louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03701906: Effect of a Mixture of New Probiotic Strains in Preterm Infants
Official title: Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Lead sponsor: ProbiSearch SL
Sponsor class: INDUSTRY
First posted: 2018-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.

The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.

Detailed description: An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.

The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.
* Written informed consent signed by the parent or legal guardian.
* Tolerate enteral feeding, at least 10mL / kg / day.
* Postnatal age ≤ 5 days

Exclusion Criteria:

* Child with malformations
* With short bowel syndrome or any surgery in the gastrointestinal tract
* With defect in the intestinal epithelial barrier

Primary outcomes:
measure: Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: ProbiSearch SL
name: Susana Manzano, PhD
role: STUDY_CHAIR
References:
citation: Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25.
Clinical trial NCT01523106: L-carnitine to Treat Fatigue Associated With Crohn's Disease
Official title: L-carnitine to Treat Fatigue Associated With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Crohn's Disease
Fatigue
Keywords: Crohn's disease
carnitine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled study, comparing the effect of L-carnitine vs placebo on fatigue among Crohn's disease patients.

The specific aim of this study is to determine if treatment with L-carnitine is more effective than placebo at decreasing fatigue severity scores, while accounting for disease activity and concomitant anemia, depression/anxiety and poor sleep quality.

Detailed description: A total of 100 patients will be recruited, in order to be able ensure to detect a significant difference in fatigue between the treatment and control groups.

Eligibility criteria: Inclusion Criteria:

* Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards.
* To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI\<16).
* In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").

Exclusion Criteria:

* Exclusion criteria will include:

  * age \<18 or \>70 years
  * pregnancy or delivery within 6 months
  * malignancy diagnosed within 1 year
  * oral/intravenous steroid treatment within 6 months
  * any surgery within 6 months
  * presence of a stoma or ileo-anal J-pouch anastomosis
  * concurrent hepatitis B or C infection
  * cirrhosis
  * renal insufficiency (CrCl\<60) and history of seizure disorder or hypothyrodism.
  * prior to study enrollment
  * women of child-bearing age will need to undergo pregnancy testing.

Primary outcomes:
measure: Change in fatigue severity scale
timeFrame: From baseline to 3 months after intervention initiation
Secondary outcomes:
measure: Change in Multidimensional Fatigue Inventory
timeFrame: From baseline to 3 months after intevention initiation
measure: Change in handgrip strength
timeFrame: From baseline to 3 months after treatment intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center, Mt. Zion Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Uma Mahadevan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165306: Enhancing Antiepileptic Drug Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: More than half of patients with epilepsy achieve full control of their seizures with antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational intervention in improving medication adherence in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* diagnosis of epilepsy according to the International League Against Epilepsy criteria
* age equal or higher than 18 years
* independence in daily living activities
* absence of major cognitive impairment or active psychiatric disorders

Exclusion Criteria:

* presence of a rapidly progressing neurological or medical disorder
* patients not receiving anti-epileptic drugs
* a history of significant substance abuse within the past year
* a diagnosis of mental retardation

Primary outcomes:
measure: changes in Patient-reported medication Adherence to antiepileptic drugs
timeFrame: changes from baseline , 3 Months and 6 months after the intervention
Secondary outcomes:
measure: changes in serum levels of antiepileptic drugs
timeFrame: changes from baseline , 6 Months, 12 months and 18 months after the interventio
measure: Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
measure: Changes in action planning
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
measure: Changes in coping planning
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
measure: Changes in quality of life
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
measure: Changes in habit strength
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
measure: Changes in Seizure Severity
timeFrame: Changes from baseline, 3 Months and 6 months after the intervention
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences, Shahid Rajaei Hospital
Study officials:
affiliation: Qazvin University Of Medical Sciences
name: Amir H pakpour, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.
Clinical trial NCT00932906: Comparison of Different Automated External Defibrillation (AED) Training Methods
Official title: Comparison of Four Different AED Training Methods in Three Different Age Groups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improvement of BLS/AED Training Programmes
Keywords: Education
Retention
Retrieval
Self training
Lead sponsor: Doczero
Sponsor class: OTHER
Collaborators: name: Laerdal Medical
First posted: 2009-07-07
Enrollment: 396
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED:

A. Traditional instructor based learning;

B. The use of a personal manikin with a DVD training to practice the necessary AED skills;

C. The use of a personal manikin with a DVD training to practice the necessary AED skills and additional scenario training;

D. Watching a 2.5 minutes DVD which shows the use of an AED.

It is hypnotised that there are no differences between these training methods, in which case method D is most efficient to reach large number of people to learn BLS/AED skills.

There are two interesting target groups to reach:

1. Younger people, as they might give the highest interest after training, as they normally live longer.
2. Older people as they are member of the most important group in risk and have therefore a higher change of being a witness of cardiac arrest.

As there might be differences in the results between different training methods than can be related to age, each training group is distinguished to three different groups:

1. 21 years of younger;
2. between 21 and 50 years;
3. older than 50 years.

It is hypnotised that there are no differences between younger and older students within each of the four training methods.


Eligibility criteria: Inclusion Criteria:

* willing to follow a BLS/AED course up to 2h

Exclusion Criteria:

* CPR training within the last five years
* professional health care provider

Primary outcomes:
measure: Kruskal-Wallis test
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Doczero
name: Wiebe de Vries, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Koenraad Monsieurs, Professor
role: STUDY_DIRECTOR
affiliation: VU Medical Centre
name: Joost Bierens, Professor
role: STUDY_CHAIR
affiliation: Academical Medical Centre Amsterdam
name: Rudolph Koster, PhD MD
role: STUDY_CHAIR
affiliation: Medicine, Wilhelmina Children Hospital - University Medical Centre Utrecht
name: Nigel M Turner, PhD MD
role: STUDY_CHAIR
References:
Clinical trial NCT00132106: The Effect of Alfa-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure
Official title: The Effect of a-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Congestive
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-08-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).


Eligibility criteria: Inclusion Criteria:

* Heart failure of at least New York Heart Association (NYHA) class II
* Left ventricular ejection fraction (LVEF) \<= 40%
* Age 18-75 years

Exclusion Criteria:

* Alfa-blockers, or beta-blockers with alfa-blocking activity (carvedilol)
* Tricyclic antidepressants
* Warfarin derivatives (acetylic salicylic acid and clopidogrel are allowed)
* Hospitalisation in 6 weeks prior to the study
* Any change in medication in 6 weeks prior to the study
* Unstable angina
* Orthopnoea
* Known chronic disease of the autonomic nervous system
* Diabetes mellitus
* Oedema of the lower extremities, complicating the insertion of a venous catheter in a vein on the foot

Primary outcomes:
measure: change in glucose uptake
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Cees J Tack, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05310006: Acute Effects of Low and High-Speed Resistance Training on Blood Pressure in Older Adults: A Crossover Study
Official title: Acute Effects of Low and High-Speed Resistance Training on Blood Pressure in Older Adults: A Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Frailty
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Participants performed three experimental sessions (i.e., HSRE, TRE, and a control session \[CS\]) in a random order and separated from one another by seven days (standard deviation \[±\] 1 day). Food consumption was maintained constant during 48 h prior to the exercise session and a standard breakfast was offered 60-90 min before the beginning of the experimental sessions. The pharmacological therapy was kept constant during the whole study, and participants took their anti-hypertensive medication at the same time in all experimental days as prescribed by their physician.


Eligibility criteria: Inclusion Criteria:

- Aged ≥60 years; Frail according to Fried's criteria (Fried et al., 2009); Possessed sufficient physical and cognitive abilities to perform all exercises required by the protocol; Had a physician authorization to participate of exercise programs.

Exclusion Criteria:

Participation in a structured physical exercise training program in the past six months; Prescription of hormone replacement therapy and/or psychotropic drugs; Presence of any acute cardiovascular event (e.g., myocardial infarction) or complication in the past six months.

Primary outcomes:
measure: Blood Pressure
timeFrame: Immediately after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 10 minutes after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 20 minutes after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 30 minutes after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 50 minutes after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 60 minutes after the end of the experimental sessions
measure: Blood Pressure
timeFrame: 24 hours after the end of the experimental sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Poá
country: Brazil
facility: Lar Mãe Mariana Nursing Home
state: SP
Study officials:
References:
Clinical trial NCT01147406: Safety and Tolerability Study of N6022 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of N6022 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nivalis Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.

Detailed description: This is a single dose escalation, first-time-in-human study with three ascending cohorts. Eligible subjects will receive a single dose of investigational medicinal product or placebo on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may last up to 36 days from the time of screening until the end-of-study follow-up visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will be followed for 48 hours postdose and safety data reviewed before the remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data in each cohort before proceeding to the next ascending dose cohort, according to the stopping rules outlined in the protocol.

Eligibility criteria: Inclusion:

* Subject is healthy

Exclusion:

* Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry.
* Subject has donated blood (\> 500 mL) or blood products within 56 days prior to Day -1

Primary outcomes:
measure: Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers
timeFrame: 7 Days
Secondary outcomes:
measure: Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration
timeFrame: 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Parexel Early Phase Unit
state: Maryland
Study officials:
affiliation: Parexel
name: Ronald Goldwater, MDCM, MSc(A)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00207506: Lay Health Advisors for Sexually Transmitted Disease Prevention
Official title: HoMBReS: A Lay Health Advisor Approach to Sexually Transmitted Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Syphilis
Gonorrhea
Chlamydia Infections
HIV Infections
Keywords: Latino
Lay Health
Access
Prevention
HIV Seronegativity
HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-21
Enrollment: 354
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.

Detailed description: This is a demonstration project which includes the development, implementation, and evaluation of HoMBReS: Hombres Manteniendo Bienestar y Relaciones Saludables (Men Maintaining Wellness and Healthy Relationships). Applying a community-based participatory research (CBPR) approach, this 3-year study uses a quasi-experimental delayed-intervention comparison group design to assess the feasibility of implementing and the potential efficacy of an adult soccer league-based lay health advisor intervention. The intervention is designed to: reduce sexual risk behaviors among Latino seasonal farmworkers; enhance access to sexually transmitted disease/HIV healthcare services; and develop effective data collection methods among Latino men.

Eligibility criteria: Inclusion Criteria:

LHA (lay health advisor) and participants:

* To be eligible for participation in this study as a lay health advisor (LHA), an LHA must:

  1. self-identify as Latino or Hispanic;
  2. work as a migrant or seasonal farmworker;
  3. be a member of the Liga Hispana de Fútbol de NC;
  4. be 18 years of age;
  5. be literate in Spanish; and
  6. provide informed consent.

Exclusion Criteria:

* Based on the characteristics of the league population, the researchers anticipate that few potential LHAs or participants will be excluded.

Primary outcomes:
measure: Reduced STD morbidity
measure: Reduced risk behavior
Secondary outcomes:
measure: Improved access to services
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Scott Rhodes, PhD
role: PRINCIPAL_INVESTIGATOR
References: