louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02035228: Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients
Official title: Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
Lung Hyperinflation
Abdominal Muscle
Functional Electrical Stimulation
Lead sponsor: Liberate Medical
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. As part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.


Eligibility criteria: Inclusion Criteria:

* Post-bronchodilator FEV1/FVC ratio of less than 0.7 and post-bronchodilator FEV1 between 30 and 80 % predicted.
* Current or former smokers with at least a 20 pack year smoking history
* Over the age of forty

Exclusion Criteria:

* Female subjects who are pregnant
* Subjects unable to give informed consent
* Subjects unable to perform required activities of the study (e.g. Six minute walk test)
* Subjects with an implanted electronic device (e.g. a cardiac pacemaker)
* Subjects who have had a chronic obstructive pulmonary disease exacerbation within 30 days prior to enrollment
* Considerable arthritic changes that limit exertion
* Patients on oral prednisone
* Patients with a hernia
* Patients with a history of pneumothorax within the last 5 years
* History of epilepsy
* History of Abnormal electrocardiogram suggestive of cardiac disease

Primary outcomes:
measure: Change in inspiratory capacity during 2 minutes of resting breathing when patients were seated
timeFrame: 2 minutes
measure: Change in inspiratory capacity during a 6 minute step test
timeFrame: 6 minutes
Secondary outcomes:
measure: Average tidal volume during 2 minutes of resting breathing while seated
timeFrame: 2 minutes
measure: Average minute ventilation during 2 minutes of resting breathing while seated
timeFrame: 2 minutes
measure: Average peak expiratory flow rate during 2 minutes of resting breathing while seated
timeFrame: 2 minutes
measure: Average breathing rate during two minutes of resting breathing while seated
timeFrame: 2 minutes
measure: Change in dyspnea measured using the modified Borg dyspnea scale during a 6 minute step test
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rodney Folz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171828: Tele-education in Ultrasound Training
Official title: Feasibility of Tele-education in Ultrasound Training: a Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Ultrasonography
Education, Medical, Continuing
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional Clinical Trial, Parallel Assignment
Primary purpose: OTHER

Brief summary: The study aims to assess the impact of remote guidance in ultrasound training for medical professionals new to abdominal ultrasound. It involves 40 participants, divided into two groups of 20 each - a self-study group and a remote learning group. Participants include licensed doctors with no prior training in abdominal ultrasound, who are over 18 years old and have consented to participate.

Detailed description: The study's design includes pre-surveys, random assignment, ultrasound training through educational videos, and distinct practice methods for each group - one with remote guidance and the other with traditional, in-person assistance. The effectiveness of training will be evaluated based on scores from evaluation forms, time taken for ultrasound imaging, frequency of requesting help, and surveys (NASA-Task Load Index, System Usability Scale, and a Self-confidence pre/post survey). Statistical analysis will be conducted using R software, employing tests such as the student t-test or Wilcoxon rank sum test.

This research is anticipated to provide valuable insights into the efficacy of remote guidance in ultrasound education, potentially influencing future medical training methodologies.

Eligibility criteria: Inclusion Criteria:

* Licensed doctor
* Participants who didn't receive prior training in abdominal ultrasound
* \> 18 years old

Exclusion Criteria:

- Individuals who do not agree to participate in the study

Primary outcomes:
measure: Ultrasound Skill Evaluation Scale
timeFrame: During the education session, approximately 30 minutes
Secondary outcomes:
measure: Ultrasound Imaging Duration
timeFrame: During the education session, approximately 30 minutes
measure: Number of Assistance Requests
timeFrame: During the education session, approximately 30 minutes
Other outcomes:
measure: NASA-Task Load Index (TLX)
timeFrame: After the training (Traditional and HMD), approximately 1hr
measure: System Usability Scale (SUS)
timeFrame: After the training (Traditional and HMD), approximately 1hr
measure: Confidence Assessment
timeFrame: After the training (Traditional and HMD), approximately 1hr
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Meonghi Son, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06374628: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction
Official title: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction: Indications, Surgical Technique and Clinical Outcomes With Histological and Ultrasound Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 44
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients who undergo two stage breast recontrustion with tissue expander and ADM

Brief summary: The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
* risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM

Exclusion Criteria:

* partial or total submuscular tissue expander placement,
* tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
* previous breast surgery

Primary outcomes:
measure: Patient satisfaction
timeFrame: 24 months of follow-up
Secondary outcomes:
measure: Pain Evaluation
timeFrame: 24 months of follow-up
Other outcomes:
measure: Complication rate
timeFrame: 24 months of follow-up
Locations:
city: Bari
country: Italy
facility: AOU Policlinico
state: BA
Study officials:
affiliation: University of Bari
name: Giuseppe Giudice
role: STUDY_DIRECTOR
References:
Clinical trial NCT01776528: Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Males or females, between 18 and 65 years of age, inclusive
* BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
* In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

Primary outcomes:
measure: Safety and tolerability
timeFrame: 7 days and 14 days
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 7 days and 14 days
measure: Pharmacodynamics
timeFrame: 7 days and 14 days
Other outcomes:
Locations:
city: Perth
country: Australia
facility: NGM Clinical Study Site
state: Western Australia
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Alex M DePaoli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06483828: Impact of Dental Anxiety Coping Module on Children with Dental Anxiety
Official title: The Impact of Dental Anxiety Coping Module on Children with Dental Anxiety: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:

1. Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
2. Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
3. Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?

Detailed description: Dental Anxiety Coping Module (DACM) is a combination of Dental Tour and Expressive Art Therapy. Participants will be randomised into 2 groups, Control group and Intervention group (with DACM). Control group will have dental procedure without any intervention. While the Intervention group will start with dental tour where they will be shown around the dental clinic followed by Expressive Art Therapy where they will have collage and finger painting done. After DACM, participants will continue with the same dental procedure as the control group.

Eligibility criteria: Inclusion Criteria:

* Malaysian child, age 7 to 11 years old that understand basic Malay and English language.
* Children that fulfil both MY-ACDAS score 26 and above and HRV-Biofeedback of very low coherence score (incoherence).
* Children with American Society of Anaesthesiologists (ASA) I and ASA II classification.

Exclusion Criteria:

* Children requiring emergency treatment such as pain, facial cellulitis, and trauma cases.
* Child with learning disabilities, hearing, or visual impairment, developmental or intellectual disability and cognitive impairment.
* Parents/guardians who refuse to allow their child to participate in this trial.

Primary outcomes:
measure: Changes in Malaysian- Abeer Children Dental Anxiety Scale (MY-ACDAS) score
timeFrame: Before intervention and dental procedure and immediately afterwards on the same day
Secondary outcomes:
measure: Changes in HRV-Biofeedback coherence
timeFrame: Before intervention and dental procedure, during dental procedure and immediately afterwards on the same day
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Universiti Malaya
state: Wp Kuala Lumpur
Study officials:
References:
Clinical trial NCT01554228: Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study
Official title: Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the surgery department of the Charite Universtiy Berlin

Brief summary: Bariatric surgery provides a strong and long-term effect in reducing weight in obese subjects. Studies showed that obesity and its comorbidities are associated with a lower cognitive performance. The aim of the researchers study is to examine the cognitive performance of the patients before and after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* BMI \> 40
* Age: 18-60

Exclusion Criteria:

* BMI \< 40
* Age \< 18 and \> 60
* Presence of Cancer
* Presence of Chronic Inflammatory Diseases
* Presence of Addiction

Primary outcomes:
measure: performance in a neuropsychological test battery before and after surgery
timeFrame: 6 month
Secondary outcomes:
measure: performance in neuropsychological test battery 12 month after surgery compared to performance after 6 month and baseline performance
timeFrame: 12 month
measure: performance in further cognitive tests
timeFrame: 6 - 12 month
measure: surrogat parameters, blood parameters
timeFrame: 6-12 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Surgery Department, Charite University
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Floeel, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01311128: Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
Official title: Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critically Ill
Keywords: Blood pressure
Heart rate
Cardiac output
Critical care
Perioperative care
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients.

Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.


Eligibility criteria: Inclusion Criteria:

* Age at least 18 years old
* Operative patients expected to require intensive care recovery at OHSU
* Planned or existing intra- and postoperative radial artery catheterization as part of routine care
* Palpable contralateral (to catheter) radial artery pulse
* Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total

Exclusion Criteria:

* No palpable radial artery pulse
* Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
* An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
* An AV shunt in the T-line arm
* Known sensitivity to pressure stimuli (dermatographism)

Primary outcomes:
measure: Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure
timeFrame: Assessed 24 times over four hours
Secondary outcomes:
measure: Agreement between the T-line and right heart catheter in determining cardiac output
timeFrame: Assessed every 30 minutes over four hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: 503-494-2465
name: Charles Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04211428: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bipolar Disorder
Bipolar I Disorder
Bipolar II Disorder
Bipolar Type I Disorder
Bipolar Disorder Mild
Bipolar Disorder Moderate
Bipolar Disorder Severe
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with bipolar disorder

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to bipolar disorder

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages.
3. Greater than seven endorsements on the bipolar disorder questionnaire.

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01263028: Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Official title: Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease Stages 3-5
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2010-12-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease
* Age: \>18yo
* Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
* Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
* Serum 25-hydroxy Vitamin D levels \< 30 ng/mL
* History of 25-hydroxy Vitamin D levels \< 30 ng/mL currently on ergocalciferol replacement

Exclusion Criteria:

* On hemodialysis
* Chronic kidney disease 5
* Hypercalcemic (Calcium level \> 11mg/dL)
* Pregnant female
* Iron deficient (iron saturation \< 20%, Ferritin \< 100ng/mL)
* Presence of active malignancy
* Presence of active infections
* Presence of active inflammatory properties
* Presence of blood dyscrasias
* Active bleeding or bleeding within the past 3 months (other than menses)
* B12 deficiency
* Folate deficiency
* Blood transfusion during participation
* Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)

Primary outcomes:
measure: Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change in Inflammatory Markers
timeFrame: 24 Weeks
measure: Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
timeFrame: 24 Weeks
measure: Change in Iron Supplementation
timeFrame: 24 Weeks
measure: Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: John J Sim, MD
role: PRINCIPAL_INVESTIGATOR
References: