louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04005573: The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
Official title: Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: vitamin D3
Vitamin D Deficiency
Lipid profile
oxidized low density Lipoprotein
omega-3 fatty acids
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 111
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency

Detailed description: Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein

Eligibility criteria: Inclusion Criteria:

* Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

Exclusion Criteria:

* Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations

Primary outcomes:
measure: VD 3
timeFrame: 8 weeks
measure: Total Cholesterol
timeFrame: 8 weeks
measure: HDL Cholesterol
timeFrame: 8 weeks
measure: LDL Cholesterol
timeFrame: 8 weeks
measure: triglycerides
timeFrame: 8 weeks
measure: oxidized LDL
timeFrame: 8 weeks
Secondary outcomes:
measure: PTH
timeFrame: 8 weeks
measure: Calcium and Phosphorus
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Applied Science University
Study officials:
affiliation: Applied science university
name: Mahmoud S Abu-Samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
Clinical trial NCT04026373: RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Official title: RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.


Eligibility criteria: Inclusion Criteria:

* All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment.

Exclusion Criteria:

* Individuals who:

  1. have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
  2. have self-inflicted injury,
  3. are more than 2 weeks post-trauma,
  4. do not meet the DSM-5 definition of a traumatic stressor for PTSD,
  5. screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
  6. are non-English speaking,
  7. are not medically stable,
  8. cannot identify a support person to attend a session with them
  9. do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.

Primary outcomes:
measure: Clinician-Administered PTSD Scale
timeFrame: Three months post-trauma
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Larsen SE, Hunt JC, Geier T, Heyrman K, Schumann N, Brandolino A, Timmer-Murillo S, Bergner C, Larson C, deRoon-Cassini TA. A Randomized Trial of Modified Prolonged Exposure to Prevent the Development of Posttraumatic Stress Disorder in Patients Hospitalized With Traumatic Injuries. J Trauma Stress. 2021 Feb;34(1):104-115. doi: 10.1002/jts.22580. Epub 2020 Aug 17.
Clinical trial NCT02436473: Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Official title: Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.


Eligibility criteria: Inclusion Criteria:

1. Demonstrates understanding of the study.
2. Aged 18 to 85 years.
3. Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. Has good general health (in the opinion of the investigator or medically qualified designee).
5. Currently living in the Indianapolis, Indiana area.
6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
7. Have no current active caries or periodontal disease and all restorations in a good state of repair.
8. Have a salivary flow rate in the range of normal values.

Exclusion Criteria:

1. Pregnant or breast feeding women.
2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
7. Recent history (within the last year) of alcohol or other substance abuse.

Primary outcomes:
measure: Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
timeFrame: 4 weeks
Secondary outcomes:
measure: Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
timeFrame: 4 weeks
measure: Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
timeFrame: 4 weeks
measure: Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01549873: Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients
Official title: Anesthesia During Neurophysiologic Monitoring in Scoliosis Patients: Volatile Agents Versus Total Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Scoliosis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Many hospitals only use IV anesthesia because they feel that measuring MEP and SSEP is easier using IV anesthesia. At this hospital the investigators typically use inhaled anesthesia and are able to successfully measure MEP and SSEP. This is a study to find out if one method of anesthesia is better than the other for measuring MEP and SSEP.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic scoliosis.

Exclusion Criteria:

* Patients with neuromuscular scoliosis.

Primary outcomes:
measure: Amplitude Required to Elicit the MEP
timeFrame: at time of surgery
Secondary outcomes:
measure: Amplitude of the SSEPs
timeFrame: day of surgery
measure: Latency of the SSEP's
timeFrame: day of surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06183073: Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries
Official title: Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):

Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.

Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).


Eligibility criteria: Inclusion Criteria:

* Children aged 3-9 years old
* Physical status I and II class of the American Society of Anesthesiologists (ASA)
* Unilateral elective surgeries below the umbilicus

Exclusion Criteria:

* Parents or legal guardian refusal.
* History of developmental delay or mental retardation
* Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
* Hemodynamic unstable patient.

Primary outcomes:
measure: 1st analgesic requirement
timeFrame: 12 hours
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: 12 hours
measure: systolic Blood Pressure (BP)
timeFrame: 12 hours
measure: diastolic Blood Pressure (BP)
timeFrame: 12 hours
measure: SpO2 -Hemodynamic assessment
timeFrame: 12 hours
measure: Total paracetamol consumption
timeFrame: 12 hours
measure: post operative pain score
timeFrame: 12 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Fouad Ibrahim Soliman
Study officials:
affiliation: Sohag University
name: Fouad I Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03315273: Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
Official title: Measuring Motor Imagery Ability in Patients With Traumatic Brain Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Healthy
Keywords: Traumatic brain injury, motor imagery ability, validation
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2017-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 2 groups: one existing of patients with traumatic brain injury and one control group of healthy volunteers matched for age, sex and educational level
Primary purpose: TREATMENT

Brief summary: 1. Validation of translated Motor Imagery ability questionnaire MIQ-RS
2. Investigating the Motor Imagery ability in patients with traumatic brain injury

Detailed description: 1. Translation of the MIQ-RS following the WHO guidelines. Followed by a validation of this translated questionnaire in patients with traumatic brain injury and in healthy volunteers.
2. Investigating the motor imagery ability using 3 different test

   * MIQ-RS (movement imagery questionnaire)
   * TDMI (time dependent motor imagery)
   * mental chronometry test

Patients and controls will perform all 3 test twice with an interval of 2 weeks to measure the test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* TBI minimum 3 months ago and maximal 1 year ago

Exclusion Criteria:

* Other neurological disorders
* Severe cognitive deficits, unable to understand the study protocol
* Severe motor impairment, unable to perform the TDMI (Time Dependent Motor Imagery) screening test

Control group:

Matched for age, sex and educational level No neurological disorders present

Primary outcomes:
measure: Motor imagery ability
timeFrame: 2 assessments with an interval of 2 weeks
measure: Validity translated MIQ-RS
timeFrame: 2 assessments with an interval of 2 weeks
Secondary outcomes:
measure: Test-retest reliability
timeFrame: 2 assessments with an interval of 2 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Kristine Oostra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02953873: Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Official title: Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immunosuppression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2016-11-03
Enrollment: 25
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: Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.

Detailed description: The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Signed informed consent
3. African American race
4. History of a solitary renal transplant
5. Stable tacrolimus dose for at least 2 weeks prior to randomization

Exclusion Criteria:

1. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
2. Currently enrolled in an investigational drug trial
3. History of a non-renal organ transplant
4. History of acute cellular rejection within 1 month prior to randomization
5. An increase in serum creatinine by \> 20% in the 2 weeks prior to randomization
6. Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil \> 1000mg TDD or mycophenolate sodium \> 720mg TDD, and prednisone ≥ 5mg daily

Primary outcomes:
measure: Dose-normalized Trough
timeFrame: Baseline to 3 months post-conversion
Secondary outcomes:
measure: Total Daily Dose
timeFrame: Baseline to 3 months post conversion
measure: Weight-Based Dose Requirement
timeFrame: Baseline to 3 months post conversion
measure: Number of Days to Reach Therapeutic Trough Goal
timeFrame: Baseline to 3 months post conversion
measure: Dose Modifications
timeFrame: Baseline to 3 months post conversion
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medicual U of South Carolina
name: James Fleming, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974973: Stem Cell Therapy in Autism Spectrum Disorders
Official title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Autism Spectrum Disorders
Keywords: autism spectrum disorders
stem cells
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders


Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of any type of autism spectrum disorders
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia

Primary outcomes:
measure: Improvement in the scales for Autism spectrum disorders
timeFrame: Six months
Secondary outcomes:
measure: Positron Emission Tomography- computed tomography to study change in brain metabolism
timeFrame: six months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
citation: Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.
Clinical trial NCT04274673: The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy
Official title: The Correlation Between the Cotinine Levels in Urine and Postoperative Acute and Chronic Pain in Open Abdominal Hysterectomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Pain, Acute Pain, Cotinine, Hysterectomy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Because of that we want to measure the levels of the cotinine in the urine and later assess the correlation with acute and chronic pain in hysterectomy patients.

Detailed description: It is well-known that smoking is very common in the public. The chronic pain after hysterectomy is 20-40%. The open abdominal hysterectomy ratio is 75% of all hysterectomy operations in our country. We know that the reasons of postoperative acute and chronic pain is multifactorial. One of them is smoking which affects the postoperative pain. The best way of measuring the level of cotinine is assesing the urine of the patient. We collect the first urine after induction.

In this study, we aimed to investigate the correlation between the levels of urine cotinine and the acute and chronic postoperative pain in hysterectomy patents.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Open abdominal hysterectomy patients

Exclusion Criteria:

* Chronic pain
* Chronic pain killer users
* Axis I psychiatric disease
* Liver disease
* Renal disease
* Drug allergy

Primary outcomes:
measure: Chronic pain: VAS score
timeFrame: Postoperative 3 months
Secondary outcomes:
measure: Acute pain: VAS score
timeFrame: Postoperative 48 hours
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University Medicine Faculty Anesthesiology Department
Study officials:
References:
citation: Montbriand JJ, Weinrib AZ, Azam MA, Ladak SSJ, Shah BR, Jiang J, McRae K, Tamir D, Lyn S, Katznelson R, Clarke HA, Katz J. Smoking, Pain Intensity, and Opioid Consumption 1-3 Months After Major Surgery: A Retrospective Study in a Hospital-Based Transitional Pain Service. Nicotine Tob Res. 2018 Aug 14;20(9):1144-1151. doi: 10.1093/ntr/ntx094.