louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04699019: Evaluating the Foot Touch Framework Model
Official title: Evaluating the Foot Touch Framework Model in Running
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barefoot Running
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: FastEquation Inc.
First posted: 2021-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, able-bodied participants will be recruited from the general public.

Brief summary: A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women
* Capable of independently walking and running at various speeds for a minimum of 30 minutes
* No history of significant injuries in the past six months
* Ability to walk and run without shoes/footwear
* Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights
* Ability to provide informed consent

Exclusion Criteria:

* Confounding chronic injury or musculoskeletal problem
* Pregnancy
* Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
* Not able to read and understand English

Primary outcomes:
measure: MatScan Forces
timeFrame: Assessed on day 1 (data collection day)
Secondary outcomes:
measure: Ground reaction force
timeFrame: Assessed on day 1 (data collection day)
measure: Ankle joint angle
timeFrame: Assessed on day 1 (data collection day)
measure: Knee joint angle
timeFrame: Assessed on day 1 (data collection day)
measure: Hip joint angle
timeFrame: Assessed on day 1 (data collection day)
Other outcomes:
Locations:
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
References:
Clinical trial NCT03422419: TIPS or Anticoagulation in Portal Vein Thrombosis
Official title: An Investigator-initiated, Multicentre, Randomized, Trial Comparing Anticoagulation Alone Versus Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Anticoagulation in Patients With Recent Obstructive Portal Vein Thrombosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Thrombosis Portal Vein
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The PROGRESS is an investigator-initiated, multicentre, randomized, trial comparing anticoagulation, which is the currently most frequently used treatment, alone, versus transjugular intrahepatic portosystemic shunt (TIPS) combined with anticoagulation, in patients presenting with recent obstructive portal vein thrombosis (ROPVT). The rationale of this study is to significantly increase the proportion of patients that achieve a complete or partial recanalization of the portal vein. The intervention of this study consists in TIPS deployment and catheter based clot removal in addition to anticoagulation. The investigators retain that this intervention will increase the proportion of patients with an open portal vein from 38% with anticoagulation alone to 83% with anticoagulation and TIPS after 6 months. Both anticoagulant therapy and clot removal/TIPS are treatments that are currently available and accepted indications for the treatment of ROPVT. Anticoagulation will be performed with unfractioned heparin or low molecular weight heparin initially and with vitamin K antagonists in the long term. The investigators plan to collect blood for biobanking at the time of inclusion and after 6 months. Blood samples for a biobank will be collected.


Eligibility criteria: Inclusion Criteria:

1. Recent complete thrombosis of the extrahepatic portal vein either with or without the involvement of intrahepatic branches and with or without involvement of splenic vein and superior mesenteric vein
2. Written informed consent

Exclusion Criteria:

1. Malignant Portal Vein thrombosis (neoplastic invasion)
2. Intraabdominal malignancy
3. Chronic diseases limiting life expectancy in the short term (6 months)
4. Liver transplantation
5. Unwillingness to participate
6. Contraindications to TIPS (including past or present hepatic encephalopathy Grade ≥2)
7. Child-Pugh-Turcotte score 11 or more points in patients with advanced chronic liver disease-

Primary outcomes:
measure: Proportion of patients with complete recanalization of the portal vein".
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Andrea De Gottardi, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06088719: Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence
Official title: Oncological Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence After Mastectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Recurrent Disease
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients with breast cancer with mastectomy and has isolated chest wall recurrences.

Brief summary: The axillary management of breast cancer patients with operable isolated chest wall recurrence after mastectomy is unclear. We aim to determine if axillary restaging surgery can be safely omitted with no increased recurrences in this group of patients.


Eligibility criteria: Inclusion Criteria: Mastectomy patients who developed pathologically confirmed invasive isolated chest wall recurrence.

-

Exclusion Criteria: -Patients with bilateral cancers

* Patients with evidence of concomitant distant or/and regional recurrences
* Patients who did not have surgery for their isolated chest wall recurrences.

Primary outcomes:
measure: recurrence
timeFrame: from date of surgery to date of recurrence, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
Clinical trial NCT05624619: The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy
Official title: The Diagnostic and Prognostic Value of Speckle Tracking Imaging in Septic Cardiomyopathy: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Cardiomyopathies
Echocardiography
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-11-22
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: PROBABILITY_SAMPLE
Study population: adult patients who are diagnosed as sepsis according to sepsis 3.0 criteria, excluding those with history of organic heart disease, heart failure, atrial fibrillation or holder of cardiac implanted device

Brief summary: The aim of this study is to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis. The investigators also intend to prove that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.

Detailed description: In order to explore if STI technology, especially TMAD, plays an important role in evaluating left ventricular longitudinal systolic function and discriminating SICM in patients with sepsis, the investigators intend to explore that TMAD may have predictive value in patients with sepsis, which is worthy of in-depth study to find strong evidence-based medical evidence for subsequent clinical practical applications.

Eligibility criteria: Inclusion Criteria:

* patients who are diagnosed as sepsis according to sepsis 3.0 criteria

Exclusion Criteria:

* patients with history of organic heart disease;
* patients with history of heart failure
* holder of cardiac implanted device;
* patients with history of atrial fibrillation;
* refusal to participate in the study

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University
name: Jieqiong Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013819: Exposure, Dose, Body Burden and Health Effects of Lead
Official title: Exposure, Dose, Body Burden and Health Effects of Lead
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Keywords: lead poisoning
central nervous system
peripheral nervous system
occupational health
genetic susceptibility
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-03-30
Enrollment: 944
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This is a study of the effects that lead has on the health of the central nervous system (for example, memory), peripheral nervous system (for example, sensation and strength in the hands and fingers), kidneys, blood pressure, and the blood forming system. A total of 803 lead workers and 135 persons without occupational lead exposure are being studied in South Korea. Lead in the body is being assessed by measurement of blood lead, chelatable lead (an estimate of lead in the tissues), and lead in bone. Subjects are tested three times each over three years. Several genetic factors are also being assessed for the role they play in the health effects of lead. These genes are known to differ among individuals. We are interested to know whether different forms of the same genes can modify the effect lead has on health.


Eligibility criteria: Lead workers in South Korea in one of 26 specific lead-using facilities.

Population controls in South Korea.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04318119: Cerebral Small Vessel Disease Registry Study
Official title: Cerebral Small Vessel Disease Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Small Vessel Diseases
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who are diagnosed as Cerebral Small Vessel Disease

Brief summary: The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.


Eligibility criteria: Inclusion Criteria:

1. Sign informed consent.
2. Age\>18
3. At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy

Exclusion Criteria:

1. Unable to cooperate with inspectors
2. Non-vascular white matter lesions
3. Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
5. Contraindications for imaging examination

Primary outcomes:
measure: Overall outcomes in patients with cerebral small vessel disease.
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 30 years
Secondary outcomes:
measure: the development of the burden of microbleeds in MRI
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 30 years
measure: the development of the burden of white matter hypertension in MRI
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 30 years
measure: the development of lacunes in MRI
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 30 years
measure: the development of enlarged perivascular space in MRI
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 30 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology , First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT03111719: Human Brown Adipose Tissue and Mitochondrial Respiration
Official title: Human Brown Adipose Tissue Histological and Mitochondrial Respiratory Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitochondrial Metabolism Disorders
Adipose Tissue, Brown
Aging
Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Culture and Science
First posted: 2017-04-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for surgery in the supraclavicular and neck region

Brief summary: This study is focused on measuring mitochondrial activity of human brown adipose tissue. During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected from the deep neck area. These biopsies will be used to examine mitochondrial function via histological analysis, biochemical analysis and in vitro experiments based on precursor cells present in the biopsies.


Eligibility criteria: Inclusion Criteria:

* Indication for surgery in the supraclavicular and neck region (more specific patients diagnosed with hyperparathyroidism, struma, benign thyroid gland tumours, implantation of a vagal neurostimulator for epilepsia and cervical neurologic disorders)
* In the thyroid gland group, euthyroid function

Exclusion Criteria:

* Pre-operatively diagnosed malign tumour
* Patients undergoing acute surgery because of critical illness

Primary outcomes:
measure: Mitochondrial respiration in human brown
timeFrame: 8 weeks
Secondary outcomes:
measure: Characterise human brown adipose tissue
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center / University of Maastricht
Study officials:
References:
citation: Nascimento EBM, Moonen MPB, Remie CME, Gariani K, Jorgensen JA, Schaart G, Hoeks J, Auwerx J, van Marken Lichtenbelt WD, Schrauwen P. Nicotinamide Riboside Enhances In Vitro Beta-adrenergic Brown Adipose Tissue Activity in Humans. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1437-1447. doi: 10.1210/clinem/dgaa960.
citation: Nascimento EBM, Sparks LM, Divoux A, van Gisbergen MW, Broeders EPM, Jorgensen JA, Schaart G, Bouvy ND, van Marken Lichtenbelt WD, Schrauwen P. Genetic Markers of Brown Adipose Tissue Identity and In Vitro Brown Adipose Tissue Activity in Humans. Obesity (Silver Spring). 2018 Jan;26(1):135-140. doi: 10.1002/oby.22062. Epub 2017 Nov 27.
Clinical trial NCT05892419: Electrophysiological Signatures of Distinct Working Memory Subprocesses That Predict Long-term Memory Success
Official title: Electrophysiological Signatures of Distinct Working Memory Subprocesses That Predict Long-term Memory Success
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Memory
EEG
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young adults

Brief summary: Healthy young adults will view pictures of items while the investigators record electroencephalogram (EEG) brain activity. Then, the investigators will ask the participants to report which items the participants remember seeing. The investigators will examine how the measured brain activity relates to which pictures the participants remember.

Detailed description: Electrophysiological signatures track distinct subprocesses of working memory, including the number of items and the spatial locations of those items. By identifying how these subprocesses predict long-term memory success in healthy young adults, this project should lead to an intricate understanding of the relationship between working memory and long-term memory. This study will investigate when and how long-term memory failures arise, by using sophisticated machine learning analyses of neural data. Moreover, this study will test the extent to which the investigators can track working memory processes in real time and how the investigators can leverage that information to improve long-term memory success. This will inform basic theories of the relationship between working memory and long-term memory and motivate future applications.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal vision

Exclusion Criteria:

* non-fluent in English

Primary outcomes:
measure: Memory performance
timeFrame: This task is performed multiple time within the experimental session, which in total lasts around 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Megan deBettencourt
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Ed Vogel
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Ed Awh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06435819: ECA-enhanced Document Explanation RCT
Official title: Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: ECA-enhanced Document Explanation RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
name: Boston University
First posted: 2024-05-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-treatment between-subjects randomized experiment
Primary purpose: OTHER

Brief summary: The investigators will evaluate a computer-animated character that explains medical illustrations to people, comparing the character to having people understand the illustrations on their own, and also comparing the computer character on a computer display to one in immersive virtual reality. The investigators will determine which method leads to the best understanding and lowest anxiety.

Detailed description: The investigators are developing a new approach to explaining patient education documents and illustrations to patients with varying levels of health literacy, involving the use of Embodied Conversational Agents (ECAs). The investigators will evaluate our ECA-augmented Document Explanation tool to determine whether it improves patient learning relative to traditional static patient education documents. The investigators will conduct a 3-arm randomized between-subjects experiment, in which participants read a patient education document with embedded medical illustration, either unaided (CONTROL), with the assistance of an ECA rendered in 2D on a standard computer monitor (ECA-2D), or with the assistance of an ECA in immersive Virtual Reality (ECA-3D).

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Speaks English or Spanish ﬂuently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents

Exclusion Criteria:

\* None

Primary outcomes:
measure: Knowledge
timeFrame: Baseline and 30 minutes
measure: State Anxiety scale from State-Trait Anxiety Inventory
timeFrame: 30 minutes
Secondary outcomes:
measure: Satisfaction with illustration
timeFrame: 30 minutes
measure: Reading Effort
timeFrame: 30 minutes
measure: Acceptability
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Timothy Bickmore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639519: A Trial to Assess the Impact of Ascorbic Acid on Cardiac Surgeries Outcomes and Complications''
Official title: 'A Prospective Randomized Trial to Assess the Impact of Ascorbic Acid on Outcomes and Complications Post Cardiac Surgeries''
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiothoracic Surgery
Lead sponsor: El-Galaa Military Medical Complex
Sponsor class: OTHER_GOV
First posted: 2018-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative

Detailed description: The study will include two arm of patients who are scheduled for elective cardiac surgery, either coronary artery bypass grafting (CABG) or Valvular replacement First arm: Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Second arm: will not be given ascorbic acid , instead a placebo 9orange carbonated beverage) will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers C- reactive protein (CRP), erythrocyte sedimentation rate (ESR) and differential total leukocytic count (TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms.

Eligibility criteria: Inclusion Criteria:

* Elective Cardiac surgery
* American Society of Anesthesiologists physical status class I-III

Exclusion Criteria:

* Allergy to ascorbic acid
* Asthma
* COPD
* Allergy to opioids
* Previous history of chemical dependence
* Prior cardiac surgery
* Known hyperoxaluria
* History of renal calculi
* History of allergic or hypersensitivity reaction to ascorbic acid products
* Currently taking 1 g or more of ascorbic acid supplementation daily

Primary outcomes:
measure: Risk of arrhythmia post operative
timeFrame: 7 days post operative
measure: pain management
timeFrame: 2 days post operative
measure: wound healing
timeFrame: 30 days post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Galaa Military Medical Complex
state: Sheraton
Study officials:
References: