louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06395181: Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea
Official title: Effect of Whole Food Plant-based Diet in Patients with Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Daytime Sleepiness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.


Eligibility criteria: Inclusion Criteria:

* Daytime sleepiness with ESS score ≥ 5.
* Patient's prior sleep study with AHI between ≥ 10 and ≤ 45 (4% scoring criterion).
* On treatment for OSA, failed or not willing to use all other OSA treatment options
* Has access to a weight scale at home or able to come into the Sleep Clinic to be weighed after the 8-week plant-based diet period.

Exclusion Criteria:

* Pregnancy or lactation.
* Current use of a vegan diet.
* BMI ≤ 22.
* Complex, central sleep apnea.
* Pre-existing significant degree of cardio-pulmonary disease-heart failure with reduced EF of 35 or lower, unstable arrythmia, severe degree of pulmonary hypertension, severe degree of obstructive or restrictive lung disease including COPD and Interstitial lung disease.
* On weight loss medications or starting new exercise regimen during the 8-week plant-based diet period.

Primary outcomes:
measure: Change in daytime sleepiness
timeFrame: Baseline, 8 weeks
measure: Change in Apnea-Hypopnea Index (AHI)
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Joseph Cheung, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00390481: Study of Carotid Occlusion and Neurocognition
Official title: Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Diseases
Keywords: Carotid Occlusion
Cognition
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-10-19
Enrollment: 294
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: To determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy alone in the Carotid Occlusion Surgery Study (COSS).

Detailed description: The Carotid Occlusion Surgery Study (COSS) evaluates whether a surgical operation, EC-IC bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one main artery in the neck that supplies blood to the brain (the carotid artery). The operation bypasses the blockage so more blood can flow to the brain. Only people with decreased blood flow to the brain, as demonstrated on a PET (positron emission tomographic) scan, are randomized into the COSS study. Among patients randomized into the COSS study, RECON will evaluate whether restoring the blood flow to the brain (with EC-IC bypass surgery) will also improve mental functioning. Participants in both the surgical and medical groups of the COSS study will participate in the RECON study. By comparing the mental functioning of the participants in both treatment groups over the course of 2 years, the investigators hope to determine whether the EC-IC bypass operation also helps improve or maintain mental functioning.

Eligibility criteria: Inclusion Criteria:

* Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

* Prior diagnosis of dementia

Primary outcomes:
measure: Cognitive Functioning on Neuropsychological assessment measures
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life and Disability
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Randolph S Marshall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Joanne R Festa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685581: Impact of Vaccenic Acid Consumption on the Metabolism of Saturated Fatty Acids: Relationship With Cardiovascular Risk Factors
Official title: Rationale, Study Design and Baseline Data of the TRANSQUAL Clinical Trial: A Study to Evaluate the Impact of Different Milk Fatty Acid Profiles on Cardiovascular Risk Factors in Healthy Volunteers; Focus on Trans Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: TFA
SFA
Clinical trial
fat milk
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.

Detailed description: 111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric, randomised, double-blind, controlled 4-week study. All the volunteers consumed 3 experimental products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55 g fat/day.

Eligibility criteria: Inclusion Criteria:

* HDL cholesterol, g/L \> 0.4
* Triacylglycerol g/L \<1.50
* LDL Cholesterol g/L \<1.60
* Waist size \< 94 cm (men) or 80 cm (women)
* Affiliated to National Health Insurance
* Normal blood pressure (diastolic \<90 mm Hg, systolic \<140 mm Hg)
* For women: effective contraception
* Subject giving his/her written informed consent
* Subject willing to comply with the study procedures

Exclusion Criteria:

* Reported food allergies
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* Hepatic or renal impairments
* Positive serologies to HIV or HCV,
* Blood donation done less than 2 months before the start of the study
* Chronic pathologies
* Refusal to be registered on the National Volunteers Data file
* Being in exclusion on the National Volunteers Data file

Primary outcomes:
measure: HDL-cholesterol
Secondary outcomes:
measure: total cholesterol
measure: LDL-cholesterol
measure: triglycerides
measure: apolipoprotein
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Study officials:
affiliation: UMR1019 INRA-Université Clermont1
name: Yves Boirie, MD, PhD, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: UMR1019 INRA-Université Clermont1
name: Jean-Michel Chardigny, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02937181: Antibiotic Prophylaxis in Open Fractures
Official title: Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Open Fractures
Lead sponsor: Triple O Research Institute PA
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2016-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures

Detailed description: Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy

Eligibility criteria: Inclusion Criteria:

* male or female \>= 18 years old
* complete an informed consent
* patients are diagnosed with a type II or III open fracture

Exclusion Criteria:

* allergy to beta-lactam antibiotics prior to screening
* prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
* pregnant female
* inability to provide consent

Primary outcomes:
measure: Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of acute kidney injury
timeFrame: 30 days
Other outcomes:
measure: Identify bacteria associated with the infections
timeFrame: 30 days
measure: identify the number of infections associated with sites other than fracture site
timeFrame: 30 days
Locations:
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
Study officials:
affiliation: Triple O Research Institute PA
name: Olayemi Osiyemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04242381: Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome
Official title: Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinesiotape
Exercise
Ultrasound
Keywords: Kinesiotape
exercise
ultrasound
Lead sponsor: Kars State Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Sham-Controlled Study
Primary purpose: TREATMENT

Brief summary: We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).

Detailed description: A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.

Eligibility criteria: Inclusion Criteria:

* at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
* magnetic resonance imaging findings
* age between 45 and 70 years

Exclusion Criteria:

* Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
* cervical pathologies,
* clinical conditions accompanied by neuromotor or sensory dysfunction,
* history of malignancy,
* pregnancies,
* partial or total rupture in the supraspinatus tendon,
* adhesive capsulitis,
* diabetes or chronic liver, or kidney failure

Primary outcomes:
measure: Pain Level
timeFrame: 4 weeks
measure: Functional Status
timeFrame: 4 weeks
measure: Joint range of motion measurements
timeFrame: 4 weeks
measure: Ultrasonography
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Hospital
Study officials:
References:
Clinical trial NCT02153281: Neuroimaging MAO-B in Medication Free TR-MDD Using Novel Tracer
Official title: Neuroimaging MAO-B in Medication Free and Treatment Resistant Major Depressive Disorder Using Novel MAO-B Tracer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Positron Emission Tomography (PET)
MAO-B
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if monoamine oxidase B (MAO-B) total distribution volume (VT), after phenelzine treatment and if so to what extent.

Detailed description: Subjects will receive a PET and MRI scan before and after treatment with phenelzine.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* good physical health
* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of current major depressive episode (MDE)
* DSM-IV diagnosis of major depressive disorder (MDD) verified by SCID for DSM-IV and a psychiatric consultation
* greater than 17 on the 17 item HDRS (Hamilton Depression Rating Scale).
* history of non-response to several different antidepressant classes

Exclusion Criteria:

* herbal, drug or medication use (that affect CNS function)
* suicide attempts
* drug or medication use within eight weeks (+5 half lives of medication)
* history of substance abuse or any neurotoxin use
* history of psychotic symptoms
* history of central nervous system (CNS) medical illness
* current substance abuse
* test positive on pregnancy test (for women)

Primary outcomes:
measure: MAO-B VT levels measured with PET in MDE secondary to MDD
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Research Imaging Centre, Centre for Addiction and Mental Health
name: Jeffrey H. Meyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418310: Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
Official title: Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Pilonidal Sinus
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the work To compare lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity

Detailed description: Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males of age 15 to 30.

The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal region in a woman.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders with symptoms from sacrococcygeal pilonidal sinus were included in our study.

Exclusion Criteria:

* Abscess formation 2. Immunodeficiency. 3. Patients with congenital asymptomatic pits. 4. Patient with psychiatric disease disabling surgical intervention. 5. Pregnant females

Primary outcomes:
measure: recurrence rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT03894410: Real World Study of Lapatinib Among Metastatic Breast Cancer Patients
Official title: Real World Study of Lapatinib Among Metastatic Breast Cancer Patients in Clinical Practice: a Multicenter, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: HER2
Lapatinib
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: A multicenter, retrospective, real world study of Lapatinib among Metastatic Breast Cancer (MBC) Patients in Clinical Practice.

Detailed description: This study collected patients used Lapatinib-base therapy among MBC, and tried to figure out if there was difference between single anti-Her2 treatment and dual anti-Her2 treatment. Furthermore, this study investigated the treatment after Lapatinib.

Eligibility criteria: Inclusion Criteria:

* Patients who were treated with Lapatinib between June 2014 to June 2018.
* Patients experienced progression on prior trastuzumab-containing regimens and a taxane.
* Complete medical history was available.

Exclusion Criteria:

* Medical history was incomplete.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06939010: 3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
Official title: 3D Interlocking Miniplates Versus Conventional Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mandibular Fractures
Miniplate
Keywords: Mental nerve
conventional miniplates
3D Interlocking
mandibular parasymphyseal fracture
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth
Primary purpose: TREATMENT

Brief summary: the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

Detailed description: A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line

Eligibility criteria: Inclusion Criteria:

* patients with recent bilateral mandibular fracture located in the mental foramina region.
* adults without gender predilection who agreed to follow-up,
* fractures requiring open reduction and internal fixation, and
* those medically fit for general anesthesia were included

Exclusion Criteria:

* medically compromised patients,
* fractures with infection,
* pathological or old fractures,
* completely edentulous patients,
* comminuted fractures

Primary outcomes:
measure: Radiographic evaluation for the assessment of mean bone density at the fracture line
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical evaluation for Intra-fragmentary mobility
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT00214110: Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
Official title: Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS patients.


Eligibility criteria: Inclusion Criteria:

* clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis

Exclusion Criteria:

* Allergic or idiosyncratic response to tamoxifen.
* Other active neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms.
* Psychiatric, psychological, or behavioral symptoms that would interfere with the subject's ability to participate in the trial.
* Clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or endocrine (poorly controlled insulin-dependent diabetes mellitus or hyperthyroidism) disease that may confound interpretation of the study results.
* Previous kidney or pancreas transplants.
* Significant hepatic or renal disease (AST \> 5 times normal, serum creatinine \> 2.0 mg/dL for males or \> 1.8 mg/dL for females).

Primary outcomes:
measure: Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
Secondary outcomes:
measure: Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
measure: Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
measure: Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
measure: Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Benjamin R Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References: