louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06641245: PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
Official title: PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Folate
Folate Bioavailability
Clinical Trials
Pregnancy
Keywords: Folic acid
Folate
Methylfolate
5-MTHF
RBC Folate
Placental Growth Factor
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Saskatchewan
First posted: 2024-10-15
Enrollment: 272
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind randomized non-inferiority trial
Primary purpose: TREATMENT

Brief summary: A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects

Detailed description: A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).

Eligibility criteria: Inclusion Criteria:

* Non-pregnant females who are:
* Currently trying to become pregnant;
* Aged 19-42 years;
* Low risk for an NTD-affected pregnancy

Exclusion Criteria:

* Trying to conceive for ≥6 months (as \~90% of pregnancies occur after 6 months of trying);
* Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
* More than 2 miscarriages in the past year;
* Undergoing fertility assistance (including current IVF or intrauterine insemination);
* Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
* Lifestyle factors known to impact maternal folate status (current smoking, \>6 alcoholic drinks per week, recreational drug use);
* On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
* Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).

Primary outcomes:
measure: RBC folate
timeFrame: At 6 (± 2) wks gestation (approximate time of neural tube closure)
Secondary outcomes:
measure: Maternal plasma placental growth factor (pg/mL)
timeFrame: At 18 (± 1) and 30 (± 1) wks gestation
Other outcomes:
measure: Human milk total folate concentrations
timeFrame: At 4 weeks postpartum
Locations:
Study officials:
affiliation: The University of British Columbia
name: Crystal D Karakochuk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Saskatchewan
name: Kelsey M Cochrane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051245: Effectiveness of a High-risk Diabetic Patients Program
Official title: Effectiveness of a High-risk Diabetic Patients Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 [C18.452.394.750.149]
Case Management [N04.590.233.624.250]
Disease Management [N04.590.607]
Diabetes Complications [C19.246.099]
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes mellitus
* Age between 18 and 80 years old
* Target organ damage (either macrovascular or microvascular)
* Patient's acceptance to participate

Exclusion Criteria:

* Moderate to severe dementia
* Life expectancy lower than one year
* Justified negative from primary care physician to intervene the patient.

Primary outcomes:
measure: Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin
timeFrame: Two years
Secondary outcomes:
measure: Quality of care process measures
timeFrame: Two years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Gastón Perman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498745: Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects
Official title: A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.


Eligibility criteria: Criteria:

* Healthy male and female subjects aged 18 to 50 years.
* Women of nonchildbearing potential (WONCBP)

Primary outcomes:
measure: The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT06937645: the Effect of Hyaluronic Acid Intrauterine Wash on Endometrial Receptivity and Pregnancy Outcome
Official title: the Effect of Hyaluronic Acid Platelets Rich Plasma on the Endometrial Receptivity and Intracytoplasmic Sperms Injection Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Infertile Patients
Keywords: hyaluronic acid
intrauterine wash
endometrial receptivity
pregnancy outcome
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyaluronic acid intrauterine wash is done for infertile females undergoing intracytoplasmic sperm injection on the day of oocyte retrieval. endometrial receptivity parameters, including the subendometrial vasculature indices were measured before and after the intervention for purpose of studying the effect of hyaluronic acid on improvement of the endometrial receptivity and subsequently the pregnancy outcome


Eligibility criteria: Inclusion Criteria:

* Infertile females aged 18-40 years.
* Infertile females scheduled for GnRH antagonist protocol of fresh ICSI cycle.
* Females use dual stimulation (GnRH agonist plus Ovetrelle) for ovulation triggering.

Exclusion Criteria:

* Infertile females diagnosed as a poor responder.
* Infertile females diagnosed with uterine pathology.
* Infertile females who are scheduled for a frozen ICSI cycle.
* Infertile females diagnosed with endocrine diseases like thyroid disease, diabetes mellitus, and hyperprolactinemia.
* Infertile females diagnosed with thrombocytopenia.

Primary outcomes:
measure: measuring the value of resistance index (RI) of the sub-endometrial blood vessels
timeFrame: for each participant twice measure will be done for (RI). The first measure will be performed on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
measure: measuring the value of sub- endometrial vessels pulsatile index (PI)
timeFrame: for each participant twice measure will be done for PI. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
measure: measuring the value of peak systolic to end diastolic ratio (S/D) of the sub-endometrial blood vessels
timeFrame: for each participant twice measure will be done for S/D. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval.
Secondary outcomes:
measure: measuring serum level of beta human chorionic gonadotropin
timeFrame: 2 weeks from the day of oocyte retrieval
Other outcomes:
Locations:
city: AL-Kadimya
country: Iraq
facility: high institute for infertility diagnosis and ARTS
state: Baghdad
Study officials:
References:
Clinical trial NCT02725645: Backpack Load and Spine Muscles Activity
Official title: Influence of Different Backpack Loading Conditions on Neck and Lumbar Muscles Activity of Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Keywords: Surface electromyography
children
backpack
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to analyze the influence of four backpack loading conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck and lumbar muscles of elementary school children.

Detailed description: Elementary school children participated in the present study, between the ages of 6 and 10. Bilateral sternocleidomastoid, rectus abdominis and erector spinae muscles activity were recorded using surface electromyography (sEMG), while tested for the effect of four randomized backpack loading conditions.

Eligibility criteria: Inclusion Criteria:

* children with tutor consent

Exclusion Criteria:

* children with cognitive impairment

Primary outcomes:
measure: Muscle Activity as a Measure of Route Mean Square
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Fernando Pessoa
name: Sandra Rodrigues, MSc, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00639145: Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
Official title: Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HIV Positive
Pregnant Women
Keywords: HIV
Pregnancy
Antiretrovirals
HIV Seronegativity
Treatment Experienced
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Centre for Infectious Disease Research in Zambia (CIDRZ)
name: University of Limpopo MEDUNSA
name: Health Systems Trust
First posted: 2008-03-20
Enrollment: 600
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV positive pregnant women attending ART clinics

Brief summary: The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Detailed description: Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.

The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Eligibility criteria: Inclusion Criteria:

* HIV positive pregnant woman on antiretroviral treatment
* Able and willing to participate and provide informed consent
* Be at least 18 years of age or older than legal age to provide consent
* If under legal age, must have legal guardian who is able to give consent
* Be an emancipated minor

Exclusion Criteria:

* History of mental illness
* History of condition that would preclude provision of consent
* Inability to provide consent

Primary outcomes:
measure: Number of Congenital birth defects
timeFrame: At birth
Secondary outcomes:
measure: Adverse Pregnancy outcomes
timeFrame: At outcome of pregnancy
Other outcomes:
Locations:
city: Medunsa
country: South Africa
facility: University of Limpopo / Elizabeth Glaser Pediatric AIDS Foundation
city: Lusaka
country: Zambia
facility: Center for Infectious Disease Research in Zambia (CIDRZ)
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Richard Marlink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01841645: CLA Metabolism and Effects on Human Health
Official title: Conjugated Linoleic Acid (CLA) Depletion-repletion: Metabolism and Bioactivity in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Inflammation
Body Composition, Beneficial
Keywords: CLA-enriched butter
CLA metabolism
inflammation
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2013-04-26
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.

Detailed description: After collecting baseline blood samples, CLA-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a CLA-enriched butter for another 8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of CLA on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers;
* 20 to 40 years;
* BMI between 18.0 and 29.9 kg/m2.

Exclusion Criteria:

* Use of dietary supplements;
* Smoker;
* Alcoholic;
* Under medication;
* History of chronic disease

Primary outcomes:
measure: Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Alexandre G Torres, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05368545: Influence of Lipid Lowering on Impaired Coronary Flow
Official title: Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: fractional flow reserve
CT derived fractional flow reserve
coronary artery disease
ischemic heart disease
stable chest pain
statin
blood cholesterol level
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: HeartFlow, Inc.
First posted: 2022-05-10
Enrollment: 109
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow

Detailed description: Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol \>2 mM), and at least one translesional FFRct value \<0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.

Eligibility criteria: Inclusion Criteria:

* Age ≥35 y
* Symptoms suggestive of stable CAD
* No pre-CTA known CAD
* At least one lesion with FFRct \<0.81
* Sinus rhythm
* LDL cholesterol \>2.0 mM
* Statin use \>2 months
* Life expentancy \< 3 years
* Signed informed consent

Exclusion Criteria:

* Known CAD
* Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
* Significant CAD in the left main or proximal coronary segments
* Referral to invasive catheterization
* Statin intolerance
* BMI \>40
* Allergy to ionidated contrast
* Pregnancy

Primary outcomes:
measure: Changes in FFRct values
timeFrame: 18 months
Secondary outcomes:
measure: Changes in FFRct values
timeFrame: 9 months
measure: Changes in low density plaque volumes
timeFrame: 0-9, and 0-18 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Denamrk
Study officials:
affiliation: Aarhus University Hospital
name: Bjarne Norgaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05333445: NURSE-led Follow-up in Patients Undergoing CATheter Ablation for Atrial Fibrillation
Official title: Assessing the Nurse-led Educational Intervention in Patients Undergoing Catheter Ablation for Atrial Fibrillation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
nurse-led
educational intervention
risk factors
quality of life
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 66
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 study aims to examine the effect of nurse-led education program on quality of life, atrial fibrillation (AF) risk factors, AF symptomatology, arrhythmia recurrence rate, and readmission rate after AF catheter ablation.


Eligibility criteria: Inclusion Criteria:

* Derivatives from the outpatient clinic of the center itself, as well as patients referred from other centers that have ours as a reference for a first AF ablation procedure.
* Have signed the informed consent.

Exclusion Criteria:

* Patients with cognitive impairment or disorientation.
* Patients with problems of comprehension or expression of Spanish or Catalan.
* Patients who are part of the medical or nursing group.
* Patient with defined heart failure with a left ventricular ejection fraction (LVEF) less than 40% and a NYHA III or IV.

Primary outcomes:
measure: changes from the baseline and better score in the validated ASTA questionnaire of the intervention group compared to the control group at 12 months in quality of life of patients .
timeFrame: 12 months
Secondary outcomes:
measure: number of patients who have the AF risk factor within normal parameters
timeFrame: 12 months
measure: number of participants with re-hospitalisation or emergency room visits for cardiovascular cause
timeFrame: 12 months
measure: number of participants with recurrences at AF rhythm
timeFrame: 12 months
measure: differences between both groups in the score received by the patients in the User Experience Questionnaire based on the Picker-33 Patient Experience Questionnaire
timeFrame: 3 months
measure: Differences between both groups in intensity, frequency and severity of symptoms related to AF evaluated with the validated ASTA questionnaire
timeFrame: 12 months
measure: differences between both groups in the score obtained in the adapted AFKAT questionnaire patient's knowledge of AF.
timeFrame: 3 months
measure: calls and emails received
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References: