louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01961024: Postprandial VLDL-TG Metabolism
Official title: Postprandial VLDL-TG Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: VLDL-TG kinetics
Postprandial state
Obesity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 21
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with diabetes from the department´s out-patient clinic. Control group of healthy volunteers

Brief summary: In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2 diabetic and healthy subjects matched for BMI in order to elucidate the potential pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes that might be involved in regulating skeletal muscle and adipose tissue FA storage.


Eligibility criteria: Inclusion Criteria:

* Written consent

Exclusion Criteria:

* Known diseases
* Alcohol abuse
* Smoker
* Regular use of medicine

Primary outcomes:
measure: VLDL-TG storage in adipose tissue
timeFrame: 3 hours
Secondary outcomes:
measure: 18F-THA fractional storage
timeFrame: 6 Hours
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology MEA, Aarhus Hospital
state: Please Select
Study officials:
References:
citation: Sondergaard E, Johansen RF, Jensen MD, Nielsen S. Postprandial VLDL-TG metabolism in type 2 diabetes. Metabolism. 2017 Oct;75:25-35. doi: 10.1016/j.metabol.2017.07.002. Epub 2017 Jul 19.
Clinical trial NCT03487224: Neural Mechanisms of Decision Making in Hoarding Disorder
Official title: Neural Mechanisms of Decision Making in Hoarding Disorder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hoarding Disorder
Keywords: Hoarding Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with Hoarding Disorder and Healthy Participants

Brief summary: The purpose of this study is to understand the neural mechanisms of decision making in hoarding disorder.

Detailed description: Hoarding disorder is a common and disabling disorder that represents a significant public health problem. This study aims to build on current research on decision making by examining these processes in hoarding disorder.

Eligibility criteria: Identify inclusion criteria.

Inclusion criteria for participants diagnosed with HD:

1. ages 18-70
2. primary diagnosis of hoarding disorder
3. sufficient severity of hoarding symptoms
4. stable on psychotropic medications for 1 month prior to study enrollment
5. capacity to provide informed consent
6. ability to tolerate clinical study procedures

Inclusion criteria for healthy control participants:

1. ages 18-70
2. capacity to provide informed consent

Identify exclusion criteria.

Exclusion criteria for participants with HD:

1. psychiatric or medical conditions that make participation unsafe
2. pregnant or nursing females
3. concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
4. presence of metallic device or dental braces

Exclusion criteria for healthy control participants:

1. any current or lifetime psychiatric diagnosis
2. current or past use of psychotropic medication
3. pregnant or nursing females
4. major medical or neurological problem
5. presence of metallic device or dental braces

Primary outcomes:
measure: BOLD signal
timeFrame: up to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT04884724: Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
Official title: Effects of Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Children and Adolescents with Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Trunk Control
Mobility
Adaptive Dance
Balance
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is to achieve a satisfying motor performance, increases motor learning with sensory, perceptual and emotional components. Although the effects of dance therapy on functionality, balance and participation in people with CP have been previously examined in the literature, it has been reported that the evidence is insufficient and more studies are needed. The aim of this study is to examine the effects of adaptive dance exercise program on trunk control, balance and functional mobility in children and adolescents with Cerebral Palsy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Cerebral Palsy
* Volunteer
* Ages between of 6-18 years
* Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
* To have cognitive skills to understand and apply adaptive dance exercises to be given.

Exclusion Criteria:

* Participants diagnosed with Cerebral Palsy having cognitive disorders
* Participants diagnosed with Cerebral Palsy having vision or hearing problems
* Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.

Primary outcomes:
measure: Trunk Control Measurement Scale (TCMS). Change is being assessed.
timeFrame: Change from Baseline TCMS Score at 8 weeks
measure: Pediatric Balance Scale (PBS). Change is being assessed.
timeFrame: Change from Baseline PBS Score at 8 weeks
measure: Time Up and Go (TUG). Change is being assessed.
timeFrame: Change from Baseline TUG Score at 8 weeks
Secondary outcomes:
measure: Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
timeFrame: Change from Baseline PODCI Score at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
city: Istanbul
country: Turkey
facility: Işıl Özel Eğitim ve Rehabilitasyon Merkezi
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Asena Yekdaneh, Pt.,MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444924: Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery
Official title: Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gynecologic Cancer
Post-operative Pain
Keywords: Pain control
Gynecologic Oncology
Surgery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC.
* Patients must be ≥18 years old.
* Patients must be English speaking.
* Patients must have the ability to understand visual and verbal pain scales.
* ASA physical status 1-3.

Exclusion Criteria:

* Known allergy to local anesthetics.
* Immunocompromised.
* Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up.
* Known history of chronic pain disorders.
* Pregnancy or lactation.
* Patient is a prisoner or incarcerated.
* Significant liver disease that would inhibit prescription of opioids.

Primary outcomes:
measure: 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: from 2 hours post-op to the afternoon/evening of post-op day #1
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837824: Severe Renal Disease Study in Fabry Patients Treated With Fabrazyme
Official title: A Phase 2, Randomized, Open Label, Dose-Ranging, Multiple Dose Study of Fabrazyme® In Patients With Fabry Disease and With Severe Renal Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fabry Disease
Chronic Kidney Disease, Stage IV (Severe)
Keywords: Fabry Disease patients with Severe Renal Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: CRL/Medinet
First posted: 2009-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to determine appropriate treatment with Fabrazyme at a biweekly dose of either 1 mg/kg or 3 mg/kg in a population of patients with severe renal disease burden.


Eligibility criteria: Inclusion Criteria:

* provided written informed consent prior to any study-related procedures being performed.
* be ≥16 years old.
* have a current diagnosis of Fabry disease (defined as abnormal α-galactosidase (α GAL) enzyme levels or Fabry genotype).
* have one of the following clinical conditions present at enrollment: serum creatinine level greater than 3.0 mg/dL (an average of two values at least one week apart), or be currently on dialysis, or be status post kidney transplant by greater than 3 months.
* have the ability to comply with the requirements of the protocol
* have a negative pregnancy test, if a female patient of childbearing potential. In addition, all female patients of childbearing potential must use a medically accepted method of contraception throughout the study.

Exclusion Criteria:

* if they did not meet the specific inclusion criteria.
* if they had participated in a study employing an investigational drug within 30 days of the start of their participation in this trial.
* had previously received enzyme replacement therapy (ERT) for their Fabry disease.
* had diabetic nephropathy.
* were pregnant or lactating.
* were unwilling to comply with the requirements of the protocol.

Primary outcomes:
measure: Time to Clinically Significant Progression of Cardiac Disease, Cerebrovascular Disease, and/or Death Among Fabry Patients With Severe Kidney Disease
timeFrame: 7 months
Secondary outcomes:
measure: Plasma Globotriaosylceramide (GL-3)
timeFrame: Evaluated at Baseline, Month 3, and Final Visit
Other outcomes:
Locations:
city: Farmington
country: United States
state: Connecticut
city: Coral Springs
country: United States
state: Florida
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05429424: Complementary Acupuncture Treatment of Dysphagia in Stroke
Official title: Complementary Acupuncture Treatment of Dysphagia in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: acupuncture
swallowing impairment
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 336
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Taiwanese study pointed out that stroke patients who have language barriers, dysphagia, and aspiration pneumonia are more likely to suffer from prolonged hospitalization. Improvements in dysphagia and subsequent complications in patients should be effective in reducing hospital stays and improving the quality of long-term care. In view of clinical medical needs and policy trends, this study aims to explore the efficacy of using traditional Chinese medicine to treat cerebral apoplexy sequelae in Taiwan. It is expected that through (1) exploration of real-world data analysis, combined with the advantages of Taiwan's biomedical database, data exploration will be carried out to provide big data (2) Multi-center prospective randomized clinical trials, providing clinical evidence of the highest level of evidence in empirical medicine.


Eligibility criteria: Inclusion Criteria:

* .Patients aged more than 20 years
* The diagnosis of first stroke was established within the six months
* Patients had a score ≥ 25 of Mini-Mental State Examination (MMSE)
* Patients met one or both indications as follows

  1. Dysphagia confirmed under the standardized swallowing assessment
  2. Nasogastric tube feeding already

Exclusion Criteria:

* Previous history of swallowing disability
* Currently known coagulopathy leading to bleeding disorder.
* Previous surgery of head or neck
* Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
* Psychological or behavior disorder
* Currently pregnant or breastfeeding women.
* Previous acupuncture treatment for any indication within 30 days of enrollment.
* Severe chronic or uncontrollable complications interference the processing of the trial

Primary outcomes:
measure: dysphagia severity rating scale (DSRS)
timeFrame: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
measure: the functional oral intake scale (FOIS)
timeFrame: baseline, the 2nd week of the intervention, 1st and 4th week of follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medicine University
name: China Medicine University China Medicine University
role: STUDY_CHAIR
References:
Clinical trial NCT03177824: Sildenafil Citrate for Treatment of Growth-restricted Fetuses
Official title: Sildenafil Citrate for Treatment of Growth-restricted Fetuses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fetal Growth Restriction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.


Eligibility criteria: Inclusion Criteria:

* Maternal age ranging from 20-40 years.
* Gestational age 28-37 weeks.

Exclusion Criteria:

* Obese patients (BMI \>30 kg/m2).
* Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
* Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
* Fetal distress.
* Pregnancy of multiple fetuses.
* Congenital fetal malformation or chromosomal abnormalities.
* Diastolic blood pressure more than 110 mmHg.
* Hypersensitivity to the drug.

Primary outcomes:
measure: date of delivery after Sildenafil citrate administration.
timeFrame: for 6 months from the beginning of the study
Secondary outcomes:
measure: Expected fetal weight by serial ultrasound after Sildenafil citrate administration
timeFrame: every two weeks after drug intake for 6 months from the beginning of the study
measure: Color Doppler changes on umbilical artery
timeFrame: weekly after drug intake for 6 months from the beginning of the study
measure: neonatal outcomes as regard birth weight
timeFrame: for 6 months from the beginning of the study
measure: neonatal outcomes as regard APGAR score
timeFrame: for 6 months from the beginning of the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams matrnity hospital
Study officials:
References:
Clinical trial NCT02002624: Patient-Specific Versus Conventional Instrumentation in TKA
Official title: RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Cochin Hospital, India
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.


Eligibility criteria: Inclusion Criteria:

* patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
* aged between 18 and 85 years
* able to understand information
* affiliated to social security.

Exclusion Criteria:

* active or suspected sepsis
* tumor around the knee
* previous partial or total knee replacement
* presence of hardware that could artifact MRI
* contraindication to MRI
* extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
* social situation that could impair follow-up.

Primary outcomes:
measure: Mechanical axis
timeFrame: 3 months
Secondary outcomes:
measure: Components position
timeFrame: 3 months
Other outcomes:
measure: Blood loss
timeFrame: 5 days
Locations:
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stephane Boisgard, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02496624: Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Official title: Cone-beam Computed Tomography (CT) Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 40
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: The Guided Therapeutics (GTx) program at the University Health Network is a network of clinicians, scientists, and engineers focused on the development and translation of image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies developed within the GTx program include a portable intra-operative cone-beam CT (in collaboration with Siemens) that has been evaluated in clinical trials for head and neck surgery. The intraoperative imaging has been integrated with tracking and navigational tools and optical imaging to provide a general "surgical dashboard" that is used to improve the accuracy of surgical resection.

A recent addition to the GTx program is the development of the GTx OR, located within the general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy Somatom Flash provides a "gold-standard" in CT imaging, while the Zeego provides excellent 3D Cone-beam CT with robotic placement for flexible integration within the operating environment. Together, the integration of these 2 components into a single OR enables critical evaluation of the limits of CT imaging technology for surgical guidance.

This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS.


Eligibility criteria: Inclusion Criteria:

* Any adult patient age 18 and older with lung nodules who are candidates for microcoil localization prior to VATS wedge resection

Exclusion Criteria:

* Patients that are unable to give informed consent
* Patients that are unable to tolerate general anesthesia
* Patients who are pregnant or patients that believe they are pregnant
* Patients with implantable devices susceptible to Radio Frequency (RF) fields
* Severely obese patients

Primary outcomes:
measure: Radiation Exposure
timeFrame: 4 years
measure: Length of time to perform procedure
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: