louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04557553: Effects of Lagenbone on Bone Mineral Density
Official title: Effects of Lagenbone on Improvements in Bone Mineral Density - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: chinese medicine
herbal medicine
osteoporosis
bone mineral density
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Sun Ten Pharmaceutical Co., Ltd.
First posted: 2020-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effects of the herbal supplement Lagenbone on Bone Mineral Density

Detailed description: To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of osteoporosis
* Able to read and understand English
* Willing to receive routine DEXA scans and comply with supplement schedule

Exclusion Criteria:

* Pregnant, lactating, or having gestational diabetes
* Diagnosed with comorbid conditions that they are taking medication for e.g. Acid reflux, Hashimoto's/Grave's Disease, Endometriosis, prostate, breast, uterine cancer, kidney disease, fibroids, psychological disorders
* Use of any medication known to interfere with bone mineral density
* Are taking any new medications/supplements/treatments/therapeutic exercise within the last two months for osteoporosis or bone density
* Involved in health-related litigation, claims
* Missing baseline visits
* Vegan or vegetarian
* Diagnosed with Alzheimer's or demonstrating onset of dementia

Primary outcomes:
measure: Dual-energy x-ray absorptiometry (DXA)DEXA Scan
timeFrame: 15 months
Secondary outcomes:
measure: Short Osteoporosis Quality of Life Questionnaire (ECOS16)
timeFrame: 15 months
measure: 36-item Short form survey (SF36)
timeFrame: 15 months
measure: Osteoporotic Quality of Life Questionnaire (OQLQ10)
timeFrame: 15 months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Prasad S Vinjamury, DACM, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05554653: Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis
Official title: Influence of Leucine Enriched Amino Acids on Myofibrillar and Collagen Protein Synthesis in Human Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Interventional
Keywords: Leucine-enriched amino acids
Carbohydrate Placebo
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover to receive LEAA or Carbohydrate placebo. Unilateral leg exercise to give 4 outcome. (1) LEAA-EX; (2) LEAA-REST; (3) PLACEBO-EX; (4) PLACEBO-REST
Primary purpose: TREATMENT

Brief summary: The primary objective will be to determine the effect of leucine-enriched essential amino acids (LEAA) compared to carbohydrate placebo on dietary incorporation of \[D5\] Phenylalanine \& \[D5\] Glycine into the three skeletal muscle protein pools (myofibrillar, sarcoplasmic and collagen), both following resistance exercise and at rest, with the two tracers provided as a 'intrinsically labeled' bolus. Other outcomes will relate to molecular regulation of protein synthesis.


Eligibility criteria: Inclusion Criteria:

* Healthy, male and female, recreationally-active participants.
* Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix B).
* Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
* Participants will be aged 18-35 years old.
* Participants are willing to abide by the compliance rules of this study.
* Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

Exclusion Criteria:

* Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor.
* Self-reported regular tobacco use.
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
* Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
* Use of birth control and discontinued use within the last 3 months (female participants).

Primary outcomes:
measure: Myofibrillar Protein synthesis
timeFrame: 4 hours
Secondary outcomes:
measure: Sarcoplasmic protein synthesis
timeFrame: 4 hours
measure: Collagen protein synthesis
timeFrame: 4 hours
measure: Protein localization via immunofluorescence
timeFrame: 4 hours
Other outcomes:
measure: Isolation of primary myoblasts for in vitro nutritional experiments
timeFrame: 6-9 months
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport at the University of Toronto
state: Ontario
Study officials:
References:
Clinical trial NCT01290653: Dry Needling Versus Strain-counterstrain on the Upper Trapezius
Official title: Dry Needling Versus Strain Counterstrain Technique: Pilot Study Comparing Effects Over the Upper Trapezius Myofascial Trigger Point
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP). Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.


Eligibility criteria: Inclusion Criteria:

* Active myofascial trigger point at the upper trapezius

Exclusion Criteria:

* Diagnosed fibromyalgia
* Cervical radiculopathy
* Facial neuralgia
* Coagulation alteration
* Cancer
* Allergy (included needles)
* History of cervical or shoulder surgery
* History of deep venous thrombosis
* History of myopathy
* History of infiltration at upper trapezius trigger point
* Anticoagulant medication
* Aspirin intake during the last 3 days
* Drug intake (AINES, narcotics, antiepileptics, or any other analgesic medication)
* Pregnancy

Primary outcomes:
measure: Pain Pressure Threshold
timeFrame: 6 sessions
Secondary outcomes:
measure: Pain at rest
timeFrame: 6 sessions
measure: Neck Disability
timeFrame: 6 sessions
measure: Electromyographic activity of the upper trapezius
timeFrame: 6 sessions
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: Eva Segura-Ortí, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segura-Orti E, Prades-Vergara S, Manzaneda-Pina L, Valero-Martinez R, Polo-Traverso JA. Trigger point dry needling versus strain-counterstrain technique for upper trapezius myofascial trigger points: a randomised controlled trial. Acupunct Med. 2016 Jun;34(3):171-7. doi: 10.1136/acupmed-2015-010868. Epub 2016 Jan 8.
Clinical trial NCT03811353: The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
Official title: Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chewing Problem
Swallowing Disorder
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with serebral palsy and healthy children

Brief summary: The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.

Detailed description: The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.The internal consistency, test-retest reliability, and criterion validity of T-MOE will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between the T-MOE and Karaduman Chewing Performance Scale and Tongue Thrust Rating Scale.

Eligibility criteria: Inclusion Criteria:

* Having chewing disorders aged between 18 months-12 years
* Being serebral palsy
* Being healthy children

Exclusion Criteria:

* No chewing disorders
* A child aged below 6 months

Primary outcomes:
measure: The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
timeFrame: 3 months
Secondary outcomes:
measure: The Karaduman Chewing Performance Scale (KCPS)
timeFrame: 3 months
measure: Tongue Thrust Rating Scale (TTRS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serel Arslan S, Demir N, Karaduman AA. Turkish Version of the Mastication Observation and Evaluation (MOE) Instrument: A Reliability and Validity Study in Children. Dysphagia. 2020 Apr;35(2):328-333. doi: 10.1007/s00455-019-10035-8. Epub 2019 Jul 10.
Clinical trial NCT01863953: A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 112
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma
* Requires intraocular pressure (IOP)-lowering therapy

Exclusion Criteria:

* Cataract surgery in one eye
* Ocular laser or intraocular surgery within 6 months
* Refractive surgery in either eye
* Anticipated use of contact lenses during the study
* Expected use of artificial tears during the study

Primary outcomes:
measure: Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: Change From Baseline in Average Eye Mean Diurnal IOP
timeFrame: Baseline, Day 14, Day 28
measure: Average Eye Mean Diurnal IOP
timeFrame: Day 14, Day 28, Day 42
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02272153: Satiety Effects of the Combination of Egg and Whole Grains
Official title: The Effects of the Combination of Egg and Whole Grains on Appetite, Blood Glucose Response and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The satiety effects of the combination of protein and fiber within egg and whole grain breakfast meals. High protein with low and high-fiber is hypothesized to be more satiating than low protein, low fiber.

Detailed description: Subjects will consume 3 different breakfast meals. Satiety will be measured by visual analogue scales; food intake will be recorded at subsequent meal as well as 24 hour food log; blood glucose response will be assessed following test meals. Subjects will consume an ad libitum lunch meal 3.5 hours after breakfast meal and food intake will be measured.

Eligibility criteria: Inclusion Criteria:

* healthy,
* non-smoking,
* BMI of 18-27,
* non-dieting,
* typically consumes breakfast/lunch

Exclusion Criteria:

* distaste for eggs,
* vegetarian,
* current smoker,
* restrained eating habits,
* recent weight change,
* history of significant disease of past medical history,
* pregnant,
* lactating irregular menstrual cycle

Primary outcomes:
measure: Satiety
timeFrame: 210 minutes
Secondary outcomes:
measure: Food intake
timeFrame: 210 minutes
measure: Blood glucose response
timeFrame: 180 minutes
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000353: Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
Official title: Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01293253: Effect of Daily Stair Walking on Cardiovascular Health
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
First posted: 2011-02-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Many adults find it difficult to perform physical exercise during leisure. The workplace may provide an optimal setting to encourage a healthier lifestyle. This study investigates the effect of daily stair walking at the workplace on cardiovascular health.

The main hypothesis is that daily stair walking for 10 weeks compared with a control group results in increased aerobic fitness.


Eligibility criteria: Inclusion Criteria:

* office worker

Exclusion Criteria:

* life threatening disease
* pregnancy

Primary outcomes:
measure: Aerobic fitness
timeFrame: before and after the 10 week intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: before and after the 10 week intervention
measure: Questionnaire-based data
timeFrame: before and after the 10 week intervention
measure: Heart Rate Variability
timeFrame: Before and after the 10 week intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lægemiddelstyrelsen
Study officials:
affiliation: National Research Centre for the Working Environment, Denmark
name: Lars L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen LL, Sundstrup E, Boysen M, Jakobsen MD, Mortensen OS, Persson R. Cardiovascular health effects of internet-based encouragements to do daily workplace stair-walks: randomized controlled trial. J Med Internet Res. 2013 Jun 21;15(6):e127. doi: 10.2196/jmir.2340.
Clinical trial NCT01229553: Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients
Official title: Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients at the CF Center at SUNY Upstate Medical University, Syracuse, NY.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to measure efficacy of our new protocol by monitoring the results of our routine respiratory cultures at the end of the new standard treatment, and during routine visits for 1 year from initiation of therapy for Staphylococcus aureus. The secondary objective will include determining the clinical course (pulmonary exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the protocol.


Eligibility criteria: Inclusion Criteria:

Eligible participants will include all patients with CF who test positive for SA from respiratory tract culture (throat, nares or expectorated sputum) and are 2-23 months of age at protocol presentation.

Exclusion Criteria:

Patients co-infected with other bacteria (e.g. Pseudomonas) or documented to have an allergy or resistance to any of the intervention substances will be excluded.

Primary outcomes:
measure: To measure the efficacy of a decolonization regimen to eliminate SA from nares, oropharynx and sputum of pediatric CF patients (2-23 months of age).
timeFrame: 1 year
Secondary outcomes:
measure: To measure adverse effects of the decolonization regimen (e.g. local irritation, skin dryness, rashes, vomiting, diarrhea) and its impact on carriage with other organisms (e.g., Pseudomonas).
timeFrame: 1 year
measure: To evaluate the effect of decolonization regimen on lung changes and/or frequency of pulmonary exacerbations.
timeFrame: 1 year
measure: To evaluate adherence to the decolonization regimen
timeFrame: 1 year
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Jana Shaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840253: Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants Undergoing Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 23
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* All patients that are candidates for and have agreed to spinal anesthesia.

Exclusion Criteria:

* none

Primary outcomes:
measure: Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)
timeFrame: Intraoperative measure
measure: Tissue Non-invasive Near Infrared Spectroscopy (NIRS)
timeFrame: Intraoperative measure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Froyshteter AB, Tumin D, Whitaker EE, Martin DP, Hakim M, Walia H, Bhalla T, Tobias JD. Changes in tissue and cerebral oxygenation following spinal anesthesia in infants: a prospective study. J Anesth. 2018 Apr;32(2):288-292. doi: 10.1007/s00540-017-2446-8. Epub 2018 Jan 12.