louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04307342: Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures
Official title: Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humerus Fracture
Keywords: humerus
fracture
osteosynthesis
Lead sponsor: Instituto Traumatologico Dr. Teodoro Gebauer Weisser
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2020-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in the emergency department of the Instituto Traumatológico for a fracture of the humerus

Brief summary: The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

Detailed description: The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

Clinical

* Pain
* ROM

Functional

* Constant Score
* MEPS
* QuickDASH

Radiological

- Bone union

Complications

* Infection
* Nerve injury

Eligibility criteria: Inclusion Criteria:

* Closed diaphyseal humerus fracture at the junction of the middle third with distal

Exclusion Criteria:

* Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma

Primary outcomes:
measure: Bone union
timeFrame: 6 months
Secondary outcomes:
measure: Pain (Quantity)
timeFrame: 1 month, 6 months, 1 year
measure: Range of Motion (Degrees of flexion, extension, pronation and supination)
timeFrame: 1 month, 6 months, 1 year
measure: Constant Score
timeFrame: 1 month, 6 months, 1 year
measure: Mayo Elbow Score
timeFrame: 1 month, 6 months, 1 year
measure: Quick Disabilities of the Arm, Shoulder and Hand
timeFrame: 1 month, 6 months, 1 year
measure: Radial nerve injury
timeFrame: 1 month, 6 months, 1 year
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto Traumatológico
state: Región Metropolitana
Study officials:
References:
Clinical trial NCT04452942: Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)
Official title: Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Coronavirus Disease 2019
SARS-CoV-2
Eicosanoids
Eicosanoid storm
Cytokine storm
Lead sponsor: EicOsis Human Health Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-01
Enrollment: 30
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 with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for COVID-19

Brief summary: This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.


Eligibility criteria: Inclusion Criteria:

1. Admitted to a hospital with symptoms suggestive of COVID-19.
2. Confirmed infection with SARS-CoV-2 as determined by polymerase chain reaction (PCR) or other commercial or public health assay in the 72 hours prior to hospital admission or any time during hospital admission.
3. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
4. Understands and agrees to comply with planned study procedures.
5. Agrees to the collection of whole blood samples.

Exclusion Criteria:

1. Inability to obtain informed consent.
2. Anticipated transfer to another hospital which is not a study site within 48 hours.
3. Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access).
4. Obstetric patients.
5. Prisoners.

Primary outcomes:
measure: Changes on eicosanoid lipid mediators
timeFrame: 10 days
measure: Changes on plasma levels of a panel of 40 human cytokines and chemokines
timeFrame: 10 days
Secondary outcomes:
measure: Severe clinical outcome
timeFrame: Through study completion, an average of 10 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References:
Clinical trial NCT05214742: Developing Derived Induced Pluripotent Stem Cells as a Model to Understand Imprinted Disorders
Official title: Developing Derived Induced Pluripotent Stem Cells From Blood as a Model for the Study to Understand Imprinted Disorders
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Induced Pluripotent Stem Cells
Lead sponsor: Institute of Cardiometabolism and Nutrition, France
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During their follow-up visit, parents and patients who meet the inclusion criteria will be asked to participate in the study. In the case of minors, their personal adhesion will be sought if their capacity of comprehension allows it after adapted written information.

Brief summary: Fetal and postnatal growth is finely regulated by genetic, epigenetic and environmental mechanisms. Parental imprinting is a regulatory mechanism that allows monoallelic expression of certain genes from a single parental allele through differential DNA methylation. Imprinted genes play a very important role in the control of fetal and postnatal growth. The pathophysiological mechanisms of these epimutations are largely unknown.

Studying the consequences of these epimutations on the molecular signature of the imprinted gene network in these patients would provide a better understanding of the epigenetic mechanisms regulating fetal growth. As these genes are weakly expressed in fibroblasts, these studies will be carried out on pluripotent stem cells or IPSCs (Induced Pluripotent Stem Cells).


Eligibility criteria: Inclusion Criteria:

1. Minor or young adult patients treated in the department, suffering from rare growth diseases: Silver-Russell syndrome (SRS), Beckwith-Wiedemann syndrome (BWS) and Temple syndrome (TS)
2. For minors, the patient's weight must be ≥ 5 kg

Exclusion Criteria:

* Patients unable to express their opposition to the use of their personal data.

Primary outcomes:
measure: The objective of the study is to understand the consequences of epimutations found
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Irène NETCHINE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608542: A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects
Official title: A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Japanese Volunteers
Keywords: fostamatinib
FosD
Japanese Healthy volunteers
Phase 1
Single and Multiple Dose Study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.

Detailed description: A Phase I, Open-label Study to Assess the Pharmacokinetics of Oral Fostamatinib in Healthy Japanese Subjects After Single and Multiple Doses

Eligibility criteria: Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) Japanese subjects
* 20 to 45 years of age
* Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg

Exclusion Criteria:

* History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
* Previous participation in a fostamatinib study

Primary outcomes:
measure: Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.
timeFrame: PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10
Secondary outcomes:
measure: Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG
timeFrame: Up to Day 20
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: AstraZeneca
name: Mark Layton, MD
role: STUDY_DIRECTOR
affiliation: PAREXEL Early Phase/California Clinical Trials Medical Group
name: David Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779542: Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification With Swept-Source Optical Coherence Tomography
Official title: Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification With Swept-Source Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Chamber Parameters
Phacoemulsification
Anterior Segment Swept-source Optical Coherence Tomography
Keywords: anterior chamber parameters
phacoemulsification
anterior segment swept-source optical coherence tomography
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent cataract surgery

Brief summary: To assess the changes of anterior chamber angle in patients with shallow anterior chamber and normal anterior chamber after phacoemulsification and intraocular lens implantation (IOL) using anterior segment swept-source optical coherence tomography (AS-SS-OCT).To observe the 60 eyes of 60 patients in our study.

Detailed description: This is a prospective case-control study; 60 eyes of 60 patients who underwent cataract surgery. Based on anterior chamber depth (ACD) and gonioscopy findings, the eyes are classified into two groups, shallow anterior chamber group (30 eyes) and narrow anterior chamber group (30 eyes). AS-SS-OCT was used to measure ACD and angle parameters (angle opening distance(AOD), angle recess area(ARA), trabecular iris space area（TISA）, and trabecular iris angle (TIA). Serial changes in each group were measured before and 3 months after phacoemulsification and IOL, and the differences between the two groups were compared.

Eligibility criteria: Inclusion Criteria: patients who underwent cataract surgery -

Exclusion Criteria:patients with mild cataracts do not require surgery

-

Primary outcomes:
measure: anterior chamber depth
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT04485442: Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face
Official title: Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face - a Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Cancer
Keywords: melanoma
SCC in the face
infiltrative basal cell carcinoma on the face
Mohs Surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with melanoma, SCC and /or infiltrative basal cell carcinoma on the face are eligible for the study and will be recruited at the Department of Dermatology and Plastic Surgery at University Hospital Basel.

Brief summary: This study is to evaluate the psychological well-being in patients diagnosed with skin cancer (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be included. All patients will receive questionnaires.


Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with melanoma, SCC and/or infiltrative basal cell carcinoma on the face for surgical treatment and planned for excision or Mohs surgery
* patients who are able to give informed consent

Exclusion Criteria:

* Electrodesication and curettage of the tumour

Primary outcomes:
measure: Change in Belastungs-Thermometer questionnaire
timeFrame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
Secondary outcomes:
measure: Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire
timeFrame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
measure: Change in WHO-DAS questionnaire
timeFrame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
measure: Change in FACE-Q questionnaire
timeFrame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
measure: Change in photos of the patients' tumors
timeFrame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel
Study officials:
affiliation: Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel
name: Dirk J Schaefer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247242: Physical Activity and Social Engagement for Persons With Disabilities in an Underserved Community
Official title: Physical Activity and Social Engagement Program for Persons With Disabilities and Chronic Health Conditions in an Underserved Birmingham Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Chronic Conditions, Multiple
Aging
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
First posted: 2022-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, Tarrant, Alabama. Participants will complete two six-week programs, specifically Lakeshore Online Fitness (Online) and Get Active with Virtual Reality (VR).

Detailed description: This project will utilize a cross-over randomized design where participants will initially be randomized into either the Online or VR intervention group. After completing the initial six weeks of the assigned intervention, participants will cross over and complete six weeks of the other intervention. No washout period is included due to several reasons, including no known washout period for certain socioemotional outcomes have been established by prior literature, ethical concerns in requiring return to baseline levels during washout, and a prolonged washout period would negatively impact participant adherence and retention to the study. Psychosocial metrics will be collected at the end of each activity session through surveys.

Eligibility criteria: Inclusion Criteria:

* Resident of Tarrant, Alabama
* 18 years or older with a physical disability or chronic health condition or older than 60 years
* Fluent in English

Exclusion Criteria:

* Visual impairment that interferes with television viewing

Primary outcomes:
measure: Change in Social Isolation from Baseline to 12 weeks
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Self-efficacy from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Loneliness from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Positive Affect from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Health-related quality of life from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Physical activity from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Enjoyment from Baseline to 12 weeks
timeFrame: 12 Weeks
measure: Change in Physical Function from Baseline to 12 weeks
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tarrant
country: United States
facility: Tarrant Parks and Recreation
state: Alabama
Study officials:
References:
Clinical trial NCT04716842: Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.
Official title: Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Keywords: sepsis
septic shock
angiotensin II
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group sepsis (n = 25): In intensive care patients with suspected or proven infection, if the SOFA score ≥2, the patients will be evaluated as sepsis and routine examination, monitoring and treatment will be applied.

Group septic shock (n = 25): Patients with sepsis who require vasopressor to keep mean arterial pressure above 65 mmHg and lactate\> 2 mmol/l will be included in the septic shock group.

Group Control (n = 25): It will be formed from patients who are hospitalized in the intensive care unit for a reason other than sepsis and septic shock, without suspected or proven infection.

Brief summary: Evaluation of plasma angiotensin II and angiotensin II receptor levels in patients with sepsis and septic shock: a prospective observational study.

Detailed description: There is an increasing number of experimental publications investigated effects of angiotensin II and receptors on the pathogenesis and treatment of sepsis and septic shock. However, its level in humans and its relationship with the severity of the disease has not been investigated. If angiotensin II plays a role in the diagnosis and prognosis of septic shock by evaluating this relationship in our study, it may be a biomarker to be used in future diagnosis, prediction of prognosis and treatment. This will enable early recognition and treatment of this disease, which causes high mortality and cost in intensive care units, thus increasing the survival rate and reducing the cost.

Eligibility criteria: Inclusion Criteria:

* intensive care unit patient

Exclusion Criteria:

* End-stage organ failure,
* immunodeficiency, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic) a life expectancy of less than 48 hours

Primary outcomes:
measure: angiotensin II levels
timeFrame: 0-3 days
measure: angiotensin II receptor I
timeFrame: 0-3 days
measure: angiotensin II receptor II
timeFrame: 0-3 days
Secondary outcomes:
measure: procalsitonine level
timeFrame: 0-3 days
measure: crp level
timeFrame: 0-3 days
measure: mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Ayse Belin B OZER
Study officials:
affiliation: Inonu University Faculty of Medicine
name: Ayse Belin B OZER
role: PRINCIPAL_INVESTIGATOR
References: