louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05336591: COVID-19, Obesity and Lifestyle in Children - Role of Professionals
Official title: COVID-19, Obesity and Lifestyle in Children - Role of Professionals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
COVID-19 Pandemic
Childhood Obesity
Overweight, Childhood
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professionals working with children with overweight and/or obesity.

Brief summary: In this study it is researched how preventive and curative healthcare for children with overweight and obesity was conducted during the Covid-19 pandemic, which barriers were noticed by professionals, and how new methods (such as e-health and telemonitorning) for coaching, communication and healthcare were used and experienced.


Eligibility criteria: Inclusion Criteria:

* Worked during the Covid-19 pandemic
* Works with children with overweight and / or obesity
* Works in The Netherlands

Exclusion Criteria:

* No knowledge of the Dutch language.

Primary outcomes:
measure: Views and experiences of health care professionals working with children with overweight and obesity during the COVID-19 pandemic
timeFrame: 2 years after the start of the Covid-19 pandemic
measure: User experience
timeFrame: 2 years after the start of the Covid-19 pandemic
Secondary outcomes:
measure: Experiences
timeFrame: 2 years after the start of the Covid-19 pandemic
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: MUMC+, Maastricht University
name: Anita CE Vreugdenhil, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436691: The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety
Official title: The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety: A Post-Test Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Anxiety
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-29
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels.

Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. The study sample comprised 59 women.


Eligibility criteria: Inclusion Criteria:

* agreeing to participate in the study,
* being able to speak and understand Turkish,
* being in the age group of 18-65 years,
* being admitted to the aforementioned clinic with a planned hysterectomy surgery,
* not having any health problems preventing the person from hearing and speaking,
* being conscious, being oriented and cooperated,
* not having received any training on hysterectomy before the surgery and during discharge.

Exclusion Criteria:

* not agreeing to participate in the study,
* not being able to speak and understand Turkish,
* being under the age group of 18 years,
* not being admitted to the aforementioned clinic with a planned hysterectomy surgery,
* having any health problems preventing the person from hearing and speaking,
* not being conscious, being oriented and cooperated,
* having received any training on hysterectomy before the surgery and during discharge.

Primary outcomes:
measure: Anxiety was assessed using the State-Trait Anxiety Scale.
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
References:
Clinical trial NCT06614491: SCOPE - Single-Point Classification Observational Peristomal Evaluation
Official title: A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ileostomy
Colostomy
Urostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 600 Subjects, or 200 Subjects with ileostomy, colostomy, or urostomy peristomal skin categories

Brief summary: Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.

Detailed description: The purpose of this study is to create an ostomy dataset and collect stoma photos to enable SACS 2.0 evaluation of images digitally versus an in-person ostomy skin assessment.

Eligibility criteria: Inclusion Criteria:

* Patients with ileostomy, colostomy or urostomy
* Age ≥ 18 years of age
* Able and willing to provide informed consent

Exclusion Criteria:

* Enterocutaneous fistulae
* Patients with two or more ostomies

Primary outcomes:
measure: Reliability of SACS assessment
timeFrame: Baseline
Secondary outcomes:
measure: Ostomy dataset
timeFrame: Baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: ConvaCare clinic
city: Bogotá
country: Colombia
facility: ConvaCare clinic
city: Medellín
country: Colombia
facility: ConvaCare clinic
Study officials:
affiliation: Principal Investigator Colombia
name: Sandra Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator Brazil
name: Maria Angela Boccara de Paula, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04256291: Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study
Official title: Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Hip Arthroplasty
Total Hip Replacement
Keywords: total hip arthroplasty
ceramic-on-ceramic
total hip replacement
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013 at National Taiwan University Hospital Yunlin Branch.

Brief summary: The pain and severe wear of hip joints caused by osteoarthritis, rheumatoid arthritis, avascular necrosis and trauma can be subjected to total hip replacement (THR). A hip implant consists of 4 components: acetabular cup, femoral stem, articular liner and femoral head. As an ideal material for THR, ceramic possesses excellent biocompatibility and stability in the human bodies. Moreover, ceramic-on-ceramic interface is highly wear-resistant, preventing generation of wear particles. With the development of latest fourth-generation ceramic Delta, larger femoral heads can be manufactured to conform to the size of native femoral heads. The rate of some of the complications after THR, such as dislocation, can be significantly reduced. The purpose of the present study is to carry out a clinical follow up for each patient who has received the ceramic-on-ceramic THR in order to understand the clinical outcome. Furthermore, the possible complications, such as dislocation and squeaking, can be determined.


Eligibility criteria: Inclusion criteria:

Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013.

Exclusion criteria:

1. Patients who are unable or unwilling to return for follow-up
2. Patients who have deep periprosthetic joint infection
3. Patients who are diagnosed skeletal dysplasia
4. Patients who suffer from mental disorders

Primary outcomes:
measure: Visual Analogue Scale- Change from baseline at 1 year
timeFrame: Change from baseline at 1 year
measure: Harris Hip Score- Change from baseline at 1 year
timeFrame: Change from baseline at 1 year
measure: Oxford Hip Score- Change from baseline at 1 year
timeFrame: Change from baseline at 1 year
measure: Radiologic analysis- Change from baseline at 1 year
timeFrame: Change from baseline at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: Department of Orthopaedics- National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Yang-Chen Chou
role: STUDY_CHAIR
affiliation: National Taiwan University Hospital Yunlin Branch
name: Chen-Chiang Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT04235491: Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
Official title: Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 37000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will include all Medicare patients with continuous claims data implanted with a Micra AV leadless pacemaker or a full-system dual-chamber transvenous pacemaker in any US location.

Brief summary: The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Detailed description: The Micra AV CED study is a study of the Medicare beneficiary population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers and will be executed by analyzing administrative claims data. The study consists of two primary objectives: estimate the (1) acute overall complication rate, and (2) the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra AV leadless pacemakers to dual-chamber transvenous pacemakers will be conducted.

The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.

Eligibility criteria: Inclusion Criteria:

* Medicare beneficiaries implanted with a Micra AV leadless pacemaker (CPT 0387T or 33274 or ICD-10 PCS 02HK3NZ) on or after the study start date will be included in the study.

or

- Medicare beneficiaries implanted with a dual-chamber ventricular transvenous pacemaker \[CPT 33208 or 33213 or 33214 or ICD-10 PCS ((0JH606Z or 0JH636Z) + (02H60JZ or 02H63JZ or 02H70JZ or 02H73JZ) + (02HK0JZ or 02HK3JZ))\] on or after the study start date.

Exclusion Criteria:

* None

Primary outcomes:
measure: Acute complication rate
timeFrame: 30 days
measure: The 2-year survival of patients implanted with a Micra AV leadless pacemaker
timeFrame: 2 years
Secondary outcomes:
measure: Chronic complication rate
timeFrame: 6 months
measure: Device-related re-intervention rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Mikhael El Chami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126891: FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study
Official title: FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle; Fatigue, Heart
Keywords: Cardiac functions
Endurance training
Senior athletes
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:

* Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
* Young recruits in military school of officers in ground forces of the French army during an intensive.


Eligibility criteria: Inclusion Criteria:

* Healthy men between 18 and 35 years old;
* Giving their writing informed consent;
* And affiliated to the French social security.

Exclusion Criteria:

* To be a smoker.
* To present any known pathology that forbids the realisation of any test, or that can alter the measurements: cardiovascular risk factors treated or not (diabetes, dyslipidaemia, arterial hypertension, obesity), cardiac arrhythmia, coronary disease, heart failure, cardiac pacemaker or defibrillator, valvular disease after surgery or not, kidneys failure with dialyse or not, kidney pulmonary cardiac or liver transplantation, chronic bronchopneumopathy, asthma, etc.
* To take any medication that could alter autonomic nervous system or cardiovascular adaptation to maximal exercise (anti-arrhythmia, anti-hypertensive, anti-inflammatory,...).
* Drinking exciting drinks (coffee or tee for example) in the 12h before the tests.
* To be under legal protection (trusteeship, guardianship) or to be deprived of liberty.

Primary outcomes:
measure: Measure of classical echocardiographic parameters to attest systolic and diastolic functions
timeFrame: day 8 (canoeists) / day 5 (military)
Secondary outcomes:
measure: Measure of classical heart rate variability parameters
timeFrame: day 8 (canoeists) / day 5 (military)
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: François FC Carré
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00660491: Endothelial Dysfunction Induced by Postprandial Lipemia
Official title: Endothelial Dysfunction Induced by Postprandial Lipemia: Complete Protection Afforded by High Intensity Aerobic Interval Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Subjects
Keywords: flow mediated dilatation
maximal oxygen uptake
blood lipid
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood.

Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high intensity interval exercise (HIIE).


Eligibility criteria: Inclusion Criteria:

* male, 20-40years, BMI between 25 and 30, resident in Trondheim.

Exclusion Criteria:

* unstable angina, CHD, heart failure,

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: baseline, post exercise, 30min, 2hour, 4hour post exercise
Secondary outcomes:
measure: blood lipid profile
timeFrame: same as flow mediated dilatation
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: National Taiwan Normal University
name: Ulrik Wisloff, Professor
role: STUDY_CHAIR
References:
citation: Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
Clinical trial NCT06060691: the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction
Official title: Randomized Controlled Trial Studying the Ameliorating Effects of Kaempferol Emulgel on Female Arousal Disorder and Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Female Sexual Dysfunction
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the quality of sexual life of females with sexual interest or arousal disorder before and after accurate application of a formulated emulgel made from natural ingredients, including kaempferol as an API


Eligibility criteria: Inclusion Criteria:

* Women between the ages of 28 and 45
* had regular periods and previous menstrual bleeding lasted between three and seven days

Exclusion Criteria:

* sensitivity to drug of therapy,
* cancer,
* autoimmune illness,
* smoking or drinking,
* liver disease,
* irregular menstruation

Primary outcomes:
measure: Female Sexual Function Index
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
Study officials:
References:
Clinical trial NCT00889291: HeRO Vascular Access Device Post Market Procedural Survey Protocol
Official title: HeRO Vascular Access Device Post Market Procedural Survey Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: End stage renal disease
Bacteremia
HeRO Vascular Access Device
Access challenged
Catheter dependent
End stage renal disease requiring vascular access. See HeRO device instructions for use for appropriate patient population
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End stage renal disease patients requiring vascular access

Brief summary: Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.

Detailed description: Evaluation Design: This is a multi-center post market observational survey designed to collect procedural data on a minimum of 50 HeRO™ patients in the commercialization phase. Data will be collected retrospectively for patients already implanted with the HeRO™ device in the commercialization phase or prospectively for patients that receive the HeRO™ Device during the data collection period. No special patient screening, testing, or procedures are required. There is no required patient follow-up.

Subject Population: Any patients the investigator deems/deemed eligible for HeRO™ implant with complete procedural data are eligible for inclusion in this post market observational survey.

Endpoints: None

Inclusion/Exclusion Criteria: There are no formal screening criteria other than patients must have all required procedural data points available for recording on the case report form.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* None

Primary outcomes:
measure: Device placement success
timeFrame: End of procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sentara Heart Hospital, Norfolk, VA
name: Marc Glickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03018691: Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Trial to Assess the Safety and Efficacy of 0.3% and 1% OPA-15406 Ointments When Administered for 4 Weeks in Pediatric Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 73
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

* Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
* Subjects who have an active viral skin infection.
* Subjects with a current or history of malignancy.

Primary outcomes:
measure: The Number of Subjects Experiencing AEs
timeFrame: Week 0-4
Secondary outcomes:
measure: Responder Rate of Investigator's Global Assessment(IGA) of Disease Severity at Week4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Visual Analogue Scale(VAS) for Pruritus Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Verbal Rating Scale(VRS) for Pruritus Score
timeFrame: Baseline, Hour 156
measure: Change From Baseline in Patient-Oriented Eczema Measure(POEM) Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Percentage Affected Body Surface Area
timeFrame: Baseline, Week 8, 16, 24
measure: Mean (SD) OPA-15406 Plasma Trough Concentrations at week1
timeFrame: Week 1
measure: Mean (SD) OPA-15406 Plasma Trough Concentrations at week4
timeFrame: week4
measure: Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week1
timeFrame: week1
measure: Mean (SD) Normalized OPA-15406 Plasma Trough Concentrations by Dose Derived From %BSA at week4
timeFrame: week4
Other outcomes:
Locations:
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References: