louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04774471: Advanced Diffusion Tensor MRI for Breast Cancer
Official title: Advanced Diffusion Tensor MRI for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Diseases
Keywords: Diffusion Tensor Imaging
MRI
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This three-year pilot study will be designed in two parts. The first phase will be a test phase, in which 10 volunteers (5 healthy volunteers and 5 volunteers with a known breast mass) will undergo a non-contrast breast MRI with non-fat-saturation T2 weighted imaging followed by a DTI protocol. The DTI data will be analyzed using the BIT-Motion software. During this phase, the scan technique and data analysis process will be optimized on the equipment at NorthShore University Healthsystem.

The second phase will then proceed with an accrual goal of 110 patients, scanning, data acquisition and analysis. The total accrual for this project is 120 subjects.

Brief summary: The purpose of this research is to evaluate the accuracy of the BIT-Motion (Breast Imaging Tensor-Motion) software with non-contrast MRI scanning to detect breast cancer.

Detailed description: The goal of this study is to answer the question: what is the ability of the BIT-Motion (Breast Imaging Tensor-Motion) software to detect and discriminate between benign and malignant breast lesions that are identified on mammogram (MG) and ultrasound (US) examinations. Women over the age of 18 who have a breast lesion that is seen on MG or US will be eligible to enroll. Participation in this study will involve one non-invasive non-contrast MRI scan of the breasts.

Eligibility criteria: Inclusion Criteria:

* Female
* scheduled for ultrasound or stereotactic guided breast biopsy
* \> 18 years of age
* able to tolerate up to 90 minutes in the MRI scanner

Exclusion Criteria:

* Male
* Has a medical condition that, in the opinion of the investigator, puts the subject at significant risk
* Has any contraindication to the MRI examination as determined by standard NorthShore University Health System relative to MRI safety
* Cannot comprehend or complete the Informed Consent Form

Primary outcomes:
measure: Pathologic diagnosis
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Jacob S Ecanow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578471: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Normal Hearing
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Electroencephalogram (EEG) data
timeFrame: 8 weeks
Secondary outcomes:
measure: Subjective Listening Effort rating
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Juliane Raether
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950971: Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation
Official title: Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation New Onset
Atrial Fibrillation Paroxysmal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.

Detailed description: After randomization, they are allocated to rhythm control strategy group or rate control strategy group. In rhythm control strategy group, patients are given amiodarone primarily for the purpose of sinus conversion of cardiac rhythm. In rate control strategy group, patients are given diltiazem or esmolol for the purpose of rate control. the rate of sinus conversion within 48 hours after treatment are compared.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Newly diagnosed atrial fibrillation or flutter
* Patients with atrial fibrillation or flutter that occurred within 7 days after non-cardiac non-thoracic surgery
* Atrial fibrillation or flutter with rapid ventricular response(HR ≥110/min)
* Patients without hemodynamic instability (MBP≥65mmHg with norepinephrine continuous infusion less than 5mcg/min or without vasopressor support)

Exclusion Criteria:

* Atrial fibrillation or flutter prolonged more than 48 hours without anticoagulation
* Patients who have decreased cardiac function or heart failure (EF \<40%)
* Patients who have cardiac conduction disorder, QT prolongation(QTc ≥500ms)

Primary outcomes:
measure: Rate of sinus conversion
timeFrame: within 48 hrs
Secondary outcomes:
measure: Time to first sinus conversion
timeFrame: during the same admission period
measure: Recurrence of atrial fibrillation
timeFrame: during the same admission period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hogeol Ryu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01625871: Artemether/Lumefantrine and Vivax Malaria
Official title: Artemether/Lumefantrine in the Treatment of Plasmodium Vivax Malaria in Eastern Sudan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vivax Malaria
Keywords: malaria
vivax
artemether/lumefantrine
Sudan
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: University of Kassala, Sudan
First posted: 2012-06-22
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The cure rate of artemether/lumefantrine in the treatment of vivax malaria.


Eligibility criteria: Inclusion Criteria:

* Patients with vivax malaria

Exclusion Criteria:

* severe malaria
* pregnancy

Primary outcomes:
measure: The cure rate
timeFrame: 28 days
Secondary outcomes:
measure: Fever clearance time
timeFrame: 28 days
measure: Parasite clearance time
timeFrame: 28 days
Other outcomes:
Locations:
city: Kassala
country: Sudan
facility: Kassala
Study officials:
References:
citation: Makanga M, Krudsood S. The clinical efficacy of artemether/lumefantrine (Coartem). Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S5. doi: 10.1186/1475-2875-8-S1-S5.
citation: Abdallah TM, Ali AA, Bakri M, Gasim GI, Musa IR, Adam I. Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan. Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.
Clinical trial NCT03331471: Alveolar Recruitment Maneuver During Pneumoperitoneum
Official title: Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
Primary purpose: PREVENTION

Brief summary: Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic surgery.

Detailed description: Peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary mechanics. Especially in the eldery, decreased pulmonary function might aggravate negative response to pneumoperitoneum. Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics. Investigator designed this study for comparision of the incidences of pulmonary complications after applying alveolar recruitment maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.

Eligibility criteria: Inclusion Criteria:

* over 65 years, patients who undergoing elective laparoscopoic colorectal surgery for cancer under general anesthesia. ASA pysical status I or II

Exclusion Criteria:uncontrolled cardiovascular disease, obstructive pulmonary disorder, acute or chronic inflammatory lesion in lung.

Primary outcomes:
measure: lung complications
timeFrame: 2 days after laparoscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Kyung Cheon Lee
role: STUDY_CHAIR
References:
Clinical trial NCT02541071: Influence of the Noradrenergic System on the Formation of Intrusive Memories
Official title: Influence of the Noradrenergic System on the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether the activity of the noradrenergic system during an intrusion-inducing stressor influences subsequent intrusive memories.

Detailed description: The investigators conducted an experimental, double-blind, placebo-controlled study in 118 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg yohimbine, stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity, or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following four days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Eligibility criteria: Inclusion Criteria:

* healthy participants
* German on a native level

Exclusion Criteria:

* former or present DSM IV Axis I disorders
* physical illnesses
* any medication intake (except oral contraceptive)
* history of sexual abuse or rape
* pregnancy or lactation period

Primary outcomes:
measure: Number of intrusive memories
timeFrame: four consecutive days
Secondary outcomes:
measure: Vividness of intrusive memories
timeFrame: four consecutive days
measure: Degree of distress of intrusive memories
timeFrame: four consecutive days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry and Psychotherapy, Charité University Medicine Berlin, Campus Benjamin Franklin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan Roepke, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03054571: Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth
Official title: Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eruption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 91
Sex: ALL
Minimum age (years): 5
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected according to the following inclusion and exclusion criteria:

1. Inclusion criteria:

   1. Healthy infants aged 5-36 months.
   2. Absence of medical and congenital diseases.
   3. Full term infants.
   4. Residents of Cairo governorate.
2. Exclusion criteria:

Presence of natal and neonatal teeth.

Brief summary: This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.

Detailed description: Alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. The more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. For these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.

Eligibility criteria: Inclusion Criteria:

- Healthy infants aged 5-36 months. 2-Absence of medical and congenital diseases. 3-Full term infants. 4-Residents of Cairo governorate.

Exclusion Criteria:

* Presence of natal and neonatal teeth.

Primary outcomes:
measure: number of erupted teeth
timeFrame: around 2 months
Secondary outcomes:
measure: body mass index
timeFrame: around 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00160771: Biomechanics/Motion Analysis Laboratory Data Bank
Official title: University of Florida Biomechanics/Motion Analysis Laboratory Data Bank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kinematics
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biomechanical/Motion Analysis Laboratory

Brief summary: The purpose of the data bank is to collect data on joint motion.

Detailed description: Biomechanical aspects, including ground reaction forces, range of motion of involved extremities, EMG data and videotape records of human motion will be collected and stored as part of the normal clinical care of patients seen in the UF Biomechanics/Motion Analysis Laboratory. All persons seen in motion analysis laboratory will be told of study and asked to participate. Those agreeing to participation will give informed consent.

Eligibility criteria: Inclusion Criteria:

* Any person having joint analysis done for medical or personal need

Exclusion Criteria:

* None, any person having joint analysis done for medical or personal need and interested in participation will be asked to sign informed consent.

Primary outcomes:
measure: Range of Motion values
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: MaryBeth Horodyski, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01003171: Pharmacokinetics of MCS in Healthy Volunteers
Official title: An Open-Label, Multiple-Dose Study of MCS-2 to Examine the Pharmacokinetics of MCS and Other Components After Once-daily Oral Dosing in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
PK
MCS
Benign Prostatic Hyperplasia
Multi-Carotenoids
Healthy subjects
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-28
Enrollment: 12
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: This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.

Detailed description: This study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of MCS and other components after once-daily oral dosing for 21 days.

Subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. During the treatment phase, subjects will receive MCS, once-daily within one hour after the evening meal. After completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. Throughout each of these phases, blood samples will be collected and assayed for concentrations of MCS and other components. The duration of protocol participation is expected to be 77 days for each eligible subject who completes the study.

Eligibility criteria: Inclusion Criteria:

* Normal healthy volunteers
* 18 years of age or older

Exclusion Criteria:

* Subjects who can not comply with the study procedures or sign the informed consent form

Primary outcomes:
measure: Serum MCS and other components levels
timeFrame: 21 days
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05278871: Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Official title: A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Arm
Breast Cancer
Lead sponsor: Microelastic Ultrasound Systems Inc
Sponsor class: INDUSTRY
Collaborators: name: Duke Health
First posted: 2022-03-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors.

The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.


Eligibility criteria: Inclusion Criteria:

* Any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). Subjects must have completed all recommended adjuvant radiotherapy. Subjects who continue on systemic therapy may be included at the discretion of the treating physician.
* Subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion.
* Subjects taking hormonal therapy are eligible for inclusion
* Subject has any stage lymphedema

Exclusion Criteria:

* Active rash or skin tears/injury in bilateral upper extremities
* Subjects with history of contralateral breast cancer treatment

Primary outcomes:
measure: Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Susan McDuff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SY, Cardones AR, Doherty J, Nightingale K, Palmeri M. Preliminary Results on the Feasibility of Using ARFI/SWEI to Assess Cutaneous Sclerotic Diseases. Ultrasound Med Biol. 2015 Nov;41(11):2806-19. doi: 10.1016/j.ultrasmedbio.2015.06.007. Epub 2015 Aug 8.