louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04282486: Medication Exposure in Older Patients With Constitutional Hemorrhagic Disease
Official title: Medication Exposure in Older Patients (AGEd > 65 Years) With Constitutional HEMORRHagic Disease (Haemophilia or Willebrand Disease).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Keywords: Willebrand disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 142
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with hemophilia or Willebrand's disease (over 65) will have a telephone interview in order to collect medication data from medical prescriptions.

Brief summary: The improvements observed in the care of patients with hemophilia or Willebrand disease have led to an increase in their life expectancy, which today approaches that of the general population. This increase in life expectancy leads in these patients to the development of comorbidities related to aging (cardiovascular and neurological diseases, cancers and kidney diseases) (e.g "Franchini \& Mannuccio", BJH, 2009). The care of these comorbidities represents a new challenge for the medical teams. Toward multiple comorbidities, polypharmacy is often associated.

Many studies about medication exposure and management in older patients were published but no study was conducted to explore the medication management of older patients with hemophilia or Willebrand disease.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling patients over 65 years with hemophilia (A or B)
* Community-dwelling patients over 65 years with Willebrand disease (Type1, 2 and 3, rate \<30%)

Exclusion Criteria:

* Patients without phone number
* Non French speaking patients

Primary outcomes:
measure: Potentially inappropriate medication (PIM) prevalence using EU-(7) PIM list.
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital des Charpennes, Institut du Vieillissement
Study officials:
References:
Clinical trial NCT01272986: Trial of Screening for ALOA-IgG AtheroAbzyme Test
Official title: Trial of Screening for ALOA-IgG AtheroAbzyme Test Comparing Healthy,Asymptomatic Myocardial Ischemic and Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Ischemia
Acute Coronary Syndrome
Keywords: Determination of the level of oxidised LDL by measuring the level of IgG in Blood
Lead sponsor: Omicron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a trial of screening for ALOA-IgG AtheroAbzyme Test comparing healthy, asymptomatic myocardial ischemic and acute coronary syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Healthy patients
* High Risk patients or Asymptomatic myocardial Ischemic patients
* Acute Coronary Syndrome patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Measuring the degree of oxidized low-density lipoprotein (LDL) by ALOA- IgG AtheroAbzyme in healthy and cardiovascular disease patients
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Bahman Hospital
state: Haret Hriek
Study officials:
affiliation: Bahman Hospital
name: Malek Mohamad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743886: Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear
Official title: Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: MCL Tear
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Detailed description: Autologous platelet-rich matrices may aid in the healing of ligaments \& tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

Eligibility criteria: Inclusion Criteria:

* age 18-40 years old
* diagnosed MCL tear grade 2/3

Exclusion Criteria:

* pregnancy
* mental or physical disabilities

Primary outcomes:
measure: time and efficiency of healing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Omer Mei Dan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284086: VO2peak and Exercise Efficiency in Upper-body Poling
Official title: Comparison of Peak Oxygen Uptake and Exercise Efficiency Between Upper-body Poling and Arm Crank Ergometry in Trained Paraplegic and Able-bodied Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Oxygen consumption
Physical endurance
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-09-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants.

Detailed description: Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance performance. In persons who are primarily able to use their upper-body during exercise, such as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested to be of importance for achieving VO2peak and exercise efficiency that are reflective of the aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode. However, it has not yet been investigated whether VO2peak and efficiency differ between ACE and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants. Participants performed four 5-min submaximal stages at increasing effort and an incremental peak test to exhaustion in both ACE and UP.

Eligibility criteria: Inclusion Criteria:

* participants between the age of 18 and 50
* well upper-body-trained participants with or without paraplegia

Exclusion Criteria:

* people with injuries or sicknesses that might have impacted the testing

Primary outcomes:
measure: Peak oxygen uptake
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Centre for Elite Sports Research
Study officials:
affiliation: Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology
name: Jorunn Helbostad, phd prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05702086: Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
Official title: Evaluating the Utility of a Psychoeducational Serious Game (SPARX) in Protecting Inuit Youth From Depression: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Emotion Regulation
Keywords: hopelessness
catastrophizing
rumination
resilience
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Government of Nunavut
name: Qaujigiartiit Health Research Centre
First posted: 2023-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot trial was to test SPARX with Inuit youth in Northern Canada. SPARX is an educational video game designed to teach cognitive behavioural therapy strategies and techniques. This "serious game" has previously shown promise in addressing symptoms of depression with Māori youth in New Zealand. Researchers in this study tested SPARX's suitability with Inuit youth in the territory of Nunavut using surveys that youth completed before and after gameplay.

Hypothesis 1: Youth who completed SPARX were expected to experience a decrease in depressive symptoms and risk factors related to depression. Hypothesis 2: Youth who completed the SPARX program were expected to experience an increase in factors related to resilience.

A team of Nunavut-based community mental health staff facilitated youth's participation in this remote pilot trial with 24 youth aged 13-18 across 11 communities in Nunavut. These youth had been identified by community facilitators as showing low mood, depression, and/or significant levels of stress.


Eligibility criteria: Inclusion Criteria:

* one or more of the following:

  * low mood
  * negative affect
  * depressive presentations
  * significant levels of stress and:
  * sufficient English language comprehension to use and understand SPARX

Exclusion Criteria:

None

Primary outcomes:
measure: "Centre for Epidemiologic Depression Scale - Revised"
timeFrame: Pre-gameplay (T=0)
measure: "Centre for Epidemiologic Depression Scale - Revised"
timeFrame: Post-gameplay (T=7 weeks)
measure: "Hopelessness Scale for Children"
timeFrame: Pre-gameplay (T=0)
measure: "Hopelessness Scale for Children"
timeFrame: Post-gameplay (T=7 weeks)
measure: "Cognitive Emotion Regulation Questionnaire - Short"
timeFrame: Pre-gameplay (T=0)
measure: "Cognitive Emotion Regulation Questionnaire - Short"
timeFrame: Post-gameplay (T=7 weeks)
measure: "Child and Youth Resilience Measure - Short"
timeFrame: Pre-gameplay (T=0)
measure: "Child and Youth Resilience Measure - Short"
timeFrame: Post-gameplay (T=7 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Yvonne Bohr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01120886: Post-mortem Genetic Testing
Official title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Ion Channelopathy
Keywords: Ion channelopathy,
Still birth
Sudden death
Lead sponsor: Thayyil, Sudhin
Sponsor class: INDIV
First posted: 2010-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unexplained still births

Brief summary: This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.


Eligibility criteria: Inclusion Criteria:

* Unexplained still births,
* No cause of death after detailed autopsy

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: Incidence of cardiac ion channelopathy mutation
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of cardiac ion channelopathy in 1st degree relatives of index case
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References:
citation: Munroe PB, Addison S, Abrams DJ, Sebire NJ, Cartwright J, Donaldson I, Cohen MM, Mein C, Tinker A, Harmer SC, Aziz Q, Terry A, Struebig M, Warren HR, Vadgama B, Fowler DJ, Peebles D, Taylor AM, Lally PJ, Thayyil S. Postmortem Genetic Testing for Cardiac Ion Channelopathies in Stillbirths. Circ Genom Precis Med. 2018 Jan;11(1):e001817. doi: 10.1161/CIRCGEN.117.001817. Epub 2018 Jan 11.
Clinical trial NCT06501586: Study of SGB-3908 in Healthy Subjects and Mildly Hypertensive Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SGB-3908 After a Single Administration in Healthy Subjects and Mildly Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hypertension,Essential
Keywords: healthy
mildly hypertensive
Lead sponsor: Suzhou Sanegene Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: Innovent Biologics (Suzhou) Co. Ltd.
First posted: 2024-07-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3908 in healthy subjects and mildly hypertensive subjects. The study will be a single ascending dose (SAD) phase.


Eligibility criteria: Inclusion Criteria:

* Has body mass index (BMI) ≥18 and ≤30 kg/m\^2 and has bodyweight ≥ 50 kg;
* Has Systolic blood pressure (SBP) ≥100 mmHg and ≤150 mmHg and diastolic blood pressure (DBP) ≥65 mmHg and ≤95 mmHg at screening;

Exclusion Criteria:

* Has mental illness, liver and kidney disease, gastrointestinal disease, nervous system disease, or other related systemic diseases that affect the trial;
* Has a history of hospitalization or other clinically significant diseases within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator;
* Has a history of orthostatic hypotension or syncope;
* Patients with clinically significant abnormalities confirmed by physical examination, 12-lead electrocardiogram, laboratory tests, etc., or those who meet any of the following conditions during screening need to be excluded:

  1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin higher than 1.5× upper limit of normal (ULN)
  2. Serum creatinine (Cr) higher than ULN
  3. Serum potassium higher than 5 mmol/L
  4. QT/QTc interval prolongation during screening (QTcF\>450 ms)

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: up to approximately 12 months
Secondary outcomes:
measure: Change from Baseline in Blood Angiotensinogen (AGT) Level
timeFrame: up to approximately 12 months
measure: Maximum Observed Plasma Concentration (Cmax) of SGB-3908 and of Potential Metabolites
timeFrame: Up to Day 3
measure: Area Under the Concentration-time Curve (AUC) of SGB-3908 and of Potential Metabolites
timeFrame: Up to Day 3
measure: Number of Participants With Anti- SGB-3908 Antibodies
timeFrame: up to approximately 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00416286: Effect of Sustained-Release Cetylpyridinium Chloride Varnish on Streptococcus Mutans and Lactobacillus in Orthodontic Patients
Official title: Phase 1: To Evaluate the Antibacterial Efficacy of Sustained Release Cetylpyridinium Chloride Varnish in Orthodontic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Cetylpyridinium chlorid
Sustained release
orthodontic patients
streptococcus mutans
Lactobacillus
Rate of bacterial load in saliva of orthodontic patients
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to was to evaluate the anti bacterial efficacy of sustain-release Cetylpyridinium chloride varnish on orthodontic patients.


Eligibility criteria: Exclusion Criteria:

* Children under 12y old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthodontic department, Dental school Hadassah Ein Kerem
name: Doron Harari, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064386: Comparative Study of Postieror Ankle Fracture
Official title: Comparative Study of Postieror Malleolar Fracture With Plate and Screw Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postieror Malleolar Fracture
Treatment
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.


Eligibility criteria: Inclusion Criteria:

supination-external rotation Ⅳ type injury

Exclusion Criteria:

Pion fracture; Isolated posterior ankle fracture.

Primary outcomes:
measure: functional score
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04463186: Time Based Effects of Different Duration Stretching on Calf Muscle Strength
Official title: Time-based Effects of Different Duration Stretching on Calf Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Keywords: Muscle strength
muscle stretching exercises
Calf Muscle
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 14
Sex: ALL
Minimum age (years): 24
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects participated in three experimental trials: Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Strength was measured before (pre), immediately after (post), and at 10- and 20- minutes post stretching.
Primary purpose: OTHER

Brief summary: Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to athletic events but with conflicting reports. This time course study aimed to assess acute effects of static stretching of different durations on isometric maximum voluntary contraction force of calf muscle.

Detailed description: Stretching is reported to decrease muscle strength and thus suggested to be avoided prior to athletic events but with conflicting reports. This time course study aimed to assess acute effects of static stretching of different durations on isometric maximum voluntary contraction force of calf muscle. Pretest posttest experimental design was used. 14 subjects participated in three experimental trials: Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Strength was measured before (pre), immediately after (post), and at 10- and 20- minutes post stretching. Each static stretching (SS) trial involved varied repetitions of 30-seconds self-stretches and 20-seconds relax periods.

Eligibility criteria: Inclusion Criteria:

* Subjects performed active foot dorsiflexion in long sitting position with back supported against wall and those having not more than 20-degree range of motion were selected
* Used to engage in 1 to 5 hours of physical activity per week

Exclusion Criteria:

* Subjects having any current injury or limits in range of motion specific to lower limb joints
* Current neuromuscular disease
* Competitive athletes were excluded from the study

Primary outcomes:
measure: Change in Isometric Maximum Voluntary Contraction Force
timeFrame: MVCF at baseline and 0, 10, 20-min post stretching
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
Clinical trial NCT04663386: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway
Official title: Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway; A Retrospective, Observational Study to Evaluate the Impact on Disease Control in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
COPD
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma and/or COPD treated with budesonide-formoterol DPI

Brief summary: This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.

Detailed description: In July 2018 Norwegian authorities decided to allow switch at pharmacy for dry powder inhalers (DPIs) containing budesonide-formoterol. Pharmacists are instructed to switch patients to the inhaler with the lowest price. The pharmacist will train the patient on how to use the new inhaler. All patients whose eligible inhaler switch occurred between 1st July 2018 and 1st March 2019 will be eligible for the study.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent has been obtained.
2. Male or female patients with a diagnosis of asthma and/or COPD whose budesonide-formoterol DPI was switched to another budesonide-formoterol DPI at pharmacy between 1st July 2018 and 1st March 2019 (referred to as the eligible switch).
3. Age ≥12 years at time of switch.
4. Treated with budesonide-formoterol for at least 12 months before the eligible switch (pre-switch period) and 12 months after the eligible switch (post-switch period). Re-switch(es) of inhaler are allowed during the post-switch period.

Exclusion Criteria:

1. Patient has declined participation in the study or failed to respond to the invitation to participate.

Primary outcomes:
measure: Disease control
timeFrame: 24 months
Secondary outcomes:
measure: Budesonide-formoterol dose
timeFrame: 24 months
measure: Training at pharmacy
timeFrame: 24 months
measure: Healthcare utilisation
timeFrame: 24 months
measure: Inhaler switch
timeFrame: 24 months
Other outcomes:
Locations:
city: Hønefoss
country: Norway
facility: Flattum Legesenter
Study officials:
affiliation: Flattum Legesenter
name: Jorn Ossum
role: PRINCIPAL_INVESTIGATOR
References: