louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04527367: Epidemiology and Long-term Outcome of Patients With VHD
Official title: Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Disease
Valvular Heart Disease
Aortic Valve Stenosis
Mitral Insufficiency and Aortic Stenosis
Mitral Stenosis
Coronary Artery Disease
Chronic Kidney Diseases
Keywords: Valvular Heart Disease
Aortic Valve Stenosis
Mitral Insufficiency
Coronary Artery Disease
Chronic Kidney Diseases
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 2500
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: Patients hospitalized in Medical University of Bialystok.

Brief summary: Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.

Detailed description: Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy.

Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment

Eligibility criteria: Inclusion Criteria:

* Valvular heart disease in moderate and severe stages

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Death
timeFrame: 3665 days
Secondary outcomes:
measure: MACCE
timeFrame: 3665 days
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Study officials:
affiliation: Medical University of Bialystok
name: Łukasz Kuźma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuzma L, Bachorzewska-Gajewska H, Kozuch M, Struniawski K, Pogorzelski S, Hirnle T, Dobrzycki S. Acute coronary syndromes and atherosclerotic plaque burden distribution in coronary arteries among patients with valvular heart disease (BIA-WAD registry). Postepy Kardiol Interwencyjnej. 2019;15(4):422-430. doi: 10.5114/aic.2019.90216. Epub 2019 Dec 8.
citation: Kuzma L, Malyszko J, Bachorzewska-Gajewska H, Niwinska MM, Kurasz A, Zalewska-Adamiec M, Kozuch M, Dobrzycki S. Impact of chronic kidney disease on long-term outcome of patients with valvular heart defects. Int Urol Nephrol. 2020 Nov;52(11):2161-2170. doi: 10.1007/s11255-020-02561-4. Epub 2020 Jul 14.
Clinical trial NCT00380367: Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
Official title: Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 110
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.


Eligibility criteria: Inclusion Criteria:

* Healthy Females Age 9 To 15 Years
* Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
* No Fevers 24 Hours Prior To The First Injection

Exclusion Criteria:

* Participant Had Received A Prior Vaccination With A HPV Vaccine
* Participant Has Allergies To Vaccine Component Including Aluminum And Yeast
* Participant Has (Human Immunodeficiency Virus) HIV Infection
* Participant Is Immunocompromised
* Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
* Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection

Primary outcomes:
measure: Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7
timeFrame: One month post-dose 3 (Month 7)
measure: Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study
timeFrame: Up to 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Garland SM, Anagani M, Bhatla N, Chatterjee S, Lalwani S, Ross C, Group T, Lin J, Luxembourg A, Walia A, Tu Y. Immunogenicity and safety of quadrivalent and 9-valent human papillomavirus vaccines in Indian clinical trial participants. Hum Vaccin Immunother. 2022 Nov 30;18(6):2105067. doi: 10.1080/21645515.2022.2105067. Epub 2022 Aug 23.
Clinical trial NCT00332267: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Official title: Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Endotoxemia
Healthy
Keywords: Sepsis
Hypoxia
Altitude Sickness
Endotoxin
Cytokines
Cerebral blood flow
Cerebral metabolism
Reactive oxygen species
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: H:S, Denmark
name: The Danish National Research Foundation, Denmark
First posted: 2006-06-01
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the present protocol is to study whether a low level of oxygen in the blood will affect the immune response to as well as cerebral blood flow and metabolism during an infection and, conversely, whether the acute systemic and cerebral physiologic response to hypoxia is modified by an ongoing inflammatory response.

Detailed description: The combination of acute infection and a low level of oxygen in the blood is a common phenomenon. Thus, acute hypoxia may complicate severe infections including severe sepsis. Conversely, healthy persons who ascend to moderately high altitudes, which will be associated with a lowering of the inspired oxygen level, may sustain an infection. Even so, it is unknown whether hypoxia modifies the systemic inflammatory response, or, conversely, whether the reaction to hypoxia is influenced by the presence of systemic inflammation. The present protocol aims to measure global cerebral blood flow, metabolism and net flux as well as the systemic response in healthy volunteers who are subjected to either normobaric hypoxia alone (N=12), low-dose IV endotoxin infusion alone (N=12), or a combination of endotoxin infusion and normobaric hypoxia (N=12).

Eligibility criteria: Inclusion Criteria:

* Healthy nonsmoking male
* Age 18-45 yrs

Exclusion Criteria:

Primary outcomes:
measure: Cerebral blood flow
timeFrame: 0, 9 hours
measure: Cerebral oxygen metabolism
timeFrame: 0, 9 hours
measure: Plasma cytokine content
timeFrame: 0, 4, 19, 12 hours
measure: Lake Louise Score
timeFrame: 0, 4, 9, 12 hours
measure: ESQ-C
timeFrame: 0, 4, 9, 12 hours
measure: Endotoxemia Score
timeFrame: 0, 4, 9, 12 hours
Secondary outcomes:
measure: Cerebral net flux
timeFrame: 0, 9 hours
measure: Mean arterial pressure
timeFrame: Hourly, 0 through 12 hours
measure: Heart rate
timeFrame: Hourly, 0 through 12 hours
measure: Oxygen saturation
timeFrame: Hourly, 0 through 12 hours
measure: Body temperature
timeFrame: Hourly, 0 through 12 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center of Inflammation and Metabolism, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Sarah Taudorf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Kirsten Moller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06716567: Maternal Determinants of Immunity to Influenza
Official title: Maternal Determinants of Immunity to Influenza (MADI-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccination; Infection
Maternal-Fetal Relations
Influenza
Immunoglobulins
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Institute for Medical Immunology, Université libre de Bruxelles
First posted: 2024-12-04
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women and non-pregnant women are recruited in parallel.
Primary purpose: BASIC_SCIENCE

Brief summary: The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.

Detailed description: The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims:

1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women;
2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women;
3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;

Eligibility criteria: Inclusion Criteria:

* Age over 18 and under 40 years.

Exclusion Criteria:

* Grade III/IV anemia
* Human Immunodeficiency Virus (HIV) infection
* Active bacterial infection
* Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
* Inability to understand the nature and extent of the study and the procedures required
* Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)
* Active neoplasia

Primary outcomes:
measure: Haemagglutination Inhibition Assay titre
timeFrame: 28 days post vaccination
measure: Haemagglutination Inhibition Assay titre
timeFrame: At delivery
Secondary outcomes:
measure: Haemagglutination inhibition assay titre
timeFrame: up to 11 months after vaccination
measure: Micro neutralization assay titre
timeFrame: up to 11 months after vaccination
measure: Influenza virus specific IgG titre
timeFrame: up to 11 month after vaccination
measure: Influenza virus specific IgG antibody avidity
timeFrame: up to 11 months after vaccination
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
Study officials:
References:
Clinical trial NCT04321967: Nitropaste in Breast Reduction
Official title: Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gynecomastia
Delayed Wound Healing
Keywords: Nitroglycerin paste
Scarring
Necrosis
Wound healing
Breast
Breast reduction
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who agree to participate will be randomized during their bilateral breast reduction procedure. Each patient will be randomized to "LEFT BREAST" or "RIGHT BREAST." The randomization result will determine which breast receives the nitroglycerin paste. Their breast reduction will be done using the Wise pattern, and all incisions will be sealed with Dermabond. At the conclusion of the procedure, 1g of topical nitroglycerin (2%) will be placed on the breast which the randomizer indicated. Patients will be monitored for AEs during the remainder of their hospital stay.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.

Detailed description: This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.

Eligibility criteria: Inclusion Criteria:

* Patients who are female and transmen
* Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
* Reduction must be performed via Wise incisional pattern

Exclusion Criteria:

* Patients who are male or transwomen
* Patients who are under 18 years of age

Primary outcomes:
measure: Change in Vancouver Scar Scoring (VSS)
timeFrame: First post-op visit (0 weeks post op) and last visit at 12 months
Secondary outcomes:
measure: Number of occurrences of wound breakdown
timeFrame: 12 months
measure: Number of side-effects of Nitroglycerin use
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter Taub, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260867: Essential Oils for Electrocautery
Official title: Utility of Aromatherapy in Reducing Burnt Flesh Smell, Decreasing Intraoperative Anxiety, and Improving the Patient's Overall Experience During Cutaneous Surgical Procedures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 111
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether essential oil aromatherapy could improve or eliminate the smell of burnt flesh from electrocautery and subsequently mitigate patient anxiety and discomfort during dermatologic skin surgery.

This is a randomized clinical trial. Approximately 210 electrocautery participants will be randomized to receive sham control/no aromatherapy or aromatherapy. Patients will be asked to complete a questionnaire after completion of the procedure to assess their experience. This study was a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Receiving same day cutaneous surgical procedure that requires electrocautery per protocol
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion)
2. Subject unwilling to sign an IRB approved consent form
3. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Primary outcomes:
measure: Self-reported perceptions of cautery smell on a 4-point likert scale
timeFrame: Immediately after surgery
measure: Patient reported anxiety State-Trait Anxiety Inventory (STAI-6)
timeFrame: Immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231567: Neurocognitive Rehabilitation After Hip Replacement
Official title: Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: hip replacement
neurocognitive rehabilitation
WOMAC questionnaire
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.


Eligibility criteria: Inclusion Criteria:

* Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.

Exclusion Criteria:

* Different diagnosis from hip osteoarthritis (eg. Fracture)
* Concomitant osteoarthrosis of the hip or knee with gait restrictions
* Lameness for more than six months
* Central nervous system or Peripheral nervous system disorders
* Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
* Systemic infectious disorders
* Cognitive impairment
* Neoplastic disorders
* Surgical revisions
* Intraoperative complications
* Suspected hip replacement infection
* Hip replacement with endoprosthesis.

Primary outcomes:
measure: Change of WOMAC Questionnaire from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Secondary outcomes:
measure: Change of Barthel Index from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
measure: Change of Visual Analogue Scale (VAS) from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
measure: Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
measure: Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
measure: Change of parameters of Gait Analysis from baseline to 24 weeks
timeFrame: baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Umberto I Hospital, Sapienza University of Rome
name: Vincenzo Maria Saraceni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00974467: Evaluating a Website for Parents of Injured Children
Official title: Evaluating a Website for Parents of Injured Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Post-Traumatic Stress Disorder
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills.

Detailed description: The purpose of the current protocol is to evaluate the ability of the AfterTheInjury website to increase parent knowledge and skills. Primary objective is to compare website condition vs control with regard to (a) immediate parent learning outcomes and (b) coping assistance provided by parents as reported at 6 wks. Secondary objective is to compare conditions as above with regard to child and parent PTS symptoms at 6 wks.

Eligibility criteria: Inclusion Criteria:

1. Children age 6 through 17 who sustained an injury within the past 2 months and their parents.
2. Have access to the Internet at home (for Stage 3 only)

Exclusion Criteria:

1. Parent does not read or understand English
2. Child's injury is due to participation in organized sports
3. Child's injury is due to suspected abuse or family violence

Primary outcomes:
measure: Scores on measure of parent knowledge re: traumatic stress and coping assistance.
timeFrame: 6 wks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Nancy Kassam-Adams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: