louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804284: Database Surveillance Safety Study of PENTACEL® Vaccine
Official title: Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae
Keywords: DAPTACEL®
PENTACEL®
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type b
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 62538
Sex: MALE
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects

Brief summary: The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.

Detailed description: The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.

Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.

Eligibility criteria: Inclusion Criteria:

* Receipt of DTaP vaccine during the study period by a previously unvaccinated child

Exclusion Criteria:

* None

Primary outcomes:
measure: A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
timeFrame: Up to 6 months post -dose 4 DTap Vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
state: California
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30.
Clinical trial NCT05741684: iCBT and ABM for Reducing Depressive Symptoms in Firefighters
Official title: Combining Internet-Delivered Cognitive Behavioral Therapy and Attention Bias Modification for Depression in Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Kungming Training Corps of National Fire and Rescue Administration
First posted: 2023-02-23
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to examine the impact of a combined internet-delivered Cognitive Behavioral Therapy (iCBT) and Attention Bias Modification (ABM) intervention to reduce depressive symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 138 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ABM exercises on alternating days and concurrently underwent four modules of iCBT courses delivered through a smartphone application.


Eligibility criteria: Inclusion Criteria:

* being an active firefighter and aged between 18 and 50
* having a score greater than zero on the Patient Health Questionnaire-9 (PHQ-9)
* with no history of severe depression

Exclusion Criteria:

* having suicidal ideation or intent
* having an active psychotic disorder other than depression
* prior participation in a cognitive-behavioral intervention
* concurrent participation in another study.

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: Immediately Post-intervention
measure: Attention Bias Score
timeFrame: Baseline
measure: Attention Bias Score
timeFrame: Immediately Post-intervention
measure: Attention Bias Variability
timeFrame: Baseline
measure: Attention Bias Variability
timeFrame: Immediately Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming Training Corps of the National Fire and Rescue Administration
state: Yunnan
Study officials:
References:
Clinical trial NCT03135184: HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Official title: HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Homozygous Familial Hypercholesterolemia
HoFH
Lead sponsor: HDL Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: MedStar Heart and Vascular Institute
First posted: 2017-05-01
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, unblinded, interventional study
Primary purpose: TREATMENT

Brief summary: Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System

Detailed description: The PDS-2™ System is intended to reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia (HoFH). Subjects will receive serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics' PDS-2 System.

Eligibility criteria: Key Inclusion Criteria:

* Clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) due to a defect in the LDL receptor, or the identification of a defect in apoB-100, or a gain of function of PCSK9, or a genetic defect resulting in the HoFH clinical phenotype
* No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion
* At least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study segment(s) will have 20% to 40% stenosis.

Key Exclusion Criteria:

* Planned change in current lipid lowering therapy
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* LDL or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint
* New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of enrollment

Primary outcomes:
measure: Change in coronary atheroma
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center (CSMC)
state: California
Study officials:
References:
Clinical trial NCT04962984: Thrombin Generation in Beta-thalassemia Major
Official title: Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Beta Thalassemia Major Anemia
Keywords: Beta Thalassemia Major; hypercoagulability; thrombin generation test
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait


Eligibility criteria: Inclusion Criteria:

* Patient with de Beta-thalassemia major
* Patient with regular blood transfusion regimen (every 4 - 6 weeks)
* informed and signed consent
* weight \> 30kg
* Hemoglobin \> 7g/dL

Exclusion Criteria:

* Emergency situation
* Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
* women of childbearing age without contraception
* pregnancy
* deprivation of liberty
* no consent

Primary outcomes:
measure: Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00874484: Enoxaparin as Treatment for Vulvodynia
Official title: Enoxaparin as Treatment for Vulvar Vestibulitis Syndrome - Vulvodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvodynia
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2009-04-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that injections of Low molecular weight heparin (LMWH) \[enoxaparin\] will reduce pain in women with vulvodynia.


Eligibility criteria: Inclusion Criteria:

* women with vulvodynia

Exclusion Criteria:

* women without vulvodynia

Primary outcomes:
measure: vestibular pain
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital- Nahariya
Study officials:
References:
citation: Farajun Y, Zarfati D, Abramov L, Livoff A, Bornstein J. Enoxaparin treatment for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):565-72. doi: 10.1097/AOG.0b013e3182657de6.
Clinical trial NCT05616884: Cemented vs. Cementless Unicompartmental Knee Arthroplasty
Official title: A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Partial Knee Replacement
Keywords: osteoarthritis
partial knee replacement
cementless
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial, unblinded
Primary purpose: TREATMENT

Brief summary: The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

Detailed description: This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.

Eligibility criteria: Inclusion Criteria:

* Age18-85 years old
* medial fixed bearing partial knee replacement
* bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.

Exclusion Criteria:

* Non-English speakers
* current smokers
* grossly porotic bone
* advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
* previous high tibial osteotomy with prior hardware
* patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts

Primary outcomes:
measure: Knee Society Score
timeFrame: 2 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: Robert Hopper
role: STUDY_CHAIR
References:
Clinical trial NCT06346184: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2303 and Co-administration of RLD2302 and RLD2102 in Healthy Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ sitSBP \<140 mmHg, 50 mmHg ≤ sitDBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~48 hours
measure: Cmax
timeFrame: 0~48 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~48 hours
measure: Tmax
timeFrame: 0~48 hours
measure: t1/2
timeFrame: 0~48 hours
measure: CL/F
timeFrame: 0~48 hours
measure: Vd/F
timeFrame: 0~48 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06994884: Patients' Experiences of Information After Total Knee Arthroplasty - A Qualitative Interview Study
Official title: Patients' Experiences of Information After Total Knee Arthroplasty - A Qualitative Interview Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthrosis
Total Knee Arthroplasty
Keywords: total knee arthroplasty
qualitative research
knee osteoarthrosis
primary care
physical therapy specialty
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2025-05-29
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from two hospitals in Region Västra Götaland, Sweden. Mölndal Hospital is located in the city of Gothenburg, while Alingsås Hospital is situated in the smaller city of Alingsås and also serves a rural population.

Brief summary: The aim of this qualitative interview study is to gain new and in-depth knowledge about patients' experiences of information following total knee arthroplasty. Participants will be interviewed in the recovery phase after surgery. Researchers will use a semi-structured interview guide. The interviews will be analysed with qualitative content analysis.

Detailed description: A qualitative interview study will be conducted. Interviews will be conducted 24-28 weeks after total knee arthroplasty. A semi-structured interview guide will be used to answer the following research questions:

* What are the patients' positive and negative experiences of the information provided before and after total knee arthroplasty (TKA)?
* What are the patients' experiences and perceptions regarding the content and scope of the information, as well as how and when it is communicated?
* What are the patients' experiences and perceptions of their access to information?
* What are the patients' experiences and perceptions of the significance of the information for postoperative care and their expectations of the surgical outcome?
* How do patients perceive the information provided before and after surgery in relation to their expectations of the information?
* How do patients think the information provided before and after TKA could be improved?

Eligibility criteria: Inclusion Criteria:

* Men and women of all ages who have undergone total knee arthroplasty due to osteoarthritis and are undergoing rehabilitation in primary care.

Exclusion Criteria:

* Previous joint replacement in the hip or knee.

Primary outcomes:
measure: Qualitative content analysis
timeFrame: Interviews will be performed 24-28 weeks after total knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04142684: Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis
Official title: Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unilateral Diaphragmatic Paralysis
Keywords: Unilateral Diaphragmatic Paralysis
Diagnose
Phrenic Nerve
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suspected unilateral diaphragmatic paralysis with available Pdi and PNC data.

Brief summary: The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

Detailed description: Inpatient patients in Raymond Poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization.

Period of date collected: November 2015 to June 2018.

The reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. The medical history, physical findings, and all available investigations including imaging studies, ENMG, lung function tests, and Pdi measurement were considered during the meeting.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years;
* Available data of Pdi and PNC;
* Suspected unilateral diaphragmatic paralysis.

Exclusion Criteria:

* Abnormalities in thoracic wall which susceptible to modify the investigation's results;
* Scoliosis;
* Pleural effusion.

Primary outcomes:
measure: Diaphragm evaluation-compound muscle action potential
timeFrame: at 1 month
measure: Diaphragm evaluation-transdiaphragmatic pressure
timeFrame: at 1 month
Secondary outcomes:
measure: Spirometry
timeFrame: 1 month
measure: Lung volume measurements
timeFrame: 1 month
Other outcomes:
Locations:
city: Garches
country: France
facility: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France
Study officials:
affiliation: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE
name: Frédéric LOFASO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE
name: Vivien REYNAUD, MD
role: STUDY_DIRECTOR
References: