louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02586376: Effects of the Low-level Laser Therapy (LLLT) on Muscle Strength (MS) of the Patients With Kidneys Failure (KF)
Official title: Effects of the Different Intensities of the Low-level Laser Therapy on Handgrip Test on Patients With Kidneys Failure: A Randomized, Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Failure
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The low-level laser therapy (LLLT) has been used in many inflammatory disorders. More recently the LLLT was associated with an improvement in the muscle strength and endurance. But, these effects were described only in health or athletic individuals. In this randomized and controlled clinical trails, the investigators will study the effects of LLLT on muscle strength of the patients with kidneys failure on long time hemodialysis treatment. Additionally, investigators will explore three different intensities up the muscle strength.

Detailed description: This study will be conducing in a large hospital that is reference in kidneys disorders treatments. 16 patients will be randomized for placebo, 4J, 6J, or 8J low-level laser therapy (LLLT). The maximal voluntary contraction (MVC) will be test by handgrip test before and after de LLLT. One-week interval between the LLLT will gave to reduce the influence between the treatments. Moreover the endurance test will be use to evaluate the muscle oxidation impact of the LLLT.

Eligibility criteria: Inclusion Criteria:

* chronic kidney failure,
* long time hemodialysis treatment (\>18 months)

Exclusion Criteria:

* any health disturbance that can reduces the handgrip test performance beyond to the produced by the chronic kidney failure.

Primary outcomes:
measure: Muscle Strength (Handgrip Test)
timeFrame: once a week throughout 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Fabrício Edler Macagnan
state: RS
Study officials:
affiliation: Universidade Federal de Ciências da Saúde
name: Fabrício E. Macagnan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217776: School-based Approaches to Help Pre-teens Manage Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-22
Enrollment: 1292
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.

Detailed description: BACKGROUND:

To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed.

DESIGN NARRATIVE:

If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys.

Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance.

Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.

Eligibility criteria: Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.

Primary outcomes:
measure: Health Care Use Data
timeFrame: At Baseline, 12 month and 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan School of Public Health
name: Noreen M. Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870076: The Effect of Healing Touch on Sleep
Official title: Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Reconstructive Surgery Population
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2013-06-05
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

Detailed description: Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.

Eligibility criteria: Inclusion Criteria:

1. 5-25 years of age, inclusive
2. Elective admission for a reconstructive operative procedure
3. Planned use of general anesthesia during the elective operative procedure
4. Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian

Exclusion Criteria:

1. History of anoxic or suspected brain injury
2. History of head injury within the last year
3. Pre-existing neurological disorder
4. History of Reynaud's syndrome
5. Intellectual disability or inability to follow directions
6. Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
7. Taking medication for diagnosis of cardiomyopathy

Primary outcomes:
measure: Healing Touch Will Improve Total Sleep Time
timeFrame: 8 hours
Secondary outcomes:
measure: Preoperative Cortisol Level
timeFrame: Labs were drawn immediately pre-op.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
Study officials:
affiliation: Shriners Hospitals for Children
name: Michele Gottschlich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618176: Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
adverse effects
Treatment Outcome
Drug Resistance, Viral
treatment naïve
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2008-02-18
Enrollment: 198
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: The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
* the subjects were antiretroviral drug-naïve
* a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml

Exclusion Criteria:

* pregnancy or breastfeeding
* anticipated nonadherence
* AIDS-defining illness within 2 weeks of entry
* white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
* transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
citation: Li T, Dai Y, Kuang J, Jiang J, Han Y, Qiu Z, Xie J, Zuo L, Li Y. Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. PLoS One. 2008;3(12):e3918. doi: 10.1371/journal.pone.0003918. Epub 2008 Dec 12.
Clinical trial NCT06481176: Blood Changes After Exercise in Restless Legs Syndrome
Official title: Proteomic Response to Exercise in Adults With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: Exercise
Proteomics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two conditions that will be occurring simultaneously.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are:

How does long-term exercise change proteins in the blood?

How does a single exercise session change proteins in the blood?

The investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise.

Participants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older;
* diagnosis of RLS;
* presence of moderate-to-severe RLS (IRLS score\>15);
* currently untreated RLS;
* being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months;
* ability to walk without assistance (does not use a cane/walker/wheelchair for mobility;
* willing to complete outcome measures and complete the exercise program

Exclusion Criteria:

* present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes);
* are at moderate or high risk for undertaking strenuous or maximal exercise

Primary outcomes:
measure: Protein Expression Profile
timeFrame: Twice at Baseline Appointment
measure: Protein Expression Profile
timeFrame: Twice at the 12-week Follow-Up
Secondary outcomes:
measure: RLS Severity
timeFrame: Baseline
measure: RLS Severity
timeFrame: 12-weeks
measure: Cardiorespiratory Fitness
timeFrame: Baseline
measure: Cardiorespiratory Fitness
timeFrame: 12-weeks
measure: Sleep Diary
timeFrame: Baseline
measure: Sleep Diary
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Emmanuel Mignot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097876: A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer Subjects
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteer
pharmacokinetic
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.

Detailed description: Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female of non-childbearing potential subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Steady state PF 04447943 Cmax and AUCtau.
timeFrame: up through day 44
measure: Steady state Donepezil Cmax and AUCtau.
timeFrame: up through day 44
measure: Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.
timeFrame: up through day 44
Secondary outcomes:
measure: There are no Secondary Endpoints
timeFrame: There are no Secondary Endpoints
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01413776: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Official title: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal and Newborn Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: International Relief and Development
First posted: 2011-08-10
Enrollment: 547
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* in first trimester of pregnancy
* plans to reside in the same village during the entire pregnancy

Exclusion Criteria:

* a minor
* not in first trimester of pregnancy
* plans to relocate during the pregnancy

Primary outcomes:
measure: Mean birth weight
timeFrame: 9 months
Secondary outcomes:
measure: Mean gestational weight gain
timeFrame: 9 months
measure: Mean maternal hemoglobin level
timeFrame: 9 months
measure: Mean birth length and head circumference
timeFrame: 9 months
Other outcomes:
Locations:
city: Kampong Chhnang
country: Cambodia
facility: 4 Health Centers
Study officials:
affiliation: University of British Columbia
name: Judy McLean, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janmohamed A, Karakochuk CD, Boungnasiri S, Chapman GE, Janssen PA, Brant R, Green TJ, McLean J. Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):559-66. doi: 10.3945/ajcn.114.104034. Epub 2016 Jan 6.
citation: Janmohamed A, Karakochuk CD, Boungnasiri S, Whitfield KC, Chapman GE, Janssen P, McLean J, Green TJ. Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia. Public Health Nutr. 2016 Jul;19(10):1842-51. doi: 10.1017/S1368980015003018. Epub 2015 Oct 16.
Clinical trial NCT06161376: Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
Official title: Prospective Study Evaluating the Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with multiple sclerosis

Brief summary: This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.


Eligibility criteria: Inclusion Criteria:

* French residents enrolled in the social security system
* Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not
* Patients scheduled for urodynamic assessment as part of their management

Exclusion criteria:

* Pregnant or lactating females
* Patients under legal guardianship
* Untreated urinary tract infection at the time of inclusion
* Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty

Primary outcomes:
measure: S1P concentration
timeFrame: Day 0, after 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Xavier Game, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736476: Efficacy and Safety of an H.Pylori Vaccine in H.Pylori-Negative Adults
Official title: Phase I/II, Randomized, Observer-blind, Placebo-controlled, Single-Center Study of the Tolerability, Immunogenicity, and Efficacy of an Novartis' Investigational H. Pylori Vaccine in H. Pylori-Negative Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Pylori Infection
Keywords: helicobacter pylori infection
vaccination
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To study the safety, immunogenicity and efficacy of an investigational H. pylori vaccine, compared with placebo.


Eligibility criteria: Inclusion Criteria:

* adults 18 - 40 years of age in good health
* HP uninfected
* not pregnant and agree to use birth control throughout the study (females who can become pregnant)

Exclusion Criteria:

* remote or current HP infection

Primary outcomes:
measure: The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.
timeFrame: 12 weeks post HP challenge
measure: Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination
timeFrame: Day 1-7 post vaccination
Secondary outcomes:
measure: The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups
timeFrame: 12 months
measure: The Geometric Mean Concentrations After HP Vaccination.
timeFrame: upto 1 month after 3rd vaccination
measure: Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.
timeFrame: 12 months
measure: Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge
timeFrame: 12 weeks post HP challenge
measure: Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)
timeFrame: 12 weeks post HP challenge
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Otto von Guericke Universität Magdeburg
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Malfertheiner P, Selgrad M, Wex T, Romi B, Borgogni E, Spensieri F, Zedda L, Ruggiero P, Pancotto L, Censini S, Palla E, Kanesa-Thasan N, Scharschmidt B, Rappuoli R, Graham DY, Schiavetti F, Del Giudice G. Efficacy, immunogenicity, and safety of a parenteral vaccine against Helicobacter pylori in healthy volunteers challenged with a Cag-positive strain: a randomised, placebo-controlled phase 1/2 study. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):698-707. doi: 10.1016/S2468-1253(18)30125-0. Epub 2018 Jul 2.
citation: Nell S, Estibariz I, Krebes J, Bunk B, Graham DY, Overmann J, Song Y, Sproer C, Yang I, Wex T, Korlach J, Malfertheiner P, Suerbaum S. Genome and Methylome Variation in Helicobacter pylori With a cag Pathogenicity Island During Early Stages of Human Infection. Gastroenterology. 2018 Feb;154(3):612-623.e7. doi: 10.1053/j.gastro.2017.10.014. Epub 2017 Oct 21.