louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04810286: Prefabricated Versus 3D-Printing Myofunctional Appliances
Official title: Comparison of Prefabricated Myofunctional Appliances and 3D-Printing Myofunctional Appliances in Children With Class II Division 1 Malocclusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Keywords: Myofunctional treatment
3D-Print
Prefabricated myofunctional appliance
Class II division 1 malocclusion
Orthodontics
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to evaluate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.

Detailed description: This study aims to investigate the dentoskeletal effects of Class II division 1 treatment in growing patients with a prefabricated myofunctional appliance versus a 3D-printing myofunctional appliance.

Eligibility criteria: Inclusion Criteria:

* Increased overjet \>4 mm
* Skeletal Class II relationship (ANB \> 4 degree)
* No previous orthodontic treatment

Exclusion Criteria:

-Craniofacial syndrome

Primary outcomes:
measure: Rate of dentoskeletal changes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Suleyman Kutalmış Buyuk, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01379586: A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
Official title: A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food on This Profile in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-4053
Healthy adult subjects
First time in humans
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Detailed description: This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Eligibility criteria: Inclusion Criteria:

* Healthy caucasian subjects aged 18-45 years inclusive
* Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
* Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.

Primary outcomes:
measure: Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.
timeFrame: At protocol-specified timepoints before and after study drug administration up to Day 14
Secondary outcomes:
measure: Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters
timeFrame: At protocol-specified timepoints before and after study drug administration up to Day 14
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Clinical Site
state: West Yorkshire
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Clinical Department
role: STUDY_DIRECTOR
References:
Clinical trial NCT02580786: Breastfeeding Preterm Infants - The Efficacy of Internet-based Peer Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Infant, Premature
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.


Eligibility criteria: Inclusion Criteria:

* Mothers giving birth before full 35 gestational weeks in a study hospital

Exclusion Criteria:

* The mother not able to speak Finnish
* The infant's condition is critical (based on the paediatrician),
* The mother has a syndrome or illness preventing breastfeeding

Primary outcomes:
measure: Duration of breastfeeding
timeFrame: 12 months
measure: Breastfeeding attitude with Iowa Infant Feeding Attitude Scale
timeFrame: 6 months
Secondary outcomes:
measure: Initiation of breastfeeding (postnatal age of the preterm infant)
timeFrame: 2 months
measure: Duration of expressing milk
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06038786: Resiliency Training on the College Campus
Official title: Resiliency Training on the College Campus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Mood Disorders
Anxiety Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist controlled design
Primary purpose: PREVENTION

Brief summary: This is a waitlist controlled study examining the initial efficacy of Resilience Training among college students at an elevated risk for a severe mental illness.


Eligibility criteria: Inclusion Criteria:

1. 18-30 years old
2. Enrolled in undergraduate program at the college or university where the intervention takes place
3. Students who endorse delusion-like experiences (DLEs): Peter's et al. Delusion Inventory (PDI) score \> 4 and/or
4. Students with mild to moderate depressive symptoms: Beck Depression Inventory (BDI) score ≥ 6

Exclusion Criteria:

1. Inability to provide informed consent
2. Not proficient in English
3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization
4. Current enrollment in psychological or behavioral health treatment.
5. Current use of psychotropic medications (other than stimulants) prescribed by a physician.

Primary outcomes:
measure: Peters Delusions Inventory
timeFrame: Baseline, 4-weeks, 12 months
measure: Beck Depression Inventory
timeFrame: Baseline, 4-weeks, 12 months
measure: Spielberger State-Trait Anxiety Inventory
timeFrame: Baseline, 4-weeks, 12 months
Secondary outcomes:
measure: Connor-Davidson Resilience Scale
timeFrame: Baseline, 4-weeks, 12 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 4-weeks, 12 months
measure: Interpersonal Reactivity Index
timeFrame: Baseline, 4-weeks, 12 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daphne Holt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03120286: OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS
Official title: OVERWEIGHT AND OBESITY ADVERSELY AFFECT IN VITRO FERTILIZATION (IVF) OUTCOMES IN WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome IVF
Keywords: OBESITY
In Vitro Fertilization (IVF)
Polycystic ovary syndrome (PCOS)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 146
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a retrospective study to evaluate the impact of obesity on ivf outcomes.

Brief summary: The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight.

Design: Retrospective cohort study.


Eligibility criteria: Inclusion Criteria:

* All women within the age limit

Primary outcomes:
measure: Live birth rate
timeFrame: On the date of delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03346863: Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion
Official title: Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Electrical Cardioversion
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Lund University
First posted: 2017-11-17
Enrollment: 270
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 \> 18 years referred for electrical cardioversion for ECG-documented persistent atrial fibrillation.

Brief summary: In patients with persistent atrial fibrillation (AF), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great clinical relevance, to avoid unnecessary procedures.

In the PRE-ELECTRIC study, we will investigate the predictive value of potential new biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. The study will be undertaken as a prospective cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international collaborators.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years referred for electrical cardioversion for persistent atrial fibrillation
* Signed, informed consent

Exclusion Criteria:

* Patients \< 18 years
* Patients with paroxysmal atrial fibrillation
* Patients unwilling to participate or without consent competence

Primary outcomes:
measure: Atrial fibrillation recurrence
timeFrame: 30 days after electrical cardioversion
Secondary outcomes:
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Bærum Hospital, Vestre Viken
state: Bærum
Study officials:
References:
Clinical trial NCT04050163: MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
Official title: Safety and Preliminary Efficacy Study of Intravenous Administration of MiSaver® (Myocardial Infarction Saver) After Acute Myocardial Infarction, a Phase I/IIa Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Keywords: Heart Attack
Lead sponsor: Honya Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: Chung Shan Medical University
First posted: 2019-08-08
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential dose escalating
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)


Eligibility criteria: Inclusion Criteria:

* Patients aged 20\~80
* Acute Myocardial Infarction 1 to 10 days
* Cardiac enzyme CK-MB or Troponin \> 2X of high-end normal value
* ST-elevation on EKG (STEMI)
* Presence of regional wall motion abnormality
* Left ventricular ejection fraction (LVEF) of ≤40%
* Hemodynamically stable past 24 hour
* Participants with adequate pulmonary function
* Peripheral artery oxygen saturation ≥97%
* Karnofsky performance status scores of ≥60.

Exclusion Criteria:

* Age \<20 or \>80
* Pregnant or breast feeding
* Positive adventitious infections (such as HIV, hepatitis )
* Revascularization via coronary artery bypass surgery is required
* Coronary revascularization procedures is anticipated during the 6-month study period
* Severe aortic or mitral valve narrowing
* Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
* Short of breath unable to receive PCI examination or treatment
* Malignant tumor
* Hematopoietic dysplasia
* Severe organ disease
* With less than 1 year of life expectancy
* Chronic kidney disease with CCr\<20ml/min
* Kidney disease on renal dialysis

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Left ventricle stroke volume
timeFrame: 12 months
measure: End diastolic volume
timeFrame: 12 months
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 12 months
measure: Participants Functional Activity by NYHA Classification
timeFrame: 12 months
measure: Participants Functional Activity by CCS Classification
timeFrame: 12 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung City
city: Tainan
country: Taiwan
facility: HONYA Medical Inc
Study officials:
References:
Clinical trial NCT05227963: Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
Official title: Comparison Between Soft Tissue Mobilization and Strengthening Exercises in Management of Local Neck Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Neck Pain
Keywords: Assessment
Neck pain
Pain measurements
Patient outcome assessment
Treatment outcome
Lead sponsor: Health Education Research Foundation (HERF)
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The randomized control study was conducted in two groups,one was experimental group received soft tissue mobilization and other was control group received strengthening exercises with supportive treatment for both groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A single-blinded, parallel-group randomized controlled trial was conducted at the national institute of rehabilitation medicine, Pakistan, from April to July 2016, on 30 females who were recruited through non-probability convenient sampling technique and randomly allocated to the experimental and control group.

Detailed description: The experimental group received STM and neck isometric strengthening exercises, whereas the control group received neck isometrics strengthening exercises only. Numeric Pain Rating Scale (NPRS) was used to assess the pain intensity, while Neck Disability Index (NDI) was used to assess the neck-related disability. The data was collected pre-, during, and post-intervention. Repeated measure analysis of variance (RM ANOVA) was used to analyze within the group changes, while independent t-test was used to analyze the differences between the groups. Data were analyzed by using SPSS version 21.

This study describes the comparative effectiveness of STM when used as adjunct to strengthening exercises and when strengthening exercises are used alone for the management of TNS. According to the results of this study, STM in combination with neck isometric strengthening exercises as well as exercises alone were effective for managing neck pain and functional disability when a comparison was made within the groups.

Eligibility criteria: Inclusion Criteria

:• Age above 30 and below 75 years

* Patients having local neck pain included
* Female included
* With chronic neck syndrome (\> month)

Exclusion Criteria:

* Age below 30 and more than 75 years
* Patients having radiating pain excluded
* Male excluded.
* With acute neck syndrome (\< 3 month)

Primary outcomes:
measure: Numerical pain rating scale (NPRS)
timeFrame: upto 2 weeks
measure: Neck disability index (NDI)
timeFrame: upto 2 weeks.
measure: Neck range of motion
timeFrame: upto 2 weeks .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02262663: Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan
Official title: A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trial, Phase I
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a study in healthy women of reproductive age to investigate the pharmacodynamics (mainly ovarian activity), pharmacokinetics and safety of vilaprisan after daily oral administration of 4 different doses over 84 days, using a randomized, parallel-group, multicenter design.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
* Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
* Pre-treatment cycle assessed as ovulatory and not longer than 44 days

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
* Known or suspected liver disorders
* Amenorrhea for more than 3 months within the last 6 months before the first screening examination
* Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)
* Positive urine pregnancy test
* Regular use of medicines

Primary outcomes:
measure: Hoogland score during treatment, day 9 to day 28
timeFrame: Day 9 to 28
measure: Hoogland score during treatment, day 63 to day 84
timeFrame: Day 63 to 84
measure: Hoogland score during follow up cycle 1
timeFrame: 4 weeks following treatment period
measure: Hoogland score during follow up cycle 2
timeFrame: 4 weeks following follow up cycle 1
measure: Number of subjects without bleeding/spotting
timeFrame: After three month treatment
Secondary outcomes:
measure: Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling
timeFrame: After three month treatment
measure: Number of subjects with TEAEs (treatment-emergent adverse events)
timeFrame: After three month treatment and during follow-up (up to 60 days)
measure: Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes)
timeFrame: After three month treatment and during follow-up (up to 60 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: