louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02971592: Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain
Official title: Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Back Pain Lower Back Chronic
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
Collaborators: name: Aerotel Ltd
First posted: 2016-11-23
Enrollment: 40
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: This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1 listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to reduce muscular aches and pains particularly of the lower back.

assessing the reduction of lower back pain. Half of participants will receive the MDcure device, while the other half will receive a mock device.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18-75
* Patients with chronic lower back for more then 3 month
* Patients who scored over 21% and below 60% in the Oswestry questionnaire

Exclusion Criteria:

* A neurological deficient in lower limbs
* Patients who scored more than 60% on the Oswestry questionnaire.
* Patients who underwent surgical intervention in spine including metal implant in lower back
* Patients diagnosed with cancer
* Patients with any type of vertebral fracture
* Patients who received steroid injection less then a month prior to starting the experiment
* Patients treated with steroids as a preventive treatment on a regular basis
* Patients using narcotic drugs for over a six month period or cannabis or any other sort of narcotic drug for over a six month period prior to their enrollment in the study
* Pregnant women

Primary outcomes:
measure: Improvement in pain in experiment group
timeFrame: 6 weeks
measure: Improvement in pain in placebo group
timeFrame: 6 weeks
Secondary outcomes:
measure: Assess period of time to attain improvement
timeFrame: maximum of 6 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Centers - Ramat Hahyal
Study officials:
References:
Clinical trial NCT05501392: South Texas Early Prevention Studies PreK
Official title: South Texas Early Prevention Studies - PreK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Prek children
obesity prevalence
Lead sponsor: University of Texas Rio Grande Valley
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2022-08-15
Enrollment: 1277
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: There were three sequential data collection periods through the process.
Primary purpose: PREVENTION

Brief summary: The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.

Detailed description: The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit of randomization, intervention, and analysis. The study was designed for two years of intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring 2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped prematurely and only results from the first three periods will be presented.

The two school districts where the study was conducted are located along the Texas-Mexico border in the county of Hidalgo. These school districts were selected because of the high poverty and health risk-factors levels.25 The preschools have two grade levels with children 3 and 4 years of age. The present study targeted preschools with children 4 years of age. Demographics of the two school districts were similar, 99% Hispanic, 92% economically disadvantaged, and 42% identified as English as a second language.

Eligibility criteria: Inclusion Criteria:

* PreK children
* Enrolled in PSJA and La Joya ISDs

Exclusion Criteria:

* na

Primary outcomes:
measure: cardiorespiratory fitness
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: University of Texas Rio Grande Valley
state: Texas
Study officials:
affiliation: University of Texas Rio Grande Valley
name: Elizabeth Alanis, Masters
role: STUDY_DIRECTOR
References:
citation: Trevino-Pena R, Wang X, Wang L, Romero Z, Alanis E, Li H. Social and Health Risk Factor Levels of Preschool Children Living Along the Texas-Mexico Border. J Sch Health. 2020 Dec 2. doi: 10.1111/josh.12979. Online ahead of print.
Clinical trial NCT02465892: Pillars4Life Trial
Official title: Pillars4Life Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Esophageal Cancer
Colon Cancer
Pancreatic Cancer
Liver Cancer
Renal Cancer
Bladder Cancer
Prostate Cancer
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Keywords: cancer
stress
chronic pain
anxiety
coping
balance
online course
psychosocial
support
tools
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-06-09
Enrollment: 284
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: This study aims to explore whether cancer patients can benefit from completing the Pillars4Life online coping program. This randomized control trial will have half its subject completing the program and the other half receiving standard care in order to measure whether the program is beneficial in dealing with stress, anxiety, and particularly chronic pain that often accompany a cancer diagnosis.

Detailed description: Subjects will complete three online surveys as part of the study. Each subject who completes the first survey will be randomized to either the control group who receive standard care from their care team or to complete the 9-week Pillars4Life curriculum. Subjects completing the Pillars4Life program will select a course day/time that works for them from those offered. Each week the program will send an email approximately 15 minutes before class time with a link. Subjects will click the link to go to the "classroom," where they will enter their name and phone number. The program will call the number provided and the subject will listen to the audio over the phone, while watching the guide and activities in the virtual classroom on their computer. Each class will last about an hour.

All subjects will complete two additional surveys, at approximately 9 weeks and 18 weeks after enrolling in the study.

Eligibility criteria: Inclusion Criteria:

* Current pain level ≥3 and at least one prior score ≥3 on a 0-10 scale as reported in EPIC;
* Age ≥18 years
* Diagnosed with Breast, GI, GU, GYN, or Thoracic cancer
* Actively receiving care at the Duke Cancer Center, Durham Regional Hospital, or Duke Raleigh Hospital
* Able/willing to have an online interaction with the Pillars4Life online CORE program curriculum
* Life expectancy ≥6 months
* Providing informed consent
* Able to read/write English.

Exclusion Criteria:

* none

Primary outcomes:
measure: Chronic pain
timeFrame: 9 weeks
Secondary outcomes:
measure: Stress
timeFrame: 9 weeks
measure: Anxiety
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Sophia K Smith, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03382392: Hypermetabolism in ALS Using Six REE Formulas
Official title: Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis,
Resting energy expenditure
Predictive equation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS patients

Brief summary: Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed.

EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.


Eligibility criteria: Inclusion Criteria:

* ALS patients
* 18 years old or more
* IC and nutritional assessment within 1.5 months
* delay between diagnosis and IC \< 12 months

Exclusion Criteria:

-

Primary outcomes:
measure: Measure of REE
timeFrame: indirect calorimetry (IC) and nutritional assessment within 1.5 months, and diagnosis and IC within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
Study officials:
References:
Clinical trial NCT00995592: Philani Home-based Nutrition Intervention Program
Official title: Philani Home-based Nutrition Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Child Weight
Keywords: nutrition
child weight
undernourishment
mentor mother
South Africa
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Philani Child Health and Nutrition Project, Khayelitsha, Cape Town, South Africa
First posted: 2009-10-15
Enrollment: 684
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malnourished children and babies with birth weights under 2500 grams are at high risk for negative outcomes over their lifespan. Philani, a paraprofessional home-visiting program, was mounted in neighborhoods in three townships in Cape Town, South Africa, from 2002 to 2004 to improve nutritional outcomes.

One mentor mother was recruited from each of 37 neighborhoods. Mentor mothers were trained to conduct home visits to weigh children and to support mothers to problem-solve life challenges, especially around nutrition. Households were randomly assigned on a 2-to-1 ratio to the Philani program or to a standard care condition. Children were evaluated over a 1-year period.

The investigators hypothesized that children in the intervention would gain more weight than children in the control.


Eligibility criteria: Inclusion Criteria:

* mother or caregiver
* with child under 5 years of age and malnourished (malnourished if less than 2 standard deviations below the World Health Organization normative mean weight for the child's age

Exclusion Criteria:

* no malnourished children under care
* malnourished children not living in household

Primary outcomes:
measure: weight-for-age z-score
timeFrame: one year
Secondary outcomes:
measure: weight in kilograms
timeFrame: one year
Other outcomes:
Locations:
city: Khayelitsha
country: South Africa
facility: Philani Child Health and Nutrition Project
state: Cape Town
city: Cape Town
country: South Africa
facility: Philani Child Health and Nutrition Project, Khayelitsha
Study officials:
References:
citation: Christodoulou J, Rotheram-Borus MJ, Bradley AK, Tomlinson M. Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa. J Am Acad Child Adolesc Psychiatry. 2019 Dec;58(12):1165-1174. doi: 10.1016/j.jaac.2019.03.016. Epub 2019 Mar 26.
Clinical trial NCT01234792: Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Official title: Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed description: The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: During 8 hours post-dose
measure: Area Under the Curve (AUC)(0-t)
timeFrame: During 8 hours post-dose
measure: AUC(0-∞)
timeFrame: 8 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05620992: Evaluation of Right Ventricular Function Post Mitral Valve Operations
Official title: Evaluation of Right Ventricular Function Post Mitral Valve Operations in Patients With Pulmonary Hypertension.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Right Ventricular Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Descriptive cross-sectional

Brief summary: We aim to determine the function of Right ventricle post mitral valve surgeries in patients with pulmonary hypertension using transthoracic echocardiography3- and 6-months post-operatively to detect the effect of mitral valve surgeries over the RV function whether improving, deteriorating, or not changing at all.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent mitral valve surgeries who also had pulmonary hypertension in the period between March 2019 and March 2022 in Assiut university heart hospital

Exclusion Criteria:

* Patients who underwent mitral valve surgeries with normal pulmonary pressure. Patients who had other valve surgeries besides mitral as aortic and/or tricuspid valve surgeries. Patients had mitral valve surgeries with other heart conditions that needed another intervention in the same session as CABG for IHD.

Primary outcomes:
measure: Right Ventricular function post mitral valve surgeries in patients with pulmonary hypertension
timeFrame: From March 2019 till March 2022
Secondary outcomes:
measure: Best mitral valve surgical modalities in patients with pulmonary hypertension
timeFrame: From March 2019 till March 2022
Other outcomes:
Locations:
Study officials:
References:
citation: Ho SY. Anatomy of the mitral valve. Heart. 2002 Nov;88 Suppl 4(Suppl 4):iv5-10. doi: 10.1136/heart.88.suppl_4.iv5. No abstract available.
citation: Tokodi M, Nemeth E, Lakatos BK, Kispal E, Toser Z, Staub L, Racz K, Soltesz A, Szigeti S, Varga T, Gal J, Merkely B, Kovacs A. Right ventricular mechanical pattern in patients undergoing mitral valve surgery: a predictor of post-operative dysfunction? ESC Heart Fail. 2020 Jun;7(3):1246-1256. doi: 10.1002/ehf2.12682. Epub 2020 Mar 26.
citation: Denault A, Deschamps A, Tardif JC, Lambert J, Perrault L. Pulmonary hypertension in cardiac surgery. Curr Cardiol Rev. 2010 Feb;6(1):1-14. doi: 10.2174/157340310790231671.
citation: Estrada VH, Franco DL, Moreno AA, Gambasica JA, Nunez CC. Postoperative Right Ventricular Failure in Cardiac Surgery. Cardiol Res. 2016 Dec;7(6):185-195. doi: 10.14740/cr500e. Epub 2016 Dec 31.
citation: Nagel E, Stuber M, Hess OM. Importance of the right ventricle in valvular heart disease. Eur Heart J. 1996 Jun;17(6):829-36. doi: 10.1093/oxfordjournals.eurheartj.a014963.
Clinical trial NCT03897192: Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis
Official title: Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Punctate Inner Choroidopathy
Keywords: punctate inner choroidopathy
multifocal choroiditis
zonal outer retinopathy
long-term outcome
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included patients of PIC/MFC and ZOR with a clinical follow up of 4 years or longer. Patients were recorded of age, sex, best corrected visual acuity (BCVA), refractive status, coexistence of choroidal neovascularization, number and total area of PIC/MFC lesions, treatment, and recurrent activity.

Brief summary: To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).


Eligibility criteria: Inclusion Criteria:

* Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
* Follow up over 4 years.

Exclusion Criteria:

* Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).

Primary outcomes:
measure: Wilcoxon Signed-Rank test
timeFrame: Baseline, 4 year
Secondary outcomes:
measure: visual acuity
timeFrame: Baseline, 6 month, 12 month, 24 month, 36 month, 48 month
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
References:
Clinical trial NCT00249392: Epidemiologic, Laboratory, and Clinical Characterization of Individuals With Ocular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Diseases
Keywords: ocular diseases
risk factors
genetic factors
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Environmental and genetic factors may play a role in the progression of ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). The goal of this project is to establish a series of case-control studies to evaluate risk factors of ocular diseases in China.

Detailed description: This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). We will accrue approximately 800 patients as experimental group. The control group consists of age/sex frequency-matched subjects who will be confirmed without ocular diseases. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress and angiogenic factors, etc.) and genetic (including oxidative stress and angiogenic factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of various ocular diseases.

Eligibility criteria: Inclusion Criteria:

* This is a study only of Chinese.
* Subjects will be allowed to participate if they self-identify as Chinese.
* Individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.) will be allowed to participate. To participate in the study as the control, subjects should be confirmed without ocular diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Department of Pharmacology, Institute of Clinical Pharmacology, Nanjing Medical University
name: Bin Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: