louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01163500: Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the mitochondrial membrane and considered as a preventive factor for coronary artery disease (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD are still inconsistent. The purposes of this study are to investigate the relation of coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery (n = 100). The second year is a double-blind, placebo-controlled intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention is going to administration for three months. The third year is a case-control study. The control group （n = 100） is comprised of healthy individuals with normal blood biochemical values, and match by age and gender with the first year CAD subjects (case group). Fasting blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine, the markers of lipid peroxidation,antioxidant enzymes activities. The differences between case and control groups will be compared by using Student's t-test. Conditional logistical regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10 level. Hopefully, the results of this study could provide the information to what has been know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the risk of CAD.


Eligibility criteria: Inclusion Criteria:

* CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery

Exclusion Criteria:

* age \< 18 years old
* pregnancy women
* taking lowering lipid drug (Statin)

Primary outcomes:
measure: Reducing lipid peroxidation and increasing antioxidant enzyme activities
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital
Study officials:
References:
Clinical trial NCT00119600: A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Official title: A Randomised, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Finding Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Anemia
Cancer
Keywords: Non-myeloid malignancy
Clinical Trial
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-14
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 evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.


Eligibility criteria: Inclusion Criteria: Part A: - Non-myeloid malignancy receiving multicycle chemotherapy - Receiving non-platinum containing chemotherapy - At least 6 additional weeks of cyclic cytotoxic chemotherapy planned Part B and Part C: - Non-myeloid malignancy receiving multicycle chemotherapy - At least 12 additional weeks of cyclic cytotoxic chemotherapy planned All Parts: - Chemotherapy induced anemia - Greater than 6 month life expectancy - ECOG 0-2 - Adequate renal and liver function Exclusion Criteria: - Chronic myeloid leukemia, AML, ALL, Burkitt's lymphoma or lymphoblastic lymphoma - History of seizure disorder - Primary hematologic disorder which could cause anemia, other than a non-myeloid malignancy - Unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia - Uncontrolled hypertension - History of pure red cell aplasia - Clinically significant inflammatory disease or active infection - Iron deficiency - ANC less than 0.8 x 10\^9 cells/L

Primary outcomes:
measure: Incidence and severity of adverse events
measure: Change in hemoglobin concentration
measure: Maximum observed concentration (Cmax)
measure: Time Cmax is observed (Tmax)
measure: AUC
Secondary outcomes:
measure: Change in FACT-fatigue sub-scores
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06990100: Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
Official title: Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery : Post-market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Rupture
Lead sponsor: SACIMEX
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive ligament reconstruction. This study evaluates its long-term performance and safety in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patient implanted with DT4-EBMCA in Médipôle Garonne for a total or partial rupture of the anterior cruciate ligaments
* Patient having answer to IKDC and KOOS pre-operative
* Patient having received information and signed informed consent

Exclusion Criteria:

* Patients who refuse to participate
* Patients unable to understand questionnaires
* Patients who, at the time of surgery, present the contraindications and Factors likely to jeopardize the success of the implant contained in the IFU :
* Acute or chronic, local or systemic infections;
* Severe muscular, neurological or vascular impairments affecting the extremity concerned;
* Bone destruction or poor bone quality that may affect device stability;
* Any concomitant condition that may affect device function;
* Patients with sensitivity to device material that may cause allergic reactions.
* Severe osteoporosis;
* Significant deformity, congenital dislocation;
* Local bone tumours;
* Systemic or metabolic disorders;
* Infectious diseases;
* Substance abuse and/or tendencies to abuse drugs or medication;
* Obesity;
* Unsupervised intense physical activity.

Primary outcomes:
measure: evaluate the performance of the DT4- EBMCA
timeFrame: 2 years post-surgery
Secondary outcomes:
measure: safety of of the DT4-EBMCA
timeFrame: 2 years post-surgery
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique MEDIPOLE GARONNE
Study officials:
References:
Clinical trial NCT03455400: Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants
Official title: Ventilation Distribution Observed With Electrical Impedance Tomography (EIT) During Spontaneous Breathing in Healthy Newborn Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Breathing
Full-Term Neonate
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 healthy full-term infants

Brief summary: Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support in neonatal and pediatric intensive care. In this observational study basic EIT parameters will be measured on 20 healthy newborn infants during spontaneous breathing and assess the effect of position changes in ventilation distribution.

Detailed description: NEO SensorBelts will be used to observe ventilation distribution in healthy newborn infants during quiet spontaneous breathing. Child's position will be changed 5 times every 10 minutes in a random order. Positions observed will be: left lateral, right lateral, supine, prone face to left, prone face to right and supine with the bed tilted 30 degrees. Total duration for the recording will be 1 hour.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from a parent or legal guardian
* Gestational age 37+0 - 42+0 weeks
* Uneventful follow-up in maternity ward

Exclusion Criteria:

* Respiratory distress
* Admission to NICU
* Thorax skin lesions
* Prior participation in this study

Primary outcomes:
measure: Anteroposterior ventilation distribution
timeFrame: 1 hour
measure: Right-to-left ventilation distribution
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT00930800: Exercise Training in Children With Congenital Heart Defect
Official title: The Effect of Exercise Training on Exercise Capacity, Physical Activity, and Health-related Quality of Life in Children After Repair of Congenital Heart Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Exercise capacity
Physical activity
Quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and healthy sedentary children. The degree of improvement after exercise training were compared between CHD children and healthy sedentary children.

Detailed description: Exercise groups took 12-week exercise training, twice in hospital and once at home, using a video game so-called Dance Dance Revolution (DDR), while the control group kept their daily routines.

Eligibility criteria: Inclusion Criteria:

* Children with congenital heart defect s/p repair \> 6 months
* Sedentary lifestyle

Exclusion Criteria:

* Unstable hemodynamics
* Impaired mental and cognition
* Systemic disease

Primary outcomes:
measure: maximal treadmill exercise test
timeFrame: 12 wks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05328700: Effectiveness of Neuromuscular Kinesiology Taping in Plantar Fasciitis
Official title: Effectiveness of Neuromuscular Kinesiology Taping in Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 36
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: One of the pathologies most studied and treated with kinesiotape (KT) is plantar fasciitis (PF). In most of the studies reviewed, it is concluded that there is an improvement in the symptoms of PF when treated with KT: either combined with other therapies or as a single treatment compared to placebo. However, most current studies have limitations because the sample is small, the effect size is small, and the evidence is insufficient or of low quality.

In the present work, the aim is to study the effectiveness of KT in PF, and to compare the results with those obtained in a placebo group, which is treated with tape. The researchers will assess the decrease in symptoms prior to performing other definitive treatments. In addition, the variability of the painful symptoms and the durability of the bandage will be studied, in order to determine whether it can be used in the short or long period of time, being able to take it into account and supposing a supplement to the pharmacological treatment.


Eligibility criteria: Inclusion Criteria:

* People with acute plantar fasciitis with less than 3 months of evolution
* Who present pain in the fascia both during ambulation and on palpation
* Ecographic image compatible with plantar fasciitis (\> 4 mm)
* The condition has not be previously treated with other treatment

Exclusion Criteria:

* Condition with no sintomatology

Primary outcomes:
measure: Visual Analogue Scale of Pain
timeFrame: Change from baseline (before intervention) to one day, two days, three days and four days after intervention
Secondary outcomes:
measure: Bandage durability
timeFrame: Change from baseline (the bandage is put on) until the first day that the loss of the bandage is documented, assessed up to 7 days
Other outcomes:
Locations:
city: València
country: Spain
facility: Universitat de València
state: Valencia
Study officials:
References:
Clinical trial NCT00825175: Treadmill Training and Orthotic Use in Infants With Down Syndrome
Official title: The Effect of Treadmill Training and Orthotic Use on the Development of Walking and Upright Play in Infants With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
Gait
Motor Development
Orthoses
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study determines the effect of orthotic use in combination with treadmill training on the development of gross motor skills and walking onset in infants with Down syndrome.

Detailed description: The goal of this study is to determine if orthotic use impacts the development of walking and upright play skills over and above the impact that treadmill training alone has. Infants with Down syndrome who can pull to stand but not walk will be recruited and assigned to a group that receives treadmill training and orthoses or just treadmill training. The infants are followed monthly until they have one month of walking experience. During the monthly visits, the infants' gross motor development is tested and their upright play behavior is observed. At the end of the study each infants gait is evaluated. We believe that the orthoses will lead to a decreased age at walking onset, an improvement in gait patterns, and an improvement in upright play ability.

Eligibility criteria: Inclusion Criteria:

* Trisomy 21
* Able to pull to stand but not walk

Exclusion Criteria:

* Additional developmental diagnoses
* Uncorrected vision or hearing impairments
* Previous orthotic intervention
* Previous treadmill intervention

Primary outcomes:
measure: Pattern of Gross Motor Development
timeFrame: monthly; starting when child can pull to stand and ending when the test determined that the child was walking.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julia Looper
role: PRINCIPAL_INVESTIGATOR
References:
citation: Looper J, Ulrich DA. Effect of treadmill training and supramalleolar orthosis use on motor skill development in infants with Down syndrome: a randomized clinical trial. Phys Ther. 2010 Mar;90(3):382-90. doi: 10.2522/ptj.20090021. Epub 2010 Jan 14.
Clinical trial NCT00203775: Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates
Official title: Efficacy of Risperidone Versus Haloperidol in the Treatment of Aggression and Hostility in Psychotic Inmates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychosis
Aggression
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica N.V., Belgium
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the efficacy of haldol versus risperdal in the treatment of aggression in psychotic prison inmates. It is hypothsized that risperdal will be more effective in decreasing aggression than haldol.


Eligibility criteria: Inclusion Criteria:age 18 or over, psychotic disorder diagnosed on SCID, inmate at correctional facility for at least 2 weeks -

Exclusion Criteria: active withdrawal from substances of abuse, non-psychotic individuals, pregnant women, people unable to give informed consent, patients on mood stabilizers

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of connecticut health center
state: Connecticut
Study officials:
affiliation: UConn Health
name: catherine f lewis, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03471975: Learning Direct Laryngoscopy Using a McGrath Video Laryngoscope as Direct Versus Indirect Laryngoscope
Official title: Comparison of Training Effect for Tracheal Intubation Following Training With McGrath Video Laryngoscope as Direct Laryngoscope Versus Training With McGrath Video Laryngoscope as Video Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Endotracheal Intubation
Medical Education
Keywords: Video laryngoscopy
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: prospective randomised trial to compare the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope

Detailed description: Tracheal intubation using direct laryngoscopy is very important technique in clinical medicine. But the training for intubation is not very easy because laryngoscopic view is difficult to share between trainee and trainer.

Recently there have been reported that tracheal intubation training using video laryngoscopy have some advantages and showed more success rate.

McGrath Video laryngoscopy can be used as either video laryngoscopy or direct laryngoscopy. Therefore when McGrath is used as intubation training tool, the trainer can monitor and educate the procedure while the trainee perform tracheal intubation.

The aim of this study is comparing the teaching effect for tracheal intubation following training with McGrath video laryngoscope as direct laryngoscope versus training with McGrath video laryngoscope as video laryngoscope

Eligibility criteria: Inclusion Criteria:

* medical students who has never experienced intubation

Exclusion Criteria:

* A person who has previously experienced intubation with Manikin or patients.

Primary outcomes:
measure: Intubation Success Rate
timeFrame: up to 10 minutes
measure: Time to Intubation
timeFrame: up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Clinical Assistant Professor
name: Jihoon Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi IK, Hwang J, Min SK, Lim GM, Chae YJ. Comparison of learning direct laryngoscopy using a McGrath videolaryngoscope as a direct versus indirect laryngoscope: a randomized controlled trial. J Int Med Res. 2021 May;49(5):3000605211016740. doi: 10.1177/03000605211016740.
Clinical trial NCT03408275: Dietry Pattern and Lead Levels in Pregnancy
Official title: Dietary Patterns and Variability in Blood Lead Concentrations Among Pregnant British Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Habits
Lead Poisoning
Pregnancy Related
Keywords: Dietary patterns
Pregnancy
Woman
Diet
Lead
ALSPAC
Lead sponsor: University of Bristol
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Medical Research Council
name: Bristol Biomedical Research Unit
First posted: 2018-01-23
Enrollment: 2167
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample for this analysis was derived from the Avon Longitudinal Study of Parents and Children (ALSPAC), which is a UK-based birth cohort set up to investigate environmental and genetic influences on health and disease. ALSPAC recruited 14,541 pregnant women resident in Avon, UK with expected dates of delivery between 1st April 1991 and 31st December 1992.

Brief summary: During pregnancy lead crosses the placenta freely and can have adverse effects on the fetus, with the potential for life-long impact on the child. Identification of dietary patterns and food groups in pregnancy in relation to measures of lead status could provide a more useful alternative to a nutrient-specific advice to minimise fetal exposure to lead during pregnancy. The aim is to evaluate whether dietary patterns and food groups are associated with blood lead concentrations in pregnancy.

Detailed description: Whole blood samples were collected from pregnant women enrolled in the Avon Longitudinal Study of Parents and Children observational birth cohort study and were analysed for lead. Dietary pattern scores were derived from principal components analysis of a food frequency questionnaire. Associations of quartiles of dietary pattern scores, and of food groups categorised by frequency of consumption, with the likelihood of blood lead concentration (B-Pb) ≥5 µg/dl will be identified with adjusted logistic regression (n=2167).

Eligibility criteria: Inclusion Criteria: Enrolled in ALSPAC, pregnant -

Exclusion Criteria: Not enrolled in ALSPAC, not pregnant

-

Primary outcomes:
measure: Blood lead concentration
timeFrame: During gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Bristol
name: Nic Timpson, PhD
role: STUDY_DIRECTOR
References: