louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02803606: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
Official title: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Keywords: hypothermia
routine care
preterm neonates
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit

Brief summary: Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.


Eligibility criteria: Inclusion Criteria:

* Preterm infants of 25-32 weeks of gestation
* Birth in one of the two maternity hospitals of Amiens agglomeration (CGO or clinic of Europe )
* Arrived in the Neonatal Medicine unit \< 2 hours of life
* Necessitated a care in an incubator

Exclusion Criteria:

* Preterm infants \> 32 weeks of gestation
* Birth outside the Amiens metropolitan area
* Arrived in the Neonatal Medicine unit after 2 hours of life
* Present a malformation syndrome or severe heart disease
* Pathology requiring support within the first 7 days of life
* Apgar score \< 5 to 10 minutes of life
* Need for initial management in open incubator
* Unavailability of a type of incubator " Caleo® "

Primary outcomes:
measure: Lowest abdominal skin temperature
timeFrame: 20 minutes
Secondary outcomes:
measure: The nadir for peripheral skin temperature
timeFrame: 20 minutes
measure: Pulse rate
timeFrame: 20 minutes
measure: Morbidity
timeFrame: 7 days
measure: mortality
timeFrame: 7 days
measure: respiratory rate
timeFrame: 20 minutes
measure: Blood pressure
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Pierre TOURNEUX, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005206: Calcium Intake, Metabolism, and Gestational Blood Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine if low dietary calcium intake and disturbances in maternal calcium metabolism were associated with increases in blood pressure in late pregnancy.

Detailed description: BACKGROUND:

The importance of maintaining dietary calcium intake and normal calcium metabolism for optimal regulation of arterial blood pressure has been demonstrated in humans and animals. Recent reports have suggested that low dietary calcium intake and disturbances in maternal calcium metabolism are associated with increases in blood pressure in late gestation. These factors may be associated with an increased risk of developing pregnancy-induced hypertension.

This study was conducted in response to a Request for Applications on Research on Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood Institute and the National Institute of Child Health and Human Development.

DESIGN NARRATIVE:

Blood pressure, nutrient intake, and markers of calcium metabolism were prospectively assessed in normal, pregnant women. Nutrient intakes, including dietary calcium, were assessed during gestation weeks 24, 28, 32, 36, and the postpartum period using 3-day food records and 24-hour dietary recalls. Concomitantly, serum measures of calcium metabolism were assessed including serum total and ionized calcium, parathyroid hormone, calcitonin, vitamin D concentration, serum magnesium, phosphorus, sodium, and potassium concentrations. During weeks 24 and 32, urinary excretion of sodium, calcium, magnesium, potassium, phosphorus, cAMP, and creatinine were measured. Blood pressures were measured at every prenatal visit and postpartum. Measures of infant growth and blood pressure were assessed at 1, 6, and 12 months of age to determine if maternal dietary calcium intake exerted long-term influences on infant development and blood pressure.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00684606: Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor
Official title: Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Induction of Labor
Keywords: Induction of Labor
Low Bishop Score
Transcervical Foley Catheter.
IV Oxytocin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-05-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Detailed description: Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy
* Medical indication for labor induction by transcervical Foley catheter

Exclusion Criteria:

* Preterm pregnancy
* Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:

  * Uterine scar
  * Multiple pregnancy
  * PROM
  * Grand-multiparity
  * Placenta previa or marginal placenta
  * Spontaneous uterine contractions (more than 3 in 10 minutes)
  * Vaginal bleeding
  * Nonreassuring fetal heart rate

Primary outcomes:
measure: The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.
timeFrame: year
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Orit Moran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04169906: A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)
Official title: A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Repeated Doses) (A Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection

Exclusion Criteria:

* History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
* History of drug and food allergy

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
timeFrame: Day 1 up to Day 14
measure: Area under the concentration-time curve AUC (tau)
timeFrame: Day 1 up to Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: The medical facility selected by Taisho Pharmaceutical Co., Ltd
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
citation: Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.
Clinical trial NCT06303206: TEC4Home Blood Pressure Randomized Controlled Trial
Official title: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home Telemonitoring for Blood Pressure Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 408
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 goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).

The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?

Secondary research questions will address:

1. How do these interventions (telemonitoring and case management) improve medication adherence?
2. Do these interventions reduce physician and ED visits?
3. Are these interventions safe?
4. How do these interventions influence patient experience?

Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged ≥ 18 years of age
* Elevated triage BP AND increased average BP in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg)
* Own a smart phone
* Willing to measure and tele-transmit home BP readings

Exclusion Criteria:

* Hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome
* Pregnant women
* Acute intoxication
* Acute surgical or trauma patients
* Psychiatrically unstable patients
* Advanced cognitive impairment
* Patient requiring admission to hospital
* Inability to use or care for home BP monitor correctly
* From nursing home
* Unstable housing
* Non-English speaking or no family members who can help translate

Primary outcomes:
measure: Systolic blood pressure controlled
timeFrame: 12-months
Secondary outcomes:
measure: Impact of intervention on other blood pressure measures
timeFrame: 6-months and 12-months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02842606: Metabolic Response to the Acute Consumption of Fiber-enriched Pasta
Official title: Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.


Eligibility criteria: Inclusion Criteria:

* BMI 18-29 kg / m2
* Good Health status

Exclusion Criteria:

* Diabetes
* Cardiovascular events (IMA or stroke) severe heart disease
* Kidney or liver failure
* Anemia and any other chronic disease

Primary outcomes:
measure: Glucose and lipid response
timeFrame: 4 hours
Secondary outcomes:
measure: Insulin response
timeFrame: 4 hours
measure: Hormone response (GLP-1, GIP, PYY and Ghrelin)
timeFrame: 4 hours
measure: Energy intake in the subsequent meal.
timeFrame: 4 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01952106: Effects of Distraction on Pain and Distress During Venepuncture in Children
Official title: Effects of Distraction on Pain and Distress During Venepuncture in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalism in Children
Pain
Keywords: venepuncture
distraction
distress
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.


Eligibility criteria: Inclusion Criteria:

* 5-7 years old
* understanding numeral

Exclusion Criteria:

* mental retard and can not nuderstand numeral

Primary outcomes:
measure: Visual Analogue pain Scale will be used to evaluate children's pain perception
timeFrame: approximately 15 mins during venepuncture process
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: chiying Tseng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787406: Motor Learning and tDCS in Parkinson's Disease
Official title: The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Transcranial direct current stimulation
Motor sequence learning
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.

Detailed description: Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. The present study sought to examine the effect of a single session of transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants learnt two finger tapping sequences, with task difficulty indexed by sequence length, and task consolidation further examined using a dual-task paradigm. Task related cortical haemodynamic activity was recorded using functional near-infrared spectroscopy.

Eligibility criteria: Inclusion Criteria:

* Right-handed (Edinburgh Handedness Inventory; ≥50)
* Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
* Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)

Exclusion Criteria:

* History of stroke
* Comorbidity
* Cephalic implants

Primary outcomes:
measure: Change from baseline sequential finger tapping performance
timeFrame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
measure: Change from baseline oxygenated haemoglobin response
timeFrame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
measure: Change from baseline shape-counting error
timeFrame: Two assessments: Baseline / pre-intervention, and immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Hung Hom
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Magaret Mak, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139449: Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Keywords: CRT, heart failure, ICD
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with congestive heart failure(including heart failure with preserved EF or reduced EF) who are undergone cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation

Brief summary: CRT and ICD has known as decreasing cardiac mortality in patient with heart failure. Especially, it has reported that CRT improved cardiac systolic function, quality of life of patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So the investigators will register patients who implant CRT or ICD (primary), and follow them up. During scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter monitoring and questionnaire on QOL.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18
2. LV ejection fraction \<40% or Clinical HF Symptom with (LV ejection fraction \>40%)
3. medication for at least 3month

Exclusion Criteria:

1. patient who refuse to enroll the study

Primary outcomes:
measure: Transthoracic echocardiography (TTE)
timeFrame: before enrollment
measure: Transthoracic echocardiography (TTE)
timeFrame: 12 month later afer enrollment
measure: EKG
timeFrame: before enrollment
measure: EKG
timeFrame: 1 month later after enrollment
measure: EKG
timeFrame: 6 month later after enrollment
measure: EKG
timeFrame: 12 month later after enrollment
measure: NYHA(New York Heart Association) evaluation
timeFrame: before enrollment
measure: NYHA(New York Heart Association) evaluation
timeFrame: 1 month later after enrollment
measure: NYHA(New York Heart Association) evaluation
timeFrame: 6 month later after enrollment
measure: NYHA(New York Heart Association) evaluation
timeFrame: 12 month later after enrollment
measure: 6 minute walking test
timeFrame: before enrollment
measure: 6 minute walking test
timeFrame: 12 month later afer enrollment
Secondary outcomes:
measure: Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
timeFrame: before enrollment
measure: Questionnaire on Quality of Life(QOL) : EQ-5D-3L (Optional)
timeFrame: 12 month later afer enrollment
measure: Cardiac MRI or Cardiac CT
timeFrame: before enrollment
measure: Cardiac MRI or Cardiac CT
timeFrame: 12 month later afer enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT00216749: Efficacy and Safety of Cilostazol for the Indication of CSPS
Official title: Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Keywords: Cerebral Infarction Prevention
Cilostazol
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in restabilization status after cerebral infarction (excluding cardiogenic cerebral embolism)

Brief summary: This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

Detailed description: This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction.

Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.

Eligibility criteria: Inclusion Criteria:

* Patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction.
* Age: more than 18 years of age

Exclusion Criteria:

* Unqualified patients judged by study investigator(s)

Primary outcomes:
measure: 1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event
timeFrame: 3M
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Korea Otsuka Pharmaceutical Co., Ltd.
name: Bo Youn Seo
role: STUDY_DIRECTOR
References: