louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04455347: Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked
Official title: Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: COVID-19 Infection
Children
Acute Myocarditis
Kawasaki-like-syndrome
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 80
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a probable or a proven diagnosis of COVID 19 admitted for systemic acute inflammation and cardiac symptoms (cardiogenic shock or chest pain or clinical suspicion of acute myocarditis or left ventricular ejection fraction)

Brief summary: To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.


Eligibility criteria: Inclusion Criteria:

1. Patient with cardiac MRI or cardiac CT scan or thoracic CT scan admitted for acute inflammatory syndrome and cardiac compromise
2. Patient with PCR or antibodies test for COVID 19 (positive of negative)
3. Patient or parents of minor patients informed about collection of personal data for the study

Exclusion Criteria:

* Patient or parents refusing personal data collection

Primary outcomes:
measure: Imaging data at Baseline
timeFrame: Baseline
measure: Imagine data at Follow-up
timeFrame: During the 2 years follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker
Study officials:
affiliation: Hôpital Necker
name: Francesca Raimondi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aeschlimann FA, Misra N, Hussein T, Panaioli E, Soslow JH, Crum K, Steele JM, Huber S, Marcora S, Brambilla P, Jain S, Navallas M, Giuli V, Rucker B, Angst F, Patel MD, Azarine A, Caro-Dominguez P, Cavaliere A, Di Salvo G, Ferroni F, Agnoletti G, Bonnemains L, Martins D, Boddaert N, Wong J, Pushparajah K, Raimondi F. Myocardial involvement in children with post-COVID multisystem inflammatory syndrome: a cardiovascular magnetic resonance based multicenter international study-the CARDOVID registry. J Cardiovasc Magn Reson. 2021 Dec 30;23(1):140. doi: 10.1186/s12968-021-00841-1.
Clinical trial NCT00728247: Objective Kinematic Correlates of Palpatory Diagnosis
Official title: Objective Kinematic Correlates of Palpatory Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine
Keywords: Cervical Spine
Kinematics
Manipulation
Biomechanics
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2008-08-05
Enrollment: 10
Sex: ALL
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: Hypothesis: Kinematic parameters can be used to monitor changes in three-dimensional head movements after Manual Therapy treatments.

Subjects who have some level of cervical dysfunction will be examined by an experienced Osteopathic physician. During the clinical assessment of cervical lateral flexion, kinematic data will be recorded. Subjects will be treated using manual therapy techniques and kinematic data will be recorded again at set intervals after the treatment.

Detailed description: The physician providing treatment will use, depending on his professional judgment for each subject, one of four treatment modalities: (1) soft-tissue stretch, (2) myofascial release, (3) muscle energy, or (4) functional (indirect) method. These modalities are standard to the care and practice of osteopathic manual medicine, they are taught in the Osteopathic curriculum, and they are practiced each day at the Michigan State University Clinical Center.

After the initial treatment, there will be an immediate follow-up kinematic test to collect the 3-D motion data. Then, subjects will return for subsequent kinematic assessments at: 24 hours post treatment, 48 hours post treatment and seven days post treatment. At the seven day mark, subjects will be evaluated as in the initial assessment and the physician will use his professional judgment to determine if the subject would benefit from a second treatment. If so, then the process of treatment and kinematic assessment would occur a second time, with kinematic assessment 24 hours post treatment, 48 hours post treatment and seven days post treatment. A maximum of two treatment sessions will be performed.

Eligibility criteria: Inclusion Criteria:

* Males and Females over the age of 18 and up to 100 years of age

Exclusion Criteria:

* Pregnant women and minors

Primary outcomes:
measure: Three-dimensional kinematics
timeFrame: Same day, 24 hours, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Biomechanical Design Research Laboratory
state: Michigan
Study officials:
References:
Clinical trial NCT00698347: A Clinical Investigation of the M2a-Magnum™ Hip System
Official title: A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Hip
Arthritis
Rheumatoid Arthritis
Joint Disease
Bone Disease
Keywords: Total Knee Replacement
Total Knee Arthroplasty
Hip Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a-Magnum™ Hip System

Brief summary: The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System

Detailed description: This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.

This product was FDA cleared in 2004.

Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis
* Rheumatoid Arthritis
* Correction of Functional Deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision of previously failed total hip arthroplasty

Exclusion Criteria:

Absolute contraindications include:

* Infection, Sepsis, and Osteomyelitis

Relative contraindications include:

* Uncooperative patient or patient with neurologic disorders that are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease

Primary outcomes:
measure: Harris Hip Score
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of revisions, removals, and/or complications
timeFrame: Any time
measure: X-Rays
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research, Biomet Orthopedics, LLC
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02870647: Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Official title: Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2016-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.

Detailed description: The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.

The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.

Predictors of the clinical outcomes will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patient successfully\* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
* Signed and dated informed consent
* The subject will be available for postoperative follow-up beyond one year

Exclusion Criteria:

* Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
* Already included in another clinical study that could confound the results of this study
* Not available to attend routine follow-up visits
* Not able to understand the aim of the study and its procedures
* Minor age (according to local regulation)
* Drug / alcohol addiction or abuse
* Known pregnancy
* Under guardianship

Primary outcomes:
measure: The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).
timeFrame: 6 months
Secondary outcomes:
measure: The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale Niguarda Ca Granda
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Vigo
country: Spain
facility: CHU de Vigo
Study officials:
References:
Clinical trial NCT02769247: Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
Official title: Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Pain
Keywords: naproxen
lidocaine
intrauterine device
IUD
pain
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2016-05-11
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

Detailed description: This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

Eligibility criteria: Inclusion Criteria:

* DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
* age 18 years and older
* desiring Paragard or Mirena intrauterine device insertion

Exclusion Criteria:

* Current pregnancy
* cervical stenosis
* severe medical illness
* known allergy or sensitivity to lidocaine or naproxen
* peptic ulcer disease
* current pelvic inflammatory disease
* patients with known renal insufficiency
* patients using chronic NSAIDs or on chronic pain medication
* women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC

Primary outcomes:
measure: Pain Control With IUD Insertion
timeFrame: within 30 minutes after IUD insertion
Secondary outcomes:
measure: Physician Perceived Pain Control During IUD Insertion
timeFrame: within 30 minutes after IUD insertion
measure: Patient Satisfaction With IUD
timeFrame: 30 days post insertion
measure: Difficulty IUD Insertion
timeFrame: within 30 minutes of IUD insertion
measure: Perceived Pain 30 Days Post Insertion
timeFrame: 30 days post IUD insertion
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: WRNMMC
name: Susan Dunlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.
Clinical trial NCT05117047: A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma
Official title: Long-term Survival Analysis of Robotic, Laparoscopic and Open Liver Resection for Hepatocellular Carcinoma in BCLC Stage 0-A: A Prospective Cohort Study With Matched Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term Effects of Cancer Treatment
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 369
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR. Among these patients, there were 102, 333, and 669 HCC patients, respectively. Ten patients were excluded due to missing data or follow-up. Finally, 369 HCC patients in the early stages were included in the analysis. After PSM, 168 patients were matched and there were 56 patients in each group

Brief summary: The investigators established three prospective cohorts of patients with BCLC stage 0-A HCC, based on different surgical approaches (open, laparoscopic and robotic). After 5 years of follow-up, the investigators used propensity score matching (PSM) to reduce selection bias and then compared the long-term oncological outcomes of the three different surgical approaches, which might provide high-level evidence in non-randomized observational studies.

Detailed description: In this study, three prospective cohorts of patients with BCLC stage 0-A HCC, underwent complete liver resection using different surgical approaches (OLR, LLR, and RALR), were established. After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.

Eligibility criteria: Inclusion Criteria:

* All HCC patients in BCLC stage 0-A underwent liver resection in hepatic surgery center, Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology. The inclusion criteria were as follows: 14- 75 years old

Exclusion Criteria:

* with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.

Primary outcomes:
measure: Overall Survival
timeFrame: 14/02/2015-30/06/2021
measure: Disease free Survival
timeFrame: 14/02/2015-30/06/2021
Secondary outcomes:
measure: postoperative complications
timeFrame: 14/02/2015-30/06/2021
measure: Textbook Outcome in liver surgery (TOLS)
timeFrame: 14/02/2015-30/06/2021
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03168347: Assessing Patient Confidence in Biologic Medications
Official title: Assessing Patient Confidence in Biologic Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Decision making
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).

Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with psoriasis (ICD-9: 696.1)
* Age 18-80

Exclusion Criteria:

* Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
* Currently or previously managed with a biologic medication

Primary outcomes:
measure: Oral survey responses
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684447: Neural and Antidepressant Effects of Propofol
Official title: Neural and Antidepressant Effects of Propofol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Treatment Resistant Depression
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants randomized to the high dose will exit the study after treatment. Participants randomized to the low dose who have not experienced response are able to crossover to the high dose.
Primary purpose: TREATMENT

Brief summary: This study will compare the antidepressant effects of propofol at two different doses while measuring potential treatment-related biomarkers.

Detailed description: Aim 1: Compare the clinical antidepressant effects of high-dose versus low-dose propofol.

Aim 2: Characterize the dose-dependent effects of propofol on brain function and gene expression

Eligibility criteria: Inclusion Criteria:

Age 18-55 years Diagnosis of major depressive disorder or bipolar disorder Current moderate-to-severe depressive episode Episode duration more than 2 months and less than 5 years Failure of at least 2 adequate antidepressant medication trials within the past 2 years 16-item Quick Inventory of Depressive Symptomatology, self-rated (QIDS) \> 10 24-item Hamilton Depression Rating Scale (HDRS) \> 18

Exclusion Criteria:

Contraindication to propofol, egg lecithin, soybean oil, or other study drugs Lifetime history of a serious suicide attempt(Gvion and Levi-Belz, 2018) Recent suicidal behavior(past 3 months) Body mass index \> 40 kg/m2 Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication Symptomatic coronary artery disease or heart failure Poorly controlled hypertension or diabetes Abnormal kidney or liver function Pregnant or breast feeding Traumatic brain injury or significant neurologic signs (past year) Substance use disorder, moderate-to-severe(past 3 months) Obsessive compulsive disorder (past month) Post-traumatic stress disorder (past month) Schizophrenia-spectrum disorder (lifetime) Neurocognitive disorder (past year) Personality disorder as a current focus of treatment ECT within the past 3months Inappropriate for ECT, or poor response to ECT within the past 5 years Incompetent to provide consent

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: approximately 17 days after randomization
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: approximately 36 days after randomization
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University Neuropsychiatric Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Brian J Mickey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: