louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01987388: Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: United States Army Research Institute of Environmental Medicine
First posted: 2013-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans. The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the current method, which is based on glucose clamp data. It is hypothesized that this new metabolic flexibility method will be a useful and noninvasive biomarker for measuring adaptation to exercise and diet challenges.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* Age 22 to 35 years at beginning of study

Exclusion Criteria:

* Women who have given birth during the previous 12 months
* Pregnant women or women who plan to become pregnant or become pregnant during the study
* Lactating women
* History or presence of diabetes, kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes.
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (for at least 6 months prior to the start of the study)
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Inclusion and exclusion criteria have been established to recruit a population of individuals across a wide age-range that has typical digestive process

Primary outcomes:
measure: Metabolic Flexibility by Room Calorimetry
timeFrame: 24 hours
Secondary outcomes:
measure: Continuous Glucose Monitoring
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Center
state: Maryland
Study officials:
References:
Clinical trial NCT04899388: Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block
Official title: Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pericapsular Nerve Group Block (PENG Block)
Lumbar Erector Spinae Plane Block
Keywords: Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-05-24
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.

Detailed description: after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.

ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.

Control group C(n =23 ): patients received spinal anesthesia without any block.

Eligibility criteria: Inclusion Criteria:

Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.

Exclusion Criteria:

Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.

Primary outcomes:
measure: the time to first postoperative rescue analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Block performance time (min)
timeFrame: immediately before surgery
measure: onset of sensory block
timeFrame: after the block
measure: pain intensity
timeFrame: 30 minutes after the end of surgery ,3,6,12 hours postoperative.
measure: The total dose of rescue analgesia
timeFrame: 24 hours postoperative
measure: adverse effects
timeFrame: 24 hours postoperative
measure: Patient satisfaction
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Aculty of Medicine,Zagazig University
state: El Sharkia
Study officials:
affiliation: zagazig U
name: Howida A kamal, M.D
role: STUDY_DIRECTOR
affiliation: zagazig U
name: Marwa m Medhat, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02599688: Open Label Extension of LipoLat-CS202
Official title: An Open-label Extension Study of the Safety and Efficacy of Subconjunctival Liposomal Latanoprost (POLAT-001) in Patients With Ocular Hypertension and Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Peregrine Ophthalmic
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were randomized to received POLAT-001 and successfully completed LipoLat-CS202

Brief summary: This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.


Eligibility criteria: * Inclusion criteria

  1. Successful completion of 3 months of participation in Study LipoLat-CS202.
  2. Treatment with POLAT-001 in Study LipoLat-CS202.
  3. Able and willing to give signed informed consent and follow study instructions.
* Exclusion criteria

Excluded from the study will be individuals with the following characteristics:

1. The development, during study LipoLat-CS202, of any exclusion criteria from that study (e.g., concomitant medication or co-morbid disease).

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goose Creek
country: United States
facility: Professional Research Network
state: South Carolina
Study officials:
References:
Clinical trial NCT04457388: Tele-Yoga Therapy for Chronic Pain
Official title: Tele- Yoga Therapy for Patients With Chronic Pain During Covid-19 Lockdown: A Prospective Non-randomized Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Tele-Yoga Therapy
Chronic Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic pain is highly prevalent and associated with a large symptom burden, that is had been more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain management are very well known. With this background we developed Tele-Yoga therapy program and evaluated the success of this single arm study.


Eligibility criteria: Inclusion Criteria:

* Chronic pain for at least 3 months
* Having access to internet and video calls

Exclusion Criteria:

* Pregnant or breast-feeding women,
* Patients not willing to give written consent
* Patients with severe psychiatric or personality disorder
* Malignancy

Primary outcomes:
measure: Pain Intensity
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: Pain Disability
timeFrame: From baseline to 6-week post intervention
measure: Anxiety
timeFrame: From Baseline to 6-week post intervention
measure: Depression
timeFrame: From baseline to 6-week post intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam UK
state: Leicestershire
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Dipa Modi
role: STUDY_CHAIR
affiliation: Aarogyam UK
name: Bhavna Pandya
role: STUDY_CHAIR
References:
Clinical trial NCT01501188: Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
Official title: Study on the Effect of Kinesio Taping on Bioelectrical Activity of Gastrocnemius Muscles and Range of Ankle Motion in Post-menopausal Women With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Venous Insufficiency
Keywords: Chronic Venous Insufficiency
Kinesio Taping
Electromyography
Range of ankle motion
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 259
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the effects of Kinesio Taping on gastrocnemius muscle activation during gait and on Range of ankle motion in postmenopausal females with Chronic Venous Insufficiency in initial stages in comparison to a placebo control group.

Detailed description: Chronic Venous Insufficiency (CVI) is a very common disease. Patients with this pathology present peripheral muscle pump impairment and restricted range of ankle motion. Few data are available on the use in chronic venous insufficiency patients of Kinesio Taping, a physical therapist's elastic dressing that permits action on muscle activity and joint range.

Eligibility criteria: Inclusion Criteria:

* Age between 50 and 75 years.
* Mild-moderate Chronic Venous Insufficiency (grades C1, C2, and C3 on clinical-etiologic-anatomic-pathophysiologic (CEAP) scale)

Exclusion Criteria:

* Chronic Venous Insufficiency (\> grade C3)
* Arterial disorders
* Cardiorespiratory disease
* Contraindications for Kinesio Taping technique including thrombosis, wounds, severe trauma, generalized edema secondary to cardiac or renal problems, carcinomas, intolerability of/allergy to surgical tape and pregnancy.

Primary outcomes:
measure: Change on surface electromyography in gastrocnemius muscles
timeFrame: At baseline and 4 weeks.
measure: Change on range of ankle motion
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Carmen Moreno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03913988: Comparative Effectiveness of Three Lucid Dreaming and Sleep Hygiene Techniques
Official title: Comparative Effectiveness of Three Lucid Dreaming and Sleep Hygiene Techniques to Reduce Stress in Graduate Students on Clinical Internship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Dreaming
Sleep
Dream
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three group, randomized, controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators will compare traditional lucid dream induction techniques, stress reduction strategies, and sleep hygiene across three study groups: (1) lucid dream and stress reduction techniques, and sleep hygiene; (2) lucid dream reduction and sleep hygiene; and (3) sleep hygiene. Participants will be first-year occupational therapy students embarking upon their first full-time 3-month clinical internship. Enrolled participants will be randomized to one of the three groups. The intervention will span 12 weeks and allow for participants to learn about and practice lucid dream induction, stress management, and sleep hygiene in bi-monthly online group sessions and through daily home exercises.

Detailed description: A significant impediment to completing academic health care programs is student stress level, which have been reported to be increasing in the last decade. Many students are not prepared for the rigor and intensity of their first clinical internship and experience exacerbations of stress and anxiety at this time. There is evidence that lucid dream induction methods have effectively alleviated stress and anxiety in veterans with post-traumatic stress disorder, and depression in community dwelling adults. Although lucid dream techniques have been used to manage anxiety in some populations, it has never been used to help health care students on clinical internship experiencing heightened stress levels. In this study, the investigators aim to determine whether lucid dream induction techniques combined with stress management and sleep hygiene could effectively help students on their first clinical internship to better manage stress and anxiety. The investigators hope to gain a greater understanding of which of three study conditions can best alleviate stress and anxiety in participants.

Eligibility criteria: Inclusion Criteria:

* Current occupational therapy student attending Columbia University and participating in clinical internship

Exclusion Criteria:

* none

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Week 12
Secondary outcomes:
measure: Lucidity and Consciousness Dream Scale
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Sharon Gutman, PhD, OTR, FAOTA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364688: Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Official title: Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vascular Calcification
Keywords: coronary calcification
vascular calcification
active vitamin D
alfacalcidol
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Detailed description: Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

Eligibility criteria: Inclusion Criteria:

* Predialysis chronic kidney disease with GFR \< 90 mL/min/1.73m2
* PTH above the upper limit of normal
* serum calcium and phosphate below the upper limit of normal

Exclusion Criteria:

* changes in GFR\>15% during the past 3 months
* receive elemental calcium\>500 mg/day
* currently taking active vitamin D, oral calcium with elemental calcium\>500 mg/day or bisphosphonate

Primary outcomes:
measure: Change in Coronary Artery Calcification
timeFrame: 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phayathai
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
References:
Clinical trial NCT06500988: Mobile Health Technology-Enabled AFib Management
Official title: Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Behavior
Keywords: Remote Patient Monitoring
Atrial Fibrillation
Risk Factor Modification
Digital Health
Mobile Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pharmaceutical Research & Manufacturers Of America Foundation
name: Apple Inc.
name: Itamar-Medical, Israel
First posted: 2024-07-15
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)


Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older at time of consent
2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
3. BMI (Body Mass Index) ≥ 27.0

Exclusion Criteria:

1. Permanent Afib (decision has been made not to attempt sinus rhythm)
2. Severe valvular disease
3. Moderate mitral valve stenosis
4. Prior cardiac surgery
5. Presence of implanted cardiac device
6. History of cardiac arrest
7. Left ventricular ejection fraction (LVEF) ≤ 35%
8. Life expectancy \< 1 year
9. Non-English speaking
10. Treating clinician deems unsafe for exercise
11. Any other reason that makes patient unsuitable for study at the discretion of the PI

Primary outcomes:
measure: Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: David Spragg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857088: Olfactory and Visual Perception in Depressed Patients
Official title: Study of the Emotional Reactivity to Olfactive and Visual Perception in Depressed Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: depression
emotional reactivity
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* no cognitive impairment that could prevent instruction comprehension
* no more than 10 cigarettes/day
* signed informed consent
* group 1: current major depressive disorder
* group 2: no current major depressive disorder

Exclusion Criteria:

* pregnancy
* visual impairment
* olfactory impairment

Primary outcomes:
measure: hedonicity score of visual stimuli
timeFrame: up to 1 month
measure: skin conductance reactivity amplitude
timeFrame: up to 1 month
measure: Skin conductance reactivity reaction time
timeFrame: up to 1 month
measure: hedonicity score of olfactory stimuli
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Sylvie Nezelof, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: