louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01855425: Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Official title: Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CerebroSpinal Fluid (CSF) Leak
Chronic Otitis Media
Otospongiosis
Otosclerosis
Pulsatile Tinnitus
Cholesteatoma
Lead sponsor: Carestream Health, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Predicate CT Scan and Investigational Cone Beam Scan
Primary purpose: DIAGNOSTIC

Brief summary: The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

Detailed description: The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Eligibility criteria: Inclusion Criteria:

* Subject must be 18-80 years of age
* Subjects has provided informed consent
* Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
* Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
* CBCT exam performed within a maximum of 2 days of the conventional CT.

Exclusion Criteria:

* Subjects under the age of 18 years, or over the age of 80 years
* Unable to collect all required case information
* Subjects not willing to consent, or consent is withdrawn
* Women in pregnancy or suspected of being pregnant confirmed by pregnancy test

Primary outcomes:
measure: Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Antwerp
country: Belgium
facility: Sint-Augustinus Hospital
city: Paris
country: France
facility: C.H.U Bicetre
Study officials:
affiliation: Johns Hopkins Medical Center
name: Douglas Reh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636125: Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Official title: Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Periprosthetic Infection
Oral Antibiotics
Revision Total Shoulder Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
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: Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections. As an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and C. acnes infection is not always obvious. Unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. Given high rates of positive C. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive C. acnes cultures for clinical decision making remains uncertain.

The purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder PJI with indolent organisms (C. acnes and CNS).


Eligibility criteria: Inclusion Criteria:

1. all patients undergoing single-stage revision arthroplasty with all implants exchanged,
2. all patients undergoing single-stage revision arthroplasty with some implants retained,
3. all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer

Exclusion Criteria:

1. patients with polymicrobial infection,
2. patients with infection by organisms other than P. acnes or Coagulase Negative Staphylococcus,
3. patients with clinical suspicion of infection but negative cultures,
4. patients with no preoperative or intraoperative signs of infection and only 1 positive culture.

Primary outcomes:
measure: Rate of Postoperative Infections
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04446325: Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
Official title: Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lateral Amyotrophic Sclerosis
Venous Thrombo-embolic Desease
Keywords: lateral amyotrophic sclerosis
venous thrombo-embolic desase
pulmonary embolism
deep venous thrombosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 227
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of brest universitary hospital during 2000 to 2019

Brief summary: Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association.

Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.


Eligibility criteria: Inclusion Criteria:

* patients with amyotrophic lateral sclerosis defined by revised El Escorial score criteria followed in competence centre of Brest Universitary Hospital during 2000 to 2019

Exclusion Criteria:

* no consent
* other neuro-degenerativ diseases

Primary outcomes:
measure: Number of venous thrombo-embolic eventsrate per year in amyotrophic lateral sclerosis patients followed between 2000 and 2019 in Brest universitary hospital
timeFrame: 19 years
Secondary outcomes:
measure: Number of predictiv factors of venous thrombo-embolism events in amyotrophic lateral sclerosis population followed in Brest universitary hospital between 2000 and 2019
timeFrame: 19 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04186325: Diaphragm Training Ultrasound
Official title: Ultrasound Assessment of Diaphragmatic Muscle Exercise in Mechanically Ventilated Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DIAPHRAGM -Ultrasound -Weaning -Mechanical Ventilation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult.

Mechanical ventilation after endotracheal intubation predisposes these patients to an increased incidence of pulmonary complications such as ventilator-associated pneumonia (VAP), increased risk of deep vein thrombosis, bedsores, increased hospital stay, and poor clinical outcome.

The weaning process from MV involves the reduction of ventilator parameters and Extubation. Daily, careful evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the MV.

The diaphragm which is the principal respiratory muscle provides nearly 75% of the resting pulmonary ventilation. However, In ICU patients, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis. Diaphragmatic dysfunction and atrophy is the main precipitating factor for difficult and successful weaning.


Eligibility criteria: Inclusion Criteria:

* patients attached to mechanical ventilation will be included in the study after the informed consent of the legal guardian.

Exclusion Criteria:

* Patients with severe acute lung injury, morbid obesity, chest wall deformity, direct diaphragmatic injury, cervical spine and patients who require neuromuscular infusion will be excluded from the study.

Primary outcomes:
measure: the incidence of diaphragmatic muscle atrophy
timeFrame: seven mechanical ventilation days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
References:
Clinical trial NCT04005625: Biotherapy Treatment on Features of Microcrystalline Polyarthritis
Official title: Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crystal-Induced Arthritis
Keywords: Crystal-Induced Arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crystal- induced arthritis Treated by biologic

Brief summary: The study will involve adult patient who had received any biologic agent for microcrystalline disease in western France (Tours, Le Mans, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018.

Investigators will answer retrospectively a questionnaire that covers patient and disease data, biologic agent use, efficacy and adverse events.

Detailed description: This is a retrospective multicentric study of all patients treated by biologic for microcrystalline disease in France in western France (Tours, Le Mans, Nantes, La Roche sur Yon, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018.

The investigators will collect all clinical (diagnosis of gout CCPD or hydroxyapatitis, tender and swollen joint count), biological (blood results: ESR, CRP, uric acid, synovial analysis), radiological data (X-rays performed and their description) .

Eligibility criteria: Inclusion Criteria:

* Crystal- induced arthritis
* Treatment by biologic
* In western France

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment duration
timeFrame: one year
Secondary outcomes:
measure: number of synovitis
timeFrame: inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHU Brest
name: Alain SARAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05800925: Triage Survey for Psychiatry Research Eligibility
Official title: Triage Survey for Psychiatry Research Eligibility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Borderline Personality Disorder
Generalized Anxiety Disorder
Lead sponsor: Adams Clinical
Sponsor class: NETWORK
First posted: 2023-04-06
Enrollment: 2000
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: Participants of any sex, age 18+, who have expressed interest in participating in an industry-sponsored clinical trial of an investigational product for indications in psychiatry will be screened for clinical appropriateness for a study trial.

Brief summary: TRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.


Eligibility criteria: Inclusion Criteria:

* Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
* Participant is at least 18 years old.

Exclusion Criteria:

* Participant is pregnant, breast-feeding, or planning to become pregnant.
* History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
* Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on C-SSRS questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
* Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
* Any condition that in the investigator's opinion makes a participant unsuitable for the study.
* Currently employed by Adams Clinical or a first-degree relative of an employee.

Primary outcomes:
measure: The proportion of participants who are eligible for industry-sponsored clinical trials, as defined as those who go on to screen for a study
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: The proportion of participants who enroll in industry-sponsored clinical trials
timeFrame: Up to 52 weeks
measure: The prevalence of disqualifying comorbid conditions that prevent screening or enrollment in industry-sponsored clinical trials
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Copley Clinical
state: Massachusetts
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
city: New York
country: United States
facility: Berman Clinical
state: New York
Study officials:
References:
Clinical trial NCT05427825: ERAS Anesthetic Care for Metastatic Spine Cancer Resection
Official title: Anesthetic Protocols for Enhance Recovery After Metastatic Spine Tumor Resection Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Bone Tumor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients in the treatment group received the study protocolized care bundle including multimodal anesthesia and HPI-assisted hemodynamic therapy.
Primary purpose: TREATMENT

Brief summary: Spinal metastases account for 60% of all malignant bone metastases and represent a medically important treatment goal. For patients with malignant tumors diagnosed at this stage, performing En bloc spondylectomy with wide margin of resection facilitate the improvement in quality of life including ambulatory ability, daily activities independence and attenuation of bone pain. However, En bloc spondylectomy is a major operation with long operation time and frequent hemodynamic instability during the operation. Therefore, the anesthetic care plays an important role and an enhanced recovery after surgery (ERAS) is the goal.

For the ERAS anesthesia protocol for En bloc spondylectomy, we propose two major components to achieve this goal: (1) an encephalographic spectrum guided multimodal anesthesia combined with ultrasound-guided nerve block and (2) the advanced machine-learning algorithm index, namely the hypotension predictive index (HPI) guided hemodynamic protocol.

Detailed description: The anesthetic protocol comprises of two major proposed components to enhanced recovery after spine cancer total en bloc resection. First, a multimodal general anesthesia consisting of GABAnergic hypnotic agent (propofol or sevoflurane), ketamine and dexmedetomidine was conducted by using the encephalographic density spectrum array. In addition, ultrasound-guided erector spinae plane block is applied. These techniques potentially prevent anesthesia induced delirium and may profoundly improve postoperative analgesic quality. Second, advanced hemodynamic monitoring device, namely the hypotensio predictive index, will be used for prevention of intraoperative hypotension and facilitate precise transfusion protocol.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing metastatic spine cancer resection surgery

Exclusion Criteria:

* Expected survival less than 6 months
* Previous surgery or radiotherapy for the spine metastasis

Primary outcomes:
measure: Postoperative quality of recovery-15 score (QoR-15)
timeFrame: 3 days
Secondary outcomes:
measure: Delirium incidence
timeFrame: 3 days
measure: Pain intensity
timeFrame: 3 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03142425: Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
Official title: Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Therapy
Lead sponsor: DxTerity Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-05
Enrollment: 150
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: Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.

Brief summary: Collect blood samples and associated clinical data prior to and post radiation treatment.

Detailed description: Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients age 18 or older
2. Diagnosed with a primary rectal or esophageal cancer
3. Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
4. Combining chemotherapy is allowed
5. ECOG Performance Status 0-2
6. Able to provide written informed consent

Exclusion Criteria:

1. Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
2. Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study

Primary outcomes:
measure: Collection of blood samples from patients prior to and post irradiation treatment.
timeFrame: Up to 4 months, from informed consent through follow up activities.
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Group
state: California
Study officials:
affiliation: President and CEO
name: Robert Terbrueggen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05459025: Effectiveness of Aromatherapy Yoga
Official title: Effectiveness of Aromatherapy Yoga in Stress Reduction and Sleep Quality Improvement Among Female College Students: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female College Students
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: College students, particularly female students, often suffer from severe stress and poor sleep. Aromatherapy yoga has become a popular exercise in recent years and may help reduce stress and improve sleep quality, although empirical evidence is limited. We investigated the effective-ness of aromatherapy yoga intervention in reducing stress and improving sleep quality among female college students. Eighty-nine participants (44 in the experimental group \[aromatherapy yoga\] and 45 in the control group \[yoga\]), with an average age of 19.88 ± 1.13 years, were en-rolled in this quasi-experimental study. Interventions were performed in the respective groups once a week for 12 weeks, for 90 minutes each time. The Wilcoxon signed-rank test and Mann-Whitney U test (including effect size) were used to test the differences in stress reduction and sleep quality before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* We included female college students aged \> 18 years, who were able to understand the questionnaire.

Exclusion Criteria:

* We excluded male students, those with a history of respiratory disease, asthma, or allergy to flowers, plants, or essential oils, those who worked at night, and those with a history of mental diseases.

Primary outcomes:
measure: Perceived Stress Scale 14 (PSS-14)
timeFrame: 10-15 minutes
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia Univeraity
state: WuFeng
Study officials:
References: