louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05188937: Validity and Reliability of the Dual-task Questionnaire
Official title: Validity and Reliability of the Dual-task Questionnaire in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Dual-Task
Validity
Reliability
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cross-Sectional
Primary purpose: PREVENTION

Brief summary: It is important to increase the independence of Multiple Sclerosis (MS) patients in activities of daily living. Almost all activities of daily living require managing many activities at the same time. For example, walking or standing while talking on the phone. There is a need for easily applicable, reliable and valid scales to evaluate dual-task performance in MS patients. Therefore, the aim of this study is to establish the Turkish cultural adaptation, validity and reliability of the Dual-Task Questionnaire scale in MS patients. This study included a total of 50 patients with MS \[age (18-65) years\]. Dual-task Questionnaire (DTQ), Timed Up and Go test (TUG) with dual-task and Nine Hole Peg test (9-HPT) with dual-task were applied to the patients. The second evaluation (retest) was carried out by the same physiotherapist one week following the first evaluation (test) in order to measure test-retest reliability.

Detailed description: This study included patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS). DTQ was used to assess the frequency of difficulties associated with daily tasks involving the dual-task. Additionally TUG with dual-task and 9-HPT with dual-task were applied to the patients. An experienced physiotherapist applied all these tests. In order to measure test-retest reliability, a retest was carried out by the same physiotherapist one week following the first evaluation. The construct validity of DTQ was tested by Pearson's correlation coefficient.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis
* Must be able to ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No relapse in the last 3 mounts

Exclusion Criteria:

* Orthopedic problems
* Visual, perception, and hearing problems

Primary outcomes:
measure: Validity and reliability of Dual-Task Questionnaire in patients with MS
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
References:
citation: Evans JJ, Greenfield E, Wilson BA, Bateman A. Walking and talking therapy: improving cognitive-motor dual-tasking in neurological illness. J Int Neuropsychol Soc. 2009 Jan;15(1):112-20. doi: 10.1017/S1355617708090152.
Clinical trial NCT01993537: The Role of Vitamin D in the Pathophysiology of Chronic Failure
Official title: The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Chronic Heart Failure
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will undergo at baseline and regular intervals:

* clinically indicated bloodwork/urine and echocardiogram testing
* biomarker studies

Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.

Detailed description: The inclusion criteria for the study is:

* an EF ≤40% within the last 12 months before recruitment
* established diagnosis of heart failure
* \>18 years of age
* patients will vitamin d levels of sufficient, mild deficiency and severe deficiency

The exclusion criteria is:

* hypercalcemia
* known hypersensitivity to Vitamin D
* patient unwilling to comply with study requirements
* any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
* women of child bearing potential
* a patient currently taking vitamin d
* severe renal impairment estimated glomerular filtration rate (eGFR) \<30

Eligibility criteria: Inclusion Criteria:

* an ejection fraction (EF) ≤40% within the last 12 months before recruitment
* established diagnosis of heart failure
* \>18 years of age
* patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency

Exclusion Criteria:

* hypercalcemia
* known hypersensitivity to Vitamin D
* patient unwilling to comply with study requirements
* any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
* women of child bearing potential
* a patient currently taking vitamin d
* severe renal impairment eGFR \<30

Primary outcomes:
measure: prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute
timeFrame: up to 3 years
Secondary outcomes:
measure: To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: The University of Ottawa Heart Insitute
name: Haissam Haddad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917109: LearningRx Cognitive Training for ADHD
Official title: LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Gibson Institute of Cognitive Research
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 3
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.

Detailed description: Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for ADHD.

Eligibility criteria: Inclusion Criteria:

* Age 15-22 previously diagnosed with ADHD
* High school students or college students with a prior diagnosis of ADHD living in the greater Colorado Springs area

Exclusion Criteria:

* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging

Primary outcomes:
measure: Evidence of overall cognitive function improvement
timeFrame: within 14 days after completing the intervention
Secondary outcomes:
measure: Evidence of change in brain activity
timeFrame: within 30 days after completing the intervention
measure: Evidence of reduction in ADHD symptoms
timeFrame: within 14 days after completing the intervention
measure: Evidence of change in brain structure
timeFrame: within 30 days after completing the intervention
measure: Evidence of improvement in visual or auditory attention
timeFrame: with 14 days after completing the intervention
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Gibson Institute of Cognitive Research
state: Colorado
Study officials:
affiliation: Gibson Institute of Cognitive Research
name: Christina Ledbetter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gibson Institute of Cognitive Research
name: Amy L Moore, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05904509: Insulin Resistance in Atopic Dermatitis Patients
Official title: The Relationship Between Insulin Resistance and Disease Severity and Duration in Atopic Dermatitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
insulin resistance
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atopic dermatitis patients confirmed by a dermatologist

Brief summary: The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis.

Detailed description: The aim of the study is to determine the relationship between insulin resistance and disease duration and severity of atopic dermatitis. EASI and SCORAD values and disease duration of atopic dermatitis patients are calculated during the examination. HOMA-IR blood test result is compared with the results.

Eligibility criteria: Inclusion Criteria:

* Atopic dermatitis patients confirmed by a dermatologist

Exclusion Criteria:

* patients younger than 2 years
* patients older than 80 years
* Atopic dermatitis patients without HOMA-IR result

Primary outcomes:
measure: HOMA-IR
timeFrame: 12 months
measure: SCORAD index
timeFrame: 12 months
measure: EASI index
timeFrame: 12 months
measure: Duration of the disease
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
References:
Clinical trial NCT05846009: A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
Official title: A Phase I, First-in-human, Two-part, Randomized, Placebo-controlled, Double-blind, Single and Repeated Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of SAR442501 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteochondrodysplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.


Eligibility criteria: Inclusion Criteria:

* Male and female participants, between 18 and 45 years of age, inclusive.
* Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment.
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any history or presence of clinically relevant medical status as per the protocol.
* Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
timeFrame: Baseline up to end of study (EOS) (Day 89)
Secondary outcomes:
measure: Assessment of PK parameter: Maximum observed concentration (Cmax)
timeFrame: Baseline up to EOS (Day 89)
measure: Assessment of PK parameter: First time to reach Cmax (tmax)
timeFrame: Baseline up to EOS (Day 89)
measure: Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
timeFrame: Baseline up to EOS (Day 89)
measure: Immunogenicity: evaluate the presence of anti-SAR442501 antibodies
timeFrame: Baseline up to EOS (Day 89)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Investigational site
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02675309: A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male Caucasian subjects aged 18 to 55
* A body weight of ≥60 kg

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.
timeFrame: 72 hours post dose
measure: Cmax of rosuvastatin alone and in the presence of MT-8554.
timeFrame: 72 hours post dose
measure: AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.
timeFrame: 24 hours post dose
measure: Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.
timeFrame: 24 hours post dose
Secondary outcomes:
measure: Safety and Tolerability as measured by vital signs
timeFrame: Up to Day 16
measure: Safety and Tolerability as measured by number of participants with adverse events
timeFrame: Up to Day 16
Other outcomes:
Locations:
city: City name
country: United Kingdom
facility: Investigational center
Study officials:
References:
Clinical trial NCT03197909: Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
Official title: Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary
Keywords: COPD (Chronic Obstructive Pulmonary Patients)
Atrophy
cell cultur
systemic inflammation
Catabolism
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Patients

Brief summary: Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.


Eligibility criteria: Inclusion Criteria:

35 to 85 years old

* COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio \<70% assessed by a spirometry
* Healthy subjects: A sedentariness assessed by a Voorrips score \<9.4 and/or a report of \<150 min/week of moderate-to-vigorous physical activity

Exclusion Criteria:

* A recent COPD exacerbation (\< 4weeks)
* The decompensation of a comorbidity
* An antioxidant supplementation or medication
* A long-term systemic corticosteroid medication

Primary outcomes:
measure: Myotube diameter of in vitro cultured myotubes
timeFrame: 6 days
Secondary outcomes:
measure: Expression and translation of markers of
timeFrame: 6 days
Other outcomes:
measure: Level of pro-Inflamatory markers
timeFrame: 6 days
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Maurice HAYOT, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04672109: The Effects of Different Montages of tDCS on Muscle Strength in Healthy Adults
Official title: The Effects of Different Montages of Transcranial Direct Current Stimulation on Muscle Strength in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of different montages of tDCS on muscle strength in healthy adults

Detailed description: Electrode montage or placement of tDCS over primary motor cortex can be categorized into unilateral (anodal or cathodal electrode over primary motor area) and bilateral tDCS (both anodal and cathodal electrode over the cortex). Previous studies reported benefits of different tDCS montages on muscle performance in healthy participants. However, there is no guideline for tDCS montages. This study aims to investigate immediate effects of different tDCS montages on muscle strength in healthy participants.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults
2. Age range between 18 - 60 years old
3. Right-handed dominant identified by the Edinburg Handedness Inventory
4. No recent muscle injuries of both limbs for a past 6-months

Exclusion Criteria:

1. Consumed caffeine within 24 hours prior the experiment
2. History of neurological symptoms i.e. seizures, weakness, loss of sensation or unclear history of pass illness
3. Present of metal implantation, intracranial shunt, cochlear implantation or cardiac pacemakers
4. Present of opened wound or infectious wound around scalp

Primary outcomes:
measure: Change from baseline muscle strength after tDCS
timeFrame: Baseline (Pretest) and 40 minutes ( posttest)
Secondary outcomes:
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Faculty of Physical Therapy, Mahidol University
state: Nakhon Pathom
Study officials:
affiliation: MU
name: Wanalee Klomjai, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05033509: Outcome of ECMO and CRRT.
Official title: Outcome of ECMO and CRRT, Experience of Hospital University MED VI, Oujda, Morocco.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of CRRT With ECMO Therapy
Mortality
and Renal Recovery
Keywords: COVID
AKI
CRRT
Ecmo
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively analyzed data of patients of all ages, genders and ethnicities, admitted in the intensive care unit of Mohammed VI University Hospital, Oujda, Morocco, on a cumulative period of 2 years

Brief summary: Background:

Although acute kidney injury (AKI) is a frequent complication in patients receiving extracorporeal membrane oxygenation (ECMO), and the CRRT impact is widely studied. The incidence of simultaneous use of ECMO and CRRT remain unclear.

Objective: The investigatore conducted this retrospective study to define the incidence of concomitant CRRT with ECMO therapy and to determine the overall impact of this strategy on patient outcomes such as mortality and renal recovery.

Methods:

The investigatore retrospectively analyzed data of patients of all ages, genders and ethnicities, admitted in the intensive care unit of Mohammed VI University Hospital, Oujda, Morocco, on a cumulative period of 2 years (January 2019 - December 2020). Were enrolled in the study patients who benefited from ECMO, and presented an acute kidney injury afterwards, using 'Microsoft Excel' as a software to utilize the information collected from the computerized patient database. 30 patients were included in the final study.


Eligibility criteria: Inclusion Criteria:

* benefited from ECMO .
* presented an acute kidney injury afterwards

Exclusion Criteria:

* patients who developed AKI before benefitting from ECMO and/or missing data

Primary outcomes:
measure: Ecmo and severe AKI requiring CRRT
timeFrame: through study completion, an average of 24 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Berkane
country: Morocco
facility: younes Oujidi
Study officials:
References: