louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00935922: CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease
Official title: CCRC: Understanding the Effects of Omega-3 Fatty Acids vs. Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Lipids
Blood Glucose
Insulin
Keywords: Flaxseed
Weight loss
Heart health
Diabetes
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Flax Canada 2015 Inc.
First posted: 2009-07-09
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.

We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).

Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).


Eligibility criteria: Inclusion Criteria:

* Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39

Exclusion Criteria:

* Women are are premenopausal
* Smoking
* Diabetes
* Cancer
* Gout
* Untreated thyroid disease
* Kidney Disease
* Liver Disease
* Use of lipid lowering drugs
* Use of insulin sensitizing drugs
* Use of ACE inhibitors or other blood pressure lowering medications
* Use of over the counter or prescription anti-obesity medications
* Weight loss of 10% or more within the last 12 months

Primary outcomes:
measure: Improved lipid profile
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mather
country: United States
facility: CCRC
state: California
Study officials:
affiliation: University of California, Davis Health System
name: Sidika Kasim-Karakas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084122: Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
Official title: Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Fracture
Surgical Intervention
Keywords: Intravenous iron sucrose
Anemia
Transfusion
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 360
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

Detailed description: The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.

Eligibility criteria: Inclusion Criteria:

* Age \>= 65 years old
* With Hip fracture or peritrochanteric fracture.
* Who needs surgical intervention.
* And sign the informed consent form.

Exclusion Criteria:

* Tumor pathological fracture.
* Two or more long bone fractures.
* Seric Ferritin levels \> 300 ng/ml.
* Hypersensitivity to Iron sucrose or any component of the formulation.
* Patients with allogeneic transfusion rejection.
* Patients with previous blood transfusion request (Hb\< 8g/dl).
* Patients treated with hematopoietic growth factors.
* Patients with Anticoagulant treatment, due to thromboembolic high risk disease.
* Asthma in treatment.
* Cirrhosis, Acute Hepatitis, or increased Aminotransferases (\> 3 times the upper limit of normal).
* Advanced Dementia (GDS\>5) from the Global Deterioration Scale.

Primary outcomes:
measure: Transfusional needs
timeFrame: 1st, 5th day and 1st and 6 th month after surgical intervention.
Secondary outcomes:
measure: Units of packed cells
timeFrame: 1st and 5th days, 1st and 6th month after surgical intervention.
measure: Postoperative complications
timeFrame: 1st and 5th day , 1st and 6th month after surgical intervention.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.
Study officials:
References:
Clinical trial NCT03656822: Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
Official title: Data Visualization of Kidney and Prostate Tumors Using Routine Pre-Operative Imaging, 3D Printed, and 3D Virtual Reality Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 303
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: Patients who have scheduled to have kidney or prostate cancer surgery

Brief summary: The purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors.

Detailed description: This early phase I trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating participants with malignant pleural effusions. These types of catheters are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. It is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating participants with cancerous pleural effusions.

Eligibility criteria: Inclusion Criteria:

* Outpatients with MPE undergoing IPC placement
* Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions

Exclusion Criteria:

* Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
* Inability or unwillingness to give informed consent
* Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC)
* Pregnancy
* Previous intrapleural therapy for MPE on the same side
* Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy ≤ 2 weeks
* Doxycycline allergy
* Extensive loculations or hydropneumothorax or other contraindication to pleurodesis
* Chylous effusions associated with malignant disease

Primary outcomes:
measure: Measure of Operative Time
timeFrame: Post Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Hersh Chandarana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947622: Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Official title: Occipital Transcranial Direct Current Stimulation in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Neuromodulation
Transcranial Direct Current Stimulation
Occipital
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and the design is a cross-over design.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Fibromyalgia, diagnosed according to the criteria of the ACR-90, with exclusion of other pathologies mimicking the FMS related symptoms by a M.D. of the department of Physical Medicine and Rehabilitation (UZA, Belgium)
* Dutch speaking
* Stability of medication during the study

Exclusion Criteria:

* History of substance abuse, unless treated and in remission during 6 months
* Cardiac disease, implanted pace-maker or defibrillator
* History of epileptic insults
* Severe organic comorbidity
* Psychiatric comorbidity with psychotic symptoms
* Pregnancy

Primary outcomes:
measure: Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire
timeFrame: baseline, directly after treatment, 3 weeks after treatment
Secondary outcomes:
measure: Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale
timeFrame: base line, directly after treatment and 3 weeks after treatment
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Dirk De Ridder, M.D. PhD.
role: STUDY_CHAIR
affiliation: University Hospital, Antwerp
name: Mark Plazier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05004922: Site of Embryo Transfer in Intracytoplasmic Sperm Injection
Official title: The Correlation Between the Site of Embryo Transfer and the Site of Gestational Sac and Placental Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infertile women

Brief summary: The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.

Detailed description: Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.

Eligibility criteria: Inclusion Criteria:

* 1- AVF uterus. 2- BMI less than 30

Exclusion Criteria:

* 1- RVF uterus. 2- BMI more than 30.

Primary outcomes:
measure: number of women who will get pregnant in each group
timeFrame: within one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Researcher, Family planning and Reproductive Health Department, NRC, Egypt
name: Sherif Elsirgany, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05831722: Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage
Official title: Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Appliance Complication
Dental Malocclusion
Bone Anchored Rapid Maxillary Expansion
Maxillary Hypoplasia
BAME
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: dental clinic patients

Brief summary: The objective of this study is to evaluate the effect of bone-anchored rapid maxillary expansion (RME) in the volume of the right maxillary sinus, left maxillary sinus and nasal and maxillary sinus airway complex, through bone anchored maxillary expansion devices (BAME); in addition, the influence of gender and age in the volume changes will be also analyzed. Material and method: 18 patients between undergone RME treatment with a jackscrew based on 4 miniscrews which will be placed in the palate on both sides of the midpalatal suture. Cone-beam computed tomography (CBCT) scans will be taken before and after suture palatine expansion and datasets will be uploaded into therapeutic digital planning software to measure the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and maxillary sinus airway complex (mm3). The airway volumes will be isolated after selecting the anatomical area in the axial, coronal and sagittal space plane and ensuring the air density measurement by reference points placement inside the selected area. Statistical analysis between preoperative and postoperative measurements will be performed using the statistical analysis of the t-test.


Eligibility criteria: Inclusion Criteria:

* adult patients
* no history of systemic conditions that could interfere in bone metabolism and in the surgical process of orthodontic mini-implant placement
* radiographic imaging (CBCT KAVO OP3D Pro FOV 13X15cm) of maxillary discrepancy of more than 3mm compared with the ideal dimensions according to their mandible

Exclusion Criteria:

* Age more than 31 years old
* Systematic conditions that interfere in bone metabolism

Primary outcomes:
measure: The paired t-test analysis will show any statistically significant differences between the preoperative and postoperative volumes of the nasal and maxillary sinus airway complex
timeFrame: 2 months after bone anchored maxillary expansion is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Clinica Odontológica de la Universidad de Salamanca
city: Salamanca
country: Spain
facility: Javier Montero
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
References:
Clinical trial NCT04846322: Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department
Official title: Pathway to Detection & Differentiation of Delirium & Dementia in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Emergency Care
Dementia
Delirium
Keywords: delirium
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All community dwelling ED patients 65 years of age or older seen in the Yale New Haven Health System (YNHHS) St. Raphael's Campus (SRC) ED or Northwestern Memorial Hospital (NMH) ED.

Brief summary: This is an observational study of the pragmatic implementation of an ED screening, outpatient referral, and care coordination process for older ED patients who may have UCID.

Detailed description: Embedded pragmatic, implementation pilot that incorporates training, ED assessment for delirium and dementia risk, referral of ED patients with undiagnosed cognitive impairment and dementia for primary care feedback and care recommendations. This pilot would gather observational data evaluating the feasibility of incorporating cognitive impairment screens into routine ED delirium assessments, and developing optimal work flow for identifying and referring ED patients with suspected (undiagnosed) dementia for confirmatory evaluation and care coordination.

Eligibility criteria: Inclusion Criteria:

* Adults age 65 or older
* Discharged from the adult ED at YNHH or the ED at NMH

Exclusion Criteria:

* Documented or known history of dementia
* Alcohol/substance intoxication while in the ED
* Non-English or Non-Spanish speaking

Primary outcomes:
measure: Percentage of Patients With Confirmed Delirium or Dementia
timeFrame: 1 year
measure: Rates of Outpatient Assessment Referral of Patients With Suspected Dementia
timeFrame: 30 days
measure: Number of Participants Diagnosed With Dementia Among Those With Completed Outpatient Assessment
timeFrame: Up to 100 days from ED discharge
measure: Rates of Connection With Primary Care
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Northwestern
state: Illinois
Study officials:
affiliation: Yale University
name: Ula Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06580522: The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms
Official title: The Effect of the Position Given to the Child After Weaning from Noninvasive Mechanical Ventilation on Physiological Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Position
Supine Position
Child
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2024-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this clinical trial was to investigate the effect of the position given to children after weaning from noninvasive mechanical ventilation on the physiological symptoms (heart rate, oxygen saturation, respiratory rate and blood pressure) of children aged six months to six years in the Pediatric Intensive Care Unit.


Eligibility criteria: Inclusion Criteria:

* Between 6 months and 6 years of age
* Being monitored for respiratory diseases
* Weaning from noninvasive mechanical ventilation during the research process
* Body temperature within the normal range (36 centigrade-37,5 centigrade)
* Verbal and written consent to participate in the study given by their parents

Exclusion Criteria:

* Congenital anomaly
* Surgical intervention that prevents supine/prone positioning
* Development of pneumothorax during research
* Hypoxia during the research

Primary outcomes:
measure: Pulse changes in children after weaning from noninvasive mechanical ventilation
timeFrame: 120 minutes after weaning from noninvasive mechanical ventilation
Secondary outcomes:
Other outcomes:
measure: Oxygen saturation changes in children after weaning from noninvasive mechanical ventilation
timeFrame: 120 minutes after weaning from noninvasive mechanical ventilation
measure: Respiratory rate changes in children after weaning from noninvasive mechanical ventilation
timeFrame: 120 minutes after weaning from noninvasive mechanical ventilation
measure: Blood pressure changes in children after weaning from noninvasive mechanical ventilation
timeFrame: 120 minutes after weaning from noninvasive mechanical ventilation
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Hospital
Study officials:
affiliation: Koç Üniversitesi
name: Duygu Gözen, Prof.Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05768022: Origin to Insertion Kinesio Tapping vs Non-Directional Kinesio Tapping on Quadriceps Peak Torque
Official title: Origin to Insertion Kinesio Tapping vs Non-Directional Kinesio Tapping on Quadriceps Peak
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quadriceps Muscle Atrophy
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2023-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Pretest posttest control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was conducted to investigate the effect of kinesio tapping on electrical activity and peak torque of quadriceps during concentric and eccentric muscle contraction were carried out in the motion analysis Laboratory.

Detailed description: A Pretest posttest control group design was used to. Two hundred normal subjects of both sexes were recruited.

Subjects were randomly assigned into two groups of equal number.

* Cura Kensio-tapping group: consisted of 100 subjects (females and males) will receive kinesio taping from origin to insertion on the superficial muscles of Quadriceps femoris (vastus medialis (VM), vastus lateralis (VL), rectus femoris (RF).
* Placebo-Group: consisted of 100 subjects (females and males) will receive placebo kinesio taping across quadriceps.

Eligibility criteria: Inclusion Criteria:

* Age must be ranged from 22-30 years.
* Body mass index must be ranged from 20-24.9 kg/m².

Exclusion Criteria:

* Knee or quadriceps disorders preventing physical stress.
* Cardiovascular or neurological problems.
* Athletic subjects.
* Smokers.
* Heavy caffeine intake subjects.

Primary outcomes:
measure: Peak Torque Measurement 1
timeFrame: Before tapping.
measure: Peak Torque Measurement 2
timeFrame: After the application of tapping by 10 minutes
measure: Peak Torque Measurement 3
timeFrame: 24 hours after tapping.
measure: Peak Torque Measurement 4
timeFrame: 72 hours After tapping
measure: Peak Torque Measurement 5
timeFrame: 5 days after removal of tapping b
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
state: Gizan
Study officials:
References: