomes:
measure: Alcohol consumption 7 days after intervention
timeFrame: 7 days after intervention
Secondary outcomes:
measure: Effect of intervention on acceptance of health information
timeFrame: Immediately after intervention
measure: Effect of intervention on engagement with health information
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Falmer
country: United Kingdom
facility: University of Sussex
state: Brighton
Study officials:
affiliation: University of Sussex
name: Kerry J Fox, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox KJ, Harris PR, Jessop DC. Experimentally Manipulated Self-Affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Information. Ann Behav Med. 2017 Dec;51(6):931-935. doi: 10.1007/s12160-017-9912-2.
Clinical trial NCT01430000: Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Official title: Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Hepatitis C
Lead sponsor: Medgenics Medical Israel Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.

Detailed description: The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.

Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure

Eligibility criteria: Inclusion Criteria:

* Signed patient consent form
* Chronic HCV patients in relapse following conventional treatment regimen (INF+Ribavirine) with detectable plasma level of HCV RNA
* Hepatitis B and human immunodeficiency virus negative at screening visit
* Able and willing to follow contraception requirements
* Screening laboratory values, test, and physical exam within acceptable range

Exclusion Criteria:

* Current enrollment in another investigational device or drug study
* Anticipated inability to complete all clinic visits and comply with study procedures
* History of, or any current medical condition, which could impact the safety of the subject during the study
* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
* Alcoholism or substance abuse with \<6 documented months of sobriety
* Known allergy or sensitivity to interferons or ribavirin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study

Primary outcomes:
measure: Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients using InfraDure Biopump
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Prof. Eithan Galun Gene Therapy Institute, Hadassah Medical Center Ein Kerem, Jerusalem, Israel
Study officials:
affiliation: No affiliation
name: Eithan Galun, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00770900: Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
Official title: Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 83
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic in patients with persistent asthma treated with montelukast


Eligibility criteria: Inclusion Criteria:

Patients Between 2-18 Years With Persistent Asthma

Exclusion Criteria:

Patients \> 18 Years Old And \< 2 Years Old

Primary outcomes:
measure: Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01951300: 68Ga-Citrate PET of Healthy Volunteers
Official title: 68Ga-Citrate Positron Emission Tomography (PET) of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-09-26
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates whole-body distribution kinetics of intravenously administered Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT). Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.

Detailed description: Six healthy male volunteers are recruited in this study. Gallium-68 citrate radiopharmaceutical is intravenously injected as a bolus and whole-body distribution kinetics are studied by dynamic whole-body positron emission tomography/computed tomography. During imaging, serial venous blood samples are drawn, plasma is separated and radioactivity is measured by gamma counter. Immediately after imaging session, urine is voided and radioactivity is measured by gamma counting. As a final point, radiation dosimetry due to single Gallium-68 citrate injection is determined.

Eligibility criteria: Inclusion Criteria:

* healthy 18-100 year-old men

Exclusion Criteria:

* ongoing infection/inflammation proven by blood or other tests

Primary outcomes:
measure: Whole-body distribution of Gallium-68 citrate
timeFrame: 4 hours
Secondary outcomes:
measure: Absorbed dose
timeFrame: 4 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital/Turku PET Centre
Study officials:
affiliation: Turku University Hospital
name: Anne Roivainen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03640000: Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy
Official title: Acute Changes in Bioimpedance During Cardia Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Systolic
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 60
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
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

Detailed description: Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.

Eligibility criteria: - Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.

Primary outcomes:
measure: Optimization of Bioimpedance measurements
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Hans Henrik Odland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02438800: Video Counseling for Effective Postpartum Contraception
Official title: Video Counseling for Effective Postpartum Contraception: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Postpartum Period
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized clinical trial to evaluate if the addition of long-acting reversible contraception (LARC) focused video-counseling during prenatal care increases uptake of postpartum LARC.

Detailed description: Eligible participants will be identified in the prenatal period and will be randomized to one of two groups. The control group will receive the standard of care contraceptive counseling during prenatal counseling. The intervention group will also receive the standard of care contraceptive counseling during prenatal care, but will also watch an evidence-based,12 minute LARC First video created by the CHOICE project which provides information on different contraceptive methods. All participants will receive information regarding access to free LARC methods in the postpartum period. All participants will be called at 12 weeks postpartum. Independent of randomization arm, they will all undergo a 5-minute survey by phone about contraceptive method choice and use.

Eligibility criteria: Inclusion Criteria:

* woman presenting for routine prenatal care visit at University of North Carolina (UNC) Resident Continuity Clinic
* least 18 years old
* fluent in English
* able to read to a third-grade reading level
* not planning sterilization for postpartum contraception
* at least 28 weeks gestation at time of enrollment

Exclusion Criteria:

* those who do not meet the previously outlined inclusion criteria
* those who are unable to provide informed consent.

Primary outcomes:
measure: Number of women who received an intrauterine device (IUD) or implant by 12 weeks postpartum
timeFrame: 12 weeks postpartum
Secondary outcomes:
measure: Proportion of women using any contraceptive method at 12 weeks postpartum
timeFrame: 12 weeks postpartum
measure: Proportion of women who attended a postpartum visit
timeFrame: 12 weeks postpartum
measure: Proportion of women answering agree or strongly agree to the following statement "I would recommend birth control counseling by video to a friend."
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Women's Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jessica Morse, MD
role: PRINCIPAL_INVESTIGATOR
References: