louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04186195: Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Official title: Psychosocial and Socioeconomic Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Glycemic control
Children
Psychosocial and socioeconomic factors
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 191
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 diabetic children aged 1-16 years followed at Tampere University Hospital and their parents . Child's disease duration minimum 1 year.

Brief summary: The aim of the study is to research psychosocial and socioeconomic factors among families that might affect glycemic control in children and adolescent with type 1 diabetes mellitus. These factors might be: living conditions, structure of the family, socioeconomic status, divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is present in the family).

Detailed description: This study is going to clarify if there are some socioeconomical or psychosocial factors that might influence child's type 1 diabetes mellitus glycemic control. Study population consists of 300-350 diabetic children aged 1-16 years who have diabetic controls at Tampere University Hospital and their families. Required information is going to be collected with 2 questionnaires, wich families are kindly asked to fill in.

Eligibility criteria: Inclusion Criteria: Type 1 diabetic children aged 1-16 years and their parents. Patient's and parents' willingness to participate

Exclusion Criteria: Type 1 diabetes duration under 1 year. Difficulties to understand written finnish.

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Primary outcomes:
measure: Children's type 1 diabetes glycemic control
timeFrame: Through study completion, an average 5 years
Secondary outcomes:
measure: Parents' divorce rate
timeFrame: Through study completion, an average 5 years
measure: Parent's type 1 diabetes glycemic status
timeFrame: Through study completion, an average 5 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University
name: Marja-Terttu Saha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00196495: Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Official title: Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Prolapse
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result from a stretching, weakening or tearing of the soft tissue structures that support the pelvic organs. These tissues become compromised because of a weakened or damaged.The purpose of the study will be to demonstrate the usability of Polypropylene Mesh for prolapse repair, using the TVM technique.


Eligibility criteria: Inclusion Criteria:

* Female candidate for surgical pelvic floor repair (at least ICS stage II symptomatic prolapse).
* Patient who is at leat 21 years of age.
* Patient whose family is complete.
* Patient may not have uncontrolled diabetes.

Exclusion Criteria:

* Patients may not have coagulation disorders.

Primary outcomes:
measure: Effectiveness of the TVM treatment in curing vaginal prolapse as indicated by recurrence rate.
Secondary outcomes:
measure: Intraoperative complication
measure: Patient tolerance of the synthetic mesh placed
measure: Postoperative complications
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03005795: Music and Colposcopy in Women With Cervical Dysplasia.
Official title: Does Mozart Reduces Anxiety in Women With Cervical Dysplasia? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: cervical dysplasia
colposcopy
anxiety
music
mozart
randomized controlled trial
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the effect of music during colposcopy on women´s anxiety.


Eligibility criteria: Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* We included women if they attended colposcopy for the first time

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* known anxiety disorder or depression
* history of conization or other treatments on the cervix uteri
* known oncological disorder
* auditory defect
* cardiovascular disease
* inadequate colposcopy

Primary outcomes:
measure: Change in anxiety scores
timeFrame: 10 minutes before and after colposcopy
Secondary outcomes:
measure: Anxiety score after colposcopy
timeFrame: 10 minutes before and after colposcopy
measure: Change in heart rate
timeFrame: 10 minutes
measure: Pain during examination
timeFrame: 10 minutes
measure: Pain after examination
timeFrame: 10 minutes
measure: general unpleasantness during examination
timeFrame: 10 minutes
measure: Anxiety during examination
timeFrame: 10 minutes
measure: Overall Satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Zydolab - Institute of Cytology and Immune Cytochemistry
state: NRW
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilal Z, Alici F, Tempfer CB, Rath K, Nar K, Rezniczek GA. Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):1047-1055. doi: 10.1097/AOG.0000000000002876.
Clinical trial NCT01216995: Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
Official title: A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Heart Attack
Regenerative Cells
Stem Cells
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).

Detailed description: This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.

Eligibility criteria: Key Inclusion Criteria:

* ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
* Ischemic symptoms AND
* ECG:
* Development of pathologic Q waves on the ECG; or
* ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
* New left bundle branch block; AND
* Creatine Phosphokinase Isoenzyme (MB Form) \> 100 IU/L, or troponin \>5x the upper limit of normal between admission and randomization
* Successful revascularization of the culprit lesion in a major epicardial vessel

Key Exclusion Criteria:

* More than 24 hours between PCI and start of liposuction
* Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
* Pacemaker, ICD, or any other contra-indication for MRI
* Patients with increased bleeding risk
* Cardiogenic shock present post-index PCI

Primary outcomes:
measure: Reduction in Infarct Size
timeFrame: 6 Months
Secondary outcomes:
measure: MACCE Rates
timeFrame: Through 36 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centrum
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
city: Krakow
country: Poland
facility: Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04245995: Blood Loss Evaluation Using a Novel Device
Official title: Quantification of Blood Loss Using a Novel Device in Comparison to Visually Estimated Blood Loss in a Simulated Blood Loss Scenario
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss, Surgical
Transfusion
Patient Blood Management
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We include healthcare professionals.

Brief summary: The study´s aim is to evaluate the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario.

Detailed description: In an operating theatre blood loss will be simulated in different scenarios. Expired whole blood donations (provided by the German Red Cross, Institute of Transfusions Medicine, Goethe University Frankfurt) will be used. Blood will be diluted by full electrolyte solutions . Sponges and canisters will be prepared with a predetermined amount of blood.

Study participants will estimate total blood loss on sponges and canisters. Study members not knowing the correct amount of prepared blood will measure the blood loss in sponges and canisters by Feature Extraction Technology (FET) and by gravimetric method before and after estimation of the participants.

Eligibility criteria: Inclusion Criteria:

* Health care professionals

Exclusion Criteria:

* None

Primary outcomes:
measure: Estimated blood loss
timeFrame: 02.05.2020 - 03.15.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
state: NRW
Study officials:
affiliation: Goethe University, Frankfurt, Germany.
name: Florian Piekarski, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piekarski F, Gerdessen L, Schmitt E, Friedrichson B, Neef V, Meybohm P, Zacharowski K, Raimann FJ, Wunderer F. Quantification of Intraoperative Blood Loss in a Simulated Scenario Using a Novel Device. Shock. 2021 Jun 1;55(6):759-765. doi: 10.1097/SHK.0000000000001615.
Clinical trial NCT02766595: Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?
Official title: Hyperventilation During Routine EEG in Children: the Impact of Body Position - Sitting vs Supine- on the Yield of the Procedure in Provoking Absence Seizures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy, Absence
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Children referred for routine EEG studies for suspected absence seizures will be asked, upon caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine position and while sitting up. We aim to demonstrate that hyperventilation is more effective in eliciting absence seizures in a sitting position than while lying down.

Detailed description: Hyperventilation is a very effective means of eliciting absence seizures in children with absence epilepsy. Worldwide EEG protocols for routine EEG recording include 3 minutes of hyperventilation. The whole EEG recording, including hyperventilation, is performed with the child lying down on a bed/coach. Our clinical experience suggests that the body position may affect the yield of hyperventilation in provoking the absence event. That is, hyperventilation may be more effective when the child is sitting up, Therefore, children referred for a routine EEG for suspected absence seizures will add 3 minutes of hyperventilation on a sitting position to the routine 3 minutes of supine hyperventilation. At least 5 minutes of rest will be allotted between both procedures.

Patients' caregivers will sign an informed consent form. Patients will randomly be divided into 2 groups: one group will first perform supine hyperventilation followed by sitting hyperventilation; the second group will perform hyperventilation in the opposite order, ie, first sitting up and then in supine position.

Eligibility criteria: Inclusion Criteria:

* Children referred for a routine EEG for suspected absence epilepsy

Exclusion Criteria:

* Patients unable to perform hyperventilation
* Children previously diagnosed with absence epilepsy
* Children receiving antiepileptic drugs

Primary outcomes:
measure: Differences in elapsed time (in seconds) to onset of absence seizure between lying supine and sitting up during hyperventilation in routine EEG.
timeFrame: 6 months
Secondary outcomes:
measure: Influence of order of performing hyperventilation, first supine and then sitting up, or vice-versa, on the time (in seconds) to occurrence of ansence seizures
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04409795: Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study
Official title: A Pilot Trial of Adding Oral Hypoglycemic Therapy to Insulin Treatment in Monogenic Variant Carriers of the Joslin 50-Year Medalist Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Monogenic Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 3
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. Our primary objective is to evaluate whether the presence of human leukocyte antigen (HLA) high-risk alleles for diabetes (DR3 and/or DR4) can affect the effectiveness of OHA in these subjects.


Eligibility criteria: Inclusion Criteria:

* Existing participants in the Joslin 50-Year Medalist Study
* Residing in the United States
* Capable of giving informed consent
* Known detectable C-peptide \>0.05 ng/mL

Exclusion Criteria:

* Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease
* Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months
* Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease
* Pre-existing liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal
* Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2)
* Active use of immunosuppressants
* Recipients of prior islet cell or pancreas transplantation
* Inability to travel due to frailty or health reasons
* Donated blood within the previous two (2) months

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Daily insulin dose
timeFrame: 3 months and 6 months
measure: Body mass index (BMI)
timeFrame: 3 months and 6 months
measure: C-peptide
timeFrame: 3 months and 6 months
measure: Total cholesterol
timeFrame: 3 months and 6 months
measure: Low density lipoprotein (LDL)-cholesterol
timeFrame: 3 months and 6 months
measure: High density lipoprotein (HDL)-cholesterol
timeFrame: 3 months and 6 months
measure: Triglycerides
timeFrame: 3 months and 6 months
measure: Area under the plasma concentration versus time curve (AUC) of C-peptide
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: George L. King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05054595: Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
Official title: Comparing the Effects of an Audio-Recorded Brief Mindfulness-Based Intervention With a Nurse-Led Brief Mindfulness-Based Intervention for Preoperative Knee and Hip Replacement Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 0
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: This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a nurse-led, very brief, preoperative mindfulness-based intervention for hip and knee replacement patients will be investigated relative to an audio-recorded very brief, preoperative mindfulness-based intervention delivered during the standard nurse consult and a nurse-led preoperative pain psychoeducation intervention during the standard nurse consult.


Eligibility criteria: Inclusion Criteria:

* 1) Age ≥18,
* 2) Scheduled to undergo unilateral total knee or hip arthroplasty

Exclusion Criteria:

* 1) Cognitive impairment preventing completion of study procedures.
* 2) Current cancer diagnosis,
* 3) Contralateral knee or hip replaced in the previous 3 months,
* 4) Intent to have contralateral knee or hip replaced or other, additional surgical procedure during the study period,
* 5) Intent to add new pain treatments during the study period (except for what is part of the study),
* 6) Other unstable illness judged by medical staff to interfere with study treatment.

Primary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Baseline and after the 10 minute preoperative nurse visit
Secondary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Baseline and after the 10 minute preoperative nurse visit
measure: Change in Pain Medication Desire Numeric Rating Scale
timeFrame: Baseline and after the 10 minute preoperative nurse visit
Other outcomes:
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Locations:
Study officials:
References:
Clinical trial NCT05630495: Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Official title: Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Airlangga University
name: RSIA Kendangsaru MERR Surabaya
First posted: 2022-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia

Detailed description: The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

* Demonstrate that Picterus system performs accurately in Indonesian newborns
* Ensure that Picterus is in line with users' needs in Indonesia

Eligibility criteria: Inclusion Criteria:

- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days

Exclusion Criteria:

- Infants transferred to the pediatric ward for advanced treatment. Infants with a skin rash or other disease that affects the skin where measurements are performed.

Infants that receive or have received phototherapy in the last 24 hours. Infants with an inborn disease

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns
timeFrame: 6 months
Secondary outcomes:
measure: Correlation with TcB
timeFrame: 5-10 minutes
measure: Correlation with Tsb and TcB
timeFrame: 1-2 hours
measure: Picterus JP accuracy in Indonesian newborn
timeFrame: 6 months
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Universitas Airlangga Teaching Hospital
city: Surabaya
country: Indonesia
facility: RSIA Kendangsari MERR hospital
Study officials:
affiliation: Picterus AS
name: Anders Aune, MD,MPH
role: STUDY_DIRECTOR
References: