louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02309463: Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension
Official title: A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with PAH, and not receiving ERA therapy in the 30 days prior to the enrolment visit, are eligible for inclusion in this study. Patients in need of ERA therapy will receive ERA treatment according to the physician's decision

Brief summary: The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I)
* Age ≥18 year
* Not receiving ERA therapy in the 30 days prior to the enrolment visit
* Signed patient informed consent form

Exclusion Criteria:

* Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device

Primary outcomes:
measure: Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
timeFrame: Baseline to Week 54
measure: Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation
timeFrame: baseline to week 54
Secondary outcomes:
measure: WHO Functional Class
timeFrame: Baseline to Week 54
measure: NT-ProBNP/BNP
timeFrame: Baseline to Week 54
measure: Echocardiography parameters
timeFrame: Baseline to Week 54
measure: Number of hospitalization due to PAH (min. overnight)
timeFrame: Baseline to Week 54
measure: Quality of Life
timeFrame: Baseline to Week 54
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05827263: Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
Official title: Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Occlusal splints
Dental occlusion
Balanced Dental Occlusion
Temporomandibular Joint Disorders
Bite Force
Centric Dental Occlusion
Dental Equipment
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this non-randomized controlled trial is to analyze and compare occlusal force distribution patterns using T-Scan III before and after hydrostatic splint therapy on both healthy subjects and subjects with temporomandibular disorders. The main questions it aims to answer are:

* Do occlusal forces for individual teeth differ before and after hydrostatic splint therapy?
* Does the percentage distribution of forces across different sectors differ before and after hydrostatic splint therapy?

Participants will:

* Perform occlusal analysis using the T-Scan III device;
* Use a hydrostatic splint for 30 minutes;
* Perform a second occlusal analysis after using the hydrostatic splint.

Researchers will compare healthy subjects and subjects with temporomandibular disorders to see if hydrostatic splint therapy makes a difference in the distribution patterns of occlusal forces.


Eligibility criteria: Inclusion Criteria:

* healthy subjects with Angle Class I and a normal line of occlusion without malpositioned or rotated teeth;
* complete permanent dentition except for the third molars;
* no fixed prosthesis;
* no dental caries;
* no restorations on the occlusal surfaces of molars and premolars extending more than one-third of the surface;
* no restorations on incisal edge;
* no tenderness on percussion of any teeth;
* no history of previous endodontic and orthodontic treatment,
* extensive maxillofacial surgery;
* no systematic neurological disorders.

Exclusion Criteria:

* presence of orofacial pain that limits mouth opening;
* malocclusion (e.g., open bite, increased overjet or reverse overjet, cross bite);
* skeletal anomalies with occlusal disturbance.

Primary outcomes:
measure: Change of percentage force distribution per sector.
timeFrame: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
measure: Change of percentage force distribution for single dental elements.
timeFrame: Change of percentage force distribution for single dental elements at 30-minute of hydrostatic appliance usage.
Secondary outcomes:
Other outcomes:
Locations:
city: Marijampole
country: Lithuania
facility: MK Dental Studio
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Mante Kireilyte
role: STUDY_CHAIR
References:
Clinical trial NCT06885463: PRP & PDO Threads in Treatment of Stress Incontinence
Official title: The Role of Platelets Rich Plasma Combined With PDO Threads in Treatment of Stress Incontinence in Egyptian Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Incontinence, Female
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.


Eligibility criteria: Inclusion Criteria:

* Nonpregnant Women with SUI
* Age between 20 to 45 years
* Patients had a history of failed conservative treatment
* Patients were on the waiting list for surgical treatment of SUI

Exclusion Criteria:

* Under anti-platelet agent treatment
* Under NSAIDs
* Platelet dysfunction syndrome
* Critical thrombocytopenia
* Hypofibrionogenaemia
* Sepsis
* Acute and chronic infections
* Chronic liver disease
* Anti-coagulation therapy
* History of malignancy
* Pregnancy
* history of active malignant pathology
* mental disorders making them unable to give consent
* genitourinary fistula
* pelvic organs prolapse stage \>2 according to the Pelvic Organ Prolapse Quantification system, and detrusor overactivity on urodynamics.

Primary outcomes:
measure: evaluation of reported SUI symptoms
timeFrame: After 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.
Study officials:
References:
Clinical trial NCT00963963: Reducing HIV Risks in African American Teens
Official title: Reducing HIV Risks in African American Teens in High Poverty Urban Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: sexual health
adolescent health
parent education
HIV Seronegativity
treatment experienced
Lead sponsor: Education Development Center, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.


Eligibility criteria: Inclusion Criteria:

* Attendance at selected schools
* 6th graders and their parents

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: youth risk behaviors
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newton
country: United States
facility: Education Development Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02388763: Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®
Official title: Clinical Evaluation of MyDay™ Daily Disposable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.

Detailed description: After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.

Eligibility criteria: Inclusion Criteria:

* Must sign informed consent form.
* Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months.
* Willing to wear lenses every day or at least 5 days per week 6 hours per day.
* Willing to discontinue artificial tears and rewetting drops usage on the days of study visits.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* Pregnant or lactating.
* Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer.
* Any abnormal ocular condition as specified in the protocol.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
timeFrame: Day 10, each product
Secondary outcomes:
measure: High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
timeFrame: Day 10, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Trial Manager, EMEA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04281563: Medium-chain Triglyceride Oil Massage on Growth in Preterm
Official title: The Effect of Medium-chain Triglyceride Oil Massage on Physical Growth in Preterm Infants Weighing Between 1500 and 2000 g: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
MCT Oil Massage
Growth
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim: To explore the effect of medium-chain triglyceride (MCT) oil massage on growth in preterm infants.

Methods: This randomized controlled trial was conducted in the newborn center of a regional hospital in Taiwan. Preterm infants weighing between 1500 and 2000 g were recruited and randomly assigned to three groups: the MCT oil massage, massage alone and no massage groups. The massages were given three times per day for 7 consecutive days. Weight, length and head circumference were measured in the three groups at birth and on study days 1 to 7.


Eligibility criteria: Inclusion Criteria:

1. gestational age between 28 and 37 weeks;
2. weight between 1500 and 2000 g after enrollment;
3. medically stable condition;
4. ≥120 cc per day feeding.

Exclusion Criteria:

1. congenital anomalies;
2. skin disease;
3. requirement for mechanical ventilation;
4. requirement for O2 therapy;
5. presence of fracture.

Primary outcomes:
measure: weight
timeFrame: on study days 1 to 7
Secondary outcomes:
measure: height and head circumference
timeFrame: on study days 1 to 7
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
Study officials:
References:
citation: Liao YC, Wan YH, Chen PH, Hsieh LY. Efficacy of medium-chain triglyceride oil massage on growth in preterm infants: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2021 Jul 30;100(30):e26794. doi: 10.1097/MD.0000000000026794.
Clinical trial NCT06423963: Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
Official title: Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition "prehabilitation" program for patients preparing for pancreatic cancer resection (removal).


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection
* Ability to read and speak English

Exclusion Criteria:

* Regular engagement in RT (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on PAR-Q
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
* Numeric pain rating scale greater than or equal to a 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function

Primary outcomes:
measure: Feasibility and acceptability of PA/N and RT/N programs
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Examine exploratory outcomes and clinical characteristics
timeFrame: Up to 16 weeks
measure: Compare clinical and treatment outcomes
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nathan Parker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403163: Transfusion Surveillance in Anaesthesia
Official title: Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transfusion Reaction
Transfusion Related Complication
Anesthesia
Anesthesia; Shock
Side Effect
Fresh Blood Stool
Blood Coagulation Disorder
Blood Loss
Keywords: transfusion
monitoring
emergency situation
shock
fresh frozen plasma
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient who received an hemostasis product during an hemorrhagic situation

Brief summary: the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

Detailed description: the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

Patients will be informed at the time of the anaesthesia consultation about the inclusion in the registry.

The data will be collected from the patients' files by the investigators of the centre without modifying their management.

The data collection period will not exceed the period of acute management.

Eligibility criteria: Inclusion Criteria:

* all patients who have received an hemostasis product

Exclusion Criteria:

* patient who refused to consent to data analysis and study participation

Primary outcomes:
measure: Hemostatic evolution through transfusion event
timeFrame: 12 hours
measure: ROTEM measures evolution through transfusion event
timeFrame: 12 hours
measure: Haematologic measures evolution through transfusion event
timeFrame: 12 hours
measure: ionic measures evolution through transfusion event
timeFrame: 12 hours
Secondary outcomes:
measure: Mortality at one month
timeFrame: one month
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Université libre de Bruxelles
Study officials:
References:
Clinical trial NCT00475163: Mentors in Motion: A Physical Activity Intervention for Obese Adolescents
Official title: Mentors in Motion: A Physical Activity Intervention for Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Mentoring
Fitness
Self-esteem
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 34
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assesing the impact of mentoring on the lifestyle choices of adolescents who are overweight

Detailed description: Randomized controlled trial of the impact of weekly contacts with mentors to improve physical activity pattern, self esteem, and weight loss in obese teenagers over a 6 month period.

Eligibility criteria: Inclusion Criteria:

* 13-17 yo Able to participate in physical activity

Exclusion Criteria:

* On medications that could affect weight

Primary outcomes:
measure: Weight gain
measure: Fitness
measure: self esteem
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Laurent Legault, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06596863: Serum Uromodulin and DN Systematic Review and Meta Analysis
Official title: Association of Serum Uromodulin and DKD a Systematic Review and Meta Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Nephropathies
Keywords: DKD, urimodulin
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2024-09-19
Enrollment: 1774
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The systematic search strategy retrieved 275 publications by the 4 databases (PubMed 76, Cochrane Library 11, Web of Science 107, and Scopus 81). 144 studies remained after exclusion the duplicates. After screening title and abstract 135 studies were excluded. 9 studies remained for full text and data reviewing. 4 studies of them were excluded as they didn't meet the eligibility criteria. In addition, 1 study was retrieved by manual search from Google Scholar. Finally, 6 articles were included \[20-25\]. The selected studies included 1774 participant

Brief summary: Several studies have investigated the association between the changes of serum uromodulin and diabetic nephropathy (DN). However, the results are still controversial. Hence, this meta-analysis aimed to evaluate the association of uromodulin with DN.


Eligibility criteria: Inclusion Criteria:

* Studies were included if they met the following criteria:

  1. serum level of uromodulin was determined;
  2. the samples were enrolled from diabetic patients;
  3. mean ± SD was reported for uromodulin between patients with and without DN;
  4. the level of albumin to creatinine ratio (ACR), glomerular filtration rate (GFR), or albumin excretion rate (AER) in patients with DN was determined

Exclusion Criteria:

* Studies were excluded according to the following criteria:

  1. duplicate studies;
  2. review articles;
  3. non original research articles;
  4. studies with insufficient data to extract;
  5. non-human research;
  6. studies that determined urine level of uromodulin.

Primary outcomes:
measure: Association of serum uromodulin with DKD: asystematic review and meta analysis
timeFrame: may, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Yniversity
state: Yes
Study officials:
References: