louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05798039: ENRICH Nurse-Family Partnership Study
Official title: Colorado Nurse Family Heart Trial for the ENRICH Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Body Composition
Blood Sugar
Body Weight
Diet Habit
Physical Inactivity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overarching goal of the proposed study is to develop and test an enrichment to Nurse-Family Partnership (NFP) using an existing, evidence-based program to improve clients' and their children's cardiovascular health from early pregnancy to 24 months postpartum. With support from NFP supervisors and nurses, the investigators will develop new NFP materials promoting healthy diet, activity, sleep, and smoking behaviors, along with optimal weight, glycemia, lipid, and blood pressure profiles. The investigators will conduct a pilot study with up to 40 NFP clients (or women similar to NFP client population) and their nurses to determine feasibility and acceptability of the materials and study protocol.


Eligibility criteria: Inclusion Criteria:

* Pregnant or \<24 months postpartum
* Aged 18 years or older
* English- or Spanish-speaking

Exclusion Criteria:

* \<18 years old

Primary outcomes:
measure: Maternal BMI
timeFrame: Enrollment
Secondary outcomes:
measure: A1C
timeFrame: Enrollment
measure: Blood pressure
timeFrame: Enrollment
measure: Diet Quality
timeFrame: Enrollment
measure: Physical Activity
timeFrame: Enrollment
measure: Smoking frequency
timeFrame: Enrollment
measure: Maternal adiposity
timeFrame: Enrollment
measure: Sleep Quality
timeFrame: Enrollment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mandy Allison, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073539: The Manikin Study of Chest Compression With One Accelerometer Feedback Device
Official title: The Method of Proper Chest Compression Depth With Conventional and One Accelerometer Feedback Device During CPR in Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Chest compression
One accelerometer
Manikin Study
Lead sponsor: Hanyang University Seoul Hospital
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Chest compression (CC) feedback devices are used to perform CC measurements effectively and accurately on patients in hospital beds. However, these devices do not take account of the compression of the mattress, which results in overestimation of CC depth. This study is the validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to overcome this limitation and thus measure compression depth more accurately when performing cardiopulmonary resuscitation (CPR) on patients.

Detailed description: Data collection The participants will be divided into three groups by random drawings. Each performer in the three-groups will compress the chest of the manikin on the bed with real-time 5cm,6cm and 7cm feed-back by one accelerometer (U-cpr).We will use two beds \[Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US) ,Shinchang SB-34p (Transport stretcher® , 850 x 2080 mm,Shinchang Co.,Busan,ROK)\]. Each participants will do 6 cycles of chest compression and 1cyle will be 2minutes. Between each cycles, participants will take a rest 5minutes.

Eligibility criteria: Inclusion Criteria:

* Postgraduates year 1,2,3,4 and Emergency physicians in emergency department

Exclusion Criteria:

* Wrist or Low back disease

Primary outcomes:
measure: Chest compression depth
timeFrame: Within 1day
Secondary outcomes:
measure: Chest compression rate
timeFrame: Within 1day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Sang hyun Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099839: A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
Official title: A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pharmacokinetics of ASP1941
Keywords: ASP1941
Miglitol
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Detailed description: This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".

Eligibility criteria: Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
* Body weight ; ≥50.0 kg, \<80.0 kg
* Body Mass Index ; ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Previous treatment with ASP1941

Primary outcomes:
measure: Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples
timeFrame: For 72 hours after each administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00985439: Study of Diclofenac Capsules to Treat Dental Pain
Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 50 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site overnight

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to Screening

Primary outcomes:
measure: Total Patient Pain Relief Over 0 to 12 Hours.
timeFrame: 12 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
Study officials:
References:
Clinical trial NCT02908139: Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
Official title: Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Calcification
Aortic Stiffness
High Blood Pressure
Kidney Transplantation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 40
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: A total of 40 consecutive patients admitted to Transplant Centre to perform kidney transplantataion were included in this study.

Brief summary: Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* no clinical cardiovascular disease during the 6 months preceding entry

Exclusion Criteria:

* not meet the above criteria

Primary outcomes:
measure: Differences in pulse wave velocity [m/s] in short postoperative period.
timeFrame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Secondary outcomes:
measure: Differences in central aortic pressure [mmHg] in short postoperative period.
timeFrame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazowian
Study officials:
References:
citation: Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.
citation: Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
citation: Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
Clinical trial NCT02428439: Identification of Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
Official title: Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Suicidal Ideation
Keywords: genetic markers
predictors
Antidepressive Agents
Suicidal Ideation
Adolescent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents between 11 years and 18 years in depressed psychiatric outpatients.

increased suicidal ideation: 14 people, non-increased suicidal ideation: 54 people, patient drop-out rate: 20%, total 80 people.

Brief summary: The objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)


Eligibility criteria: Inclusion Criteria:

1. Aged between 11 and 18 years
2. Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia
3. Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

Exclusion Criteria:

1. presence of intellectual disability
2. presence of hereditary disorder
3. past and/or current history of acquired brain injury, like cerebral palsy
4. presence of seizure, other neurological disorder or sensory impairments
5. past and/or current history of pervasive developmental disorder
6. past and/or current history of schizophrenia, bipolar disorder or psychosis
7. presence of severe learning disorder

Primary outcomes:
measure: Evaluation of Suicidal ideation and behavior
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluation of treatment effect of antidepressants(CDRS)
timeFrame: 8 weeks
measure: Evaluation of treatment effect of antidepressants (YMRS)
timeFrame: 8 weeks
measure: Evaluation of treatment effect of antidepressants(P-GBI)
timeFrame: 8 weeks
measure: Evaluation of treatment effect of antidepressants(CGI-S)
timeFrame: 8 weeks
measure: Genome wide association analysis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyowon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03389139: Cerebral and Renal Oxymetry and Anesthetic Techniques in Newborns
Official title: Comparison of the Effects of Anesthetic Techniques Used for Cesarean Delivery on Neonatal Cerebral and Renal Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery Affecting Newborn
Keywords: Cesarean
newborn
cerebral and renal oxygenation
anesthesia
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neonatal adaptation to extrauterine life has many physiological changes in neonatal organ systems. These adaptative changes may be affected such as type of delivery and anesthesia management at birth. near infrared spectroscopy (NIRS) is a popular non-invasive method that can be used in newborns thus monitorize tissue oxygenation regularly. In this study we have purposed to compare the effects of general anesthesia versus spinal anesthesia on newborn's cerebral and renal oxygenation in elective cesarean operations

Detailed description: The cases divided into two groups those spinal anesthesia group ( group:1; n:30 ) and general anesthesia group (group:2; n:30). The preoperative and intraoperative mean arterial pressures (MAP), heart rate (HR), arterial oxyhemoglobin saturation (SpO2), intraoperative blood loss values of pregnants and 1st-5th minute APGAR scores, preductal and postductal SpO2, perfusion index, heart rates, body temperature, cerebral and renal regional oxygen saturations of newborns after birth have been recorded.

Eligibility criteria: Inclusion Criteria:

* patients who undergo elective cesarean
* American Society of Anesthesiologists class 1 to 2
* Ability to consent
* Gestational age: from 37 to 41 weeks

Exclusion Criteria:

* Pulmonary disease
* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Neurologic disease
* Coagulation disorders
* newborns with anomalies
* low birth weight newborns
* newborns needing neonatal resuscitation

Primary outcomes:
measure: Change in renal and cerebral regional oxygenation (rSO2) in newborn
timeFrame: 60 minutes after birth
Secondary outcomes:
measure: preductal SpO2
timeFrame: 60 minutes after birth
measure: postductal SpO2
timeFrame: 60 minutes after birth
measure: perfusion index
timeFrame: 60 minutes after birth
measure: body temperature
timeFrame: 60 minutes after birth
measure: apgar scores
timeFrame: 1st and 5th minute after birth
Other outcomes:
Locations:
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ulku Arslan, MD
role: STUDY_DIRECTOR
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ozge Dagdelen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133039: A New Type of Bioabsorbable Screw in the Hallux Valgus Surgery
Official title: Comparative Experimental and Clinical Study: a New Type of Bioabsorbable Screw and the Titanium Screw in the Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Hallux Rigidus
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators sought to determine whether bioabsorbable cannulated screws could perform as well as titanium cannulated screws in the Lapidus procedure and MTP1-joint arthorodesis in anatomical models and clinical series of the foot.


Eligibility criteria: Inclusion Criteria:

* valuntary 18-65-yers-old, patient have hallux valgus or hallux rigidus deformity which need surgery treatment

Exclusion Criteria:

* Over 65 yers-old or less than 18-years-old, diabetes, rheumatism, smoker or lack of co-operation

Primary outcomes:
measure: AOFAS score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Faculty of Medicine
state: Pirkanmaa
Study officials:
References:
Clinical trial NCT06357039: Validation Study of Sleep Tracking Devices
Official title: Validation Study of an Artificial Intelligence-based Sleep Stage Classification for a Home Sleep Tracking Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Sleep Disorder
Keywords: Sleep
Polysomnography
EEG
PPG
Wearable Device
Lead sponsor: PNAPS Health Informatics and Space Technologies Inc.
Sponsor class: OTHER
Collaborators: name: Analog Devices
First posted: 2024-04-10
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes individuals aged between 18 and 65 who have voluntarily agreed to undergo sleep measurements specifically individuals suffering from sleep disorders such as sleep apnea. Participants in the study have been referred for polysomnography (PSG) testing by neurologists, pulmonologists, psychiatrists, and otolaryngologists.

Brief summary: In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.

The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years.


Eligibility criteria: Inclusion Criteria:

* Participants suffering from sleep disorders
* Participants sent to PSG test by neurologists, pulmonologists, psychiatrists, and otolaryngologists

Exclusion Criteria:

* Anyone who has been diagnosed as having a contagious skin disease
* Participants who do not have consent to have an additional device in their forehead area
* Incomplete of sleep measurement

Primary outcomes:
measure: Sleep Stages Classification Accuracy
timeFrame: 4-5 months
measure: Interoception analysis from PPG data collected from facial skin
timeFrame: 4-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pnaps Health Informatics and Space Technologies Inc
state: Başıbüyük, Maltepe
Study officials:
affiliation: PNAPS Health Informatics & Space Technologies Inc.
name: Asuman Çevik, Master's
role: STUDY_CHAIR
affiliation: Marmara University
name: Hasan Birol Çotuk, PhD
role: STUDY_DIRECTOR
References: